When doctors use various medical devices, all parties involved expect the devices to function as intended. Unfortunately, that does not always happen. In fact, there have been numerous instances of medical devices failing for doctors and patients, leading to severe injuries or deaths to patients. However, what has been even more disturbing about these situations is the discovery that the FDA has given manufacturers of medical devices an exemption, allowing them to list reports of malfunctions in a database that is hidden from viewing by doctors and the public.
To many doctors and others in the healthcare field, this feels much like a cover-up. According to recent investigations, the FDA has a large repository of incident reports related to medical device malfunctions, with the number currently surpassing 1.1 million dating back to 2016. Known by the FDA as an “alternative summary reporting” repository, these incidents are reported here rather than in the database known as MAUDE, which is open to doctors as well as the general public for viewing.
At last count, the hidden database had reports stating malfunctions for over 100 different medical devices, ranging from surgical staplers, balloon pumps implanted in veins, mechanical breathing machines, and many more. According to FDA officials, reporting standards were changed in 2017, allowing for an increased amount of voluntary reporting by medical device manufacturers into the little-known database. But according to many healthcare legal experts, the new reporting program is so obscure that not only do most doctors and engineers not know of its existence, but in fact a former FDA commissioner also admitted he too had no knowledge of the program.
While many doctors agree they as well as the public have a right to view these reports and know about possible malfunctions related to medical devices, the FDA has continued to create more opportunities for manufacturers to be granted reporting exemptions. In general, these new exemptions have been given specifically to manufacturers of medical devices that have been the subject of numerous personal injury and wrongful death lawsuits, such as pelvic mesh implants as well as cardiac defibrillators.
However, as requests for transparency within the FDA have gained momentum over the past year, the agency is gradually allowing access to various reports contained within hidden databases. Yet even when an individual files a Freedom of Information Act request with the FDA, it often takes as much as two years to get a response.
While the FDA states that by changing its reporting procedures it has allowed the agency to more effectively and efficiently review the information submitted to it by the device manufacturers, others claim the agency has for all practical purposes given up its authority to oversee device manufacturers. In doing so, many doctors and legal experts argue the FDA can no longer maintain the safety of these devices, and also cannot ensure their effectiveness as well for doctors and patients.
Based on data from the FDA, the alternative summary reporting program was started as an effort to reduce paperwork within the agency, freeing up employees to more actively analyze large amounts of data more efficiently. However, as thousands of reports began to come in each month and only 15 FDA employees to review them, the agency thus began granting exemptions to manufacturers. By doing so, the agency began looking only for spikes in unusual activity, rather than reviewing each report individually.
While this reporting program has now been modified to exclude many products, it does still exist for cardiac devices. Thus, activists and others continue to demand more transparency, while the FDA continues to stand by its actions.
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