ISO 13485 & MDR Blog

How to manage recalls and advisory notices for medical devices according to ISO 13485

A recall, along with necessary advisory notices, is an important but reactive approach that is used by medical device manufacturers to remove a medical device from the market due to regulatory violation, serious risk of injury, damage, or deteriorating health of the patient. A recall is an effective way to rescue a company from a lawsuit that could result in billions of dollars in claims. Recall activities include return of a medical device to the supplier, rework on the recalled device by the supplier at the place where it is used or on the supplier’s end, exchanging the device for a defect-free device and destruction of the recalled device, and increasing awareness about the handling of the recalled devices with the help of advisory notices.

Recalls are sometimes confused with market withdrawal; however, it should be noted that market withdrawal consists of activities like normal stock rotation or the substitution of an outdated device with the latest updated model. A recall and its advisory notices are only issued where there is a risk of adverse impact of a medical device, and thus should not be confused with market withdrawal. Advisory notices are issued to distributors, users, and sometimes the general public through regulatory bodies.

Management of a medical device recall

Different departments work in collaboration to manage a medical device recall. The ISO 13485 standard requires companies to report adverse events like recalls to regulatory bodies, distinguish recalled devices from conforming product, and issue related advisory notices for the recall where needed. Companies can manage their recall effectively by taking the following measures:

Formation of a recall committee: Usually, although not explicitly required by the standard, the first step in managing recalls is for top management to appoint a recall committee, which should comprise the GM, Regulatory Affairs (RA) Manager, Quality Assurance (QA) Manager, Production Manager, and Sales Manager. The recall committee initiates the recall and organizes associated activities.

Document a well-defined procedure: The second step after the formation of the committee is to create a well-defined procedure for recalls and advisory notices. The procedure shall identify the process flow for the recall, and identify all responsibilities and roles within the committee.

Process flow for a recall in practice: Recalls can be triggered internally within the organization, or by any external source. In normal industrial practices, these reports of possible recalls are immediately forwarded to the Quality Assurance Manager and the Regulatory Affairs Manager. The Quality Assurance Manager reviews the medical device against the device specifications, whereas the Regulatory Affairs Manager reviews it against the regulatory requirements. Both managers analyze the situation and determine the severity of the reported deficiency, including whether it constitutes a recall or not. Any of the managers can call a meeting of the recall committee. Usually, the production and sales departments are responsible for managing activities related to recalls. These activities include the identification of suspected lots, both internally and externally.

Analysis of the recall report: The recall committee, in a recall report presented by the QA or RA Manager, analyzes the recall situation and decides whether a recall can be avoided or not and, if so, examines the following:

  • Magnitude and type of health hazard and classification of the recall
  • Projected depth of the recall
  • Method(s) of sending advisory notices to recipients, e.g., email, letter, fax, telephone, or multiple communication channels
  • Content of the advisory notices
  • Mechanism for checking the effectiveness of the recall

When the above data and information are finalized, the proposed recall plan is communicated to relevant authorities.

Issue of advisory notices: The recall committee makes the final determination as to whether advisory notices must be issued. The advisory notices are sent through a traceable method, such as certified mail. The records of advisory notices are maintained and the effectiveness of advisory notices is monitored.

Protocols for receipt of recalled devices: ISO 13485 requires organizations to physically separate returned recalled products from conforming products. Recalled devices are received from the market by the supply chain department, and are stored in a quarantined area under the supervision of the quality assurance department, where they are marked as recalled products to distinguish them from other, conforming products. Recalled devices are to be noted in a Recall Log that identifies the source, quantity returned, defect, and lot numbers.

Decision for recalled devices: The nonconformities listed in the Recall Log are reviewed critically by the quality assurance and regulatory affairs departments to make a decision. Devices within the scope of the recall can be reworked, destroyed, or substituted according to the decision made as per defined procedures.

Corrective action and preventive action request: Concerning good manufacturing practice, the quality assurance department raises a corrective action and preventive action request when a recall is issued. In this process, the root cause of the defect is addressed and a corrective action is taken by a given deadline, so that such issues will not arise again in the future.

Importance of managing recalls and advisory notices

Effective management of recalls for medical device manufacturers is extremely important. There are examples in the market where recall situations are ignored by companies, resulting in heavy financial losses due to litigation and lawsuits filed by the patients. The loss of reputation can result in an even greater negative impact on the company. Therefore, it is vital for medical device manufacturers and suppliers to manage recalls through an effective system.

With this recall management system, an organization can manage recall situations effectively and minimize the damage incurred through the use of hazardous devices.

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