Medical device recalls
THE UNITED STATES – Sept 1, 2020 – According to a recent report published on stericycleexpertsolutions.com, the total number of medical devices recalled, during the second quarter of 2020, grew by over 30 percent. The actual number of medical devices recalled in Q2 of 2020 was 341 devices. This is the first time the number of medical devices recalled in one quarter exceeded 300 units in the past few years.
The total number of medical device recalls is forecasted for 2020 is over 1,200 medical devices. If 2020 ends with at least 1,200 medical devices recalled, this would represent an increase of over 35%. The first quarter of 2020 has far fewer recalled medical devices than Q2. Also, the number of recalled medical devices in 2020 does not include defective face masks or any personal protective equipment that is managed at the non-federal level.
Medical devices that were recalled due to safety concerns accounted for about 14 percent or 48 recalls of the total second-quarter medical device recalls. This is the first time in four years that the number of safety issues surpassed the number of medical device recalls concerning software issues. However, connected medical devices, hospitals, health systems, and healthcare organizations are seeing an increase in the number of cyberattacks.
The leading cause of medical device recalls is improper sterilization. Sterilization problems accounted for nearly 63% of all medical device recalls in the second quarter of 2020. The surge in the number of medical devices recalled due to sterilization issues was due, in part, to one recent recall affecting approximately 16 million syringes. In 2019, the FDA reported that some State Environmental Protection Agencies banned the use of ethylene oxide due to environmental concerns. Ethylene oxide is the most prevalent chemical used to sterilize medical devices manufactured with plastic, certain polymers, resins, glass, and various metals. The sterilization chemical is also highly effective when sterilizing medical devices that have “hard-to-reach crevices and multiple layers of packaging,” according to the FDA. Ethylene oxide also does not damage the medical device during the sterilization process and are frequently used in the manufacturing process for surgical kits used in emergency procedures, emergency Caesarean sections (“C-sections”) kits, cardiac surgery kits, hip implants, knee implants, feeding tube devices used in neonatal intensive care units, catheters, shunts, drug-eluting cardiac stents, and many other types of implantable devices.
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