Embracing Recalls

By RQM+ Subject Matter Experts

When managing recalls effectively, they don’t need to be feared – they can be embraced.

Recalls get a bad reputation, especially when it comes to medical devices.  After all, these devices are meant to improve the lives of patients, and hearing that there’s something wrong with the device you are using that could lead to serious injury or death is the last thing that you want to hear. 

But the truth is, despite our best efforts, recalls are sometimes necessary. However, when recalls are managed effectively – supported by a strong regulatory and quality strategy – they can be beneficial for both the patient and your company.  They provide opportunities for continuous improvement, transparency with customers and patients, and protect the brand/reputation.  Most importantly, quickly identifying and taking appropriate action on an issue shows a commitment to patient safety – which is ultimately the main priority.

When managing recalls effectively, they don’t need to be feared – they can be embraced.

FSCA, recall or advisory notice?  

When a company takes action to reduce the risk of an issue with a medical device, there are several terms that may be used, such as recalls, Field Safety Corrective Actions (FSCAs), safety alerts, or advisory notices.  These terms will vary depending on regions.   However, the actions associated with these terms are the same.  A company may take action to correct, remove, replace, destroy, or modify a device within the field.  For this article, “recalls” will be used as a generic term to encompass all of these actions for all regions.

Recalls are communicated to impacted consignees (customers, distributors, patients, etc.) through a letter.  In the United States, the letter is referred to as an “Urgent Medical Device Correction” (UMDC) letter.  In other regions, such as Europe, it is known as a “Field Safety Notice” (FSN). Different regions are also required to report to specific regulatory authorities within their jurisdictions.  Reporting timelines may vary, and there can be differences in what qualifies as a reportable recall.  However, even with regional differences, the overall requirements for a company taking these actions are the same.

Best Practices for managing a recall

When a recall is necessary, it is critical for the company to have a clear plan on how to implement the recall.  This includes everything from identification of the issue, communicating to stakeholders and impacted consignees, reporting to regulatory authorities, execution of required activities, and monitoring of the recall.

Outlined below are the general steps and best practices for effectively managing a recall.

1. Identification of the issue  

There are several sources for identifying an issue that may require a recall. Some examples include:

These issues can be triggered by many factors, such as device malfunctions, identification of health and safety risks, regulatory non-compliance, software failures, or labeling errors. This is why it is imperative to have strong quality systems and post-market surveillance in place, as well as a robust process for risk management. The sooner issues can be identified, the quicker a company can take the necessary actions. 

When an issue is identified, there are often immediate actions that need to be taken prior to a decision on a recall.  For example, containment actions may need to be taken, such as quality or delivery holds, production holds, or quarantine.

2. Risk Assessment and Evaluation 

Once an issue is identified, the scope and impact of the issue needs to be identified. 

• Risk Assessment: A risk assessment analyzes the potential risks the issue may have on patient safety or device performance. The assessment considers the risk for the general population, as well as the population(s) at greatest risk. It should also review the risk if removal of the device from the field is necessary to determine the availability of replacements or alternatives. 
  • Keep in mind that if an issue is identified that is not currently included in the risk management file, the scope of the work surrounding the recall – and the necessary quality system remediation support – will likely be greater. This impacts not only the recall itself, but also the risk management process.

• Classification: Some regions may classify recalls into categories. These classifications are based on risk.  Classification systems are dependent on regions.  The table below shows an example of how recalls are classified in the US:

• Corrective and Preventative Actions (CAPA): The root cause of the issue needs to be determined.  This is done through the CAPA process, consisting of the following:
  
  • Root Cause Analysis
  • Additional containment actions (e.g. quarantining additional devices identified during the root cause analysis)
  • Immediate field corrections (e.g. issuing updated advice to users about detecting a fault situation and what to do when it is detected. This does not remove the issue but reduces the potential for harms to occur)
  • Corrective Actions
  • Secondary field corrections (e.g. the implementation of a corrective action on affected devices in the field such as the installation of a redesigned component)
  • Preventative Actions (if applicable)

When assessing the issue, keep in mind that there can be a fine line between a recall and modifying the device to enhance the functionality or performance.  The issue should be evaluated closely with necessary stakeholders, and all decisions should be thoroughly documented. If an enhancement to the device is deemed appropriate, ensure that a justification is included with the decision, and clearly explains why the action you are taking to enhance the device does not constitute a recall.

