Mary Logan: We Need Science, not Scapegoats, in Sterility Assurance Debate

“How clean is clean enough?” has resurfaced as a pressing question in medical device reprocessing because of national media coverage of superbug outbreaks involving contaminated duodenoscopes.

While the intense media interest is new, the issue itself is not. Over the past several years, a number of hospitals have had to send sobering letters to patients who were exposed to an infectious disease (e.g., hepatitis) from treatment involving an endoscope. The challenge of “how clean is clean enough” was one of the most important issues discussed at the 2011 AAMI/FDA Medical Device Reprocessing Summit.

Progress has been made since the summit to address some of the challenges with cleaning scopes: Last year, AAMI published a new technical information report for manufacturers on applying human factors engineering to device design and reprocessing procedures. The FDA’s CDRH has released a new guidance document for manufacturers. The CDC has issued a “surveillance protocol” dealing with endoscope reprocessing. CMS is likely to get in on the “reminders” about the rules for cleaning. And AAMI has a brand new standard—with publication set for later this spring—on the reprocessing of scopes, not satisfied that its general reprocessing standard was enough for these tricky devices.

Little progress has been made, though, on that big science question: How clean is clean enough? We should all be calling for—perhaps demanding—more research in the science of sterility assurance. Rules, standards, and reminders about rules are great, but not enough. I’m willing to wager that we are going to see new outbreaks even after this recent rash of publicity and flurry of rules and reminders.

When it comes to contaminated medical devices, everyone wants to find a scapegoat, but this is a complex challenge that won’t be resolved by pointing fingers: It’s too easy to blame manufacturers for the design; the FDA for not forcing better designs; healthcare delivery organizations for not being disciplined enough about proper cleaning; the people who do the cleaning; etc.

All of the above are crucial factors, but we need to press for more science before we settle for simple answers. There are many things we don’t know and need science to address. Here is my list of things worthy of further study and consideration:

1. The type of bug: Is clean enough for the superbug different from clean enough for Ebola, MRSA, hepatitis, or new bugs that are difficult to kill?

2. Culturing: How do we know that culturing is an answer? Is there sufficient science to support culturing and in all cases?  What don’t we know?

3. The type of scope: This problem is broader than a single type of scope, so we need to be careful not to focus too narrowly on a single point of failure with one type of scope.

4. Cool New Tools: Some hospitals are buying special drying cabinets for cleaned scopes. Others are making an investment in ethylene oxide sterilization equipment. If the other issues are not addressed, are these additional tools and steps really better or enough? More scientific discussion is needed about these and possibly other new tools.

5. Proper training and credentialing: More attention is needed on the skills and credentialing of reprocessing staff in acute and non-acute healthcare delivery organizations. There are at least two national certification programs, and it’s worth giving more consideration to their value and importance.

6. More time: Reprocessing professionals advocate slowing down the process and maintaining a sufficient inventory of reusable medical devices, so that each step in sterility assurance is followed in a disciplined way, using AAMI standards, and in recognition of the full cycle. A handful of healthcare delivery organizations have added precautions and made a significant financial investment to slow down the process. This approach increases the costs, at a time when healthcare facilities are under tremendous pressure to hold them down. Taking a more deliberate and thorough approach seems practical, like washing the dishes on a “heavy duty” cycle will result in cleaner dishes. Do we really know scientifically that it makes a difference?

7. Asking questions during surveyor visits: Surveyors for accreditation organizations for acute and non-acute HDOs should be asking specific questions about reprocessing, and should know and understand the reprocessing standard. If healthcare delivery organizations are prepared for surveyor questions, they are paying more attention to this area and thus doing more to do the right things in the right way.

8. Standardization of instructions for reprocessing by industry: This recommendation came out of the 2011 AAMI/FDA Summit, and AAMI subsequently worked on a draft standard that attempted to do this. The standard was put on indefinite hold for a host of reasons, including that there already is an international standard on instructions for use. I’m still not satisfied with the current state and think tighter standardization of instructions is needed. We are expecting humans to remember steps that are too voluminous and variable.

9. Standardization of inventory: Healthcare delivery organizations need to standardize their scope inventory. It’s even more challenging for the sterile processing staff to have to follow different instructions for multiple brands, models, and types of scopes. Standardization of the inventory can help. How much can it help? We don’t really know.

10. Better design of scopes:  Yes, the design of scopes and their component parts must improve to make reprocessing easier and safer. This will come, but will take years because these are sophisticated, complex instruments. This is part of evolving the engineering side of science, with sterility assurance and materials science in a strong supportive role.

