Medical Device Recalls: Managing and Implementing Effective Measures
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A recall, along with necessary advisory notices, is a reactive but crucial approach used by medical device manufacturers to remove a device from the market due to regulatory violations, serious risk of injury, or deteriorating health of the patient. It’s an effective way to prevent lawsuits that could result in significant financial claims. Recall activities include returning the device to the supplier, reworking it at the place of use or the supplier’s end, exchanging it for a defect-free device, and increasing awareness about handling the recalled device through advisory notices.
Recalls are sometimes confused with market withdrawal, which involves activities like normal stock rotation or substituting an outdated device with an updated model. Recalls and advisory notices are issued when there is a risk of adverse impact from a medical device.
Medical Device Recall Management Measures
Formation of a Recall Committee
Documentation of a Well-Defined Procedure
Process Flow for a Recall in Practice
Analysis of the Recall Report
Issuance of Advisory Notices
Protocols for Receipt of Recalled Devices
Decision for Recalled Devices
Corrective Action and Preventive Action Request
What is a Medical Device Recall?
Manufacturers are required to monitor their devices and report any adverse events or malfunctions. If a device poses a risk to public health, a recall must be initiated. Recalls can be voluntary or requested by competent authorities. Recalls address issues with safety, quality, or performance, and must be initiated promptly to minimize harm.
The recall process is covered in section 8.3 of ISO 13485:2016, which outlines requirements for controlling nonconforming products and handling corrective and preventive actions, including recalls.
FDA Recall Classes
Class I Recalls: Issued when there is a risk of serious health problems or death.
Class II Recalls: Issued when there is a risk of temporary or reversible health problems.
Class III Recalls: Issued when there is unlikely to be any adverse health consequences.
Under MDR 2017/745, manufacturers must take corrective actions to bring the device back into conformity or withdraw it. The advisory notice communicates important safety information to healthcare providers and patients, ensuring transparency and accountability.
Managing Medical Device Recalls
Different departments collaborate to manage recalls. The ISO 13485 standard requires companies to report adverse events, distinguish recalled devices from conforming products, and issue related advisory notices.
Steps for Effective Recall Management
Formation of a Recall Committee: Top management appoints a committee comprising the GM, RA Manager, QA Manager, Production Manager, and Sales Manager.
Documentation of a Procedure: Create a well-defined recall procedure identifying process flow, responsibilities, and roles within the committee.
Process Flow for Recall: Recalls can be triggered internally or externally. Reports are forwarded to the QA and RA Managers for review against device specifications and regulatory requirements. The recall committee decides on the recall’s necessity and manages related activities.
Analysis of Recall Report: The committee analyzes the recall situation, examining health hazards, recall depth, communication methods, advisory notice content, and recall effectiveness.
Issuance of Advisory Notices: Advisory notices are sent through traceable methods, and their effectiveness is monitored.
Protocols for Receipt of Recalled Devices: Recalled devices are separated from conforming products and stored in a quarantined area under QA supervision.
Decision for Recalled Devices: QA and RA departments review nonconformities and decide whether to rework, destroy, or substitute the recalled devices.
Distinguishing Medical Device Recalls from Medical Device Enhancements
According to the FDA, a medical device recall involves removing or correcting a marketed device that violates laws administered by the agency, and against which legal action, such as seizure, would be initiated.
A medical device enhancement, however, is a modification to a legally marketed device that could significantly affect its safety or effectiveness. The key difference lies in the existence of a violation of the FD&C Act or associated regulations enforced by the FDA.
Importance of Managing Recalls and Advisory Notices
Effective management of medical device recalls is crucial for manufacturers. Ignoring recall situations can lead to significant financial losses due to litigation and lawsuits filed by patients. Moreover, the loss of reputation can have an even greater negative impact on the company.
Proper recall management can help an organization handle recall situations effectively and minimize the damage caused by hazardous devices. Advisory notices issued as part of the recall process inform distributors, users, and the general public, enhancing safety and compliance.
By having a robust recall management system, medical device manufacturers and suppliers can protect their reputation, avoid financial losses, and ensure patient safety. This system should include forming a recall committee, documenting procedures, analyzing recall reports, issuing advisory notices, and managing returned devices properly.
