A critical, and sometimes overlooked, aspect of voluntary medical device recalls is the conduct of effectiveness checks. Manufacturers need to understand FDA’s expectations for effectiveness checks, because missteps may substantially lengthen the process and delay formal recall closure. This article addresses how the design of a recall strategy can impact effectiveness checks and discusses strategies to enhance them. The challenge of dealing with significant new information that emerges during the conduct of a recall, including new information about root cause or risk to health, is also covered.

Purpose of Effectiveness Checks   

In 21 CFR § 7.42(b)(3), FDA’s guidance says: “The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action.” FDA views the conduct of effectiveness checks as the responsibility of the recalling firm but “will assist in this task where necessary and appropriate.” To fully appreciate FDA’s expectations for the conduct of effectiveness checks, manufacturers should consider the preamble to 21 CFR Part 7, Subpart C, FDA guidance,  and the guide Methods for Conducting Recall Effectiveness Checks, which is provided by the FDA District Recall Coordinator when a company first reports that it intends to conduct a voluntary recall.

Regardless of the specific procedures used, the process that a manufacturer tailors for each recall should ensure that the firm can verify and demonstrate to FDA that:

-The recall communication was received by the consignee.
-The consignee read and understood the communication.
-The consignee followed the recall instructions.
-The recall reached the intended appropriate level in the distribution chain.3

A device manufacturer should prepare an effectiveness checks plan as part of its recall strategy. The plan should specify the methods to be used for ensuring an effective recall and the level of the effectiveness checks that will be conducted.

Factors That Impact Checks Process

At least four factors affect the effectiveness checks process. They are:

Depth of the Recall. Based on the magnitude of the potential health hazard and the extent of distribution of the product under recall, the manufacturer must determine how far into the distribution chain the recall will extend to each of the following levels: consumer or user; retail; intermediate wholesale; or wholesale. The failure to accurately determine the appropriate depth of the recall before starting it can undermine the effectiveness checks process by causing delays in the conduct of the recall. Determining the recall’s depth serves as the basis for developing the consignee list. The list identifies each party in the distribution chain that is to receive a formal notification of the recall.

Consignee List. The accuracy and completeness of the consignee list can also impact the effectiveness of the checks process. This master contact list is used to verify that the appropriate customers in the distribution chain were notified about the recall and managed the recalled product in line with the company’s instructions. The consignee list is required to be included in Reports of Corrections and Removals submitted to FDA. It must include, among other things, the name and full contact information of each consignee that is to be notified about the recall.  It is important to consider foreign as well as United States customers. The compilation of the list should consider any federal consignees, such as the Department of Defense, Veterans Affairs, and USDA. In addition, if the product was sold under a government contract, the manufacturer should include the contract number, contract date, and implementation date.3

To facilitate the tracking and reconciliation process during the effectiveness checks process (described below), manufacturers should consider assigning a unique numerical identifier—or common identifier—to each consignee. This unique identifier would then be used on all recall notifications to the individual consignee, including the initial recall communication, the return response questionnaire, and its outer envelope. It will also be used for any subsequent written communications, follow-up telephone communications, or personal visits that are entered in the tracking log.

Recall Communications and the Questionnaire for Reporting by the Recipient. The accuracy and completeness of the recall communication has significant impact on both the effectiveness of the recall and the plan for the questionnaire that the consignees receive. The consignees receiving notification about the recall must take certain actions. All recall communications should be succinct, aligned with the magnitude of the potential health risk of the product being recalled, and avoid marketing messages. They should include, at a minimum, the following eight elements:

-Notification that the product is subject to a recall.
-Specific information to ensure immediate identification of the recalled product (such as lot and serial numbers).
-The reason for the recall.
-A description of the potential risks to health, if any.
-Instructions on whether further distribution or use of the product should cease immediately.
-Instructions on whether the consignee (such as a wholesaler or retailer) should in turn notify downstream customers who received the product.
-Specific instructions regarding what is to be done with the product.

-A response questionnaire. This is a “ready means for the recipient of the communication to report to the recalling firm whether it has any of the product, e.g., by sending a postage-paid, self-addressed postcard or by allowing the recipient to place a collect call to the recalling firm.”

It is important to initiate a recall using a highly reliable method for the recipient, or consignee, to rapidly report to the firm that it has received the notification and is following instructions regarding the recalled product. This is an essential “feedback loop” for the subsequent effectiveness check process.

