Since 1999, the Food and Drug Administration (FDA) has implemented an Alternative Summary Reporting program for medical device manufacturers. Under this program, medical device makers had the authority to report incidents of patient injuries, illnesses, and even deaths due to device malfunctions only to the FDA and not to the public. The Alternative Summary Reporting system has been a topic of controversy for the last 20 years. The FDA recently announced it is disbanding the program and opening past records to the public.
The Alternative Summary Reporting program, or the ARS, instructed medical device manufacturers to submit adverse events related to their products to the FDA. The FDA would approve certain adverse events for the ARS instead of the typical adverse event reporting process, which would have released the information to the public. Cases involving mechanical heart valve deaths, multiple serious injuries, or explosions or fires were excluded from the ARS, but almost every other type of adverse event qualified.
The ARS acted as an alternative to MAUDE, the Manufacturer and User Facility Device Experience, reporting system. MAUDE is a system that keeps track of adverse events that manufacturers, health care professionals, patients, and consumers report to the FDA. All information submitted through MAUDE becomes part of public record. This allows doctors and patients to review the health and safety record of a certain medical device. Many did not realize that since 1999, certain adverse events qualified to go through the private ARS instead. The FDA has hidden ARS reports from the public eye for two decades.
On March 7th, 2019, Kaiser Health News published its findings after an investigation into the ARS database. The report showed that since 2016, over 1.1 million incidents have gone into the ARS rather than being disclosed to the public. Although manufacturers must report adverse events that result in death to MAUDE, they can keep serious injuries and major malfunctions quiet by passing them through ARS instead. Information that may have been able to prevent thousands of patient injuries has been concealed using the ARS from doctors, hospitals, and patients for years.
According to the FDA, the ARS has serious injury reports relating to over 100 medical devices. Many of these devices are medical implants or devices used in surgeries. Involved devices appear to include mechanical breathing machines, balloon pumps, and surgical staplers. When asked about the ARS, the FDA simply said that the program recorded “well-known and well-documented” adverse events. Yet most physicians were unaware of the obscure database until recently. Engineers in charge of medical device safety were also in the dark.
In May 2019, the FDA’s principal deputy commissioner and the device center director announced their decision to end the Alternative Summary Reporting program. They said the decision was meant to increase transparency about the safety of one specific medical device – breast implants. The FDA will end ARS exemptions for cardiac defibrillators, tooth implants, and pacemakers. The FDA also pointed out that it began shutting down the program in 2017, revoking exemptions for saline breast implants and blood vessel balloon pumps. The public will have access to decades of concealed medical device adverse events records in the coming weeks.