New Reports Highlight Medical Device Recall Trends

Two recent reports outline the state and rate of medical device recalls in the United States. Global Business Intelligence (GBI) Research and Stericycle ExpertRECALL both released reports outlining their findings.

According to the summary provided by GBI, the report analyzes the number of recalls by year between 2005 and 2010, focusing on the top 10 device recall companies. It also examines the reasons for recalls, which do not always mean the device must be completely removed from the market. U.S. Food and Drug Administration (FDA) recalls could occur for relabeling, adjustment, inspection, repair or other purposes.

According to the FDA, the number of medical device recalls per year increased from 578 in 2005 to 928 in 2010. There were a total of 4,343 medical device recalls during that time, the main reasons being problems with device design and process control, the incorrect labeling of medical devices and the mistaken use of materials and components, as well as medical devices that pose a risk to patient health, devices that violate law, products with sterility failure and maintenance problems, and product repairs and contamination.

As for 2012, the ExpertRECALL Index provides some more current data. According to this report, there were 277 medical device recalls documented by the FDA in the first quarter of 2012, a 161 percent increase over the previous quarter. However, when compared the corresponding quarter of last year, there was a 14 percent decrease in recalls. Further, the recall rates of the last quarter of 2011 were unusually low. Some of the product types named by the report include alcohol prep pads, catheters, needles and latex gloves.

The number of actual units recalled this quarter was 82 million, which reflects a 508 percent increase over the previous quarter, and an 89 percent increase over the same quarter of last year.

“While the quarter-over-quarter increase in medical device recalls is significant, this change was not all that unexpected given that recalls documented in fourth quarter 2011 enforcement reports were at an unprecedented low,” explained Mike Rozembajgier, vice president of recalls at Stericycle ExpertRECALL. “However, what is troublesome is the dramatic increase in units affected by the recalls and continued number of repeat offenders. It’s scary to think about given the increasing number of devices that American patients rely on to maintain and improve their health. Consumer and patient safety should be the number-one priority for every manufacturer, distributor, retailer, doctor’s office and healthcare facility.”

“Companies should be doing everything possible to minimize the safety concerns that would result in recalls,” Rozembajgier continued. “Similarly, any business or individual within a supply chain, whether a distributor or a doctor, should keep close tabs on the products they handle to ensure that potential safety concerns are identified early and reported to the manufacturer and the regulatory agency. This due diligence ensures that the impact of recalls, when they do happen, is minimized. Ultimately fewer units, and thus fewer consumers, will be affected.”

The 2012 first-quarter ExpertRECALL report aggregates and tracks cumulative recall data from the Consumer Product Safety Commission and the FDA.