Medical Device Contract Manufacturing: Medical Device Reprocessing

medical device reprocessing

The U.S. Food and Drug Administration today announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. The new recommendations are outlined in a final industry guidance aimed The suit states, however, that the device-maker had responsibilities to patients such as Gomez. “The manufacturer must ensure that the validated reprocessing protocol is disseminated to medical facilities and professionals,” the suit states. After issuing draft guidance in 2011 and considering hundreds of comments, FDA released its finalized guidance on medical device reprocessing on Thursday. This guide is meant for cleaning, disinfecting, and sterilizing reusable devices that are reprocessed The FDA issued a final guidance on March 12, which lays out new guidelines for reprocessing of reusable medical devices (PDF). The guidance is aimed at medical device manufacturers and calls for them to consider challenges to cleaning the devices early in especially devices that pose a greater risk of infection, according to a news release. The document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” includes recommendations medical device manufacturers "Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low," William Maisel .

The suit states, however, that the device-maker had responsibilities to patients such as Gomez. "The manufacturer must ensure that the validated reprocessing protocolis disseminated to medical facilities and professionals," the suit states."Olympus failed and has noted that the majority of devices are used without incident and to the benefit of patients. However, FDA's latest guidance document, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, seems to be aimed at The new FDA document, called Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, includes the following criteria, as RAPS points out: Such guidelines may have an interesting downstream effect on the medical device “Medical devices intended for repeated use are commonplace in health care settings,” the FDA statement read. “They are typically made of durable substances that can withstand reprocessing, a multi-step process designed to remove soil and contaminants .

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