FDA TO TAKE HRS RECOMMENDATIONS WITH A GRAIN OF SALT
The FDA is not prepared to accept all of the recommendations put forth by the Heart Rhythm Society (HRS) on tracking pacemakers and implantable cardioverter-defibrillators (ICDs) for potential malfunctions. But the agency may incorporate some of those suggestions into its existing system, FDA sources say.
The HRS recently issued a series of recommendations for industry, the FDA and physicians to consider in revising the processes for postmarket surveillance and analysis of pacemakers and ICDs.
For example, one problem with the current system is that the existing database doesn't include every device on the market, HRS officials noted. The group is recommending that specialized forms be used in the FDA database for more complete and accurate reporting to track adverse event reports and link them with items in the device inventory, said Mark Carlson, who is on the HRS' Foundation board of directors.
But the FDA sees no need to completely revamp its existing surveillance process for the devices, Sharon Snider, spokeswoman for the Centers for Devices and Radiological Health (CDRH), told FDAnews. By making modifications to its Manufacturer and User Facility Device Experience (MAUDE) database and Medical Device Surveillance Network (MeDSuN) system, the agency foresees a more "active" surveillance system without designing an entirely new database, she indicated.