This past weekend, following the work of nearly a year, a large group of journalists published a report on the safety of medical devices via The Associated Press, a group member. The International Consortium of Investigative Journalists (ICIJ) comprises more than 250 journalists in 36 countries from more than 50 media groups. The report highlighted injuries from spinal cord stimulation implants, but the broader purpose of the ICIJ’s efforts was to examine the safety of medical devices in general. In particular, the report casts a harsh light on the U.S. Food and Drug Administration’s (FDA) medical device testing, approval, and monitoring processes. Today, Monday, November 26, the FDA announced changes to modernize the agency’s 510(k) clearance program to review the safety and effectiveness of medical devices.
According to the ICIJ report, spinal-cord stimulators are among the sales front-runners in the $400 million medical device industry. Manufacturers and physicians present e-stim implants as alternatives to opioid painkillers and for elderly people with chronic pain. From a study of more 1.7 million medical injury reports submitted to the FDA, the ICIJ found that spinal-cord stimulators accounted for the third-highest number of reports, more than 80,000, in the past ten years. Hip replacements and insulin pumps were the only devices included in more reports than the stimulators.
The ICIJ report focused on testing and found that the FDA “puts people at risk by pushing devices through an abbreviated approval process, then responds slowly” when it comes to forcing companies to correct flawed products that may even be life-threatening. The report also cited manufacturer fees paid to doctors and hospitals which, though not illegal, were not disclosed to patients who might have questioned the enthusiasm with which the stimulators were offered as an alternative pain control treatment.
The FDA did not clarify the specifics of its new approval and clearance processes but pointed to “the increasing complexity of rapidly evolving technology” as the primary cause for the transition. The 510(k) process was instituted in 1976 to fix what was then viewed as an archaic and slow process. The regulation allowed faster and easier passage of devices that deemed similar to previously-approved products that were considered to do no harm. The gist of the FDA’s policy shift, as revealed so far, is to test submitted devices against new patient safety and performance technology standards. The other side of the FDA’s shift will be to review previously approved devices to be sure they still measure up to more advanced standards.
The timeline for the ICIJ report and the FDA announcement provide a dramatic juxtaposition, but the greater perspective of improved medical device testing and monitoring is encouraging. The prospect of safer medical devices is a common benefit that deserves high priority attention.