Product News and Recalls

Why Was the FDA Keeping a Secret Database of Medical Device Injuries?

secret FDA database of medical device errors exposedAccording to the mission statement published on its website, the FDA “is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”

One has to wonder then how an agency charged with such an important task can justify the existence of a database of medical device injuries that was such a closely guarded secret that few – even within the agency itself – knew of its existence.

The fact that that the contents of such a database are finally being made public fails to excuse its secret existence in the first place. Yet, for almost 20 years, reports of malfunctions and injuries tied to defective medical devices had been redirected away from public eyes and into this database instead. The result was some 5.7 million reports hidden from view from the doctors, patients, and regulators that could have used that information to make better decisions to keep themselves, their patients, and the American people safe.

In some cases, the number of reports that remained hidden per device stretched into the thousands. For example, based on public numbers, only 84 injuries or malfunctions of the Covidien surgical stapler were known to have occurred. However, close to 10,000 incident reports related to the device existed behind the walls of the agency’s internal database. The only way to gain access to these additional reports was to file a FOIA, or Freedom of Information Act, request. While FOIA may exist to lend a certain feeling of transparency between the government and its people, requests made under the legislation can take up to two exhausting years to process.

The full contents of the database – at least according to the agency that kept its existence secret in the first place – have been available since June of this year. Since then, everyone from patients and doctors to lawyers and even FDA regulators themselves have been pouring over the records to fill in gaps that they quite literally needed to know yesterday.

One has to wonder what purpose such a database would serve other than to protect the profits and reputations of the companies whose failures are documented within it.