More than 650 medical device recalls encompassing 180 million units were recalled in the second half of 2016, some of the highest numbers seen since the turn of the century, notes a new industry report by Stericycle ExpertSOLUTIONS.
Some of the mistakes were basic. “Parts issues” and “mislabeling” were deemed responsible for just over 50 percent of the total units recalled in the fourth quarter of the year.
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Other device errors, however, highlight the complexity of modern medtech designs. “Software issues” were responsible for close to a quarter (23 percent) of all Q4 med device recalls.
Software malfunctions are undoubtedly an area to watch in the coming years, as the field increasingly operates at the nexus of health IT, health care services, devices and even therapeutics. Medtech and infotech convergence was a major theme in EY’s 2016 Medical Technology Pulse of the Industry report.
In late 2015, Johnson & Johnson signed a partnership with Verily Life Sciences (formerly Google Life Sciences) to create Verb Surgical, a digital surgery platform that combines robotics, advanced visualization, advanced instrumentation, data analytics and connectivity.
Verily also united with GlaxoSmithKline to form Galvani Bioelectronics, which is working to develop a miniature implantable to modify nerves signals, collect information and leverage analytics and software to treat patients more precisely.
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Medtronic and supercomputer IBM Watson have also been collaborating for some time, in fields such as diabetes. While Boehringer Ingelheim partnered with Qualcomm Life to develop an Internet-connected respiratory inhaler.
In a Q&A last year, Stericycle Vice President Kevin Pollack told MedCity News he expects both great progress and greater risk in the coming years, driven by technology convergence.
We are really at the dawn of the connected device age, and we’re seeing healthcare really start to embrace connectivity. Medical devices are really at the cornerstone of that within healthcare. With these advances, there will be information security breaches. It’s not a matter of if, that will happen, it’s just a question of manufacturers continuing to do what they are already doing, which is ensuring that they are keeping codes up to date and making sure they have a plan should a breach take place.
According to the latest recall index, some 46 companies experienced more than one recall in Q4, the second highest number since Q1 2014.
“We’ve witnessed recall activity fluctuate across industries in recent quarters, and companies never know when their product will be next,” said Michael Good, Vice President of Commercial & Client Services at Stericycle in a new release. “It is crucial for businesses of all types and sizes to update their recall plans and prepare in advance to avoid potential consequences with both regulators and customers.”
Photo: Besjunior, Getty Images
