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E Killing the Bugs! Endoscopy Instrument Care and Handling

An Online Continuing Education ActivitySponsored By

Grant Funds Provided By

Welcome to

Killing the Bugs! Endoscopy Instrument Care and Handling

(An Online Continuing Education Activity)CONTINUING EDUCATION INSTRUCTIONS

This educational activity is being offered online and may be completed at any time. Steps for Successful Course CompletionTo earn continuing education credit, the participant must complete the following

steps:1. Read the overview and objectives to ensure consistency with your own learning

needs and objectives. At the end of the activity, you will be assessed on the attainment of each objective.

2. Review the content of the activity, paying particular attention to those areas that reflect the objectives.

3. Complete the Test Questions. Missed questions will offer the opportunity to re-read the question and answer choices. You may also revisit relevant content.

4. For additional information on an issue or topic, consult the references.5. To receive credit for this activity complete the evaluation and registration form. 6. A certificate of completion will be available for you to print at the conclusion.

Pfiedler Enterprises will maintain a record of your continuing education credits and provide verification, if necessary, for 7 years. Requests for certificates must be submitted in writing by the learner.

If you have any questions, please call: 720-748-6144.

CONTACT INFORMATION:

© 2014All rights reserved

Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014www.pfiedlerenterprises.com

Phone: 720-748-6144 Fax: 720-748-6196

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OvERvIEWAdvancements in endoscopic surgery techniques and the related instrumentation continue to provide enhanced surgical treatment options for many patients. However, the increasing intricacy and complexity of this equipment often present challenges to personnel who are responsible for its proper care, cleaning and sterilization, in order to reduce the risk of cross-contamination. This is especially true today, in the face of newly recognized and antibiotic-resistant pathogens, public awareness about infections resulting from ineffective endoscope reprocessing, and the current economic pressures to reduce health care-associated infections. Therefore, perioperative staff members must be knowledgeable about proper care, cleaning and processing of endoscopes and endoscopic instruments to effectively kill the bugs and ultimately promote positive patient outcomes. This online continuing education activity will provide a brief review of the history and evolution of the use of endoscopes and endoscopic instrumentation for diagnosis and treatment. The various types of endoscopes, including their advantages and disadvantages based on use, will be discussed. Proper processes for cleaning, disinfecting and sterilizing/high-level disinfecting endoscopic equipment will be presented. The risks associated with improper reprocessing of endoscopes, including the impact of recent infections and surgical site infections today, as well as effective methods for mitigating these risks will be discussed. Finally, current recommended practices and guidelines for proper care and handling of endoscopic instruments will be outlined.

LEARNER OBjECTIvESUpon completion of this online educational activity, the learner should be able to:

1. Trace the history and evolution of the use of endoscopic instruments used for diagnosis and treatment.

2. Describe the types of endoscopes as well as the advantages and disadvantages based on use.

3. Discuss the process for cleaning, disinfecting and sterilizing endoscopic instruments.

4. Identify the risks and methods for mitigating these risks based on the type of endoscope and the cleaning process.

5. Review recommended practices and guidelines for care and handling of endoscopic instruments.

INTENDED AUDIENCEThis online continuing education activity is intended for use by perioperative registered nurses, certified surgical technologists, central processing personnel, and other health care professionals who are interested in learning more about the proper care, cleaning and reprocessing of endoscopes and endoscopic instruments.

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CREDIT/CREDIT INFORMATIONState Board Approval for NursesPfiedler Enterprises is a provider approved by the California Board of Registered Nursing, Provider Number CEP14944, for 2.0 contact hour(s).

Obtaining full credit for this offering depends upon completion, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes.

The certificate of course completion issued at the conclusion of this course must be retained in the participant’s records for at least four (4) years as proof of attendance.

IACET Credit for Allied Health ProfessionalsPfiedler Enterprises has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102; (703) 506-3275.

CEU STATEMENTAs an IACET Authorized Provider, Pfiedler Enterprises offers CEUs for its programs that qualify under ANSI/ IACET Standard. Pfiedler Enterprises is authorized by IACET to offer 0.2 CEUs (2.0 contact hours) for this program.

AST Credit for Surgical TechnologistsThis continuing education activity is approved for 6.0 CE credits by the Association of Surgical Technologists, Inc. for continuing education for the Certified Surgical Technologist and Certified Surgical First Assistant. This recognition does not imply that AST approves or endorses and product or products that are discussed or mentioned in enduring material.

RELEASE AND EXPIRATION DATEThis continuing education activity was planned and provided in accordance with accreditation criteria. This material was originally produced in August 2013 and can no longer be used after August 2015 without being updated; therefore, this continuing education activity expires in August 2015.

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DISCLAIMERAccredited status as a provider refers only to continuing nursing education activities and does not imply endorsement of any products.

SUPPORTGrant funds for the development of this activity were provided by Stryker Endoscopy.

AUTHORS/PLANNING COMMITTEE/REvIEWERjulia A. Kneedler, RN, MS, EdD Aurora, COProgram Manager/ReviewerPfiedler Enterprises

Rose Moss, RN, MN, CNOR Elizabeth, CONurse Consultant/Author

Judith I. Pfister, RN, BSN, MBA Aurora, COProgram Manager/PlannerPfiedler Enterprises

Chad Edmonson, CST Lone Tree, COCertified Surgical TechnologistSky Ridge Medical Center

DISCLOSURE OF RELATIONSHIPS WITH COMMERCIAL ENTITIES FOR THOSE IN A POSITION TO CONTROL CONTENT FOR THIS ACTIvITYPfiedler Enterprises has a policy in place for identifying and resolving conflicts of interest for individuals who control content for an educational activity. Information listed below is provided to the learner, so that a determination can be made if identified external interests or influences pose a potential bias of content, recommendations or conclusions. The intent is full disclosure of those in a position to control content, with a goal of objectivity, balance and scientific rigor in the activity.

Disclosure includes relevant financial relationships with commercial interests related to the subject matter that may be presented in this educational activity. “Relevant financial relationships” are those in any amount, occurring within the past 12 months that create a conflict of interest. A “commercial interest” is any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

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Activity Planning Committee/Authors/Reviewers: julia A. Kneedler, RN, MS, EdD Co-owner of company that receives grant funds from commercial entities.

Rose Moss, RN, MN, CNOR No conflict of interest

Judith I. Pfister, RN, BSN, MBA Co-owner of company that receives grant funds from commercial entities.

Chad Edmonson, CST No conflict of interest.

PRIvACY AND CONFIDENTIALITY POLICYPfiedler Enterprises is committed to protecting your privacy and following industry best practices and regulations regarding continuing education. The information we collect is never shared for commercial purposes with any other organization. Our privacy and confidentiality policy is covered at our website, www.pfiedlerenterprises.com, and is effective on March 27, 2008.

To directly access more information on our Privacy and Confidentiality Policy, type the following URL address into your browser: http://www.pfiedlerenterprises.com/privacy-policy

In addition to this privacy statement, this Website is compliant with the guidelines for internet-based continuing education programs.

The privacy policy of this website is strictly enforced.

CONTACT INFORMATIONIf site users have any questions or suggestions regarding our privacy policy, please contact us at:

Phone: 720-748-6144Email: [email protected] Address: 2101 S. Blackhawk Street, Suite 220 Aurora, Colorado 80014

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INTRODUCTIONIn all perioperative practice settings, preventing infections for every surgical patient is an expected outcome of care.1 Despite advances that have been made in various infection control measures, such as improvements in operating room (OR) ventilation, sterilization modalities, surgical technique and the availability of antimicrobial prophylaxis,2 surgical site infections (SSIs) remain common health care-associated infections (HAIs), representing one of the leading causes of postoperative morbidity and mortality, and are also associated with significant additional costs for hospitals and health care systems.3

As both rigid and flexible endoscopes and their related instrumentation continue to evolve and become more intricate in their design, nurses, technologists, and other personnel should know and understand the proper care, cleaning, handling, and reprocessing recommendations for all endoscopes and accessories in order to reduce risk for SSIs. This is especially true today, as recent incidences of infection related to suboptimal infection prevention practices during endoscopy or lapses in endoscope reprocessing have been well publicized.4 Today, newly recognized pathogens, well-known microorganisms that have become resistant to current therapeutic modalities,5 and pressure from federal and other economic initiatives to reduce HAIs, and the additional costs of care reinforce the need to adhere to proper reprocessing techniques for endoscopic equipment.

HISTORY OF ENDOSCOPIC INSTRUMENTSSince their inception, the ongoing development of endoscopic techniques and related instrumentation has provided exciting new treatment options across multiple surgical specialties. In order to appreciate the technological advancements in endoscopic instrumentation, it is helpful to review the evolution of endoscopic surgical techniques and the improvements in instrument design and various surgical applications.

Endoscopy, defined as the examination of body cavities or organs with the use of an endoscope, has been used for several centuries.6 While primitive, the first use of reflected light for inspection of the vagina and uterine cervix is attributed to Arabian physician, Abul Kasim (936-1013). After this initial success, instrumentation to examine nasal sinuses and urinary bladders was developed. During this initial era of endoscopy, the primary concern was thermal tissue damage caused by the intense heat emitted by the light sources used. Eventually, incandescent lighting was incorporated into the tips of certain endoscopes (eg, cystoscopes and ureteroscopes) that could be cooled by continuous irrigation. Further modifications allowed endoscopic examination of the nasal sinuses, larynx, bronchus, and sigmoid colon; however, procedures were restricted to endoscope placement in external body orifices.

In 1806, the first endoscopic device used in medical practice to illuminate body cavities was developed in Germany by Philipp Bozzini.7 The instrument – called the Lichtleiter, which means light conductor – consisted of a candle attached to a thin cannula that permitted illumination of body orifices or viscera. This device had no magnification or

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optics and was inserted into the rectum, urethra or vagina, while the physician looked through the device. At the time, other physicians did not readily accept the device because the visibility was poor and placing the device into body orifices was painful for the patient.

