Millions of Americans use medical devices on a daily basis to live better and longer. There’s no doubt that new and innovative devices are having a huge, and sometimes life-saving impact. Why then have medical device recalls increased substantially in the last 10 years? According to a recent U.S. Food and Drug Administration report, annual recalls of medical devices doubled from 2003 to 2012 (going 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% 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, 72% of recalls affected consumers nationwide and 56% of recalls affected at least two countries. This is a 7% 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.
Given this environment, it’s critical that medical device manufacturers minimize recall risks and set up a recall preparedness program to respond efficiently, quickly and at the lowest cost to both the financial bottom line and the company’s reputation. To minimize recall risk, manufacturers must educate themselves on the safety standards, distribution, and storage and handling practices of every touch-point in the distribution network.
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. The tens of millions of patients with implantable devices must keep their own records and then check manufacturing codes and dates of recalled products against theirs. Even with the proliferation of mobile medical applications, the industry seems to lag behind in technology best practices. For example, most pacemakers rely on hard telephone lines to transmit critical data to physicians. But who has a land line anymore?
Last September, the FDA issued a Final Rule that will require that most medical devices sold in the U.S. carry a unique device identifier (UDI). With the first deadline for identifiers on high-risk devices coming in September, the Food and Drug Administration has released guidance to manufacturers on how to set up accounts and start making submissions to its Global Unique Device Identification Database (GUDID).
Device makers have much to do to implement UDIs. Those that are cautiously optimistic see value in the data beyond patient safety and plan to use the labels to improve their own tracking, customer service, and internal productivity. For patients, 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 also help companies during a recall by determining the full scope and ensuring 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.