Overall medical device recalls have increased substantially in the last ten years. According to a recent U.S. Food and Drug Administration report, recalls of medical devices doubled from 2003 to 2012 (they went from 604 to 1,190.) This number is not shocking though when you consider that the annual rate of recalls is growing more slowly than the U.S. med tech market as a whole.
When we look at data from the most recent Stericycle Recall Index, there were 330 documented medical device recalls in the first quarter of 2014. Interestingly, this figure is also the average number of recalls in the industry over the past two years. Of those in Q1, 93 percent were Class II which is consistent with the data from prior quarters, and 13 recalls were Class I – the lowest number in two years. While we are not seeing huge spikes in actual events, the medical device industry experienced a 243 percent increase in affected units in the first quarter of the year.
Medical device recalls continue to reflect the broader trend of globalization and increased complexity. For example, seventy-two percent of recalls affected consumers nationwide and fifty-six percent of recalls affected at least two countries. This is a seven percent increase from Q4 2013. Recalls that are spread across geographies or impact more than one country can create complicated logistics issues for companies that need to communicate with dispersed patients, speaking multiple languages. Growth in the medical device market means that devices will continue to reach more patients in more countries and these issues will likely expand moving forward.
One of the biggest challenges the industry is facing is its inability to quickly and easily track recalled product. It lags behind in its capacity to alert patients about safety issues. In contrast to drugs, which are tracked using a long established system called National Drug Codes, there is not an equivalent national system for medical devices. For the tens of millions of patients with implantable devices they must keep their own records and then check manufacturing codes and dates of recalled products against theirs.
Last September, the FDA issued a Final Rule which will require most medical devices sold in the U.S. to carry a unique device identifier (UDI). Having UDIs on medical devices will provide valuable data such as the name of the manufacturer, the specific model of the device, its lot number and serial number. Having that information can help companies determine the scope of the recall and ensure an efficient recall process. By embracing available tracking technology and working with a recall expert during an event, medical device companies will reach more impacted patients sooner.
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