Reuters reports that the FDA proposed a new plan to speed up medical device approvals. The program is called the Expedited Premarket Approval Application Program, and it is in theory designed for patients who have exhausted all other available treatment options. It is not a new pathway to market, but instead a “change in approach.”
The reason the FDA gives for the program to respond to criticisms that the already existing process for device approval is too slow, and that it delays patients’ access to potentially life-saving products. Delays in treatment are certainly a legitimate concern, and properly tested medical devices that are safe and can save lives absolutely should be used in medical treatment. The goal here is a noble one. But there are also serious risks involved that will have to be addressed as the program is rolled out.
Medical Device Reporting
The FDA admits that it receives hundreds of thousands of reports each year of suspected medical device malfunctions, sometimes resulting in serious personal injury or even death. The program that tracks these malfunctions is called “Medical Device Reporting” or “MDR.” Manufacturer, device user facilities, and importers of medical devices are required to report malfunctions, but other malfunctions are only reported on a volunteer basis. In other words, there are likely more malfunctions than the reported numbers. These malfunctions happen under the old, slower approval process for these products.
Increase in Medical Device Death and Injury
In 2012 The Telegraph reported that deaths and serious injuries involving medical devices were up 29% in the United Kingdom. The number of fatalities reported had increased 50% in just two years. Investigations showed that 1 out of 3 of malfunctions turned out to be the fault of the manufacturers of the devices, and that one 1 out of 4 of the malfunctions involved what they call “active and inactive implants.” Active and inactive implants include extremely common devices like pacemakers, replacement hips, gastric bands, and contact lenses. Fifteen percent of the malfunctions involved surgical equipment, and another fifteen percent involved devices like life support machines and incubators.
Medical Device Recalls Up in the United States
The FDA recently released a report detailing medical device recalls between 2003 and 2012. The results are staggering. It shows that the number of annual recalls of such devices increased by a full 97% during the studied time frame. So the number of recalls nearly doubled in a decade. The report also showed that the “most frequent causes for recalls are related to device design, software, and non-conforming material or component issues.”
What this means is that there is a serious problem. While the purpose of medical devices is to prevent injury and save lives, all too often mistakes are made and people wind up hurt. This has been going on for years. A push now to speed up an approval process that already lets flawed devices slip through could lead to more dangerous devices being used on ill patients. The FDA needs to be cautious going forward so as to not allow haste to hurt more patients than it helps.