3. Creating a Team 

Once a decision is made that a recall is necessary, a recall team will need to be put together. The team will work cross-functionally to implement the steps necessary to execute a recall.  Some key team members may include, but are not limited to:

Depending on the recall, the nature of the actions required, and the impact to safety, it may not be necessary to involve all of these stakeholders in every step.  Alternatively, more complex recalls may require a larger team of stakeholders from various other functions. Some things to keep in mind when deciding on your recall team:

• Try to limit the team to only the stakeholders that can provide productive input and expertise.
• With larger teams, you may experience delays in initiating your recall due to factors such as receiving feedback and input, waiting for approvals, and trying to coordinate meetings with everyone’s busy schedules.   However, it can also mean a more rounded review and strategy when the appropriate stakeholders are involved.
• Your team can grow, or shrink, as you begin to learn more about the specifics of the recall.

4. Planning and strategy

If a decision is made that a recall is necessary, the recall team will need to develop a plan.  Key inputs when planning your recall include:

Strategy: the strategy should take into account the circumstances of the recall that have been identified through the risk assessment.  This will determine the scope of the recall and whether a correction or removal is necessary.  The following factors should be included in your strategy:

• Identification of affected devices – Identify specific models, serial numbers, lots, or batches, and the impacted regions and consignees.
• Communication plans – Determine who needs to be informed (e.g. regulatory authorities, customers, distributors, patients, etc.) and the method of communication.  A recall letter should be distributed to all affected consignees. 
• Logistics – Develop a strategy for execution of the recall.  Will the device require a correction, or does it need to be removed from the field? How will  those actions be executed? Who will execute those actions? What questions should have answers in advance (e.g. who will pay for the field correction or replacement parts?)?
• Monitoring effectiveness of the recall – Effectiveness checks will need to be put in place to ensure that tracking of communication and the actions associated with the recall are effective. Your strategy should define the level and method of effectiveness checks required.

• Timing: Timing is crucial when it comes to planning your recall, especially in cases where there is a risk of serious injury or death.  Customers and patients need to be made aware of the issue in a timely manner, so that they can take appropriate actions on their end. There may be times when not all information is available, as further testing may be required to understand the issue but there may still be a need to take action to reduce the immediate risk before longer actions can be implemented.  In other cases, a resolution to fully address the issue may not be available right away (such as a software update).  In these situations, communication of the issue remains a top priority and should not be delayed.  Follow-up communications can be sent once further information is available.

• Recall Letter: All affected consignees must be notified of the recall. This is generally communicated through a letter.  As mentioned above, these letters are referred to differently among regions, but the intent remains the same.  At a minimum the letter should communicate the following:
  • The product subject to the recall
  • The issue that has been identified
  • Any hazards/harms associated with the issue
  • Actions that the customer, distributor, and/or patients need to take to mitigate the risk of the issue occurring
  • Actions that your company is taking to fully resolve the issue

The letter should be clear and to the point. Things to keep in mind when writing your letter:

• Ensure that recipients of the letter are provided with enough information to confidently identify the device subject to the recall.
• Describe the issue in a way for all audiences to understand.  Avoid details that are too technical.
• Don’t provide information that has not yet been confirmed by your company. If further testing or data is needed in order to better understand the issue, be transparent in the letter and state that further information will be provided once it is available.
• Ensure that the hazards/harms are clear enough so the recipient understands the risks of continuing to use the device. Do not downplay the risk associated with the issue.
• Be specific with instructions to the recipient on actions that they need to take.
• Be transparent in your strategy and the actions that your company will take to resolve the issue.  However, avoid committing to hard dates and actions that have not yet been established.
• Do not include marketing or promotional material.
• Consider including a listing of impacted serial numbers specific to each consignee, if possible
• Include instructions for consignees to acknowledge the letter. A form is typically included with the letter for consignees to fill out and return. Alternatives include the use of a QR code linking to an online form.

5. Execution

Once a strategy is developed and communication is prepared, you can initiate and execute your recall.  Execution involves the following:

• Consignee notification: You company needs to inform all affected consignees of the recall.  This may include customers, distributors, and patients. Some things to keep in mind when notifying consignees:
  • Different regions may have different requirements for communicating the letter to the affected consignees.  Sending the letter through the mail is most common.  However the letter is communicated, your company needs to ensure that communication is effectively tracked.  Each affected consignee should receive a copy of the letter. When sent through the mail, ensure that tracking information is available.  If other methods are used, such as email or telephone, ensure that all communication is documented.
  • Your company will need to keep records of consignees that have been notified, as well as consignees that have and have not responded. Follow-up attempts should be made for those consignees who did not respond. Internal procedures should define how many attempts should be made to confirm receipt and what to do in the event of no response.  These are known as effectiveness checks for the communication of the recall.  Further details on effectiveness checks can be found below.
    • Keep in mind that obtaining this information relies upon adequate traceability of distribution of your products, as well as distributors maintaining their records. The goal is to ensure your recall letters are sent to the intended audience that need to be aware of the recall.  Without systems in place for traceability, communication of the recall will be ineffective.