During the 1800s, several advances improved the efficacy of endoscopy.8 In 1853, a French surgeon, Antonin Jean Desormeaux, was the first to introduce the use of a lens to focus a direct light source, which provided a clearer image in comparison to Bozzini’s device. This enabled the endoscope to be used to visualize structures or remove foreign bodies. In 1868, Bevan performed the first esophagoscopy procedure. In 1870, J.A. Kussmaul performed the first esophagogastroscopy in a patient who was a professional sword swallower.

The next major advance in the evolution of endoscopy was the introduction of the cystoscope, which had both an illumination source and a working channel.9 This device was developed by Maximilian Nitze, a urologist from Berlin, who worked with Louis Beneche, an optician also from Berlin, and Joseph Leiter, an instrument manufacturer from Vienna. This device consisted of a working channel, a light source, and an optical lens through which light was reflected. By 1887, the cystoscope was improved by adding a small light bulb at the distal end, thereby improving visualization.

In the early 1900s, the endoscope was being used for diagnostic and therapeutic purposes in the pelvis, abdominal cavity, and later, the thorax.10 George Kelling developed these techniques and performed the first laparoscopic surgery in dogs in 1902; later, he refined these techniques and published his report on laparoscopic surgery in humans 14 years later.

In 1910, Hans Christian Jacobaeus, a Swedish physician, was the first to report using a cystoscope to examine the peritoneal cavity; however, he was able to only diagnose conditions since the ability to create pneumoperitoneum had yet to be developed.11 Several complications, including injuries to bowel and vascular structures, were associated with these initial efforts in performing laparoscopy. In an attempt to reduce the associated morbidity, gynecologists introduced the cul-de-sac approach to pelvic endoscopy. It was during this era that the importance of introducing air into the abdomen was realized. Air was introduced with the use of a needle and syringe; the knee-chest and Trendelenburg positions were used to facilitate this procedure. The German gynecologist Kurt Semm developed an automatic insufflation device in 1964.

During this time, laparoscopy was still considered to be blind and therefore did not gain popularity in North America or Europe.12 However, during the 1960s, the two following developments advanced the laparoscopic revolution:

• The rod-lens system, designed by British optical physicist Harold Hopkins in 1966, that improved brightness and clarity; and

• Fiberoptic (ie, cold) light sources that further reduced the risk of bowel and visceral burns.

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From the late 1970s to early 1980s, endoscopy moved from diagnostic to operative applications.13 Semm’s pioneering work, which he termed “pelviscopy”, led to several technological advancements in instrumentation, equipment, and practice. As a result, both diagnostic and operative endoscopies were becoming the techniques of choice for gynecologists worldwide. In addition, rigid and flexible endoscopic procedures were increasingly performed by urologists, internists, and otorhinolaryngologists. In the 1970s, arthroscopy was being developed by orthopaedic surgeons.

In the late 1980s, the laparoscopy revolution began in the United States as general surgeons developed and refined techniques to perform procedures with the use of a laparoscope, thereby eliminating the need for a large incision.14 As surgeons and perioperative personnel accessed evolving information about these techniques, the surgical industry worked to accommodate the rapid transition from open surgical procedures to the newer, minimally invasive approach. Since the 1990s, equipment, instrumentation, and both surgical skills and knowledge have expanded significantly as minimally invasive surgery has become a safe approach for many procedures across multiple surgical specialties.

There are several benefits of endoscopic surgical techniques, including smaller incisions and less trauma, reduced postoperative discomfort, and shortened recovery times, all of which contribute to a shorter inpatient stay and reduced perioperative morbidity.15 The advantages of endoscopic surgery techniques over open procedures are summarized in Table 1.

Table 1 – Advantages of Endoscopic Surgery over Open Surgery16

Endoscopic Surgery Open Surgery

• Ambulatory or short hospital stay • Hospital admission

• Short postoperative recuperation period • 4 to 6 week recuperation period

• Decreased postoperative pain; reduced need for pain medications

• Postoperative pain related to the surgical site; analgesics required

• Earlier return to normal lifestyle • Return to normal lifestyle varies with recuperation period

An important advantage of endoscopic surgery is that it has been shown to reduce the rate of SSIs, in comparison to open surgery. An early retrospective analysis of 11,662 admissions from 22 hospitals with an HAI monitoring system conducted by Brill, et al, demonstrated that, in comparison to open surgery, laparoscopic cholecystectomy and hysterectomy were associated with statistically significant lower risks for HAIs.17 In a prospective study of SSI on 1,011 patients who had elective colorectal resection, Poon, et al, found that the laparoscopic approach was associated with a reduction in the SSI rate by more than 50% when compared with open surgery; therefore, this

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approach would have a strong impact on the prevention of surgical infection.18 Kiran, et al, also found that the laparoscopic approach for colorectal surgery was independently associated with a reduced risk for SSI when compared with open surgery and should, when feasible, be considered for colon and rectal conditions.19 A retrospective analysis conducted by Varela, et al, found that in academic medical centers in the United States, laparoscopy significantly reduces SSIs, as patients treated with laparoscopic appendectomy, cholecystectomy, anti-reflux surgery, or gastric bypass are less likely to experience SSIs compared to open procedures; furthermore, after stratification by severity of illness, admission status, and wound classification, laparoscopic techniques demonstrated a protective effect against SSI.20

Today, while conventional laparoscopy is the most widely adopted minimally invasive surgical technique due to its relatively low costs, robotics and single port surgery continue the evolution of endoscopic surgery.21

DEFINITION OF ENDOSCOPES AND LAPAROSCOPIC INSTRUMENTSThere are various types of both rigid and flexible endoscopes available today for multiple surgical applications. The types of endoscopes and related instrumentation are described in greater detail below, including their surgical applications, advantages, disadvantages, and potential complications.

LaparoscopesTechnological advancements in laparoscope design and development continue to result in innovative laparoscopes and related instrumentation.

• Standard Laparoscopes (see Figure 1). Standard 5 mm and 10 mm laparoscopes, in 30 cm and 45 cm lengths, are available with sapphires and the latest rod lens technology for improved light transmission and detail recognition, plus enhanced optics for better color rendering, center to edge resolution, depth of focus, and reduced image distortion for a better image quality.

Figure 1 – Standard Laparoscope

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Laparoscopes are used in several surgical specialties, including, but not limited to: ◦ General surgery. Laparoscopic surgery on the gastrointestinal (GI) tract

requires laparoscopic instruments intended for abdominal surgery.22 Laparoscopic procedures include Nissen fundoplication, appendectomy, colectomy, and cholecystectomy.

◦ Gynecology. Endoscopic evaluation of the peritoneal cavity is used to investigate and diagnose causes of abdominal pain, pelvic pain and infertility; it is also used to evaluate pelvic masses.23 Ancillary procedures, including aspiration of cysts, tissue and ovarian biopsies, aspiration of peritoneal fluid for cytologic studies, ovarian cystectomy, oophorectomy, removal of ectopic pregnancy, tuboplasty, and tubal sterilization. Laparoscopy may also be used for oocyte retrieval in in-vitro fertilization procedures; electrosurgery and lasers can also be used during laparoscopy.

• Articulating Laparoscopes (see Figure 2). Articulating laparoscopes provide surgeons with improved utility, comfort, and precision. Typically, an angled handle and friction-assist control levers allow the surgeon to place and fix the articulating tip with greater precision, which helps to control image selection and improve horizon maintenance. Some systems offer a combined light-source/video cable that reduces cable clutter during the case.

Figure 2 – Articulating Laparoscope

Flexibility with articulating laparoscopes may be further enhanced by:

◦ Various diameters, eg, 5 mm and 10 mm; ◦ Various lengths of working channels, eg, 330 mm in a standard scope; 430 mm

in a bariatric scope; ◦ 15 degree handle bend for proper horizon orientation; ◦ High resolution;

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◦ Elimination of the light cord/post connection to decrease clutter in the working space;

◦ No locking lever to complicate the device; and ◦ Capability to toggle between rigid and flexible tip camera images, which provides

a seamlessly integrated and versatile platform, thereby improving OR efficiency.

Articulating laparoscopes are useful in laparoscopic sigmoid colectomy and

laparoscopic Nissen fundoplication with mini-laparotomy procedures.

• Bariatric Laparoscopes (see Figure 3). Bariatric laparoscopes, both 5 mm and 10 mm, are generally available in a 45 cm length. Bariatric laparoscopes should be durable and reliable, and ideally provide off-setting of instrumentation during single port surgery.

Figure 3 – Bariatric Laparoscope

Bariatric laparoscopes are used for mini-lap gastric bypass procedures and single

port lap band surgeries.

• Pediatric Laparoscopes (see Figure 4). Pediatric length laparoscopes (eg, 2.9 mm/20 cm working length) are designed to accommodate small anatomical structures while combining high definition imaging with optimal contrast resolution. These scopes are used for pediatric single-incision laparoscopic cholecystectomy and pediatric laparoscopic hernia repair without mesh.

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Figure 4 – Pediatric Laparoscope

Laparoscopic instrumentation includes, but is not limited to:

◦ Multifunction handle (see Figure 5).

Figure 5 – Multifunction Handle

◦ Scissors, eg, curved Metzenbaum, peritoneal, and hook (see Figure 6).

Figure 6 – Curved Metzenbaum (left), Peritoneal (center), and Hook (right) Laparoscopic Scissors

◦ Dissectors, eg, needle nose, tapered bullet, and Maryland dissectors

(see Figure 7).

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Figure 7 – Needle Nose (left), Tapered Bullet (center), and Maryland (right) Laparoscopic Dissectors

◦ Graspers, eg, alligator, blunt and double action atraumatic (see Figure 8).

