we cannot afford to go back - j&j medical devices · mm.09.01.01 addresses antimicrobial...
TRANSCRIPT
Antimicrobial StewardshipWe cannot afford to go back
Objectives
• What is antimicrobial stewardship?
• Why the concern over antibiotic resistance?
• Discuss the role and use of antibacterial medical devices decreasing the use of antibiotics.
Perspective
1994 1989 1974 1959 1945
First Smartphone. Time.com http://time.com/3137005/first-smartphone-ibm-simon/ Accessed 4/24/17History of the Web. World Wide Web Foundation. http://webfoundation.org/about/vision/history-of-the-web/?gclid=CN3EpN2R5NMCFQ9LDQodkJYFuw Accessed 4/24/17Invention of the PC. History.Com http://www.history.com/topics/inventions/invention-of-the-pc Accessed 4/24/17History of the seatbelt. Center for Auto Safety. http://www.autosafety.org/history-seat-belt-development/ Accessed 4/24//17Discovery and Development of Penicillin. American Chemical Society. https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/flemingpenicillin.html Accessed 4/24/17
Human Impact
Leading causes of U.S. deaths
Achievements in Public Health, 1900-1999: Control of Infectious Diseases. The Centers for Disease Control and Prevention. https://www.cdc.gov/Mmwr/preview/mmwrhtml/mm4829a1.htm Accessed 4/27/17 Life expectancy at birth, at 65 years of age, and at 75 years of age, by race and sex: United States, selected years 1900–2007. The Centers for Disease Control and Prevention. https://www.cdc.gov/nchs/data/hus/2010/022.pdf Accessed 4/27/17Deaths: Preliminary Data from 2000. The Center for Disease Control and Prevention. https://www.cdc.gov/nchs/data/nvsr/nvsr49/nvsr49_12.pdf Accessed 4/27/17
20001900
0% 10% 20% 30%
SepticemiaNephritis
Alzheimer's diseaseInfluenza and pneumonia
Diabetes mellitusAccidents
Chronic lower resiratory diseasesCerebrovascular diseases
Malignant neoplasmsDisease of the heart
0% 5% 10%
DiptheriaSenilityCancerInjuries
Liver DiseaseStroke
Heart DiseaseDiarrhea and Enteritis
TuberculosisPneumonia
Life Expectancy 46.3Years
48.3Years
30.4% of all deaths were children under 5
74.1Years
79.5Years
1.4% of all deaths were children under 4
What is it?
refers to coordinated interventions designed to improve and measure the appropriate use of antimicrobials by promoting the selection of the optimal antimicrobial drug regimen, dose, duration of therapy, and route of administrationto reduce or avoid their use.
Promoting Antimicrobial Stewardship in Human Medicine. Infectious Disease Society of America. http://www.idsociety.org/stewardship_policy/ Accessed 4/24/17
Antimicrobial stewardship
Why the concern?
refers to microbes’ ability to changeand become less susceptible to drugs.
Antimicrobial Resistance. Infectious Disease Society of America. http://www.idsociety.org/Topic_Antimicrobial_Resistance/ Accessed 4/24/17
Antimicrobial resistance
The development of antimicrobial drugs (antibacterials [antibiotics], antivirals, antifungals and antiparasitics) to treat otherwise life-threatening infections has been one of the most notable medical achievements in human history.
The growing problem of resistance has undermined antimicrobials’ effectiveness resulting in the loss of countless lives and placing public health and national security at serious risk.
achievements in human history. one of the most notable medical
Some microorganisms of concern
Enterococci cause a range of illnesses, mostly among patients receiving healthcare, but include bloodstream infections, surgical site infections, and urinary tract infections.
Antibiotic Resistance Threats in the United States, 2013 CDC page 67
Some microorganisms of concern
Methicillin-resistant Staphylococcus aureus (MRSA) causes a range of illnesses, from skin and wound infections to pneumonia and bloodstream infections that can cause sepsis and death. Staphylococcus bacteria, including MRSA, are one of the most common causes of healthcare-associated infections.
Antibiotic Resistance Threats in the United States, 2013 CDC page 77
Some microorganisms of concern
Streptococcus pneumoniae (S. pneumoniae, or pneumococcus) is the leading cause of bacterial pneumonia and meningitis in the United States. It also is a major cause of bloodstream infections and ear and sinus infections.
