FDA Issues New Rules for Testing of Reusable Medical Devices

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.”

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.