Based on our experience, we advise that the recall communication contain a written pre-addressed and pre-stamped response questionnaire to be signed by the recipient in order to facilitate return mail response to the firm recalling the product. We do not recommend relying on telephone-based or e-mail responses by the consignee as the primary mode of recipient response. If communication is very urgent due to health risk, overnight delivery may be used. We also advise that the recall communication always include a toll-free 800 telephone number that is specific to the recall and staffed by employees trained to address consignee queries. To facilitate the effectiveness check process, the recall strategy should: 1) include a log system plan for recording and tracking questionnaire responses, 2)identify a timeline or other triggers for determining when a recipient has failed to respond to the initial recall communication; and 3) specify the actions the manufacturer takes in order to “close the loop” with each consignee.   

Public Warning. A public warning is a special mode of communication about the recall. The warning must be monitored during the effectiveness check process and modified if its message is not understood by recipients or if the methods of distribution were inadequate to achieve its purpose. The purpose of the warning is to mitigate “a serious hazard to health” where “other means for preventing use of the recalled product appear inadequate.” Before initiating a recall, the manufacturer must evaluate the potential risk to health based on the company’s Health Hazard Evaluation and determine whether it should issue a public warning. The warning could be a press release to the general public or specialized notifications direct to physicians or their professional societies, or both. FDA requests that the manufacturer submit any public warning and distribution plan to the agency for review and comment.  Importantly, FDA commonly issues its own public warning, i.e., a press release and other notifications, for voluntary recalls that it deems to be associated with a potentially serious risk to health. One of the challenges that manufacturers may face during the effectiveness check period is misunderstanding between FDA and the company regarding the magnitude of the risk to health or instructions to physicians and patient users about the recalled product, or both. 

Enhancement Strategies

Three key strategies are available to device manufacturers for implementing and enhancing effectiveness checks:

Initiating the Effectiveness Checks Process. The effectiveness checks process serves in part as a formal function for determining whether the initial recall strategy is serving the intended goals or needs to be modified. Therefore, some manufacturers rely on a separate team that is distinct from the group responsible for the design of the recall strategy. Regardless of whether these two functions are separated, the reporting structure of the team that is accountable for effectiveness checks should be clearly defined. The team members’ work should be given priority over their day-to-day responsibilities.

The effectiveness checks process depends on the completeness of the master consignee list and the tracking log system. When the responsible team begins its work, it may be required to independently corroborate that the consignee list matches the depth of distribution chain that is to be reached by the product recall. The team should also corroborate that the contact information for the consignees is sufficiently detailed to reach each target recipient. As the recall is carried out, the team responsible for effectiveness checks may identify gaps in the master consignee list. In addition, emerging information may suggest that the level of effectiveness checks should be more stringent or less stringent than originally defined. Once the recall is in progress, standard operating procedures should clearly specify the designated personnel and processes for updating the master consignee list or modifying the level of effectiveness checks.   

Before starting the recall, the manufacturer should create a log to track and document all initial recall communications and verification actions in order to ensure that the consignee received the notification and then followed instructions regarding the recalled product. Standard operating procedures should also clearly specify the designated personnel and processes for making log entries as well as modifying and correcting entries. The procedures also should make clear who is responsible for executing the “data lock” on the log, i.e., closing the database when the effectiveness checks process is complete.

Verification: Closing the Loop. The objective of the effectiveness checks process is to verify and document that the recall communication was received by the consignee and that the product was handled as instructed in this notification. Based on the magnitude of the health hazard and associated urgency, the effectiveness checks plan should specify:1) the methods for tracking and documenting the distribution of the recall communications with the response questionnaires; 2) the timeline for follow-up if a response questionnaire is not returned by a consignee; 3) the methods for follow-up; and 4) the methods for determining if the recalled product under the control of each consignee was handled correctly. The effectiveness checks plan should also specify reasonable efforts criteria regarding the number of follow-up queries, timeline, and methods of conducting repeat efforts to deliver the primary recall communication and obtain the completed response questionnaire.

Based on the information returned in the response questionnaires as well as other communications with the consignees, the verification process should be capable of linking the recalled product with the consignee that controls the product. The process should also be able to track the current status of the product for recall. This means tracking whether the product has been appropriately returned, quarantined, destroyed, or repaired in the field. It also means determining whether a correction has been implemented, including new instructions to the physician or patient. The verification process should also determine whether there are additional consignees that must be notified. 

Direct Audits of Consignees. If units of recalled product are accurately linked to individual consignees, the tracking and documentation of the returned product verify that the recall communication was received, understood, and that instructions were acted upon.

