Medical device manufacturers should track and report device malfunctions, serious injuries, and deaths that occurred after device market approval. Postmarketing requirements also include post-approval surveillance studies. FDA has not developed any guidance on postmarketing surveillance studies yet. Nevertheless, agency actively funds development of new postmarketing surveillance approaches, and one of the facilitators for surveillance is Unique Device Identifier (UTI). Every single medical device is marked with UTI by FDA before reaching US market, so, when such device is used in a patient, UTI is recorded in electronic health record so that every distinct device could be monitored properly and tracked back to the manufacturer is a case of any safety or efficacy concerns.
Results of one of such postmarketing studies initiated and funded by FDA were published in NEJM recently. The study was conducted to evaluate the safety of Mynx, a vascular closure device used for hemostasis in percutaneous coronary intervention (PCI). Data from 73124 patients in whom Mynx had been used after PCI were analyzed. Adverse events related to Mynx use were prospectively recorded. This information was obtained from The National Cardiovascular Data Registry (NCDR®). The registry contains epidemiological data regarding diverse cardiovascular diseases, including information about PCI outcomes in the US.
Adverse events incidence rate after vascular closure with Mynx was compared to the corresponding rates after vascular closure with alternative devices. Data analysis revealed that Mynx is less safe compared to other devices in terms of risks for vascular complications and bleeding as well as the frequency of haemo transfusions. Confirmatory analysis was performed on data from another 48922 subject with virtually similar results. Extensive use of electronic tracking and databases allowed researchers to identify and confirm Mynx’s safety issues only in 12 months, and this approach is likely to become one of the preferred FDA approaches to postmarketing surveillance for medical devices.