Medical device recalls
According to a news article posted on medtechintelligence.com, medical device recalls fell by about 30% in Q3, but the number of medical device recalls in 2020 is expected to exceed 2019 totals. The most common causes for medical device recalls include defective parts, software issues, and quality of manufacture.
According to Stericycle’s Q3 Recall Index, the recall totals would be much higher if items such as Personal Protective Equipment (PPE) were included in the data collected by the federal government.
Software and cybersecurity issues continue to lead the way as the most common cause of a medical device recall. In fact, software issues have topped the recall causation list 17 out of 18 quarters. There were 50 recalls associated with defective software in Q3. The software defect recalls accounted for about five million medical devices.
Quality manufacturing was second in terms of the number of types of devices recalled. Quality issues led to a recall of approximately six million units. About 55% of all FDA-recalled medical device products were distributed globally.
According to Stericycle’s Q3 2019 Recall Index report, the number of recalls also grew by 21.5% in Q3. The medical device industry is under increased pressure to help those affected by the coronavirus pandemic, while at the same time, striving to decrease risks ordinarily associated with hurried quality control and manufacturing processes.
Medtechintelligence.com believes that automated manufacturing technologies might help manufacturers reduce recall risks by protecting their supply chain, cutting costs, and increasing quality productivity.
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