Antibiotic Resistance Threats in the United States, 2013 CDC page 79
Some microorganisms of concern
Clostridium difficile (C. difficile) causes life-threatening diarrhea. These infections mostly occur in people who have had both recent medical care and antibiotics. Often, C. difficile infections occur in hospitalized or recently hospitalized patients.
Antibiotic Resistance Threats in the United States, 2013 CDC page 51
Antibiotic introduction and resistance development
Antibiotic Resistance Threats in the United States, 2013 CDC page 28
Antibiotic Resistance Identified
Antibiotic Introduced
1950Tetracycline
1972Vancomycin
1996Levofloxacin
1996Levofloxacin
1950 1960 1970 1980 1990 2000 - Today
1959Tetracycline
1968Erythromycin
1988Vancomycin
1962Methicillin
1953Erythromycin
1960Methicillin
Antibiotic introduction and resistance developmentAn even bigger concern…
The number of new antibiotics developed and approved has steadily decreased in the past 3 decades, leaving fewer options to treat resistant bacteria
Antibiotic Resistance Threats in the United States, 2013 CDC page 44
Number of Antibacterial New Drug Application (NDA) Approvals vs. Year Intervals*
1980-1984 1985-1989 1990-1994 1995-1999 2000-2004 2005-2009 2010-2012
*Intervals from 1980-2009 are 5-yr intervals; 2010-1012 is a 3-yr interval. Drugs are limited to systemic agents. Data courtesy of FDA’s Center for Drug Evaluation and Research (CDER)
NDA
“Voluntary”Antibiotic StewardshipPrograms in the US
Mandatory Antibiotic Stewardship InitiativesThe Joint Commission recently announced a new Medication Management (MM) standard for hospitals, critical access hospitals, and nursing care centers. Standard MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017.
September 29, 2016 Center of Medicaid and Medicare Service (CMS) finalized improvements in care, safety, and consumer protections for long-term care facility residents.
Updating the long-term care facility’s infection prevention and control program, including requiring an infection prevention and control officer and an antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use.
CMS is in the process of developing a Condition(s) of Participation (CoP) on antimicrobial stewardship for hospitals.New Antimicrobial Stewardship Standard. Joint Commission. https://www.jointcommission.org/assets/1/6/New_Antimicrobial_Stewardship_Standard.pdf Accessed 4/24/17CMS finalizes improvements in care, safety, and consumer protections for long-term care facility residents. Center for Medicare and Medicaid Services. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2016-Press-releases-items/2016-09-28.html Accessed 4/24/17
So what can we do?
https://www.cdc.gov/vitalsigns/protect-patients/
Breaking the Chain of Infection
Infectious Agent
SusceptibleHost
Portal of Entry
Reservoirs
Portal of Exit
Means of Transmission
Microorganism (bacteria, virus, fungi)
Host which allows the microorganism to live, grow and multiply
Path for microorganism to escape from host (ex. Blood, respiratory tract, skin, etc.)
Vehicle to carry to other hosts
Path for microorganism to
enter new host
Person susceptible to the
microorganism
Interesting study 47% relative reduction in the CAUTI rate
observed with silver-alloy hydrogel catheter compared to standard
catheter when both the old and the most recent CDC CAUTI definitions
were used
Antimicrobial days for CAUTIs decreasedfrom 1165
(standard catheter period)
to 406(silver-alloy
hydrogen period)
Lederer J, Jarvis W, Thomas L, Ritter, J. Multicenter cohort study to assess the impact of a silver-alloy and hydrogel-coated urinary catheter on symptomatic catheter-associated urinary tract infections. Journal of Wound Ostomy Continence Nursing. 2014 Sep-Oct;41(5):473-80
Those of you who participate in the National Healthcare Safety Network’s voluntary Antimicrobial Use and Resistance module and track antimicrobial days may find data like this extremely relevant.
Most Bloodstream Infections and Surgical Site Infections are caused by bacteria from patients own skin
HAIs – Major Site of Infections Estimated No.
