This is welcome news in the wake of that UCLA superbug scare: The FDA has issued new guidance that requires the manufacturers of reusable medical devices to thoroughly test and label their devices to make sure patients accidentally exposed to dangerous pathogens, RAPS reports.
The current regulations around hospitals informing patients of pathogen risks are actually quite lax, Bloomberg points out. But outbreaks like the CRE scare – which happened because a reusable duodenoscope that was difficult to clean infected a number of patients – are bringing these regulatory issues to the forefront.
The new FDA document, called Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, includes the following criteria, as RAPS points out:
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Those criteria are:
- Labeling should reflect the intended use of the device.
- Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
- Reprocessing instructions should indicate the appropriate microbicidal process for the device.
- Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
- Reprocessing instructions should be comprehensive.
- Reprocessing instructions should be understandable.
Such guidelines may have an interesting downstream effect on the medical device industry – will patient fears, once informed of the risks, reduce use of reusable machines? It remains to be seen. Bloomberg continues on the general lack of information disclosure to patients:
But little of this information reaches patients or the general public. The FDA, which regulates medical device makers, didn’t issue an alert warning that the contaminated endoscopes implicated in the UCLA outbreak may be impossible to fully clean until the day after news broke. On Wednesday, in an update to that alert, the agency disclosed that manufacturer Olympus didn’t have proper FDA clearance to market the specific model used at UCLA. These specialized devices, known as duodenoscopes or ERCP endoscopes, are inserted through the mouth and threaded through the gastrointestinal tract to reach small ducts in the digestive system.
The agency said it has no evidence that the lack of clearance was linked to infections, which have also been associated with other brands of the devices. Olympus spokesman Mark Miller said that in 2010 the company made changes to a model of scope that was already cleared by the FDA and Olympus “determined” that the new model didn’t require a separate approval. The FDA asked for a new application in March 2014, said agency spokeswoman Leslie Wooldridge, and the company submitted one in October. The FDA said it’s not pulling the scopes from the market because that could lead to a shortage of the devices, which are used in 500,000 procedures in the U.S. each year.
