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In this Saturday, August 25, 2018 photo, Medtronic and Boston Scientific Sales Representatives are working on their booth at the Neuromodulation Conference in New York. For years, medical device manufacturers and doctors have introduced spinal cord stimulators as a panacea for millions of patients suffering from a wide range of intractable pain disorders. However, according to an Associated Press survey, devices, surgically placed inside the back, that use electrical currents to block pain signals before reaching the brain are more dangerous than many patients understand this (Photo AP / Mary Altaffer) The Associated Press
More than 250 journalists from 36 countries representing more than 50 media organizations, including The Associated Press, have spent nearly a year reviewing the safety of medical devices, including 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 injured and nearly 83,000 deaths believed to be related to medical devices had been reported to the Food and Drug Administration. US Drug Administration over a period of 10 years.
The US agency has the most sophisticated adverse event notification system in the world, but recognizes that its data is inconsistent and incomplete.
The probe was anchored in an analysis of more than 8 million device-related health records, including reports and recalls of deaths and injuries.
AP and ICIJ used the FDA's MAUDE database to analyze device issues that are more than three decades old. They eliminated reports from literature studies or university studies and largely focused on reports from 2008 to 2017. For some devices, they also analyzed the most recent data available for the first time. semester of 2018.
To analyze the MAUDE data, the partners have standardized the names of the device manufacturers as much as possible – correcting misspellings, correcting irregularities and tracing the subsidiaries back to their parent company. Cases were followed on the date they were reported to the US Health Agency. Reporters also used the FDA's device approval data sets to help understand the issues related to the devices being examined as part of the agency's less stringent approval process, which covers the the vast majority of devices entering the market.
The FDA's product categorization system was used to group similar devices together for their general purpose. Spinal cord stimulators, which are at the heart of PA reports, all belong to one product category; in the case of other devices, several categories of products have been combined to encompass the universe of devices. For example, insulin pumps belong to five product categories; breast implants fall in half.
Using an automatic learning algorithm to search millions of FDA reports, the notification group also uncovered 2,100 cases over a five-year period during which people died, but their deaths were classified wrongly in the category dysfunction or injury. Due to incomplete and inconclusive data, only 220 of these could be directly related to the medical device.
The Global Reporting Team has completed more than 1,500 access to information requests and interviewed patients, physicians, manufacturers and regulators around the world. He also reviewed whistleblower claims in federal prosecutions, studied academic papers and reviewed the results of device tests.
In the absence of such global resources, ICIJ has created the International Medical Device Database, a publicly available research tool, which includes more than 70,000 reminders and safety advisories from 11 country.
Copyright 2018 The Associated Press. All rights reserved. This material may not be published, disseminated, rewritten or redistributed.
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