Figure 8 – Alligator (left), Blunt (center), and Double Action Atraumatic (right) Laparoscopic Graspers

◦ Biopsy forceps and punches (see Figure 9).

Figure 9 – Laparoscopic Biopsy Forceps (left) and Biopsy Punches (right)

◦ Needle holders (see Figure 10).

Figure 10 – Laparoscopic Straight Needle Holder

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◦ Monopolar electrosurgery probes (see Figure 11).

Figure 11 – Monopolar Electrosurgery Probes: Spatula Tip (left) and L-Tip (right)

• Advantages.24 Laparoscopic surgery provides distinct benefits for patients, as well

as surgeons. As noted above, benefits to the patient include minimal blood loss, reduced risk for infection, less immune suppression than with open techniques, reduced postoperative pain and use of analgesics, adjunct to preoperative staging, and application of chemotherapy and brachytherapy. Advantages for the surgical team include:

◦ Enhanced imaging resolution, ◦ Abundant light, ◦ Magnification, ◦ All members of the surgical team can see the same image, and ◦ Image/video recording option.

• Disadvantages and Potential Complications.25 Laparoscopic surgical techniques are also associated with disadvantages and potential complications. The fundamental concept of laparoscopic surgery is traditional laparoscopic port placement via triangulation; this technique places the instruments on planes where they meet to support dissection with adequate visualization and identification of anatomy and pathology. However, incorrectly placed ports can result in “sword-fighting” instruments and indirect access to the intended target. Delivering intact specimens through small ports may also be challenging.

For the patient, the increased intra-abdominal pressure from the insufflation of carbon dioxide (CO2) to create pneumoperitoneum applies pressure on the diaphragm and femoral vessels; this can compromise patients with existing cardiac or respiratory disease and lead to the development of deep vein thrombosis. Other potential complications include trocar site bleeding, vascular injury, hemorrhage, laceration or perforation of internal organs, infection, anastomotic leaks, inadvertent electrosurgical injury (eg, alternate site burns), and pulmonary problems.

For surgeons, there is a considerable learning curve to achieve competence; other potential disadvantages are:

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◦ This approach is ergonomically challenging, ◦ The fulcrum effect, ie, the instruments move in the opposite direction, ◦ The loss of haptic sensation and tactile feedback, ◦ Critical moves with the non-dominant hand are necessary, and ◦ The surgeon sees two-dimensionally, but must perceive three-dimensionally.

Gynecology Resectoscopes and Hysteroscopes• Resectoscopes. For complex gynecologic procedures, rigid resectoscopes (see

Figure 12) are designed for clarity as well as comfort during minimally invasive procedures. Other advantages include:

◦ Smooth actuation and electrode designs that facilitate resection and provide rotational stability,

◦ Ergonomic, light-weight design for optimal control during resection procedures, ie, tissues can be cut and coagulated through various electrodes, and

◦ Connections that make instrument integration quick and secure, which allow the staff to smoothly and safely exchange instruments during a procedure.

Figure 12 – Rigid Resectoscope

Grasper, punches, scissors, and various electrodes are available for use with rigid resectoscopes. Gynecologic resectoscopes are used for laparoscopic oophorectomy, laparoscopic-assisted supracervical hysterectomy, and tubal ligation.

• Hysteroscopes. Hysteroscopy is the endoscopic visualization of the uterine cavities and tubal orifices.26 Common indications for hysteroscopy include evaluation of abnormal uterine bleeding (with possible endometrial ablation), location and retrieval of lost intrauterine devices, evaluation of infertility, diagnosis and treatment of intrauterine adhesions, verification of endometrial polyps, and tubal sterilization. Laparoscopy may be done in conjunction with hysteroscopy to assess the external contour of the uterus.

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Today, both rigid and flexible (video and fiberoptic) hysteroscopes are available (see Figure 13).

Figure 13 – Hysteroscopes: Rigid (left) and Flexible (right)

Advantages of rigid hysteroscopes include exceptional flow rates, fully rotatable stopcocks, large working channels, and connections that are intuitive and simple to ensure quick assembly of all components. Flexible hysteroscopes are also available with a single-use sterile sheath so that the scope itself does not come into contact with the patient (see Figure 14). In addition, the sheath eliminates the need to run high-level disinfection (HLD) processes between procedures, thereby reducing costs, turnover times, and the need for backup scopes. Flexible hysteroscopes also have other advantages, including:

◦ Angulation design for both standard and intuitive tip deflection, ◦ Complete viewing of the anatomy through increased deflection, and ◦ Control over procedural infusion or suction.

Figure 14 – Hysteroscope Sheath Tip

A significant disadvantage related to hysteroscopy is the potential for intravasation of the fluid used to distend the uterine cavity, which can lead to

http://www.stryker.com/en-us/products/Endoscopy/Gynecology/Hysteroscopes/FlexibleHysteroscopes/index.htm

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hyponatremia.27 The perioperative nurse is responsible for accurately monitoring fluid intake and output during hysteroscopy; the surgeon and anesthesia provider must be notified of discrepancies of 500 mL or more.

ArthroscopesPrecise visualization is a critical factor in the success of any arthroscopic procedure. Therefore, scopes used in arthroscopy should incorporate the latest rod lens technology to provide high-definition images with uniform brightness through enhanced light distribution and transmission. Examples of arthroscopes available today include 4 mm, C-mount and small-joint scopes (see Figure 15). Scopes should be made from stainless steel with laser-welded joints, soldered windows, and reinforced tubing. In addition, scopes with recessed cover glass made from sapphires provide high scratch resistance.

Figure 15 – C-Mount (left) and Small-Joint (right) Arthroscopes

Arthroscopy is commonly performed on the knee, shoulder, and wrist and less often on the elbow, hip, and ankle.28 Improvements in scope and camera systems, sharper scope optics, and miniaturization have made operative arthroscopy the logical extension of diagnostic arthroscopy; therefore, many therapeutic procedures that previously required an arthrotomy or other open procedure are now performed with the use of an arthroscope. In addition, surgical arthroscopy has been advanced by the development of various second puncture instruments and devices to excise and repair defects; motorized shaving and abrader systems; irrigation systems that provide regulated distention of a joint; integrated video systems; and the ability to use lasers and electrosurgery in tandem with arthroscopic equipment.

Examples of manual arthroscopic instrumentation include, but are not limited to:

• Punches, typically available in various configurations and with teeth to smoothly pull tissue into the jaws for precise resection (see Figure 16).

Figure 16 – Arthroscopic Straight Punch

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• Scissors with a smooth nose for safe entry and a reduced risk of tissue damage (see Figure 17).

Figure 17 – Arthroscopic Scissors

• Graspers designed to access any area of a joint to securely grasp tissue and

loose bodies (see Figure 18).

Figure 18 – Arthroscopic Graspers

• Advantages.29 The development and progress in arthroscopes and related instrumentation have changed the approach, diagnosis, and treatment of many joint problems. While these techniques require skill and expertise in identifying three-dimensional relationships, their advantages, as listed below, exceed the disadvantages:

◦ Easier, more rapid surgical procedures; ◦ Smaller incisions; ◦ Reduced inflammatory response; ◦ Decreased recovery and rehabilitation time; ◦ Reduced postoperative pain, scar, and extensor disruption; ◦ Fewer complications; and ◦ Shorter hospital stay and reduced costs.

• Disadvantages and Potential Complications.30 The disadvantages associated with arthroscopy generally relate to the size and delicacy of the instrumentation. In addition, maneuverability within a joint may be difficult and result in scuffing and scoring of the articular surfaces.

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CystoscopesDirect observation of the entire urinary tract is possible through the use of advanced endoscopic techniques; cystoscopes permit visualization of the bladder, while ureteroscopes allow visualization of the upper urinary tract. 31 In addition, biopsy, resection of suspicious lesions, and stone extraction and transurethral resection of the prostate gland can also be performed endoscopically. Potential disadvantages and complications of cystoscopy include gross hematuria and possible symptoms of urgency, frequency, and burning on urination.

Today, rigid and flexible cystoscopes, as well as semi-rigid ureteroscopes are available.

• Rigid Cystoscopes (see Figure 19). Cystoscopes are composed of a light source, a working sheath, an obturator, and set of optical lenses (eg, 0, 30, 70, and 120 degrees).32 Bridges and deflector mechanisms permit the introduction and passage of ureteral stents; these components also allow electrosurgical devices (eg, Bugbee electrode), electrohydraulic lithotrite electrodes, laser fibers, and cold cup biopsy forceps to be introduced. Cystoscopy is indicated for patients with hematuria (gross or microscopic), voiding dysfunction, recurrent infections, stone disease, and fistulas.

Figure 19 – Rigid Cystoscope

In addition to sheaths and obturators, various rigid and flexible biopsy cups,

grasping forceps, cutting biopsy forceps, crushing forceps, and scissors are available with rigid cystoscope systems.

◦ Advantages of rigid cystoscopes include: ▪ Stainless steel construction, ▪ Shaft insulation to ensure longer instrument life, patient safety, and reduced instrument maintenance costs, ▪ 360 degree shaft rotation for one-finger control of the instrument and variable resistance, based on pressure, ▪ Handle designs that allow for greater dexterity, and ▪ Large finger rings to prevent finger fatigue.

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• Flexible Cystoscopes. Flexible cystoscopes are used for patients who are unable to be placed in the lithotomy position (eg, those with spinal cord injuries or severe arthritis) or cannot tolerate rigid endoscopy and those with obstructive symptoms resulting from prostatic hyperplasia and rigid prostatic urethra.33,34

• Today, both video and fiberoptic cystoscopes (see Figure 20) are available. In addition, advancements in technology have resulted in the development of a single-use sterile sheath, as previously described, which protects patients from cross-contamination since the cystoscope does not come into contact with the patient. This technology provides a durable, protective barrier between the patient and the scope, plus a disposable working channel; it also promotes patient and staff safety, since it reduces the risks associated with exposure to toxic disinfectants, which may be hazardous to some patients as well as staff members. In addition, by decreasing the scope’s exposure to potentially harmful cleaning agents, the sheath may prolong the scope’s lifespan by eliminating channel-based repairs, clogged suction line repairs, and reprocessing damage, thereby lowering capital and repair costs.

