The FDA (U.S. Food and Drug Administration) has just released over a decade’s worth of adverse event reports received from medical device manufactures, which total over six million between 1997-2019. This comes after last week’s official shutting down of its Alternative Summary Reporting Program – something that the FDA has been in the process of doing for months.
Many have labelled the program as an opportunity for countless manufacturers to hide their faulty and dangerous devices and conceal defects from the general public, as it allowed certain manufacturers exemptions to the standard reporting rules around adverse events or faults. This included 108 exemptions since the program’s inception in 1997, allowing the exempted manufacturers to submit summaries of adverse event reports on a quarterly basis, as opposed to every occurrence. Some of these included manufacturers of dental implants, implantable cardiac defibrillators and pacemaker electrodes.
Dr. S. Lori Brown, formerly from the FDA said the program’s closing is a “victory for patients and consumers.”
“The No. 1 job of the FDA — it shouldn’t be ‘buyer beware’ — is to have the information available to people so they can have information about the devices they are going to put in their body,” she said.
In their official statement, the FDA said “First, we have formally ended the Alternative Summary Reporting (ASR) Program. Under this program, manufacturers of certain devices could request an exemption from the requirement to file individual medical device reports for certain events that were well-known and well-established risks associated with a particular device and to instead submit quarterly summary reports of such events.”
“Since the program’s inception in 1997, the FDA granted 108 such exemptions to individual manufacturers for certain well-known events associated with specific devices, which were often already described in the product labeling available to health care professionals and patients. The ASR Program allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks.”
The program’s shutdown is, according to the group, an effort to “increase transparency in medical device reporting”. The adverse event data is now available to the general public here, via the FDA’s website. It also notes in its official statement that the reports are only one source of data collection when it comes to devices.
“This type of reporting system has limitations, including the potential submission of incomplete, inaccurate, untimely, duplicative, unverified or biased data. Modernized, active surveillance that utilizes real-world data is the future of medical device safety signal detection, and is a primary focus for the FDA.”
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