The FDA’s Center for Devices and Radiological Health is working to improve its monitoring of devices already in the field. According to Medical News Today:
Under the “Postmarket Transformation Initiative” the agency said it will develop an electronic reporting system for adverse reactions, standardize the identification process, obtain medical records of patients who use the devices, and increase communication with professional organizations and the medical device industry (CQ HealthBeat, 1/20). According to the Wall Street Journal, the program was addressed in an FDA report prepared internally that critiqued the agency’s handling and safety practices of medical devices such as defibrillators and pacemakers.
The report concluded that the current monitoring system at FDA’s Center for Devices and Radiological Health lacks “quality information” on approved devices, while at the same time the volume of information received “exceeds the center’s ability to consistently enter or review the data in a routine matter.”
It seems like the problem is this: in order to actively monitor the multitude of postmarket medical devices, the FDA needs to collect and process way more information than it can handle. They either need an army of data-crunchers or some really good database software.
Any IT entrepreneurs reading?
More from Medical News Today
Link to the FDA CDRH page outlining the details of their study and plans for action.
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