Under pressure to strengthen medical device monitoring, the FDA announced 3 upcoming public workshops covering topics around medical device post-market surveillance.
Taking place next month, the trio of meetings will cover ways to strengthen the FDA’s medical device surveillance systems, priorities in surveillance improvement and how to leverage registries to improve monitoring through a device’s total life-cycle.
The FDA been in the hot seat in recent months as a slew of high-profile medical device recalls, including St. Jude Medical’s (NYSE:STJ) Riata defibrillator leads and DePuy Orthopaedics’ metal-on-metal hip implants, have some doubting the agency’s ability to protect the public from medical devices once they hit the market.
On September 10 the FDA will host an all-day meeting entitled "Strengthening the National Medical Device Postmarket Surveillance System," during which time the federal watchdog agency will solicit public feedback on strategies for boosting agency monitoring of devices already on the U.S. market.
On September 11 the agency will hold an all-day public workshop entitled "The Medical Device Epidemiology Network as a Partnership for Building Global Medical Device Epidemiology and Surveillance Capabilities," which will focus on setting strategic priorities and developing an action plan for "improving regulatory science and the public health."
On September 12 and 13 the FDA will hold another public workshop entitled "Leveraging Registries with Medical Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle," for discussing best practices for using registries for postmarket surveillance, clinical studies, and evidence appraisal.
Agendas have not yet been released for the meetings, but registration is open until September 5. The events will also be webcast, according to the FDA notices.
The renewed push for post-market safety comes in part from physician pressure following a study, authored by prominent cardiologist Dr. Robert Hauser and published last month, linking St. Jude Medical’s (NYSE:STJ) recalled Riata defibrillator lead with 22 deaths.
Hauser has been an active voice in criticizing what he sees as fundamental issues with the FDA’s oversight of medical devices, namely the fast-track 510(k) approval process that allows devices on the market without prior clinical studies and the lack of mandated post-market surveillance for high-risk devices.
In addition, medical device makers can’t detect product defects until a device has already affected thousands of patients, according to Hauser.
"Patients in the U.S. continue to be exposed to under-performing and potentially hazardous medical devices after they have been approved by the FDA, despite multiple recalls and some tragic adverse events," Hauser wrote in an article for the New England Journal of Medicine.
The agency has been under the gun to boost its post-market surveillance efforts as high-profile recalls have spurred requests from legislators and citizen advocates.
A report issued last month warned that the number of software-related medical device recalls is growing rapidly and that the FDA needs to update its surveillance systems to better monitor and track the issues.
