A nearly year-long international investigation into medical device safety by 252 journalists from 36 countries representing 59 media partners has concluded. The intense examination looked into how medical devices are tested, approved and monitored by various regulatory agencies. The results will forever change the world of medical device manufacturing.
The International Consortium of Investigative Journalists (ICIJ) 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 United States Food and Drug Administration (FDA) over a 10 year period.
The FDA acknowledged that its method of compiling data is both inconsistent and incomplete. What makes this shocking is two-fold:
First, the FDA has the world’s most sophisticated reporting system for medical device adverse events. If the FDA’s method of compiling adverse event data is flawed, so are the systems of the regulatory agencies of other countries.
Second, health care providers and patients rely on this reporting system, and how the FDA responds to adverse events, in making medical decisions that involve life and death.
Medical device manufacturers rely on this reporting system to make decisions regarding liability that can go to the core of a company’s fiscal viability. If this reporting system of medical device adverse events is unsound, then so are those decisions made in reliance upon that system.
As a result the ICIJ findings, the organization has created the International Medical Device Database (IMDD). The IMDD is a research tool that is available for public use.
To date, that database has gathered information from more than 70,000 medical device recalls from 11 countries (USA, Canada, Switzerland, Spain, Australia, Finland, Lebanon, Netherlands, Peru, India and Mexico).
The IMDD is presently current through October, 2018, and can be accessed at https://medicaldevices.icij.org. You can search by device or by manufacturer.
From the perspective of a patient or health care provider, this information portal can be invaluable in deciding whether to utilize a particular medical device.
From the perspective of a medical device manufacturer, the information available from the IMDD can cause significant changes, such as labelling changes, that may reduce legal liability in the event a device is subsequently claimed to be defective.
The reason for this is that in a negligence lawsuit, one key element of the case will be what the medical devices manufacturer knew or reasonably should have known. If such information was readily available and not utilized, it would seem that liability for an adverse event would be more likely.
It is now more critical than ever for Medical Device Manufacturers to assess their technology stack and ensure that their Enterprise Resource Planning (ERP) platform is flexible enough to meet the demands of a shifting regulatory environment.
With the forthcoming FDA response, success will depend on a companies' ability to adapt quickly, and address regulatory change within their technology, process and people. Is your company prepared to weather the upcoming storm?