FDA reminds providers of post-market surveillance responsibilities

The FDA posted an advisory to its website this week, reminding healthcare providers that it conducts post-market surveillance on medical devices, including equipment used in mammography.

Following reporting requirements established by both the Safe Medical Device Act of 1990 and the Medical Device Reporting (MDR) rules of 1995, the FDA explained that this reporting helps with the identification, monitoring, and correction of various problems. Reporting also helps check up on past corrective actions to see if they were sufficiently effective.

“It is essential that device manufacturers, importers, and user facilities understand both their responsibilities and how to properly fulfill their reporting obligations,” the advisory read.

According to the FDA, two of the most important sources of medical device reporting are the device user facilities and healthcare professionals; facilities because that’s where patients interact with the devices, and healthcare professionals because of their hands-on interaction with the devices.

Suspected device-related deaths must be reported to the FDA, the advisory noted, while device-related significant injuries must be reported to the manufacturer (or, if the manufacturer can’t be reached, the FDA). Radiation dose and image quality are two common areas where problems may occur.

Voluntary reports are also welcomed, the FDA said.

“The FDA encourages device user [facilities], health care professionals, and patients to electronically submit voluntary reports of medical device adverse events or product problems through MedWatch,” the advisory read.

The FDA has been posting these advisories in recent months to help providers make sure they’re doing everything expected of them in regards to their medical devices. In December, the agency posted a reminder about maintaining PACS, warning that facilities could face penalties or potentially lose important data if they do not comply.