How To Smoothly Implement A Recall

By Angela Brown, Halloran Consulting Group

As we enter the last quarter of 2016, the U.S. medical device industry continues to see a decline in recalls, compared to previous years. Some of that drop-off may be attributed to manufacturers implementing internal quality system improvements to identify non-conforming products earlier in the process. Still, despite our best efforts, there always is a possibility that a recall will be necessary.

Recalls often stem from issues with quality system maintenance, sterility, design control, and late adverse event reporting. A manufacturer has a lot to manage when the decision has been made to conduct a recall; therefore, it’s imperative for every medical device manufacturer to have a reliable process in place to perform a removal (from the market) or a correction as quickly as possible.

A recall is initiated when a manufacturer decides, voluntarily, to remove or correct a U.S.-marketed product, either to reduce a health risk or because the product is in violation of the Federal Food Drug and Cosmetic (FD&C) Act. The FDA has the authority to initiate a medical device recall on behalf of the manufacturer, but this only occurs in extreme circumstances. Because the stakes can be high, the procedure that guides a leadership team’s decision whether or not to initiate a recall should allow for swift decision-making.

First, the manufacturer must take into consideration all compliance requirements for all affected countries, as the applicable regulatory agencies may have policies that differ from FDA guidelines. Manufacturers should take specific note of the FDA guidance document Factors to Consider Regarding Benefit- Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions, released in June. This document clarifies the FDA’s position regarding the considerations for benefit-risk factors that medical device manufacturers use to evaluate appropriate responses to non-conforming product or regulatory compliance issues (e.g., a voluntary recall). FDA measures the success of a recall by the effectiveness of these actions and, in many cases, recalls must meet a 100-percent-effective rate prior to the manufacturer’s request for closure from the FDA. Adhering to all requirements provides the best approach for implementing a recall and bringing quick closure to the situation.

Once a decision has been reached for removal or correction, many internal and external actions are required to implement the recall.  Manufacturers need to act with a sense of urgency and avoid further internal crises through a defined recall process. This process should include defendable decision-making, supportive team efforts, and effective internal communication. Once the process begins, each step should happen in quick succession and/or simultaneously. The team, and each team member, will have one or more responsibilities, which may include:  

• Documenting the decision to initiate the recall
• Identifying the team lead and cross-functional team
• Notifying the FDA with a Notice of Corrections and Removals, commonly known as an 806 Report
• Recall management
• Product management
• Identifying consignees
• Communications
• Record-keeping and retention

Your team lead should be confident in overseeing the recall process, as well as knowledgeable about  FDA recall stipulations — and possibly other countries’ regulatory agency requirements — to successfully guide the company to recall closure. This requires the ability to juggle many tasks and an awareness of potential delays, due to a number of factors, such as lengthy approval processes or limited product replacement availability. The team itself should include department members from regulatory, quality, logistics/operations, communications, marketing, customer service, and legal, at a minimum.  The company also may want to consider outsourcing to ensure that the recall can move forward, and that day-to-day business be maintained with minimal impact. 

Each area of responsibility mentioned above includes its own action items, which will need to be addressed with the same level of diligence and urgency. With this in mind, it is important for the team lead to conduct daily meetings, ensuring that all activities are executed efficiently and nothing is overlooked.  

One of the most important steps in conducting a recall is notifying the FDA via an 806 Report, which contains information including:

• A cover letter
• Company names and contact information
• Awareness date
• Recall initiation date
• Number of total consignees
• Method of notification
• Details of recalled product (quantities, lot numbers, regulatory info)
• Product use
• Reason for recall and its root cause
• Health hazard summary
• Recall strategy
• Additional attachments, including a consignee list, product labeling, and customer notification letters

Before submitting an 806 report, manufacturers should be sure to have an effective regulatory strategy, and be prepared to report on the status of the investigation, intended actions, and corrective actions for the root cause. 

After providing FDA with the initial 806 Report, companies can expect to revise the customer notification letters. If necessary, they also have the option to negotiate the assigned classification of the recall. Manufacturers then are expected to provide monthly status reports regarding the recall’s effectiveness. 

Once a recall begins, it can be stressful for everyone involved. Avoid unnecessary tension by preparing before a recall occurs. Your time will be limited, so getting ahead of the game now is imperative to achieving a quick closure. Ask yourself these important questions to know if you’re prepared for a recall.

Resources

• Do you have the proper resources for issuing and sending the notification?
• Who will be responsible for tracking and record-keeping?
• Who will manage product returns and product replacement?
• Who can best handle customer and media calls?

Manufacturing

• Do you have a team to bracket the issue?
• Who can correct the product issue?
• Do you have the right person to correct the manufacturing process?
• Do you have someone to document the corrections, including verification/validation activities?

Product Management

• How will you address the following?
  • Product returns
  • Product storage
  • Product quarantine
  • Product replacement
  • Product inventory
  • Product destruction

Customer Notification Letter

• Who will draft the Customer Notification Letter (CNL)?
• Who will review and approve the CNL?
• Will regulatory have final decision-making authority for the letter’s content?
• Who will send out the notifications?
• How will you confirm that each consignee has been notified (e.g., return receipt, courier notification)?

Communication

• Who will communicate the initiation of the recall to internal and external employees, investors, distributors, affiliates, partners, etc.?

A cross-functional team that keeps these considerations at the forefront of decision-making will be well-positioned for customer satisfaction, expeditious closure, and positive FDA interaction. These factors are critical to helping your business get through this challenging time. 

Every company wants to avoid a recall, but when they happen, the best way to minimize negative impact on your business is to implement effective, robust, and efficient processes with the right people leading the effort.

About The Author

Angela Brown is a principal consultant, bringing to Halloran Consulting Group more than 20 years of regulatory affairs and quality assurance experience in the medical device industry. Prior to joining Halloran in 2015, Angela served as VP of Regulatory Affairs and Quality Assurance at Plasma Surgical, Inc.; as Director of Regulatory Affairs at C. R. Bard; and as Senior Manager of Regulatory Affairs at Teleflex. She Holds a B.S. in biology from Campbell University (Buies Creek, N.C.), and is an active member of the Regulatory Affairs Professional Society (RAPS), where she has published papers and been a guest speaker at numerous events. Angela is Regulatory Affairs Certified (RAC).