Figure 20 – Flexible Cystoscopes: Video (left) and Fiberoptic (right)

Other advantages of flexible cystoscopes include:

◦ Capabilities for both full diagnostic and therapeutic uses, ◦ Angulation design, with standard and intuitive tip deflection, ◦ Complete viewing of anatomy via increased deflection, and ◦ One-touch control of procedural infusion or suction, eliminating the need for

external units.

• Semi-rigid Ureteroscopes. Semi-rigid endoscopes allow movement through a deflectable tip to provide a complete field of view from various angles.35 In urology, navigating tortuous ureters requires the smallest and least trauma-inducing scopes; semi-rigid ureteroscopes (see Figure 21) are useful in helping surgeons assess and perform these types of procedures. Flexible biopsy cups and grasping forceps are available for these endoscope systems.

http://www.stryker.com/en-us/products/Endoscopy/Urology/Cystoscopes/FlexibleCystoscopes/FlexibleVideoCystoscope/index.htm

http://www.stryker.com/en-us/products/Endoscopy/Urology/Cystoscopes/FlexibleCystoscopes/FlexibleFiberopticCystoscope/index.htm

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Figure 21 – Semi-Rigid Ureteroscope

The indications for ureteroscopy are outlined in Table 2.

Table 2 – Indications for Ureteroscopy36

Indication ProcedureEvaluation and Treatment of Urothelial Tumors

• Direct visualization• Biopsy• Selective cytological evaluation• Resection• Laser photocoagulation• Follow up

Evaluation and Treatment of Ureteral Obstructions

• Examination and localization of stones and/or ureteral strictures

• Ureteral dilation• Stone retrieval and/or disintegration• Internal ureterotomy• Stent placement

Evaluation and Treatment of Upper Urinary Tract Bleeding

• Localization of bleeding sites• Diagnosis• Treatment

◦ Advantages of semi-rigid ureterorscopes include: ▪ High density, fused quartz bundles to provide rod lens-like, high resolution image; ▪ Increased light fiber distribution for a brighter image; ▪ A small, slim tip that facilitates insertion into the ureteral orifice; ▪ A one-piece tapered conical shaft for gradual, atraumatic ureteral dilation; and ▪ A dual working channel – one channel can be dedicated for fluid distention and the other for instrument and/or laser introduction; this allows for an uninterrupted flow and the ability to clear the field of view.

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◦ Disadvantages of ureteroscopy include the associated potential complications, such as ureteral disruption and perforation, urinary extravasation, bleeding, instrument breakage, and infection.37 The primary long-term disadvantage of ureteroscopy is the potential for development of ureteral strictures.

PROCESS FOR CLEANING AND STERILIzATION/DISINFECTION OF ENDOSCOPES AND ENDOSCOPIC INSTRUMENTATIONThere are certain risks associated with the use of improperly cleaned and processed endoscopes and instrumentation. Therefore, this delicate and complex equipment must be properly cleaned in order to promote positive patient outcomes. The United States Food and Drug Administration requires that any device purchased as reusable must have written instructions for reprocessing.38 The manufacturer’s written, validated instructions for handling, cleaning, and reprocessing instruments and equipment should always be followed; this is especially important for endoscopes and delicate instruments.39 The general steps for proper cleaning, handling, and disinfecting/sterilizing of endoscopes and related instrumentation are outline below.

Precleaning40

Both endoscopes and related instrumentation must be clean and free of all bioburden before they are subjected to a sterilization or HLD process. Bioburden accumulates in the channels, ports, crevices, and other movable parts of scopes and instruments during routine use. Therefore, gross blood and bioburden should be removed periodically during a case by flushing the channels and wiping the surfaces with sterile water. By keeping endoscopes and instruments relatively clean during a procedure, debris is not permitted to dry; this facilitates the cleaning process and protects the device. It is important to note that saline should never be used to routinely remove bioburden and other gross debris during a procedure since this salt solution can leave mineral deposits on or in the equipment.

Transportation to Central Processing Area41

At the conclusion of the procedure, all instruments and equipment must be contained in a manner that prevents exposure of patients or personnel to blood or other potentially infectious materials; containment devices include closed plastic bags, containers with lids, and transport carts with doors or a plastic cover. All soiled instruments and equipment should be transported to the designated decontamination area in a timely manner. Transporting instruments that are soaking should be avoided because of the potential for a liquid spill, the associated clean up problems, and the difficulty of safe disposal of the contaminated liquid, unless a disposable unit is available.

Cleaning and Inspection42,43

After use, all endoscopes, instruments, and other equipment must be thoroughly decontaminated. Personnel in the decontamination area must wear appropriate personal protective equipment (PPE), eg, scrub attire, a plastic apron or jump suit, hair covering, safety glasses or a face shield, and rubber or plastic gloves.

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Immersible equipment is cleaned or flushed with an enzymatic or other cleaning solution recommended by the manufacturer; this loosens organic material and makes it easier to remove. For endoscopes and related instrumentation, use of the appropriate cleaning agent is vital. Detergents consist of various formulations which may include pH builders, buffers, and surfactants that result in the chemical composition that cleans the devices. The amount of cleaning power is determined by the pH of the formulation. For example, a detergent with a very low pH can cause staining and pitting on the surfaces of stainless steel instruments because they are more susceptible to damage due to prolonged exposure to acidic solutions. Combining detergents with the mechanical or automatic force of a cleaning spray facilitates the removal of bioburden. A low sudsing detergent is recommended so that the detergent can be completely removed. Cleaning agents with surfactant are less desirable because they are more difficult to rinse off. If surfactant remains on the surface, the instrument or scope may feel gummy or sticky, which could affect its electrical conductivity. Both the detergent and type of device being cleaned must be considered; certain detergents are not appropriate for cleaning both endoscopes and endoscopic instruments.

Following the cleaning process, the items must be carefully rinsed and flushed with copious amounts of water. Deionized or demineralized water is often recommended for the final rinse to minimize mineral buildup from tap water. Again, the manufacturer’s written instructions for cleaning and processing should always be followed. After the final rinse, the instruments and equipment must be dried.

An automatic cleaning device that flushes the ports of endoscopic instruments is an effective and economical method for cleaning reusable channeled instruments and equipment. While these instruments have flush ports, debris can become lodged distally. Some automatic cleaning systems have a mechanism to flush in a retrograde fashion, thereby forcing debris from the larger proximal port. The use of this type of system can also test sealed instruments for seal integrity.

After endoscopes and instrumentation have been thoroughly cleaned, rinsed, and dried, they should be inspected for cleanliness, integrity, and functionality prior to assembly of the tray, packaging, or disinfection or sterilization. Personnel involved in reprocessing endoscopic equipment must be aware of instrument composition, design, and use; personnel must understand how an instrument works in order to ensure that its functionality has not changed during reprocessing. For example, any device with electrosurgical capabilities must be inspected and checked to ensure that the integrity of the insulation sheath has not been compromised. Other parameters that should be verified include:

• Alignment; • Evidence of corrosion, pitting, burs, nicks, wear, cracks, or chipped inserts;• Sharpness of cutting edges;• Any missing parts; and• Removal of moisture.

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Cleaning Flexible Endoscopes44

Flexible endoscopes should be cleaned according to the manufacturer’s written instructions in regard to the cleaning processes, selection of a cleaning product, selection of disinfectant/sterilization product, use of alcohol, and compatibility with automated endoscope reprocessors (AERs). Failure to follow the manufacturer’s written instructions could result in ineffective cleaning that interferes with sterilization or high-level disinfection, thereby increasing the infection risk for the patient. Flexible endoscopes and accessories should also be precleaned at the point of use, before organic material has dried on the surface or in the channels of the endoscope, prior to transport to the decontamination area. Once in the decontamination area, but before cleaning, leak tests should be performed on flexible endoscopes with this capability. After leak testing but before high-level disinfection using a manual process or an AER, flexible endoscopes and accessories should be manually cleaned before any remaining organic material dries on the surface or in the channels. Immediate cleaning reduces the amount of microbial contamination and the formation of biofilms; if microbial contamination and biofilm are not removed, the surface underneath the bioburden will not be disinfected, as the disinfecting solution will not be able to come into contact with all surfaces.

Packaging After endoscopes and related instrumentation and accessories have been thoroughly cleaned and inspected, they should be organized for packaging in a manner that allows the sterilant to contact all exposed surfaces and provide adequate drying.45

Key considerations for packaging include, but are not limited to, the following46,47: • Manufacturers of packaging systems should be consulted for proper package

preparation, configuration, and sterilization.• Combination paper-plastic peel pouches should not be placed in a container or

wrapped set unless the pouch or container manufacturer has validated this process. • Instruments should be placed in a container tray or basket that is large enough to

evenly distribute the metal mass in a single layer.• Instruments should be contained within the tray or basket in a way that protects

them from damage and prevents puncturing of the sterilization wrap material. Delicate and sharp instruments should be protected with a tip protector or other device.

• Only validated containment devices should be used to organize or segregate instruments within set.

• Suction lumens and other channeled devices should be flushed with distilled, demineralized, or sterile water prior to steam sterilization. Stylets should also be removed from lumens to enable the sterilant to contact the lumens.

• The total weight of the instrument set should not exceed 25 pounds. Instrument sets over this weight are known to be difficult to dry with lengthy drying times; they also increase the risk for ergonomic injury.

