In 2012, FDA issued its report “Strengthening Our National System for Medical Device Postmarket Surveillance,” which outlines four key steps for creating a national surveillance system that would quickly identify poorly performing devices. The system would also generate real-world evidence of the benefits of such technologies of devices on the market and support future device development. The four steps are:
- Establish a unique device identification system and promote its incorporation into electronic health information.
- Encourage the development of national and international device registries* for selected products.
- Modernize adverse event reporting and analysis.
- Develop and use new methods for evidence generation, synthesis, and appraisal.
In order to inform the implementation of recommendations from FDA’s report, The Pew Charitable Trusts, the Blue Cross Blue Shield Association, and the Medical Device Epidemiological Network, or MDEpiNet, Science and Infrastructure Center at Weill Cornell Medical College worked together to develop recommendations on the use of registries that would improve the nation’s post-market surveillance system. In the past year, a series of facilitated meetings were convened in which diverse stakeholders discussed major objectives for optimizing the use of registries that can collect data over time on patients who are exposed to a specific medical device or type of device. Registries can support patient care decisions and improve outcomes by providing health care professionals with reliable information on the performance of a technology, and can highlight factors that affect the data collected, such as patient selection or operator experience. Registries can also go further than the premarket trials necessary for FDA approval by allowing for the evaluation of devices in wider populations and practice settings.
SOURCE: Pew Trusts