• Reporting: Regulatory authorities may need to be notified of the recall. As mentioned above, there are differences in reporting requirements depending on the region(s) affected by the recall.  Many regions have specific reporting forms or formats that should be submitted with your notification.  While some of the information may vary, these are the general details to include:
  • Scope of the recall (affected models, batches, lots, etc.)
  • Description of the issue
  • The risks associated with the issue.  In many cases, providing a copy of the risk assessment is necessary.
  • Details of the actions that your company is taking to resolve the issue (field correction, removal, etc.)
  • Actions that customers should take to mitigate or prevent the risk of the issue
  • Timelines for implementation
  • Timelines for follow-up reports (e.g. progress of the recall)

Reporting timelines will also vary across regions.  For example, FDA requires a manufacturer or importer to submit their report (known as an 806 report) to FDA within 10 working days of initiation of the recall (21 CFR 806.10).  FDA also requires monthly reports to monitor the progress of your recall.  Follow-up reports are also required for other regions, though the timing may vary.

Although there are requirements for reporting, keep in mind that transparency with regulatory authorities is important. Early communication is beneficial, and when it comes to complex or serious recalls, having a discussion with them prior to initiation may be helpful. To make the most of your company’s time and the authority’s time, ensure that the appropriate stakeholders are involved in the discussion to speak to details of the issue that are pertinent to them.  For example, if there is a software issue, ensure that a software engineer is available to provide the technical information surrounding the issue.

• Monitoring: A company must ensure that their recall notification to consignees was effective, and that the actions to resolve the issue are being completed.  There are two key pieces to monitoring your recall:
  • Effectiveness Checks: Effectiveness Checks verify that your recall communication was received by your consignees, and that they understood and followed the instructions provided in the recall letter.  A method for consignees to acknowledge notification of the recall should be provided should be provided with the letter (such as a form, QR code, etc.). 
  • Tracking the progress of your recall: The specific actions required to resolve the issue identified in your recall will need to be monitored for completion.  The method for tracking this information will vary depending on a company’s capabilities. Some methods include:
    • Inventory management systems
    • Recall management software
    • Return management systems/processes

• Documentation is critical in the execution phase.  Ensure that all consignee responses and correspondences are kept with the recall files, and that status reports are maintained and generated on a regular basis. Any additional decisions concerning the recall, such as a change in strategy, should also be documented.  These will all serve as inputs into status reports required for regulatory authorities, as well as request for closure of the recall. If the recall was initiated due to complaints or adverse events, records of additional complaints / adverse events should also be traceable to the ongoing recall.

6. Closure

Once consignee notification has been confirmed according to the response rate identified in the strategy, and the actions associated with the recall have been completed, your company can request closure (or termination) of the recall with applicable regulatory authorities. A final report should be submitted to applicable regulatory authorities.  Although exact requirements may vary between regions, a final report typically includes:

• Scope of the recall
• The number of affected devices that have been corrected, removed, replaced destroyed, or modified within the field
• Corrective actions that have been taken
• Evidence of effectiveness
• Note: if the targeted effectiveness level that was defined in your strategy was not achieved, provide a justification as to why it was not met and why it is acceptable to close the recall

Conclusion

Recalls aren’t just about identifying an issue and going through the motions to fix it.  The priority should be on patient safety.  It’s easy to lose sight of that when we have so many other competing priorities in our day-to-day activities. But when we stop to remember the end goal, it allows us to focus on the impact that the recall has on patients relying on our devices. 

But recalls can often be overwhelming and disruptive, often pulling us even further away from focusing on the end goal.  This is why understanding how to effectively manage a recall is so important.  When a robust recall management system and quality framework is in place, it allows for timeliness of communication, execution, and closure in a smooth and compliant manner. It also provides opportunities for continuous improvement, transparency with customers and patients, and protecting your company’s brand/reputation. 

Ultimately, when we learn to embrace recalls we can get back to focusing on our commitment to patient safety.

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