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Sterilization/High-Level Disinfection Endoscopes and related instrumentation have specific requirements for proper care and handling because in most endoscope systems, the fiberoptics and lenses are heat sensitive; however, some scopes have been designed to withstand the high temperatures of steam sterilization.48,49 Both the high temperatures and the moisture generated by steam autoclaves can damage the materials used in the scope or lead to deterioration of the sealant, making moisture accessible to the lens. Therefore, alternatives to steam sterilization for endoscopic equipment (eg, ethylene oxide, cold sterilization, high-level disinfection) may be used, but require considerations related to patient care options for consistency.

Endoscopes and endoscopic instruments to be reprocessed are categorized as critical, semicritical, and noncritical, according to the Spaulding classification system, based on the nature of the item, the manner in which it is to be used, and the risk of infection for the patient.50 Named for its developer, Earle Spaulding, this system has withstood the passage of time and continues to be used in practice today to determine the correct processing method for preparing instruments and other items for patient use.51 Each classification is described in greater detail below and in Table 3.52

• Critical Items. Items that enter sterile tissue or the vascular system are considered critical; surgical instruments, needles, implants, and certain types of catheters are examples of critical items. These items should be subjected to a sterilization process and be sterile at the time of use. If a critical item is not purchased from the manufacturer as sterile, it should be steam-autoclaved, if it is heat-stable and moisture-stable. If the item cannot withstand heat or moisture, it may be sterilized by another sterilization method as indicated in the manufacturer’s written instructions.

• Semicritical Items. Items that contact nonintact skin and mucous membranes, but do not generally penetrate the blood barrier are considered semicritical; examples of semicritical items include anesthesia breathing circuits, fiberoptic endoscopes, and laryngoscopes. These items require high-level disinfection, that is, they must be free of microorganisms other than bacterial spores.

• Noncritical Items. Items that come into contact only with intact skin are considered noncritical; blood pressure cuffs, linens, furniture, and floors are examples of noncritical items. Since the skin is an effective barrier to most microorganisms, the majority of noncritical items can be cleaned at the point of use; intermediate-

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level or low-level disinfectants may be used to process noncritical items.Table 3 – The Spaulding Classification System53

Device Classification/Definition

Examples Level of Reprocessing Efficacy

Critical – items that come into contact with sterile body tissues or the blood stream

• Surgical instruments

• Endoscopic accessories that penetrate the mucosal barrier

• Implants• Cardiac

and urinary catheters

• Sterilization, eg, saturated steam, ethylene oxide, low-temperature hydrogen peroxide gas plasma, ozone, dry heat, glutaraldehyde-based formulations, peracetic acid, stabilized hydrogen peroxide 6%

• Chemical sterilants, eg, glutaraldehyde-based formulations, peracetic acid, stabilized hydrogen peroxide 6%, wet pasteurization, sodium hypochlorite

• Sterilization destroys all microbial life, including pathogenic and non-pathogenic microorganisms and spores

Semicritical – items that come into contact with mucous membranes or non-intact skin

• Endoscopes such as bronchoscopes, colonoscopies and similar scopes

• Laryngoscope handles and blades

• Vaginal and rectal probes

• Thermometers

• High-level disinfection – when sterilization is not possible, eg, glutaraldehyde-based formulations, peracetic acid, stabilized hydrogen peroxide 6%, wet pasteurization, sodium hypochlorite

• High-level disinfection destroys all microorganisms, but not necessarily a large number of bacterial spores

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Noncritical – items that come into contact with intact skin and those exposed to blood or other potentially infectious material

• Blood pressure cuffs

• Pneumatic tourniquet cuffs

• Skin probes

• Intermediate-level disinfection with the use of an Environmental Protection Agency-registered hospital disinfectant with label claim for tuberculocidal activity, eg, chlorine-based products, phenolics

• Intermediate-level disinfection destroys viruses, mycobacteria, fungi, and vegetative bacteria, but not bacterial spores

According to the Spaulding classification system, sterility is required for all laparoscopic procedures, since the instruments and devices contact sterile tissues.54 Arthroscopes and their related instrumentation also enter sterile tissue and therefore are examples of critical items, which should be subjected to a sterilization process and be sterile at the time of use.55 Endoscopy of the genitourinary tract is considered a Class II (clean-contaminated) procedure and according to the Centers for Disease Control and Prevention (CDC) and Association for Professionals in Infection Control and Epidemiology (APIC) guidelines; presently this equipment requires high-level disinfection rather than sterilization.56 The use of a high-level disinfecting agent, such as activated glutaraldehyde that can kill vegetative microorganisms, most fungal spores, tubercle bacilli, and small nonlipid viruses is recommended. In most clinical situations, the routine of meticulous cleaning of endoscopic instruments, ensuring that all channels are accessed, followed by appropriate HLD, provides reasonable assurance that the items are safe to use. The level of disinfection is based on the contact time, temperature, and concentration of the active ingredients of the disinfectant and also the nature of the microbial contamination.

Another important point is that invasive procedures that access the vascular system (eg, biopsies) are commonly performed during many endoscopic procedures.57 Because high-level disinfection does not easily destroy viruses (eg, human immunodeficiency virus [HIV], hepatitis B and C viruses), microorganisms (eg, Mycobacterium tuberculosis), and antibiotic-resistant organisms, the adequacy of high-level disinfection must be evaluated for these procedures. Even though high-level disinfection has been the accepted standard of reprocessing for some endoscopic equipment, the concern about microorganisms and viruses has led to a debate about the adequacy of high-level disinfection. As a result, many health care facilities are treating endoscopic interventions as sterile, since sterilization provides the greatest assurance that the risk of cross-contamination transmitted by contaminated instruments has been eliminated; therefore, sterilization is quickly becoming the standard for reprocessing endoscopes and endoscopic instruments.58,59

Facility policy provides the staff guidelines on reprocessing methods; however, insight and coordination are required in order to provide comparable levels of care when there are too few instrument sets for the number of procedures.60 In this regard, if sterile

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instruments are required for a particular procedure, then sterile instruments should be provided for all patients undergoing that procedure. To meet this standard of care, sufficient numbers of scopes, instruments, accessory items, and equipment must be purchased to accommodate case volume or other reprocessing measures must be implemented.

The various methods for sterilization and high-level disinfection of endoscopic equipment are described below.

• Sterilization. When sterile endoscopes and instruments are needed, multiple sterilization modalities are available today.

◦ Steam.61,62 Saturated steam under pressure should be used to sterilize heat- and moisture-stable devices, unless otherwise specified by the device manufacturer. Steam must not be used to sterilize some delicate endoscopes; however, the accessory instrumentation may be able to tolerate the heat produced during steam sterilization.

Immediate use steam sterilization (IUSS), formerly known as flash sterilization, should be kept to a minimum and used only in selected clinical situations in a controlled manner, as its use may be associated with an increased risk of infection to patients. This method should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization; moreover, IUSS should not be used as a substitute for insufficient instrument inventory. Other considerations for IUSS include:

▪ Items to be steam sterilized for immediate use should undergo the same decontamination processes as all instruments to be sterilized; ▪ It should be performed only if the device manufacturer’s written instructions include instructions for IUSS; ▪ The device manufacturer’s written instructions for cleaning, cycle parameters and drying times (if recommended) are available and followed; ▪ The items are placed in a containment device that has been validated for IUSS and cleared by the United States FDA for this purpose and in a manner that allows the steam to contact all instrument surfaces

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and the containment device manufacturer’s written instructions are followed; ▪ Measures are taken to prevent contamination during transfer to the sterile field; and ▪ The items subjected to IUSS are used immediately and not stored for later use or held from one procedure to another.

The minimum cycle times for steam sterilization of instruments and porous items in gravity-displacement and dynamic air-removal steam sterilizers are outlined in Tables 4 and 5, respectively.

Table 4 – Typical Minimum Cycle Times: Gravity-Displacement Steam Sterilization63

Item Exposure Temperature

@ 250°F (121°C)

Exposure Temperature

@ 270°F (132°C)


@ 275°F (135°C)

Drying Time

Packaged instruments

30 minutes 15 minutes 15 to 30 minutes

Nonporous items subject to IUSS

See device and container manufacturer instructions for use


See IUSS container manufacturer instructions for use

Nonporous and porous items in mixed load subject to IUSS




Table 5 – Typical Minimum Cycle Times: Dynamic Air-Removal Steam Sterilization64

Item Exposure Temperature

@ 270°F (132°C)


@ 275°F (135°C)

Drying Time

Packaged instruments

4 minutes 3 minutes 20 to 30 minutes16 minutes

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Nonporous items subject to IUSS




Nonporous and porous items in mixed load subject to IUSS




◦ Ethylene oxide (EO).65,66 Ethylene oxide is a low-temperature sterilization process that has been used for many years to sterilize heat- and moisture- sensitive surgical items, including endoscopes and instrumentation, when indicated by the item’s manufacturer. At sterilizing temperatures, EO destroys microbes in hard to reach areas without damaging the devices.

Ethylene oxide is an alkylating agent that results in microbial death when used under controlled parameters. Ethylene oxide takes the place of hydrogen atoms on molecules (eg, proteins and DNA) that are necessary to sustain life; by attaching to these molecules, EO stops the normal life-supporting functions of these molecules. Under low-temperature sterilizing conditions, so much EO is used that this disruption is lethal to microbial life.

Ethylene oxide should be used if other methods of sterilization are not

available or incompatible with the devices being processed. Health care facilities use 100% concentration of EO or EO mixtures with inert diluent gases (eg, hydrochloroflurocarbons [HCFCs]) for EO sterilization procedures. Because HCFCs deplete the ozone layer, the Environmental Protection Agency will begin regulating HCFCs in 2015; 100% concentrations of EO will continue to be available.

Users of EO sterilization should be aware of and comply with federal, state and local regulations regarding HCFC use in EO sterilizers. All items, including lumens, should be clean and dry before they are packaged for EO sterilization. The sterilizer manufacturer’s written instructions for EO sterilization parameters and placement of items within the sterilizers should be followed.

