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Reprocessing Medical Devices; Can It Be Done?

Reprocessing Medical Devices; Can It Be Done?


With superbugs becoming a more prevalent problem in healthcare, is it even possible to safely reprocess medical devices without a risk of cross-contamination? After almost two hundred patients at UCLA’s Ronald Reagan Medical Center were exposed to carbapenem-resistant, or CRE, a bacterial infection with an over 50 percent mortality rate and now a second potentially deadly outbreak at Virginia Mason Medical Center in Seattle, it seems clear that more aggressive processing may not be enough. What can the medical community do to ensure this trend doesn’t escalate?

Let’s Talk About Reprocessing

The recent outbreaks have changed some of the regulatory practices, allowing the Federal Food and Drug Administration to reach into areas that were out of bounds before. In 2011, the FDA issued a draft guidance that covers the reprocessing of endoscopes and other multiuse medical devices. At the time, this new regulatory expansion was not well received, but possibly necessary given the outbreaks associated with duoendoscope use.

It took years for the FDA to complete the guidelines. This opens up two questions.

First, what took the FDA so long to finalize of this material? They issued the first draft in 2011, but didn’t finalize it until 2015. The regulatory authority in Canada produced similar guidelines years before the U.S.

The second question is what does this guidance even mean? The facilities involved in the duoendoscope outbreak followed the instructions for reprocessing provided by the device manufacturer and they still had cases of cross-contamination. The first outbreak at Virginia Mason Medical Center resulted in 11 deaths. What good are these guidelines if the patients die anyway?

Is This a New Problem?

It’s unclear whether the cross-contamination of pathogens via an endoscope is new or just now becoming obvious. It is entirely possible that this is not a new problem. The Seattle Times reports there are approximately 500,000 thousand procedures are done each year using a duoendoscope. It seems unlikely that these are the first cases in the history of cross-contamination with this medical device. Chances are other infections presented outside the medical facility, so the connection to the procedure was not apparent.

Currently, one of every 25 hospital patients end up with some type of healthcare-associated infection – many as a result of exposure to a multiuse medical device like an endoscope.

Improved Guidelines for Reprocessing

The FDA’s answer is to create more comprehensive cleaning protocols for these devices. There is also a question about whether the agency went far enough with their regulations.

For example, all reprocessing instructions should recommend a thorough cleaning of each medical device. Even if that were not an obvious step in the cleaning and disinfection process, what measurement is applicable to “thorough?” Even if the instructions offered contamination limits, it is unlikely that they could be sure what level of contamination is safe.

Cleaning some of these complex designs is almost impossible, so perhaps that is where the guidelines should begin. Manufacturers need to look closer at their products and decide upfront whether they are cleanable. Some bacteria can survive a long time when trapped in a crevice or nook that is unreachable regardless of extensive cleaning. Wouldn’t it be better to create a single-use device instead or to develop a product that can be taken apart and cleaned more thoroughly?

Working Together to Improve Patient Safety

Given the financial chaos that ensues from an outbreak, it makes more sense to look for solutions as a community. The problem needs to be addressed at two levels.

  • One – With better engineering, if manufacturers create a product that can’t be cleaned, no amount of guidance is going to keep the patients safe. Manufacturers need to apply some common sense to their design process and create devices that break down to improve cleaning if necessary.
  • Two – Improved regulation, because right now the manufacturers decide if their cleaning and disinfecting instructions are adequate for most medical facilities. The FDA guidelines do suggest the cleaning instructions be feasible for the intended locations and users. If the manufacturers are not doing the actual cleaning, though, why are they given the power to decide what is feasible?

Manufacturers need to partner with their customers to create more realistic designs and to provide more hands-on cleaning instructions by spending time in the clinical setting to see how they reprocess their equipment. That is how the healthcare community can learn from the scenarios like seen in Los Angeles and Seattle.

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