According to the instructions in the recall communication, some recalled products are designated for management in the field instead of return to the manufacturer. In these cases, it may not be sufficient to simply perform actuarial tracking of response questionnaires from consignees affirming that they have managed the product as instructed. Depending on the level of the effectiveness checks that have been pre-specified, direct audits of a percentage of consignees should be conducted to corroborate that consignees have actually followed the instructions for managing the recalled device. The sample of consignees to be contacted may be based on a random statistical sample from the total consignee list or may be developed using a risk-based procedure.

Managing New Information

Two challenges can arise that require the manufacturer of a recalled product to modify its recall process:

Inadequate Compliance with Instructions.  If the effectiveness checks process determines that instructions are not being followed regarding the management of the product in violation, the manufacturer must immediately take necessary steps to make the recall effective. These actions may include distributing a new notification that more clearly and accurately identifies the product and the instructions to be followed. In addition, the company should consider contacting the customer directly.

New Information That Potentially Relates To Health Risk or Root Cause. The verification process during effectiveness checks should also determine whether the consignee is aware of any injuries, illness, or complaints.  To address new information that emerges during the effectiveness checks period, a rigorous process must be in place to ensure that new information flows accurately and rapidly to several functions. The new data must flow to the firm’s complaint-handling process that carries out Medical Device Reporting (MDR) determinations. New information must also rapidly flow to the Health Hazard Evaluation function assigned to the recall. This evaluation tracks the frequency, types of injury, and level of seriousness of injuries potentially associated with the device under recall. New information must also flow to the function responsible for determining root cause, regardless of whether or not the root cause investigation is underway or has been completed. New information regarding both potential malfunctions as well as injuries associated with the recalled product may substantially modify the understanding of root cause or the assessment of potential health risk, or both. These updated analyses may necessitate changes in the extent of devices that are to be recalled. They may also require changes in the instructions regarding how to handle the product and the health risk during the recall. If new information that relates either to health risk or understanding of root cause is determined to be significant, the recall strategy, including the effectiveness checks plan, will need to be promptly modified.

Potential FDA Actions   

It is the manufacturer’s responsibility to make sure that the recall is effective. However, FDA may separately contact a percentage of the consignees and conduct audit checks to determine whether the manufacturer is carrying out its responsibilities and the consignee is correctly following instructions regarding removal or correction of the device. If FDA determines that the recall is ineffective, the agency typically will ask the device manufacturer to take specific actions, such as issuing a new recall communication.3 If a manufacturer is unwilling to extend or modify the recall after FDA notifies it that the effort is ineffective, the agency may consider taking additional actions. Possibilities include an FDA-requested recall, an initial or further public warning, a seizure, or an injunction. The final closure of a recall depends on the manufacturer’s ability to document and demonstrate to FDA that the recall was effective.

In summary, the effectiveness checks process of a product recall depends upon the initial development of a cohesive and detailed recall strategy with the core elements expected by FDA. To mitigate risk during the conduct of a recall, manufacturers should ensure that there is capability and accountability for rapid integration of new information that may modify the extent of products that are to be recalled, the depth of the recall in the distribution chain, or instructions regarding the removal or correction of the product. The team should assume that the recall strategy will change and be ready to modify the effectiveness checks process accordingly.

References
1. 21 CFR § 7.42(b)(3).
2. Federal Register 43:26218, June 16, 1978.
3. FDA, Industry Recall Guidance: Product Recalls, Including Removals and Corrections. Available from Internet: http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm.
4. FDA, Attachment H—Methods for Conducting Effectiveness Checks. Available from Internet: http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProcedure....
5. 21 CFR § 7.42(a)(3).
6. 21 CFR § 7.42(b)(1).
7. 21 CFR § 806.10(c)(11).
8. 21 CFR § 7.49(a),(b), and (c).
9. 21 CFR § 7.42(b)(2).
10. Id.
11. As an example, see FDA, Regulatory Procedures Manual, Chapter 7, Recall Procedures. Available from Internet:
http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/uc....
12. FDA, Regulatory Procedures Manual, Section 7-8.  Available from Internet: http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/uc....

Beverly H. Lorell, M.D., (pictured to the left) is the senior medical and policy advisor in the FDA & Life Sciences Practice Group of King & Spalding (Washington, D.C.) A cardiologist, she was previously a professor of medicine at Harvard University and served as vice president and global chief medical and technology officer at Guidant Corporation. Dr. Lorell can be reached at blorell@kslaw.com.

Pamela Furman Forrest is a partner in the Washington, D.C., office of King & Spalding in the FDA & Life Sciences Practice Group. Forrest may be reached at 202/661-7888 or pforrest@kslaw.com.