“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.