SOURCE: Stericycle ExpertSOLUTIONS

Stericycle ExpertSOLUTIONS

November 20, 2014 09:00 ET

Recall Challenges Ahead for Medical Device Sector:

Impact of New Regulatory Requirements and Software Among the Factors Analyzed in Q3 2014 Report

INDIANAPOLIS, IN--(Marketwired - Nov 20, 2014) - Stericycle ExpertSOLUTIONS (NASDAQ: SRCL) today released the findings of its Q3 2014 Stericycle Recall Index, highlighting hidden complexities within medical device recalls. The index shows that the outlook is still volatile despite the fact that the medical device industry has escaped dramatic recall fluctuations experienced by the auto industry and other sectors. The Q3 Index identified factors such as size and location as well as new regulatory challenges that are converging to contribute to the industry's complexity.

Managing recall execution across international markets has become a reality of the global economy, and the medical device sector is no exception. Fifty-seven percent of Q3's recalls affected at least two countries, a trend that has remained steady throughout the year. Not only are medical device recalls spanning multiple geographies, the Q3 Index found that these global recalls are increasingly affecting island countries and isolated locales.

"Recalls that are spread across geographies or impact more than one country can create complicated logistics for companies that need to communicate with dispersed patients speaking multiple languages," said Mike Rozembajgier, Vice President, Stericycle. "As medical device recalls become more global and far-reaching it's critical that manufacturers have a streamlined process for notifying physicians and patients when there's an issue."

Medical device technology is another contributing factor to the uncertainty. The Q3 Index analysis revealed that software issues are emerging as one of the primary drivers of medical device recalls. Combined with labeling/packaging issues, these categories contributed to more than 40 percent of the quarter's activity. Another factor affecting the industry is the FDA's Unique Device Identification (UDI) System, which began its multi-year rollout in Q3. The UDI system is intended to provide a consistent method of identifying medical devices and improve the quality of information received by the FDA in its medical device adverse event reports, thereby improving patient safety.

"With new regulations comes increased complexity," continued Rozembajgier. "While the implementation of the UDI rule could ultimately improve many facets of recall execution, it also introduces an entirely new set of challenges for manufacturers and other stakeholders. In terms of global medical device technology, we believe this presents a number of opportunities to both improve patient care and enable companies to operate more effectively. As manufacturers invest in technical innovations, recall planning and preparation cannot be overlooked. Failing to adapt recall planning accordingly is a critical mistake -- and one with potentially disastrous consequences."

The full Q3 2014 Stericycle Recall Index contains a detailed analysis of the medical device industry's recall drivers, as well as an examination of recall data within the pharmaceutical, food, consumer products and auto sectors. To learn more about these findings from the Q3 2014 Stericycle Recall Index, please download the report in its entirety here.

About the Stericycle Recall Index
The Stericycle Recall Index is the only report that aggregates and tracks recall data to help manufacturers and other industry stakeholders navigate the regulatory environment and identify trends. Each quarter Stericycle analyzes data from the U.S. Consumer Product Safety Commission (CPSC), the National Highway Traffic Safety Administration (NHTSA), the FDA and the USDA. For more information, please visit

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

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