FDA Issues New Rules for Testing of Reusable Medical Devices

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The U.S. Food and Drug Administration (FDA) recently announced its tougher new requirements for testing reusable medical devices.  According to the FDA’s News Release, the new rules are “aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.”  The guidance document (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) also includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices.

The new rules and recommendations are based on draft proposals that the FDA released in 2011 for public comment.  The rules’ issuance follows the news of the deaths of two patients from “superbug” infections that have been linked to reusable medical scopes. Olympus, the manufacturer of the implicated scopes, is being sued for failing to issue updated cleaning instructions after a recent redesign, and for selling a “defective scope,” among other allegations.

The FDA’s new rules will only apply to new devices receiving FDA approval, not to devices that are currently on the market.  The New York Times reported that “Officials acknowledged that they could only recommend — not require — that products on the market use the more rigorous testing.”

The FDA has said that that the new rules incorporate new testing requirements intended to make reprocessing reusable medical devices more effective.  For example, manufacturers will be required to submit data to show that their reusable medical devices, such as duodenoscopes, endoscopes, and bronchoscopes, can be properly disinfected.  Manufacturers had previously been required to collect this data, but were not required to submit it to the FDA.

According to the FDA’s press release, the guidance document further “recommends that manufacturers consider reprocessing challenges early in device design.”

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