The limitations of EO sterilization are the prolonged aeration time needed and the installation and personnel monitoring requirements for this modality.

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All items sterilized in EO sterilizers should be properly aerated, according to the device manufacturers’ written instructions, in a mechanical aerator to remove EO before they can be used safely, since EO is a known human carcinogen and has the potential to cause adverse reproductive effects in humans. The permissible limits for exposure to EO established by the Occupational Safety and Health Administration (OSHA) are 1 part per million (ppm) of airborne EO expressed as a time-weighted average for an 8-hour work shift in a 40-hour work week, or 5 ppm for short-term exposure. Personnel who have the potential for exposure should wear EO-monitoring badges that meet the National Institute for Occupational Safety and Health (NIOSH) standards for accuracy. Personnel should also take appropriate safety precautions (eg, wearing butyl rubber, nitrile, or neoprene gloves) when they handle unaerated EO-sterilized items.

◦ Hydrogen peroxide gas plasma.67,68 This modality is also used for moisture- and heat-sensitive items when indicated by the manufacturer. In this process, which uses a combination of hydrogen peroxide vapor and low-temperature hydrogen peroxide gas plasma, hydrogen peroxide (a strong oxidizing agent) destroys microorganisms by the hydroxyl free radical. This highly reactive free radical can attack membrane lipids, DNA, and other vital cell components. The plasma breaks down the hydrogen peroxide into a cloud of highly energized species that recombine, converting the hydrogen into water and oxygen.

This system sterilizes within 50 to 75 minutes and dissociates into nontoxic residuals and by-products, eg, oxygen and water in the form of humidity; therefore, the items processed do not require aeration. The items are dry at the completion of the cycle. Hydrogen peroxide is an eye, mucous membrane, and skin irritant; it is considered to be nonmutagenic and noncarcinogenic. It is important for users to understand the limitations (eg, lumen restrictions) of a gas plasma system in order to determine if it would meet the facility’s needs for endoscope or instrumentation sterilization. In general, hydrogen peroxide gas plasma is not used to sterilize flexible endoscopes.

◦ Ozone.69,70 Ozone sterilization is also indicated for moisture- and heat-sensitive items, when indicated by the manufacturer. Ozone has been cleared by the United States FDA for use in sterilizing metal and plastic instruments, including some instruments with lumens. It is a powerful sterilizing agent since it oxidizes organic matter (eg, viruses, bacterial spores, and fungi); in addition to being low-temperature, ozone is easy to use, cost-effective, and compatible with anodized aluminum containers. With this modality, oxygen is used in a natural process to produce ozone, ie, when oxygen is exposed to an intense electrical field, the molecule separates into atomic oxygen, which then combines with other oxygen

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molecules to create triatomic oxygen, which is ozone. Ozone quickly reverts back to its oxygen state while producing no toxic residuals; therefore, items sterilized with ozone do not need aeration. The manufacturer’s instructions must be followed regarding operation of the sterilizer, device and instrument preparation (including specifications for lumen length and diameter), and device limitations.

◦ Peracetic acid.71,72 Liquid chemical sterilant instrument processing systems using peracetic acid can be used for endoscopes and instruments that are immersible, heat-sensitive, are approved for this process by the manufacturer, and cannot be sterilized using terminal sterilization methods. Peracetic acid is an oxidizing agent that is effective in the presence of organic matter; it is also an effective biocide at low temperatures. Its chemical formula is acetic acid plus an extra oxygen atom; this highly reactive extra atom reacts with most cellular components, which causes cellular death and is responsible for the broad spectrum activity of peracetic acid. As peracetic acid returns to acetic acid (ie, vinegar) and the oxygen decomposes, it is rendered nontoxic and environmentally safe. Liquid chemical sterilant systems should be used only on items that have been validated for processing in liquid peracetic acid. Items that have not been validated for use in these systems may not be compatible with the sterilant or the process, which could result in damage or an ineffective sterilization process.

These systems are fully automated and run a standardized, single-use cycle; therefore the need for concentration testing is eliminated. There are no adverse health effects to users under normal operating conditions; however, serious eye and skin damage may occur after contact with the concentrated solution. Peracetic acid has the potential for incompatibility with some materials (eg, dulling of aluminum anodized coating).

A 0.2% peracetic acid solution is used for sterilization under the following conditions:

▪ 30 to 45 minutes for a rapid sterilization cycle. ▪ Low-temperature, 50°C to 55°C (122°F to 131°F) liquid-immersion sterilization; single-use.

Critical items processed by this method should be transported to the point of use and used immediately, they should not be stored for later use or held from one procedure to another.

Sterilized items not intended for immediate use should be packaged, labeled, and stored in a manner to ensure sterility; each item should be

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marked with the sterilization date. Transportation of sterile items should be controlled, ie, in a covered or enclosed cart with solid-bottom shelves.

• High-level Disinfection (HLD). High-level disinfectants play a critical role in processing semicritical endoscopic equipment; they should be practical, safe, fast-acting, and easy to use.73 Disinfection is defined as the process of eliminating many or all pathogenic organisms, except bacterial spores, from inanimate objects; high-level disinfectants destroy all microorganisms except high numbers of bacterial spores. As with sterilization, all items must be thoroughly cleaned and decontaminated before they can be subjected to a high-level disinfection process. When using any high-level disinfectant, personnel should always use PPE.74

Thermal pasteurization, a process that destroys all microorganisms except high numbers of bacterial spores, is a heat-automated high-level disinfection process that uses time and heat.75,76 Items to be processed should be placed in the washer/pasteurizer chamber according to the manufacturer’s written instructions.

An agent cleared by the United States FDA should be used to achieve high-level disinfection.77 Agents selected for chemical high-level disinfection should be effective and compatible with the materials and items to be disinfected. Chemical HLD should be achieved by immersing the items for the specified contact conditions, ie, temperature, concentration and time period, in an FDA-cleared chemical agent; disease transmission can result from improper selection and/or use of disinfecting agents. The manufacturers’ written instructions should be followed when preparing disinfectant solutions, calculating the expiration dates, and labeling the soaking containers.

Items to receive high-level disinfection should be cleaned and completely immersed in the disinfectant solution according to the device and high-level disinfectant solution manufacturers’ written instructions and with established infection control practices.78 Total immersion allows all surfaces of the item to come into contact with the solution; perfusion of the disinfectant solution into all channels eliminates air pockets and ensures contact with the internal channels. Lumens and ports should be flushed and filled with the disinfectant solution and the entire item completely immersed for the specified exposure time. Flushing the lumens and ports eliminates air pockets and also facilitates contact of the disinfectant with the internal channels. If an AER is used for high-level disinfection, the AER manufacturer’s written instructions should be consistent with the endoscope manufacturer’s written instructions, or the endoscope should not be processed in the AER.

After an item is exposed to the disinfectant solution for the required exposure time, critical and semicritical items should be thoroughly rinsed with water,

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according to the manufacturers’ written instructions.79 Rinsing is necessary to remove toxic and irritating residues that can lead to tissue damage or staining. Rinsing critical and semicritical items with sterile water eliminates the potential for recontamination that could result from rinsing with tap water.

Selected processes and agents used for high-level disinfection of semicritical items are outlined below and summarized in Table 6.

◦ Glutaraldehyde.80,81 Glutaraldehyde is a saturated dialdehyde that has wide acceptance as an effective overall high-level disinfecting agent and chemical sterilant; it is noncorrosive to endoscopic equipment, rubber, and plastic items. Aqueous solutions of glutaraldehyde are acidic and in this state are not sporicidal; the solution is activated when agents are added to make the solution alkaline. Glutaraldehyde has a broad antimicrobial range, with effectiveness against vegetative bacteria, Mycobacterium tuberculosis, fungi, and viruses.

Glutaraldehyde is associated with certain hazards for the staff, which must be considered in its selection and use. The maximum recommended exposure level of glutaraldehyde established by OSHA is 0.2 ppm. The odor of the solution becomes an irritant at 0.3 ppm and causes tearing, nausea, and other adverse effects. When the solution is being poured after mixing or when items are being submerged, the level rises to about 0.4 ppm, double the recommended maximum exposure level.

◦ ortho-Phthalaldehyde (OPA).82 ortho-Phthalaldehyde, a 0.55% solution in an aqueous buffer with a pH of 7.5, is considered a high-level disinfectant. This solution is bactericidal, virucidal, and fungicidal; at a minimum exposure time of 12 minutes at room temperature. OPA can be used for most applications in which glutaraldehyde is used and has broad materials compatibility. In addition, it has certain potential advantages over glutaraldehyde, such as excellent stability over a wide pH range, it is odorless, and it is not known to be an irritant to the eyes or nasal passages.

◦ Hydrogen peroxide.83 Hydrogen peroxide is active against various microorganisms, including bacteria, fungi, viruses, yeasts, and spores. Stabilized 6% hydrogen peroxide is sporicidal and can be used as a liquid sterilant with adequate exposure time. However, this solution is corrosive and damaging to copper, zinc, brass, and silver/nickel plating; it can also damage rubber and plastic. The dilution of hydrogen peroxide must be regularly monitored by testing for the minimum effective concentration.

