The Implant Files: A Global Investigation of Medical Device-Related Injuries

The International Consortium of Investigative Journalists (ICIJ) has published a report on the findings of a year-long, global investigation into the regulation of implantable medical devices.

Investigators collected more than 8 million device-related records, including recall notices, safety warnings, legal documents and corporate financial filings. These records include more than 5.4 million “adverse event” reports sent to the Food and Drug Administration (FDA) over the last decade; the reports describe cases where a device is suspected to have caused or contributed to a serious injury or death, or has experienced a malfunction that would likely lead to harm if it were to recur.

Medical devices that broke, misfired, corroded, ruptured, or otherwise malfunctioned after implantation or use were linked to more than 1.7 million injuries and nearly 83,000 deaths over the last decade; nearly 500,000 reports mentioned a surgery to remove a device in connection with an adverse event.

The Implant Files investigation revealed that less than 20% of the countries in the world had public data online permitting citizens to find medical device safety alerts and recalls. The ICIJ has compiled an International Medical Devices Database (IMDD) of recalls, safety alerts, and field safety notices from 11 countries. The IMDD offers a searchable portal that anyone can access to discover whether a device was flagged for a safety concern. The initial November 25, 2018, data release includes data from 11 countries; ICIJ intends to add data from more countries, flagging each update on the IMDD as it appears.

TractManager is dedicated to keeping healthcare providers and payers up-to-date on medical device safety concerns. We recognize that unbiased assessments of the peer-reviewed, published literature, performed with scientific rigor, are absolutely crucial to providing care that is both safe and effective. Our comprehensive suite of solutions includes:

  • MD Buyline’s Recall Tracker helps healthcare organizations identify, track, and manage FDA recalls and track manufacturers’ notices of defective or unsafe medical equipment, food, or drugs. Based on the organization’s purchase history, MD Buyline can reconcile purchases against inbound recalls and generate an alert when there is a potential match, allowing the purchaser to address the recall expediently.
  • Hayes Evidence Solutions (Medical Technology Directory, Health Technology Briefs, and Technology Prognosis) include critical analyses of the clinical evidence supporting regulatory approval/clearance of medical devices. The unbiased evidence assessments provided by Hayes are a “deep dive” into the published, peer-reviewed literature, performed with scientific rigor by clinical experts and PhD-level scientists.
  • Hayes Search & Summary reports and Clinical Research Responses are non-analytical, abstract-based reports designed to provide a “snapshot” of the current scope of published literature and other relevant information for technologies that have not been addressed in other Hayes Evidence Solutions reports. These reports provide a description of the technology, with FDA regulatory information, including the FDA’s Manufacturer and User Facility Device Experience (MAUDE) adverse events and recalls.

TractManager will continue to push for the use of unbiased, thoroughly scrutinized evidence to transform the delivery of healthcare. If you’re not a TractManager client, schedule a demo to experience our solutions and see how we’re not just a part of the future of care delivery; we’re helping to define it.

Beth Bontemps, Product Manager, Prognosis and News Service

Beth Bontemps joined Hayes in September 2014 as a Senior Analyst. In 2017, she was promoted to the position of Product Manager, Prognosis and News Service. She comes to Hayes from JR Associates Inc., a medical technology reimbursement consulting firm where she worked as a clinical and reimbursement consultant.

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