The Food and Drug Administration (FDA) has issued an extensive report on how the agency aims to modernize is surveillance of medical devices to help ensure patient safety and increase manufacturer liability. The report comes in the wake of litigation over injuries caused by faulty medical devices from metal-on-metal hip implants to transvaginal mesh.
The report, commissioned by the FDA and prepared by an expert panel of representatives from agencies, organizations and corporations, involves the implementation of the agency’s new unique device identifiers, or UDIs. The system is intended to assign a unique identifier to medical devices by the year 2020. The agency also aims to resolve challenges with electronic health records so that different types of records can communicate but not cause more red tape for providers.
The FDA report does say there are challenges to building a national surveillance program and implementing the changes, such as cost, which the agency estimates would be about $200 million to start. The panel recommends that the surveillance system begin with a two-year stage of pilot projects followed by a five-year phase of implementation.
Though costly, the benefits would be far-reaching, in particular in regards to patient safety and medical device maker liability. For example, improved tracking could help better identify adverse events or efficacy issues with specific medical devices, which would help providers make smarter decisions about which devices to use.
For instance, had a surveillance system for medical devices been in place a decade ago, health care providers could have better identified the higher than expected failure rate of metal-on-metal hip implants, or the “not uncommon” yet serious complications associated with transvaginal mesh for the treatment of pelvic organ prolapse.
The FDA says it will accept public comments on the report and that a separate task force report will be released in the months to come to further inform the public of this effort to improve medical device oversight.
Source: Law 360