Pneumonia 157,500
Gastrointestinal illness 123,100
Urinary tract infections 93,300
Primary bloodstream infections 71,900
Surgical site infections from any inpatient surgery 157,500
Other type of infections 118,500
Estimated total number of infections in hospitals 721,800
Reducing Surgical Site Infections: A Review. US National Library of Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2812878/ Accessed 4/24/17Catheter-related bloodstream infections. US National Library of Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4093967/ Accessed 4/24/17HAIs at a Glance. Centers for Disease Control and Prevention. https://www.cdc.gov/hai/surveillance/index.html Accessed 4/27/17
Skin Colonization
Portal Exit
Infectious Agent
Reservoir
Pre-PrepBacteria colonies exist not only on the surface, but below the surface as well, particularly within the hair follicles and sebaceous glands
Post-Prep (immediately following antiseptic application)
Prepping the skin reduces colony counts of bacteria from the surface only – it never completely sterilize the skin
Skin Colonization
Portal of
entrySusceptible
host
Means of Transmission:Central Venous Catheter
Means of Transmission:Surgical Incision
Susceptiblehost
Portal of entry
Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017
Recommendation Classification
Administer preoperative antimicrobial agents only when indicated based on published clinical practice guidelines and timed such that a bactericidal concentration of the agents is established in the serum and tissues when the incision is made.
Category IB
Administer the appropriate parenteral prophylactic antimicrobial agents before skin incision in all cesarean section procedures. Category IA
In clean and clean-contaminated procedures, do not administer additional prophylactic antimicrobial agent doses after the surgical incision is closed in the operating room, even in the presence of a drain.
Category IA
Do not apply antimicrobial agents (i.e., ointments, solutions, or powders) to the surgical incision for the prevention of SSI. Category IB
Application of autologous platelet-rich plasma is not necessary for the prevention of SSI. Category II
Implement perioperative glycemic control and use blood glucose target levels less than 200 mg/dL in patients with and without diabetes Category IA
Maintain perioperative normothermia. Category IA
For patients with normal pulmonary function undergoing general anesthesia with endotracheal intubation, administer increased FIO2 during surgery and after extubation in the immediate postoperative period.
Category IA
Advise patients to shower or bathe (full body) with soap (antimicrobial or nonantimicrobial) or an antiseptic agent on at least the night before the operative day Category IB
Perform intraoperative skin preparation with an alcohol-based antiseptic agent unless contraindicated. Category IA
Application of a microbial sealant immediately after intraoperative skin preparation is not necessary for the prevention of SSI. Category II
The use of plastic adhesive drapes with or without antimicrobial properties is not necessary for the prevention of SSI. Category II
Consider intraoperative irrigation of deep or subcutaneous tissues with aqueous iodophor solution for the prevention of SSI. Category II
Do not withhold transfusion of necessary blood products from surgical patients as a means to prevent SSI. Category IB
In prosthetic joint arthroplasty, recommendation 1E applies: in clean and clean-contaminated procedures, do not administer additional antimicrobial prophylaxis doses after the surgical incision is closed in the operating room, even in the presence of a drain.
Category IA
Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Network. http://jamanetwork.com/journals/jamasurgery/fullarticle/2623725 Accessed 4/27/17
Triclosan Coated Sutures Recommendations“Consider the use of triclosan-coated sutures for the prevention of SSI.”CDC Guideline for the Prevention of Surgical Site Infections 2017*
Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017.JAMA Surg. http://jamanetwork.com/journals/jamasurgery/fullarticle/2623725 Accessed 4/25/17
* The CDC, WHO, ACS & SIS guidelines on reducing the risk of surgical site infections are general to triclosan-coated sutures and are not specific to any one brand.
Triclosan Coated Sutures Recommendations“Triclosan antibacterial suture use is recommended for wound closure in clean and clean-contaminated abdominal cases when available”American College of Surgeons & Surgical Infection Society (ACS & SIS) Surgical Site Infection Guidelines*
* The CDC, WHO, ACS & SIS guidelines on reducing the risk of surgical site infections are general to triclosan-coated sutures and are not specific to any one brand.
Journal of the American College of Surgeons. DOI: http://dx.doi.org/10.1016/j.jamcollsurg.2016.10.029. Accessed 4/24/17
Triclosan Coated Sutures Recommendations“The panel suggests the use of triclosan-coated sutures for the purpose of reducing the risk of SSI, independent of the type of surgery”World Health Organization (WHO) Global Guidelines for the Prevention of Surgical Site Infection*
* The CDC, WHO, ACS & SIS guidelines on reducing the risk of surgical site infections are general to triclosan-coated sutures and are not specific to any one brand.
