Medical Device Postapproval Safety Monitoring: Where Does the United States Stand? | Journal Scan
- Rajan PV, Kramer DB, Kesselheim AS.
- Circ Cardiovasc Qual Outcomes 2015;Jan 6:[Epub ahead of print].
The following are 10 important points to remember about currently available and still evolving medical device postapproval safety monitoring:
- Postapproval (postmarket) device surveillance falls into three main categories: passive surveillance, active postapproval surveillance of prospective clinical studies, and active postapproval surveillance of medical product registries.
- Postapproval passive surveillance consists of Medical Device Reporting (MDR), through which manufacturers, physicians, and consumers submit reports of device-associated malfunctions, injuries, or deaths. Manufacturers and hospitals are mandated to do so, while patients and healthcare providers are not legally required to submit reports. All submitted reports are publicly available via the Manufacturer and User Facility Device Experience (MAUDE) database. The Food and Drug Administration (FDA) receives approximately 100,000 reports annually through this system.
- A secondary source of passive surveillance is the FDA’s Medical Product Safety Network (MedSun). MedSun consists of approximately 280 hospitals and other facilities specifically trained in collecting and submitting adverse event reports. FDA receives approximately 5,000 MedSun reports annually.
- Despite positive outcomes from the passive surveillance system, the system is far from perfect due to the following limitations: missing information about device identification, missing critical information on the adverse events, late and inconsistent submission, double counting of duplicate reports, bias in the distribution of adverse event reports, and underreporting. One fundamental drawback of passive surveillance is the lack of a denominator.
- Postapproval device registry surveillance could use a distributed data system to actively and prospectively collect and store data on individual exposures to specific devices. De-identified administrative or claims data in such a model are institutionally maintained and sourced by a central hub to monitor the safety of regulated products. The advantages of a registry-based surveillance system are large sample size and diverse sets of patients, which allow for generalizability.
- Until registries are consistently linked to comprehensive clinical information, their data will be susceptible to confounding, which can impair assessment of clinical effectiveness of medical devices.
- The FDA is working to develop a framework to encourage manufacturers and other organizations to build and maintain local registries, which could collate device data in an accurate and timely fashion. Because the FDA cannot mandate registry participation by institutions, the extent of voluntary institutional participation remains to be seen.
- The proposed Global Unique Device Identification Database will place individual labels on all devices and device packages to be able to track clinical use and distribution. It will allow linkage of the unique device identifier (UDI) to premarket approval reports or trade and manufacturer information, and automatically report adverse events in real time.
- Partnership between the FDA and the Centers for Medicare and Medicaid Services may provide the necessary infrastructure to encourage and support hospital and institutional registry initiatives.
- Like the FDA, many European policy advisers are seeking expanded use of registries in collecting device data. The FDA should actively work with foreign authorities to stabilize and standardize registries for the use in a future globalized distributed data system.
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