FDA changing sterilization rules to aid in superbug fight

Thinkstock | dina2001

We’ve been following the CRE superbug outbreak spread by duodenoscopes that have not been completely sanitized. Now, the Food and Drug Administration (FDA) is making moves to improve the safety of procedures involving these scopes.

The FDA announced recently that it will now require manufacturers to prove that new devices can be reliably cleaned by following manufacturer-issued instructions, according to the Los Angeles Times. The federal organization also released new guidelines for “reprocessing”—or sterilizing—devices.

Of course, the release of these new guidelines means that the FDA hadn’t previously required manufacturers to prove their recommended sterilization practices are effective. Although the hospitals that reported the outbreak say they followed manufacturer recommended sterilization procedures, the FDA never had to evaluate whether those procedures were effective.

FDA regulators also said they have no authority to require manufacturers to redesign the scopes, though it is accelerating its work on new proposed rules for requiring proof that the devices can be cleaned reliably. The FDA’s chief scientist reported that the organization started work on these rules four years ago, but never finalized them.

We’ve also posted an article about a World Health Organization report that stated that without action against superbugs, the world may be heading into a “post-antibiotic era.” Fortunately, many advances in cleaning techniques have emerged in recent years, including fighting superbugs with computers and new sterilization techniques using UV light.