Infection prevention and control. World Health Organization website. http://www.who.int/infection-prevention/publications/ssi-guidelines/en/ Accessed 4/24/17
Prospectively planned meta-analyses of randomized control trials were performed on the use of suture containing triclosan to lower SSI rates
Significance of the recommendation
Three new evidence-based SSI prevention guidelines were published inpeer-reviewed medical literature. The ground-breaking news across all of these guidelines is that for the first time, the choice of a wound-closure device is being recognized as an evidence-based component within a bundle of interventions aimed at addressing risk factors for SSI.
Reducing Colonization
Antibacterial Sutureshown in vitro to inhibit
bacterial colonization of the suture for 7 days or more
The petri dish image is for illustrative purposes only, zone of inhibition testing results can vary.
Recommendations for CLABSIreduction practices from Healthcare Infection Control Practices Advisory Committee of Centers for Disease Control and Prevention
RECOMMENDATION CLASSIFICATION
Hand hygiene prior to catheter insertion Category IB
All inclusive catheter carts or kits Category IB
Maximal sterile barrier precautions Category IB
Chlorhexidine for skin anti-sepsis Category IA
Antimicrobial catheters Category IA
Subclavian vein insertion Category IB
Disinfect hubs and needle-less connectors Category IA
Remove non-essential CVCs Category IA
Chlorhexidine cleansing Category II
CVC (transparent film) dressing Category IA
Chlorhexidine impregnated sponge dressing Category 1B
Topical antibiotic use (dialysis) Category IB
Antibiotic or anti-infective “locks” Category II
Educational interventions Category IA
Catheter bundles or “checklists” Category IB
Use of specialized CVC insertion teams Category IAPrevention of Central Line-Associated Bloodstream Infections: Brief Update Review. US National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK133364/ Accessed 4/25/17
Revised CHG Impregnated Dressings Recommendation
1. For patients aged 18 years and older:a. Chlorhexidine-impregnated dressings with an FDA-cleared
label that specifies a clinical indication for reducing catheter-related bloodstream infection (CRBSI) or catheter-associated bloodstream infection (CABSI) are recommended to protect the insertion site of short-term, non-tunneled central venous catheters. (Category IA)
2017 Updated Recommendations on the Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections. CDC.gov. https://www.cdc.gov/infectioncontrol/guidelines/pdf/guidelines/c-i-dressings.pdf Accessed 11/7/17
Some of the evidence cited by the CDC support the recommendation
Areas of Opportunity
Central Venous
Catheters
DialysisCatheters
ArterialCatheters
PICC Lines
Peripheral IVs
Mid Lines EpiduralCatheters
Implanted Venous Ports
External FixatorPins
Drains
Rebaselining
HAI Progress Report – FAQ. Centers for Disease and Control website. www.cdc.gov. Accessed 11/8/17
Interesting case study
Methodist Hospitals of Northwest Indiana aligned their Peripheral IV (PIV) policy to INS Standards of Practice, moving from the routine replacement of PIVs to clinically indicated replacement of PIVs. They proactively protected the lines by implementing a PIV bundle (education, Protective Disk with CHG, securement dressing, alcohol impregnated caps, integrated closed IV catheter system and sterile gloves) and tracked their data for 12 months to understand the impact of these changes. The hospitals realized a:
37% reduction in house-wide laboratory confirmed bloodstream infections
19% reduction in peripheral IV-related BSIs
68% fewer CLABSIs than predicted via NHSN
2 Years Post Implementation
Sustained
Sustained
6% Further Reduction
DeVries M, Valentine M. Mancos P. Protected Clinical Indication of Peripheral Intravenous Lines: Successful Implementation. Journal of Vascular Access. June 2016. Volume 21, Issue 2, Pages 89–92
Summary• Antibiotics have become an integral part of healthcare and have
had a tremendous impact on our very existence• Antibiotic resistance poses a real threat to the treatment of disease
as we know it• We can take steps to break the chain of infection to help mitigate
the problem
Summary• Antibiotics have become an integral part of healthcare and have
had a tremendous impact on our very existence• Antibiotic resistance poses a real threat to the treatment of disease
as we know it• We can take steps to break the chain of infection to help mitigate
the problem
Prevent infections
from catheters and after surgery
Prevent bacteria from
spreading
Reduce or eliminate
antibiotic use+ =
Break the chain of infection with the use of evidenced
based products
Follow good clinical practice
Questions?
© 2018 Ethicon US, LLC . 086412-171231