SILVER SPRING, Md. — The FDA recently announced that it was strengthening its testing protocols for manufacturers of reusable medical devices. This news comes after the UCLA superbug scandal involving contaminated endoscopes.

The new testing procedures will apply to new devices seeking FDA approval, not to those already on the market. It will apply only to the following new reusable medical devices:

  • Reusable medical devices that are initially sterile and require the user to clean/disinfect/sterilize the device for subsequent patient use.
  • Reusable medical devices that are initially non-sterilized but then require the user to clean/disinfect/sterilize the device for initial and subsequent patient use.
  • Reusable medical devices intended to be reused only by a single patient and intended to be reprocessed between each use.
  • Single-use medical devices initially supplied as non-sterile to the user, and requiring the user to process the device prior to its use.

The stricter guidelines will require manufacturers of reusable medical devices to be responsible for providing labeling that provides adequate directions for use and preparation of the medical device for repeated use. The FDA will also require the makers of the devices to provide sufficient scientific validation of the reprocessing of the medical devices. So, for example, the makers of devices like the maligned endoscopes need to provide data proving that the device can actually be properly cleaned and disinfected by hospital staff.

If a company does not meet the stricter testing requirements, the FDA can order the device to be recalled or can order a stop in distribution.

Superbug Led to Change in Testing Procedures

The changes to the testing procedures come after the agency received flak for the infections and exposure caused by the improperly or insufficiently sterilized endoscopes – infamous now for the multiple superbug cases. Improperly cleaned medical devices are a serious threat in hospitals because they not only expose people to a variety of germs and diseases, but they put those individuals with compromised immune systems at greater risk. These patients often will succumb to diseases or infections that would normally not have a fatal result because of their weakened medical state. It is imperative that hospitals maintain the highest levels of cleanliness in all of their facilities and products.

The FDA’s acknowledgement of this growing problem is reflected in their decision to revise the testing protocols. It had been investigating the issue with regards to the hard-to-clean duodenoscopes as early as 2009, but at the time it was believed hospital staff were simply not following the proper cleaning process. By 2013, however, it became more clear that the process was in fact being followed by the users (hospital staff) and instead something was fundamentally wrong with the process or the device itself. The superbug fiasco merely reinforced that belief.

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