In a hearing on the FDA role in protecting patient safety as part of the medical device approval process, US Senator Herb Kohl, chairman of the Senate Special Committee on Aging, highlighted problems with the process, letting FDA and industry know that he and his committee would be watching reform efforts closely.

The panel featured testimony from Marcia Crosse, PhD, director of the Health Care Team at the Government Accountability Office (GAO). Crosse’s testimony outlined the preliminary findings of an ongoing GAO investigation into FDA’s management of medical device review, postmarket monitoring, and recall processes.

“Concerns persist about the effectiveness of the 510(k) process in general, including its ability to provide adequate assurance that devices are safe and effective,” Crosse said in her testimony. “Gaps in FDA’s postmarket surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled.”

Kohl opened the hearing by emphasizing that “the FDA must constantly strive to maintain a delicate balance between safety and innovation. The drive toward getting new technologies to market shouldn’t be done at the risk of patient safety,” Kohl said. “Faulty medical devices, especially those implanted in the body, can have a disastrous impact on the health of those who use them.”

For more on the hearing, check out Sherrie Conroy’s blog at http://blog.medicaldesign.com/perspectives/. Click on “Senate hearing takes device approval process to task, advocating for further reforms.”