FDA issues guidance for reusable medical devices linked to ‘superbugs’

The Food and Drug Administration has issued new guidance for the healthcare industry on reusable medical devices that have been linked to the spread of superbugs.

Commonplace in healthcare facilities, these devices are typically made of hard plastic and can withstand cleaning and sterilization. Some, however, are so complexly designed that they are hard to clean.

{mosads}Hospitals around the country from California to North Carolina have seen outbreaks of the drug-resistant bacteria, known as CRE, in recent months. The spread of the superbug has been linked to contaminated duodenoscopes, which are tubes that are threaded through the mouth into the stomach as part of medical procedures.

When writing instructions for devices, the FDA guidance says manufacturers should list the intended use of the device; include steps on how to thoroughly clean the device; indicate the appropriate microbicidal process; be technically feasible to clean in their intended location, be it a healthcare facility or private home; be comprehensive to enable the user to understand precisely how to prepare the device for reuse; and be easy to understand — clearly, legible and provided in sequential order.

The guidance also recommends that manufacturers consider reprocessing challenges early on when designing the device. Manufacturers will be expected to conduct validation testing to show with a high degree of certainty that their cleaning and disinfection or sterilization instructions will consistently reduce contamination.

Despite the recent out breaks, FDA officials say the risk of acquiring an infection from a reprocesses medical device is low.

“This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them,” William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a statement.

Sen. Patty Murray (D-Wash.), who earlier this week asked FDA Commissioner Margaret Hamburg to complete a full review of the FDA’s pracitices regarding duodenoscopes, said she hopes the spread of superbugs can be avoided with this new guidance. 

“When someone gets sick, they must be able to trust not only their doctor to prescribe the best treatment, but also the FDA to ensure their treatment is safe and effective,” she said in a release. 

She said she will continue to monitor the FDA as it reviews why these infections occur and what can be done to prevent them.