The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.
Quarterly recall events increased for the first time since Q2 2020.
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
Top reasons for recalls include software, quality and parts issues.
Moving too quickly in the product development process can lead to mistakes.
Medical device recalls were up more than 31% during Q2 2020, activity that suggests recalls will reach 1200 by the end of the year, according to Stericycle’s latest recall report.
Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.
The medical device industry is pressured to aid those stricken by the pandemic, while at the same time working to mitigate increased risks usually associated with hurried manufacturing and quality control procedures.
Being prepared significantly improves the odds that an organization will successfully manage and mitigate risk, sustain trust and loyalty, and protect and preserve their brand.
Recalls for failure are chronic in the medical device industry. The sources of those failures could originate anywhere in the supply chain. Fixing supply chain issues is ultimately the responsibility of the instrument’s maker.
