What are Recall Management Solutions?

Product corrective actions, recalls and remediation’s impact hundreds of device manufacturers every year. According to MedTech Dive, there were 70 Class I recalls overseen by the FDA in 2022, a 48% increase over the average of the previous 5 years. Product recalls require special care when handling the communication and remediation activities. The actions made following a product recall can make or break a company’s reputation within the healthcare industry.

Medical devices are engineered and manufactured with the highest precision and attention to quality to ensure they perform reliably — but nothing is fool-proof. The only way to know how a product will withstand day-to-day use is by monitoring it over time in the field. Only in a real-world setting can devices be put to the actual test, demonstrating their ability to withstand unpredictable and sometimes extreme conditions.

If a device manufacturer discovers a design flaw, it is critical that they act quickly and remediate the situation to prevent the possibility of causing patient harm.

No device manufacturer ever plans a recall. This plan is typically not included in the core competencies of the quality and regulatory teams to assemble and execute programs of this magnitude without disrupting routine business functions.

In the event product remediation or a field corrective action is required, Quest brings white-glove services to our OEMs with a predictable recall management solution cost model to counter unpredictable and unbudgeted events.

What Does a Recall Management Plan Look Like?

Recall Management Plan

At Quest, we put together a plan that brings a fit-for-purpose approach to Remediation Management and Field Corrective Action (FCA) services with a predictable cost model. This All-In-One Program is customized to fit your specific needs.

It is developed using various components to handle the end-to-end process from outreach to remediation, such as:

Call Center
Depot
Field
Logistics solutions

Quest can devise a flexible, best-in-class, successful recall program on your behalf while increasing overall customer satisfaction.

Our plan implements the following steps:

Recall plan development - The operation team interviews the client to develop a custom solution plan.
End-user identification - We partner with the client to identify affected customers and prioritize the next steps.
Customer notification - We notify each of our client’s customers of the upcoming efforts required for the remediation efforts.
Customer response/coordination - The program managers will coordinate with the end-users about the next steps.
On-site deployment/depot services - Field engineers travel to the customer site, or the customer sends us the device.
Product remediation - We service the device based on the plan and meet manufacturer specs.
Documentation, archiving, regulatory reporting - We document the serial numbers and work performed along with any parts consumed with serial and lot numbers so accurate reporting may be submitted to the relevant regulatory bodies.
Customer surveys - We follow up with each end user to ensure customer satisfaction and that the device is performing optimally.
Case resolution/ review - We review the results with the client to address any final issues.

Device manufacturers plan for the launch of their new products, not for a recall. A recall management plan helps provide relief to device manufacturers in the event it may be required. The device manufacturer will have peace of mind knowing that if their devices face an error, they will be swiftly repaired—with the end-user experience as the number one priority. In the end, having a plan ahead of time will save device manufacturers time, money, and their reputation in the long run without stretching their resources thin.

For more information on how device manufacturers can plan ahead to streamline their serviceability solutions, read our article - Managing Priorities: Scheduled vs Reactive Service Events here.

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