While a product recall can be challenging for any manufacturer, medical device recalls can present a potentially life-threatening incident and attract additional scrutiny from the media. Because of this, it is critical that medical device manufacturers establish a recall plan in advance. This can save your brand and bottom line, and it may end up saving your company.
Very few companies realize that a recall is inevitable, and a disorganized or ineffective recall plan can result in irreversible damage.
A mock recall simulation is one of the best ways to test your recall plan and allows you to identify holes in your plan before it’s too late. It can also save your organization from wasting resources when a recall is necessary. One thing that medical device manufacturers often forget is that a recall simulation can also be extended beyond your four walls to your suppliers. Coordinating with your supply chain during a recall test can help ensure that your plan is efficient and effective at every step of the production process, even the ones you don’t control. If you organization hasn’t faced a recall, it is recommended to execute a mock simulation at every 12 to 18 months, as roles and responsibilities can change or increase.
When planning a recall simulation, you should ensure that upper management fully supports the recall preparation, and identify any third-party allies that would assist in a product recall situation. At a basic level, you should identify your company’s most likely recall scenarios and make sure you have a robust recall team in place. The mock recall should walk through the physical product recall process, as well as review your communication systems and strategies for customers and regulatory agencies alike. Finally, a mock recall will test data collection and analysis, making it critical that you have a thorough data collection, analysis, and maintenance system in place.
There are key points to consider when constructing your recall plan in order to protect the public and maintain trust in your brand:
- Speed is important, but quality is critical. Especially with medical device recalls, it’s essential to remove products from the market as quickly as possible to avoid any unnecessary damage to the health and safety of the public. This means establishing and testing a recall plan in advance, in order to execute it successfully. However, while speed should be a priority, conducting a recall thoroughly and completely is critical. Companies should assess their entire corporate structure, including supply chain operations, manufacturing and distribution centers, and consumer-facing retailers, to involve all aspects of the production process.
- Have the right data. One of the most difficult things about managing the recall of a medical product is determining exactly who has the product, where that person is, and how to reach them. It is critical that medical device manufacturers, as well as distributors, have the means to track and trace their devices and their owners before a recall hits because these data are essential for alerting consumers about risks associated with their medical device. The U.S. Food and Drug Administration will be watching to make sure that you are in compliance with recall regulations and that your recall management process is effective.
- Knowledge is power. In addition, having a dedicated team made up of persons from multiple departments who are thoroughly educated in their roles and responsibilities will ensure that your recall plan is both efficient and effective. A recall team should understand the processes for regulatory agency notification, the company communication guidelines, and the policies for closing out a recall, all of which should be outlined in your recall plan.
- Communicate on the customer level. The recall of a medical device product can be stressful for consumers, particularly if the device is used with children or the elderly. It’s your responsibility to reassure your customers and demonstrate the proficiency of your recall process by communicating effectively. It’s imperative that you give consumers multiple communication methods, which could include a website with key information regarding the recall situation that is effectively-supported and prepared for a potentially high number of hits. In addition, establishing a call center with trained staff can provide consumers with a listening ear for them to express their concerns and questions.
Following these guidelines and testing your recall plan through simulations ensures that your organization will have the most up-to-date, successful recall plan available. These preparations will help your company stay prepared for the inevitable and safeguard your company against unnecessary damage.
Editor’s Note: On June 11-12 in Indianapolis, Ind., industry professionals will gather to discuss these issues at the CBI Bio/Pharmaceutical and Medical Device Midwest Product Recalls Summit, as well as techniques and strategies for executing effective product recalls. During this summit, the benefits of mock recall simulations also will be discussed.
Mike Rozembajgier is vice president of recalls for Stericycle ExpertRECALL, based in Indianapolis, Ind. Rozembajgier is responsible for all aspects of recall service offerings, including development of strategic recall business initiatives and product enhancements. He has more than 10 years of experience in the healthcare industry. Prior to joining ExpertRECALL, Rozembajgier held various management positions at Guidant Corp. (now Boston Scientific) and at Deloitte in the Strategic Consulting practice.