One of the greatest challenges facing global healthcare systems is patient safety. Medical error has now become the third leading cause of death in North America, right behind heart disease and cancer. These adverse events are devastating for patients and their families – and they are very costly to the organization and the healthcare system.
In April 2018, the US Federal Drug Administration (FDA) released its Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, which describes recent actions the FDA has taken to enhance device safety and outlined their vision for how the agency can build on these initiatives to further assure the safety and effectiveness of medical devices.
More recently on November 20, 2018, the FDA has released a Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety. The updates include a focus on several key actions to create a more robust medical device safety net for patients through better data. They also announced several new steps related to important health devices that impact women, including surgical mesh for transvaginal surgical repair.
Days later the International Consortium of Investigative Journalists (ICIJ) released reports on the first-ever global examination of the medical device industry. The “Implant Files” is a global investigation that tracks the harm caused by medical devices that have been tested inadequately or not at all. To access their International Medical Devices Database, please click here.
SCAN Health is an International Knowledge Translation Platform funded by the Government of Canada's Networks of Centres of Excellence to accelerate knowledge translation and address key problems, challenges and opportunities of high strategic importance for health systems in Canada and around the globe. By mobilizing supply chain best practices to track health products and processes to patient outcomes we can significantly reduce medical error, increase health system sustainability and drive economic growth for companies globally.