The last several years have brought many changes to the medical device quality and regulatory...
The quality community received a sobering reminder recently of the importance of their work when Southwest Airlines flight 1380 had an engine suddenly explode soon after takeoff. While the pilot was able to safely land the crippled plane, there was one passenger fatality – the first on a United States airline since 2009. There will of course be a detailed investigation of the accident’s cause, including review of the design and maintenance of the faulty engine.
While there are some significant differences between the medical device and aerospace communities regarding the applicable standards and practices, this should be seen as a reminder of the importance of maintaining high standards for quality. It is tempting to be lulled into complacency while performing day to day operations, but each product or device has an end user that must be remembered.
According to the FDA website, “Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions.” While not every suspected malfunction is preventable, and the majority are relatively minor, there is no shortage of incidents where a malfunctioning device resulted in patient deaths. In 2017, Mylan issued a recall after 228 reports were filed regarding failure of the EpiPen device to deploy correctly. At least seven fatalities occurred as result.
Audits, both internal and external, training, and day to vigilance can often be seen as a hassle or unnecessary expense, but the stakes are high for medical device manufacturers, and our end users place a trust in those who are responsible for the quality of the products on which they rely. The goal of every quality system and process should be to ensure that trust is well placed.
Sources:
https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm
https://www.nytimes.com/2018/04/17/us/southwest-airlines-explosion.html