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Table 6 – FDA-Approved Chemical Agents Used for High-Level Disinfection84

Chemical Agent

Advantages Disadvantages Concentration Contact Time/

Conditions

Glutaraldehyde • Relatively inexpensive

• Excellent materials compatibility

• Numerous published studies on its use

• Pungent and irritating odor

• Respiratory irritation from vapor

• Relatively slow mycobacterial activity

• Coagulates blood and fixes tissue to surfaces

• Allergic contact dermatitis

• 2.5% glutaraldehyde AER

• 1.12% glutaraldehyde and 1.93% phenol

• 5 minutes at 35°C (95°F); 28 days maximum reuse


ortho-Phthalaldehyde (OPA)

• Fast-acting• No activation

required• No significant

odor• Claim of

excellent materials compatibility

• Claim of not coagulating blood or fixing tissues to surfaces

• More expensive than glutaraldehyde

• Eye irritation with contact

• Slow sporicidal activity

• Repeated exposure may lead to hypersensitivity in some patients with bladder cancer

• 5.75 % OPA• 0.55% OPA

manual processing AER

• 5 minutes at 50°C (122°F); single use



Hydrogen Peroxide

• No activation required

• No odor or irritation issues

• No disposal issues

• May enhance removal of organic material and organisms

• Does not coagulate blood or fix tissues to surfaces

• Inactivates Cryptosporidium

• Published studies of use

• Concerns regarding materials compatibility (eg, copper, zinc, brass, silver/nickel plating), is corrosive

• Serious eye damage with contact

• 7.5 % hydrogen peroxide


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All high-level disinfected items should be protected from contamination until they are delivered to the point of use; using aseptic technique will protect the items from recontamination prior to patient use.85 High-level disinfected items should be processed immediately before use, since they cannot be placed in appropriated barrier materials and therefore are prone to recontamination during storage.

RISKS ASSOCIATED WITH THE USE OF IMPROPERLY PROCESSED ENDOSCOPES

OverviewThere are risks associated with the use of endoscopes and instrumentation that are not properly cleaned, disinfected, or sterilized. Today, implementation of an effective reprocessing protocol is more important than ever, as public awareness of the risks associated with the use of contaminated endoscopes due to improper reprocessing increases with reports of adverse events, as outlined below.

• As far back as late 2001, the unfortunate deaths of two patients who developed pneumonia after being examined with a contaminated bronchoscope renewed focus on the importance of proper cleaning and terminal processing of all instruments used in surgical and/or invasive procedures.86

• In 2002, patients at one hospital were notified that the scope used during various sinus, nose, or throat procedures over a two year period may have been contaminated with the hepatitis B or hepatitis C virus.87

• In 2009, after one patient developed an infection after rotator cuff surgery, the hospital subsequently discovered that there were at least seven other joint surgery patients who also reported an infection over a 2-week period.88 This discovery caused the facility to close its ORs and cancel knee and shoulder surgeries, as the hospital and CDC investigators inspected the cleaning and sterilization processes. This investigation, which used a small video camera to inspect the cleanliness of the instruments, found pieces of human tissue and bone as well as a bristle from a cleaning brush in arthroscopic shavers and cannulae.

• The results of an analysis of 275 flexible duodenoscopes, gastroscopes, and colonoscopes used at five hospitals across the United States presented at the June 2013 APIC conference found that 30%, 2%, and 3% respectively did not pass a cleanliness rating; they were found to harbor unacceptable levels of “bio dirt”, ie, cells and matter from a patient’s body that could pose potential infection risk.89

Surgical Site InfectionsSurgical site infections are a significant health care concern today. In addition to the incidents noted above, the overall statistics are alarming. In 2010, an estimated 16 million operative procedures were performed in the U.S.90 A recent prevalence study identified

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SSIs, which accounted for 31% of all HAIs among hospitalized patients, as the most common HAI.91 Data from the CDC’s National Healthcare Safety Network for 2006 to 2008 identified a total of 16,147 SSIs after 849,659 operative procedures, for an overall SSI rate of 1.9%.92 In addition:

• Patients who develop an SSI have a 2 to 11 times higher risk of death, compared to surgical patients without an infection.93

• Surgical site infections are associated with a 3% mortality rate; 75% of this mortality rate has been directly related to the SSI.94

• In hospitals across the U.S., SSIs are associated with an estimated 8,205 deaths.95

• An estimated 40% to 60% of SSIs are preventable.96

Surgical site infections also contribute to higher health care costs as the result of prolonged hospitalization; additional diagnostic testing; therapeutic antibiotic treatment; and, in rare cases, additional surgical intervention.97 In 2009, it was estimated that an SSI was associated with a 9.7 day increase in the length of hospital stay and also increased costs by $20,842 per admission; this amounts to over $900 million in additional hospital costs, with hospital readmission due to an SSI accounting for an additional $700 million in health care spending.98 A recent report analyzing the results of 16 studies related to the cost of SSIs showed an average increase of 115% for the cost of care for a patient with an SSI as compared with noninfected control patients.99

It is important to note that microbial contamination of the surgical site is a prerequisite for an SSI; and, the risk of an SSI increases with the dose of bacterial contamination and the virulence of the bacteria.100 Surgical site infections may be caused by endogenous or exogenous sources. The source of pathogens for most SSIs is endogenous, or resident, flora of the patient’s skin, mucous membranes, or hollow viscera. Incision of the skin and/or mucous membranes increases the risk for contamination with endogenous flora of the exposed tissues. Another potential source of pathogens is seeding of the operative site from a distant focus of infection, particularly in patients who have a prosthesis or other implant placed during the procedure, as these devices provide a nidus for attachment of the organism. Exogenous sources of pathogens that may lead to SSIs include personnel (especially members of the surgical team); the operating room environment, including the ambient air; and all equipment, instruments, and materials brought to the sterile field during an operative procedure.101

Consistently, the leading causative agent of HAIs, including SSIs, is Staphylococcus aureus; in addition, the incidence of methicillin-resistant Staphylococcus aureus (MRSA) strains is rising dramatically.102 Other pathogens that frequently contribute to SSIs include103:

• Coagulase-negative staphylococci,• Enterococcus species, • Escherichia coli,

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• Pseudomonas aeruginosa • Enterobacter species, • Proteus mirabilis, • Klebsiella pneumonia, • Streptococcus species, and • Candida albicans.

As noted above, microbial contamination of the surgical site is a prerequisite for an SSI. While there are many factors that contribute to the development of SSIs that perioperative personnel cannot control, eg, the patient’s status in regard to age, overall health, nutrition, and history of drug and/or tobacco use, proper instrument processing is one important risk factor that is under the control of perioperative personnel; furthermore, it is one which has the potential for a significant impact on the prevention of surgical site infections.104 The CDC notes, in its Guideline for Disinfection and Sterilization in Healthcare Facilities, that failure to properly disinfect and sterilize equipment carries not only the risk associated with breach of host barriers, but also the risk for person-to-person transmission and transmission of environmental pathogens; further, thorough cleaning is required before disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes.105

PROFESSIONAL RECOMMENDED PRACTICES, STANDARDS AND GUIDELINESIn recognition of the importance of proper cleaning and reprocessing of today’s intricate endoscopic equipment, several agencies and professional organizations have developed, and regularly update, recommended practices, standards, and guidelines that provide direction for perioperative personnel in the proper care, cleaning, and high-level disinfection or sterilization of endoscopes and related instrumentation and accessories. The relevant guidelines are summarized below. Please refer to the current version of these documents for the complete recommendations.

Association of periOperative Nurses (AORN) Recommended PracticesAORN provides four recommended practices related to proper processing of endoscopes and related equipment, as outlined below.

• The Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment.106 This document provides general recommendations to assist perioperative personnel in the proper decontamination and preparation of surgical instruments for terminal sterilization and disinfection. It reviews key clinical considerations in cleaning instruments including, but not limited to, keeping instruments free of gross soil during a procedure; cleaning instruments as soon as possible after use, with appropriate PPE; transporting contaminated

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instruments appropriately; and the steps involved in the cleaning process, ie, decontamination, inspection, and organization for packaging. It also emphasizes that the instrument, device, or equipment manufacturer’s validated instructions should be followed for the types of cleaning agents to be used for decontamination (eg, detergents, enzyme preparations), the type of water used for cleaning, and the types of cleaning methods (eg, manual or automated).

• Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories.107 These recommendations provide guidance to assist perioperative personnel in all aspects of processing flexible endoscopes and related accessories. The practices contained in this document pertain only to flexible endoscopes and cover following the manufacturer’s instructions, precleaning, transport to the decontamination area, leak testing, cleaning, HLD, alcohol treatment, drying, inspection, storage, care and handling of damaged flexible endoscopes, care of accessories, and the use of PPE.

• Recommended Practices for Sterilization.108 These evidence-based recommendations provide direction for sterilizing items that will be used in the perioperative practice setting. As noted, one of the expected outcomes following surgical intervention is that the patient is free from infection; therefore, all members of the perioperative team share the responsibility for minimizing the patient’s risk for infection. Key measures to minimize this risk and promote positive patient outcomes are the creation and maintenance of an aseptic environment and providing surgical items that are free from contamination at the time of use. This is accomplished by effective cleaning and decontamination of surgical instruments and supplies and then subjecting them to a disinfection or sterilization process, according to the Spaulding classification system. Sterilization provides the greatest level of assurance that critical surgical items are free of viable microbes.

This document reviews the Spaulding classification system; the processes for cleaning, decontamination, inspection, and packaging of items to be sterilized; the various sterilization modalities; as well as packaging, labeling, transporting, and storing sterilized items. It also emphasizes the importance of following the manufacturer’s written instructions for the type of sterilization method, exposure parameters, and drying times.

• Recommended Practices for High-Level Disinfection.109 These recommendations provide direction for achieving safe and effective HLD of reusable instruments. This document also reviews the Spaulding classification system and the level of disinfection required for patient care items. It also emphasizes the importance of thorough cleaning and decontamination of all items before they are subjected to a high-level disinfecting process. It also provides a description of the various agents cleared by the United States FDA to achieve chemical HLD of medical devices, including patient and staff safety considerations.

