Information Related to the Joint Commission Letter.

The Joint Commission (formerly JAHCO) released a document titled “Infection Prevention and Control (CAMH / Hospitals)” on October 24, 2011.

There has been A LOT of discussion about what this letter says regarding the processing of Laryngoscopes. As a service to you, we will analyze what the letter specifically says about blades, and how a HEINE Laryngoscope System will meet and exceed the standards set forth by the Joint Commission.

Semicritical Designation for Blades

“The last page of the guideline lists laryngoscope blades as semicritical items. Recommendation IIIA1b (pages 57-58) states how semicritical items must be processed and packaged:

“Whenever possible, use steam sterilization (by autoclaving) or high-level disinfection by wet heat pasteurization at >158F (>70C) for 30 minutes for reprocessing semicritical equipment or devices (i.e., items that come into direct or indirect contact with mucous membranes of the lower respiratory tract) that are not sensitive to heat and moisture (see examples in Appendix).

Use low-temperature sterilization methods (as approved by the Office of Device Evaluation, Center for Devices and Radiologic Health, FDA) for equipment or devices that are heat-or moisture sensitive”

There is nothing new in these statements. Blades have been listed as “semicritical” for some time now.

The letter recommendations “steam sterilization (by autoclaving) or high-level disinfection by wet heat pasteurization at >158F (>70C) for 30 minutes for reprocessing semicritical equipment or devices…”

With regard to steam sterilization, the HEINE temperature limit is 134C / 273F, and their cleaning guidelines state: “Cycles of 18 minutes or even 60 minutes in specified cases should not damage the metal part of the blade.”

The HEINE cleaning guidelines go on to state: “There may be a reduction in light transmission with frequent / repeated long-term steam sterilization, particularly if the steam quality is not ideal.”

What does this mean?

1. HEINE blades are designed to MORE than handle the temperature and time frame specified in the JC letter.

2. While there “may be a reduction in light transmission”, the HEINE warranty covers users if this happens to the point there is a light transmission issue – there is nothing in the HEINE guidelines that states that repeated long-term sterilization voids the blade warranty.

How will the inexpensive lookalike products fair under these guidelines? Not good! Most manufacturers don’t offer warranties on their product performance, they simply state they can be sterilized –“Compatibility” statements, are not a warranty.

Some companies that do have a warranty have light output measurements, but upon closer inspection they hide behind technicalities to protect their exposure:

- Their guaranty specifies that their LED handles must be used when determining the light output. LED offers the greatest handle light output and therefore protects the manufacturer. If you are not using LED handles, their warranty threshold will be drastically different from yours.

- They offer no distance at which the light measurement is taken. When measuring light intensity in LUX, you must specify the distance at which the light will be measured. Measurements from close to the source will be higher than those further away. Without a distance specification the manufacturer is protected.

The fact is that HEINE blades have been designed for high-level disinfection, and HEINE offers the soundest warranty on the performance of their product when sterilized in accordance with this designation.

The last portion of the statement: “Use low-temperature sterilization methods (as approved by the Office of Device Evaluation, Center for Devices and Radiologic Health, FDA) for equipment or devices that are heat-or moisture sensitive.”

This relates primarily to the STERRAD and Steris processes, which HEINE blades are compatible with as well.

Packaging – The Biggest Change

Here is where the update / change to protocol has occurred - packaging.

“After disinfection, proceed with appropriate rinsing, drying, and packaging, taking care not to contaminate the disinfected items in the process (308;310). CATEGORY IA””

The letter goes on to say….

“Joint Commission surveyors will evaluate processes related to laryngoscope blades to ensure that they are safe for use on the next patient. They will check that laryngoscope blades are:

-Processed via either sterilization or high-level disinfection.

-Packaged in some way. HICPAC guidelines do not specify the manner in which laryngoscope blades should be packaged.

-Stored in a way that would prevent recontamination. Examples of compliant storage include, but are not limited to, a peel pack post steam sterilization (long-term) or wrapping in a sterile towel (short-term). Examples of noncompliant storage would include unwrapped blades in an anesthesia drawer, as well as unwrapped blades on top of a code cart.”

As stated in the document, for the purposes of JC evaluation, the only noncompliant process listed is leaving blades lying in or on a code cart.

It is likely that you are already doing this in one form or another. Whether it is using sterile towels after STERRAD / Steris cycles, or peel open pouches after autoclaving.

What if you aren’t packaging blades currently? This new “addition” simply means that your blades have to be added to an already existing protocol within your hospital.

Are Disposables are the answer?

The issues with disposables have always been:

- Quality and Performance.

- While per unit cost is low, the costs to implement and maintain a disposable system are high.

It is important to note that based on the semicritical designation of Laryngoscopes; the Joint Commission requires disposable blades to be sterilized before use. However, not all disposable blades are packaged sterile. If the disposable blades are not packaged sterile, the Commission requires them to be sterilized prior to use.

Handle Processing

“Please note that laryngoscope handles are considered contaminated after use and must be processed prior to use on the next patient. Most manufacturers suggest a low-level surface disinfectant be

utilized on the surface of the handle, but processes vary by manufacturer. As is the case with all medical devices, the manufacturer’s indications for use (IFU) must be followed. Please also check your state for additional law or regulation; we are aware of at least one state that requires additional processing.”

As a manufacturer, HEINE suggests high-level cleaning for handles, advocating a totally safe and clean system. HEINE handle outer shells are Steam, Steris and STERRAD Compatible. Complete handles (outer shell, inner sleeve, batteries, and bulb) are compatible with the STERRAD system.

*No LED handles system can be high-level sterilized. LEDs cannot be subjected to high heat or pressure. The outer shell of our LED handles can be autoclaved, but the inner sheath may only be wiped down.

For the purpose of safety, we recommend our 3.5V Xenon rechargeable handle system. This system can be processed complete in the STERRAD machines. Our 3.5V Xenon system is 200% brighter than standard 2.5V bulb systems, so their brightness is excellent.

What is our take on this?

Richard’s embraces these changes, and sees them as being positive. We have to focus on the most important part of the process - the sterilization process – where HEINE blades outperform every other product.

HEINE products are designed to withstand higher standards than the JC is specifying. We feel that long term, HEINE Classic Laryngoscopes provide the highest quality, best performing, and most cost efficient approach for hospitals following the JC requirements. Although HEINE laryngoscopes may initially cost more, they meet and exceed the new JC requirements for cleaning and will last longer than any other laryngoscope even with the harshest cleaning methods used today.

Please contact us with any concerns, questions or comments.

800-227-0814www.richardsmedical.com