Some of my friends and family members have asked whether they should postpone or forgo treatment using endoscopes. The answer of course is a resounding “no.” Endoscopes are an incredible advancement. The risk needs to be put into perspective of all of the other risks we face each and every day, in or out of a healthcare delivery organization.

That said, we should not just breathe a sigh of relief when the media frenzy dies down. The science of sterility assurance needs our support. “How clean is clean enough” should be the question that we all ask—and one which deserves a scientifically sound answer.

Mary Logan, JD, CAE, is president of AAMI.

3 thoughts on “Mary Logan: We Need Science, not Scapegoats, in Sterility Assurance Debate

  1. The recent proliferation of superbugs at the Ronald Reagan UCLA Medical Center, Virginia Mason Medical Center in Seattle, the Advocate Lutheran General Hospital, and other facilities raises high significant concerns: If antibiotics can’t destroy antibiotic resistant superbug organisms, and sterilization can’t destroy them either, then this is a double whammy.

    But how is it that despite a sterilization process, superbugs (e.g., enterbacteria such as Klebsiella) can survive, which can easily be inactivated)? Klebsiella is less resistant than Mycobacterium required to be inactivated for high-level disinfection (e.g. low pressure steam, 630C for 30 minutes). Could it be because the liquid sterilant couldn’t reach the microorganism within the minuscule areas of the device(s), the bioburden was too hidden, increased resistance, uncleansed and protected, making the sterilant inaccessible to the bug?

    Per UCLA, “the hospital pulled all the devices and stopped (the cleaning and sterilization) procedures once contamination was found.” UCLA said it now uses a gas (ethylene oxide) sterilization method and has increased its standards, as has Advocate Lutheran General Hospital. EO sterilization has excellent gas penetration. Low-pressure steam (not hot water) also has excellent penetration and more so with slight addition.

    The UCLA cases are not the first outbreak linked to hard-to-clean duodenoscopies. Stricter sterilization steps beyond FDA recommendations may help hospitals avoid more infections.

    UCLA identified the specific Carbapenem Resistant Enterobactereacea (CRE) drug-resistant superbug infection in its scopes. In a couple of different hospitals routine (cleaning and sterilization) process they were using were not quite adequate.” The UCLA and Cedars-Sinai CRE clusters are the fourth and fifth reported CRE outbreaks associated with ERCP duodenoscopies. Despite the non-lethality of the superbugs and survival of intense procedure through a reprocessor, hospital officials still indicate that this is only a rare incidence. However, out of 500,000 usages of this endoscope-type procedures per year, several have caused failures and deaths. And this is a greater risk than the 1 in 10-6 probability of survivor criteria for sterilization. It is a great risk than previously indicated (e.g. 1.8 X 10-6) per authorities. Others than UCLA have noted that duodenoscope remain contaminated despite reprocessing. One manufacturer is aware of more than 95 complaints with its device associated with infections. The FDA has announced that from January 2013 and December 2014, a total of 75 reports were made to the administration involving 135 patients in the US for possible microbial transmission from preprocessed duodenoscopies. Between 2004 and 2009, there were 62 reports of endoscope contamination or sterility failures. This span period (2004-2015) of these sterility failures of endoscopes appears to be increasing despite implemented precautions and appear to exceed the sterility failure period of the early 1970s LVP contamination problem. Consequently, Mary Logan’s proposed list of things worthy of further study and consideration requires and demands a further discussion and scientific creativity of this significant issue–now.

  2. I think Mary makes some very good points. There are inherent risks in having any procedure. I recently wrote a blog on reprocessing medical devices in which I detailed some of the problems that are encountered. I believe that fixing this problem requires a collaborative effort of all the parties involved in reprocessing: medical device manufacturers, regulatory agencies, test labs, professional organizations, and medical device reprocessors. Unfortunately, it seems that medical device reprocessors are frequently not consulted when new devices are designed and when it comes to developing the reprocessing procedures for the new device. This needs to be done early in the design process. Failure to do so leads to the problems we are seeing. Until this changes and medical device reprocessing personnel are involved in the early stages of the design process, we will continue to have problems.

  3. Deserving a scientifically sound answer says we will not violate the trust of our patients and breach the internal body with instruments that have not been processed (chemically, biologically,and mechanically) to validate their sterility. Without adhering to this mandate, I see no reason to support any technology designed with specific areas of possible inconsistent contact with the applied sterilants, mechanical action, validated terminal biological exposure, and surface contact. The gentle cycle options available are not effective terminal processes for sterilization. Until manufacturers admit this, their continued designs around these types of sterilization methods will place our population at risk.

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