Medical device manufacturers face particularly acute challenges during product recalls. From satisfying complex FDA regulatory requirements and other governing bodies’ compliance requirements, to coordinating seamless notification and response, product retrieval, field repair or destruction, the process can be daunting. Failure can pose significant health risks and the potential for major litigation.

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Adding to this, recalls for medical devices have become increasingly global events that impact patients across all geographies. According to the most recent Stericycle Recall Index, in the fourth quarter of 2013, 76 percent of recalls affected consumers nationwide and 49 percent of recalls affected at least two countries. Of these international events, over 70 percent affected European countries and approximately 40 percent affected the Asia Pacific and/or Australia/New Zealand regions.

Recalls that are spread across geographies, or impact more than one country, can create complicated logistical 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. Therefore, these issues will likely expand moving forward.

The Index also found that numerous companies had more than one recall in the fourth quarter. Thirty-three percent of companies announced at least two recalls, and one manufacturer was responsible for 29 events. Obviously, the challenges of managing a recall are significantly compounded when organizations are faced with multiple events.

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.

Understand the Situation

Before preparing for a recall, it is important to understand the distinctions between a product recall and a market withdrawal. Recalls are actions taken by a company to remove a product from the market and may be initiated by the company, by FDA request, or by FDA order under statutory authority. Typically, a recalled product must present a significant threat to consumers due to a product defect, or violate a minimum federal or state safety standard.

Product recalls are further distinguished by three classifications of severity:

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.

Class II recall: a situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III recall: a situation in which use of or exposure to a product is not likely to cause adverse health consequences.

In some cases, medical safety alerts are also considered recalls but they fall under a separate classification. They are issued in situations where a medical device may present an unreasonable risk of substantial harm.

By definition, a market withdrawal occurs when a manufacturer voluntarily stops producing or selling a product that has a minor violation not subject to FDA legal action. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal. Also, normal stock rotation practices, routine equipment adjustments, and repairs would all fall into this category.

An Ounce of Prevention

We all know that the best offense is the best defense and medical device companies should approach the problem that way. To minimize recall risk, manufacturers must educate themselves on the safety standards, distribution, and storage and handling practices of every touchpoint in the distribution network.

Companies can greatly reduce the potential for a recall by implementing measures that will ensure greater traceability of product in the supply chain. By closely tracking data such as manufacturing codes and dates, they can identify faulty components and materials on the production line before they are integrated into the final product. In September 2013, the FDA issued a Final Rule which will require most medical devices sold in the U.S. to carry a unique device identifier (UDI.) 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.

While enacting the Final Rule may pose a challenge to some manufacturers, 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 this information will improve traceability and help companies in the event of a recall to determine the breadth of the problem and ensure an efficient retrieval process.

Companies also need to consider how to execute the recall across international boarders, and ensure they have a system to manage and report on the status of its effectiveness in real-time.

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