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Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities110

This AAMI guideline outlines recommendations to guide health care personnel in the proper used and processing of equipment. Recommendations related to cleaning and other decontamination processes, disassembly, methods of cleaning, rinsing, and steam sterilization of surgical instrumentation are included. It notes that the type of decontamination required for specific contaminated device depends on the biohazard that the device presents. The cleaning and/or microbial process appropriate for a particular device is dependent on:

• The device manufacturer’s written instructions. • The level of microbial kill needed, ie, a higher assurance of lethality is required for

items that have been in contact with body tissues, blood, or body fluids. • The design of the device; ie, items that have been contaminated with blood

or body fluids and that have sharp points or edges capable of puncturing or abrading the skin should be subjected to a decontamination process that includes disinfection or sterilization.

• Other device characteristics, eg, whether the materials from which the device is manufactured can tolerate high temperatures or if the device is fully immersible.

• Whether the device has been exposed to prions, such as the prion that causes Creutzfeldt-Jakob disease (CJD), and therefore would require specialized processing steps.

Upon arrival in the decontamination area, surgical instruments that are composed of more than one piece or part (eg, laparoscopic instrumentation) should be disassembled to expose all surfaces to the cleaning process. The device manufacturers’ instructions for disassembly and reassembly of all processed items should be included in the procedure manual for the decontamination area and should always be followed. Hidden surfaces and crevices can prevent thorough cleaning; residual organic matter or large numbers of microorganisms can reduce the effectiveness of the subsequent microbiocidal processes. Personnel should wear appropriate PPE when decontaminating and cleaning instruments.

International Association of Healthcare Central Service Materiel Management (IAHCSMM) Central Service Technical Manual 111

In this document, IAHCSMM notes that advancements in technology have resulted in new and more sophisticated types of instruments, which are complex in design and constructed from various materials. As a result, these devices create cleaning and processing challenges because they often contain:

• Long, narrow lumens and channels in instruments that were not designed to facilitate cleaning;

• Multiple internal channels;

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• Channels that are not freely accessible; • Valves; • Luer-locks; • Clamps that cannot be opened for cleaning; • Crevices, joints, or surface pores;• Components that cannot be easily disassembled; • Rough, irregular surfaces that can entrap or retain bioburden;• Porous materials;• Junctions between insulating sheaths and activating mechanisms;• Heat-sensitive materials; and• Electrical components.

It reviews selection and usage concerns for cleaning agents, the steps in manual cleaning, automated cleaning processes, key considerations in cleaning delicate and hard to clean instruments and flexible scopes, as well as high-level disinfection and sterilization procedures.

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008112

This evidence-based guideline from the CDC updates the previous 1985 guideline; it is written in accordance with the AAMI and AORN recommendations just reviewed, as well as the CDC’s 1999 Guideline for Prevention of SSI. Two key issues related to instrument cleaning outlined in this document are:

• Cleaning plays a critical role in reprocessing. Research has shown that cleaning alone is ineffective in reducing the number of microorganisms from devices. For most surgical instruments, mechanical cleaning with a washer-disinfector is highly effective in reducing the number of microorganisms. Studies have shown more that 80% of surgical instruments have less than 100 microorganisms and a washer sterilizer can remove all or nearly all of them.

• Neutral pH detergent solutions that contain enzymes are compatible with metals and other materials used in medical instruments and are the best choice for cleaning endoscopes.

Manufacturer’s Written InstructionsIt should be noted that reference to the manufacturer’s written instructions is a common theme in all of the professional recommendations and guidelines reviewed above. In light of both the clinical and economic implications of preventing SSIs in today’s health care environment and with the increased sophistication of endoscopes and instrumentation, it is more important than ever to ensure that this equipment is properly cleaned and processed. As previously noted, the United States FDA requires

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all manufacturers of reusable instruments to provide complete and comprehensive instructions for reprocessing; perioperative personnel have the obligation to follow these instructions. Therefore, it is important that perioperative personnel involved in the selection and use of all surgical instrumentation obtain the written, validated instructions for handling and reprocessing from the manufacturer in order to determine the facility’s ability to adequately clean and reprocess the equipment prior to purchase.113 Device manufacturers are also responsible for providing a summary and interpretation of the test results, verifying that their products can be safely and effectively decontaminated.114

SUMMARYIn all surgical practice settings, minimizing the risk of transmissible infection in order to prevent postoperative SSIs for all patients is a priority for all members of the perioperative team. Microbial contamination of the surgical site is a prerequisite for a surgical site infection. Further, when endogenous organisms are introduced into body tissues through surgical instruments, the pathogenic potential of these microorganisms increases. Failure to properly clean and sterilize surgical instruments has been identified as one factor that not only increases the risk associated with breach of host barriers, but also increases the risk for person-to-person transmission, as well as the transmission of environmental pathogens.

As both rigid and flexible endoscopes and their related instrumentation continue to evolve and provide new diagnostic and therapeutic capabilities, their intricate design often presents challenges in effective cleaning and reprocessing. The need for proper reprocessing protocols is more important than ever today, in the face of newly recognized and antibiotic-resistant pathogens, public awareness about infections resulting from ineffective endoscope reprocessing, and the current economic pressures to reduce health care-associated infections. A key component in the development and implementation of effective reprocessing protocols is the understanding of professional recommendations and guidelines, as well as the documentation provided by the equipment manufacturer, specifically the validated cleaning and sterilization/high-level disinfection instructions. Through this knowledge, all members of the surgical team involved in the use and care of endoscopic instrumentation will play an integral role in killing the pathogens, thereby minimizing the risk for surgical site infections and ultimately promoting positive patient outcomes.

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GLOSSARY

Aeration A method by which absorbed EO is removed from EO-sterilized items by circulating warm air in an enclosed chamber specifically designed for this purpose.

Automated Endoscope Reprocessor (AER)

A unit for mechanical cleaning, disinfecting, and rinsing of flexible endoscopes.

Bioburden The number of microorganisms (ie, microbial load) with which an object is contaminated.

Biofilm A thin coating containing biologically active organisms, that have the ability to grow in water, water solutions or in-vivo, that coat the surfaces of structures (eg, inner surfaces of instruments and other medical devices). Biofilm contains viable and nonviable microorganisms that adhere to surfaces and become trapped within a matrix of organic matter, which prevents antimicrobial agents from reaching the cells.

Contamination The presence of potentially infectious pathogenic microorganisms on animate or inanimate objects or surfaces.

Cleaning The removal, usually with detergent and water or enzyme cleaner and water, of adherent visible soil, blood, protein substances, microorganisms, and other debris from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment by a manual or mechanical process that prepares the items for safe handling and/or further decontamination.

Critical Items Items that enter sterile tissue or the vascular system; examples include surgical instruments, needles, implants, and certain types of catheters.

Decontamination The use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point that renders the item safe for handling, use, or disposal.

Decontamination Area An area designed for collection, retention, and cleaning of soiled and/or contaminated items.

Disinfection The process of eliminating many or all pathogenic organisms, except bacterial spores, from inanimate objects.

Endogenous Growing from or on the inside; caused by factors within the body or arising from internal structural or functional causes.

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Enzymatic Cleaner A cleaner that uses enzymes to remove protein from surgical instruments.

Exogenous Growing from or on the outside; caused by factors or an agent (as a disease-producing organism) from outside the organism or system; introduced from or produced outside the body.

Health care-Associated Infection (HAI)

An infection caused by a wide variety of common and unusual bacteria, fungi, and viruses during the course of receiving medical care; the infections may not become apparent until the patient has been discharged from the hospital.

High-Level Disinfection (HLD)

A process that kills all microorganisms, except for high numbers of bacterial spores and prions. High-level disinfectants have the ability to inactivate hepatitis B and C viruses, HIV, and Mycobacterium tuberculosis, but do not inactivate the virus-like prion that causes Creutzfeld-Jakob disease.

Immediate Use Steam Sterilization (IUSS)

A sterilization process designed for steam sterilization of patient care items for immediate use; the term replaces “flash sterilization”.

Intermediate-Level Disinfection

A process that kills Mycobacterium tuberculosis, vegetative bacteria, and most viruses and fungi, but does not necessarily kill bacterial spores.

Intravasation The entrance of foreign material or solution into a blood vessel.

Minimum Effective Concentration

The minimum concentration of a liquid chemical germicide that achieves the claimed microbiocidal activity.

Noncritical Items Items that come into contact only with intact skin; examples include blood pressure cuffs, linens, furniture, and floors.

Pasteurization A process that uses time and heat for high-level disinfection; the intensity of the heat and duration of exposure must be determined by the manufacturer of the unit as well as the manufacturer of the item to be cleaned.

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Personal Protective Equipment (PPE)

Protective equipment (eg, masks, gloves, fluid-resistant gowns, goggles, and face shields) for eyes, face, head, and extremities; protective clothing; respiratory devices; and protective shields and barriers designed to protect the wearer from injury. PPE must be used wherever it is necessary by reason of hazards of processes or environment, chemical hazards, radiological hazards, or mechanical irritants encountered in a manner capable of causing injury or impairment in the function of any part of the body through absorption, inhalation, or physical contact.

Pneumoperitoneum The state of the peritoneal cavity being filled with gas, often induced for diagnostic or therapeutic purposes.

Resolution An optical device’s ability to separate fine detail.

Semicritical Items Items that contact nonintact skin and mucous membranes, but do not generally penetrate the blood barrier; examples include anesthesia breathing circuits, fiberoptic endoscopes, and laryngoscopes.

Single Port Surgery One incision is used, instead of several incisions, to insert laparoscopic instrumentation through a single deployment device.

Sterile The state of being free from all living microorganisms. In practice, usually described as a probability function, eg, as the probability of a microorganism surviving sterilization being 1 in 1,000,000.

Sterilization Validated processes by which all microbial life, including pathogenic and nonpathogenic microorganisms and spores, are destroyed.

Surgical Site Infection (SSI)

An infection that occurs within 30 days after an operative procedure; defined as superficial incisional, deep incisional, and organ/space.

validation Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.

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