Delving deeper on FDA’s final guidance for reprocessing medical devices in healthcare settings.
After digesting last week’s final FDA guidance on medical device reprocessing, stakeholders discussed their impressions of the agency’s recommendations. A lawyer points out a new quirk manufacturers will need to consider, while a patient advocate explains why he believes the guidance does not address the underlying problem.
As reported last week, FDA has released its final guidance on medical device reprocessing. This gives manufacturers guidelines for cleaning, disinfecting, and sterilizing reusable devices that are reprocessed in the health care setting.
The subject of medical device reprocessing of reusable devices has been under consideration by FDA for years. Back in 2011, the agency held a public workshop and issued draft guidance on the topic.
Interest in medical device reprocessing has spiked in recent months, as dozens of cases of carbapenem-resistant enterobacteriaceae (CRE) infections at hospitals around the country have been linked to duodenoscopes, a type of endoscope used to diagnose and treat diseases of the liver, bile duct, and pancreas. FDA has issued a safety communication pointing out that duodenoscopes can be difficult to sterilize completely because small space around its “elevator” mechanism can be hard to brush or clean perfectly. Duodenoscopes are one type of device covered by the final guidance.
FDA has also admitted that one duodenoscope model, made by Olympus Corp. of the Americas and blamed for some of the infections, never received FDA approval because the maker initially believed agency review was not required. The company submitted a 510(k) after FDA requested it; that submission is still under review.
The Finer Points
One unique issue to consider in the guidance is FDA’s recommendation that manufacturers validate its reprocessing instructions and consider human factors when developing the reprocessing steps. Allyson Mullen, an associate at Hyman, Phelps & McNamara, P.C., points out that this is unusual because it asks makers to go one step further. Usually, Mullen says, companies must prove they’ve validated the reprocessing, but now they should also validate the reprocessing instructions. They’re being asked to make sure that users can understand the steps and put them into practice, she says.
FDA’s guidelines suggest something akin to a human factors study for validating the reprocessing instructions. The guidance recommends:
- “validation study participants should be representative of the professional staff that would perform these actual reprocessing procedures,” including protective gear
- participants can demonstrate their understanding by “perform[ing] an actual or simulated reprocessing procedure or verbally describ[ing] what they would do”
- the actual environment should be simulated if it might affect performance of the instructions
- watching and taking notes on behavior during the study will help evaluate understanding and identify mistakes
- interview study participants to learn more about any difficulties and confusion and clarify wording
- re-validating revisions to the reprocessing instructions
Mullen says it is difficult to know what FDA’s exact expectations for this type of validation study are. “I think it’s too early to know at this point [if that’s a challenge],” she says, adding that the guidance doesn’t give specifics on the ideal size or design of a validation study.
Mullen points out another unique feature of the guidance is Appendix E, which contains a list of devices for which 510(k) submissions should contain data to validate reprocessing instructions, calling it an “additional bar” for those manufacturers.
FDA notes that they call out these devices because they are believed to be more likely to transmit infections without proper reprocessing. While the guidelines emphasize that all devices should have validated reprocessing instructions, these devices should include protocols and validation test results in 510(k) submissions. Various types of endoscopes, including duodenoscopes, are included on this list.
An Olympus Corp. spokesperson declined to comment on the final reprocessing guidance.
Patient Advocate: Guidance Doesn’t Address Flawed Protocols
Zooming out from the details, a patient advocate says he doesn’t think the recommendations get at the heart of the matter—that cleaning protocols were followed yet numerous patients still got infected.
Dr. Frank Nemec, patient advocate and board member of Hepatitis Outbreaks National Organization for Reform (HONOReform), a foundation focused on injection safety, points out that in the recent CRE infection cases, FDA reported that the duodenoscopes had been reprocessed properly. It appears that the reprocessing protocol itself is flawed, he says, and the guidance doesn’t address this issue because an alternative protocol has not been validated.
The Centers for Disease Control and Prevention (CDC) issued an interim surveillance protocol alongside FDA’s reprocessing guidance, advising culturing for cleaned duodenoscopes. However, that protocol notes that “a negative culture does not completely exclude the possibility of a contaminate duodenoscope.”
“I think most important is getting a protocol that specially addresses the problem and that’s been proven to address the problem,” says Nemec. “The culture and quarantine may or may not be the solution.”
One issue with culturing is the time required to allow the cultures to grow, Nemec says. Culture and quarantine is not a practical solution for many centers, he says, especially high-volume hospitals, which need to keep duodenoscopes in rotation in order to keep up with patient volume. Additionally, buying large numbers of the devices will not be a popular solution for centers, which are often keenly aware of their profit margins.
Nemec also notes that while FDA’s guidance recommends that validation study participants be representative of professional staff that would perform the actual reprocessing, there is a large gap between a manufacturer’s study participants and reprocessing reps in the real world. He says that in his experience, these reprocessing positions tends to be among the lowest paid roles with fairly high turnover, particularly in the ambulatory setting. Mixing a lot of new people with complicated reprocessing protocols makes potential breaches in protocol more likely, he says, and FDA’s guidance does not address this reality.
“Really, what we’re looking forward to is maybe a design change that eliminates the accumulation of biofilm that is probably responsible for these organisms residing in the instruments” despite a fairly vigorous reprocessing protocol, Nemec says.
FDA is slated to discuss the duodenoscope-linked CRE infections during a public advisory panel on May 14 and 15.
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