More than 250 journalists in 36 countries representing more than 50 media organizations, including The Associated Press, spent nearly a year examining the safety of medical devices, such as how they are tested, approved and monitored by regulatory agencies.
Led by the International Consortium of Investigative Journalists, the group found that more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices had been reported to the U.S. Food and Drug Administration over a 10-year period.
The U.S. agency has the most sophisticated adverse event reporting system in the world but acknowledges that its data is inconsistent and incomplete.
Anchoring the probe was an analysis of more than 8 million device-related health records, including death and injury reports and recalls.
AP and ICIJ used the FDA's Manufacturer and User Facility Device Experience database, or MAUDE, to analyze device problems, going back more than three decades. They eliminated reports that stemmed from academic literature reviews or studies, and largely focused on reports from 2008 through 2017. For some devices, they also analyzed the most-recent data available for the first half of 2018.
To analyze the MAUDE data, the partners standardized as much as possible the names of device manufacturers - correcting misspellings, fixing irregularities and tracing back subsidiaries to their parent companies. Cases were tracked by the date they were reported to the U.S. health agency. Reporters also used FDA device approval datasets to help understand the issues involving devices reviewed under the agency's less stringent approval process, which covers the vast majority of devices that enter the market.
The FDA's product categorization system was used to cluster similar devices by their general purpose. Spinal-cord stimulators, a focus of AP's reporting, all fall into one product category; in the case of other devices, multiple product categories were combined to encompass the universe of devices. For instance, insulin pumps fall into five product categories; breast implants fall into two.
Using a machine-learning algorithm to search the millions of FDA reports, the reporting group also found 2,100 cases over a five-year period in which people died but their deaths were misclassified as malfunctions or injuries. Due to incomplete and inconclusive data, only 220 of those could be directly linked to the medical device.
The global reporting team made more than 1,500 Freedom of Information requests and interviewed patients, doctors, manufacturers and regulators around the world. It also examined whistleblower claims in federal lawsuits, studied academic papers and scrutinized the outcomes of device trials.
Because no such global resource exists, ICIJ created the International Medical Devices Database, a publicly available research tool which gathers more than 70,000 recalls and safety notices from 11 countries.