ExpertRECALL™ Index Shows Medical Device Recalls Soar During First Quarter

In short

Medical device recalls increased more than 160 percent in the first quarter of 2012, affecting more than five times as many units than the previous quarter, according to the quarterly ExpertRECALL™ Index, released today and detailed in a company press release.

Background

Products impacted by the increase include alcohol prep pads, catheters, needles and latex gloves. Consumer product recalls also increased in the first quarter of 2012. Conversely, the ExpertRECALL Index found that pharmaceutical and food recalls decreased compared with previous quarters.

Medical device recalls documented in first quarter U.S. Food and Drug Administration (FDA) Enforcement Reports affected nearly 82 million units, representing a 508 percent increase over the previous quarter and recording a five-quarter high. Additionally, about one-third of companies that faced recalls in the first quarter were involved in more than one recall event — a trend that has continued over the last five recent quarters.

Company comments

“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 said. “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.”

Data source

The 2012 first-quarter ExpertRECALL Index is the only report that aggregates and tracks cumulative recall data from the CPSC and the FDA. Stericycle ExpertRECALL compiles the ExpertRECALL Index from data issued by the U.S. Food and Drug Administration and the Consumer Product Safety Commission.

About Stericycle ExpertRECALL™

Stericycle ExpertRECALL™ is the industry leader in managing consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. Stericycle ExpertRECALL streamlines the entire product recall process and manages Notification & Response, Processing & Tracking, and Compliance & Reporting for a variety of companies. For more information, click here.

Source: ExpertRECALL™