Overview of controlling adverse events and product recalls for medical devices

Kazi
Last modified: August 25, 2024

This product recall procedure outlines the processes for a patient incident, adverse event, safety alert, customer information bulletin, and medical device recall from the market.

The procedure also identifies specific individuals empowered with responsibilities and accountability during such events to ensure that all actions are undertaken correctly and that any regulatory reporting is submitted within the appropriate time frame identified by the applicable Regulatory authority.

This article will explore the following areas:

– The reporting of patient incidents, adverse events, safety alerts, customer information bulletins, and product recalls.

– Communication of such actions and reporting when you need to.

– The notification to regulatory bodies by the regulatory affairs team and

– Raising and distributing advisory notices, safety alerts, and customer information bulletins.

– Approval, implementation, and reporting of product recall actions.

The procedure also ensures compliance with ISO 10393 and ISO 13485 requirements and provides control mechanisms for post-market surveillance.

Key Takeaways

– You can collect information on patient incidents or adverse events through various channels and conduct a risk assessment to determine whether the regulatory affairs team needs to report the incident to the respective regulatory agencies.

– Once a patient incident, such as an adverse event, is found reportable, the device manufacturer’s regulatory affairs team must review the draft information and analyze the number of devices affected locally and internationally. The regulatory affairs team then formally submits all details to the regulatory agency

– Where applicable, the device manufacturer must issue safety alerts in the public domain, whether voluntarily or at the request of regulatory authorities. An acknowledgment form should be included for the consumer to sign and return. Customer information bulletins are issued for less severe incidents.

– When a product recall is decided, a recall coordinator coordinates between teams. A product recall team should be established, including regulatory affairs, quality assurance, logistics, warehouse, customer services, etc.

– There are three types of product recalls: product withdrawal, batch recall, and recall for correction.

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Initiating patient incident and adverse event reporting

You must raise an initial notification when you become aware of a patient incident. You can use different communication channels to collect information about such incidents. These can be:

– Direct communication from a hospital/user

– Via a Product Specialist

– Notified by the manufacturer

– Notified via a Regulatory Body

– Via a media report

The details are recorded on the product complaint and incident reporting form.

The regulatory affairs team should assess the details of the adverse events as soon as possible and complete the decision tree for reporting to Regulatory authorities.

The decision tree will facilitate whether the incident must be reported to a regulatory body (e.g., an adverse incident). At this stage, based on its criticality and risk to public health, the period during which the event must be reported is also determined.

Where regulatory affairs deem the incident not reportable, the rationale for such a decision must be clearly recorded on the form. This activity is undertaken in accordance with post-market activities guided by the regulatory agency.

The regulatory affairs department will also raise a corrective action report (CAR) to control all activities associated with the patient incident.

How to report adverse events to regulatory bodies

Where the patient incident is deemed reportable (e.g., an adverse event), the regulatory affairs team must enter all relevant details as required by the regulatory bodies and submit them with proper acknowledgment.

The legal manufacturer’s regulatory affairs team should review and amend any information in the report if required.

The legal manufacturer will usually be required to enter information relating to the number of devices manufactured and supplied to the market and the number of similar incidents for the product in the local and international markets.

When the draft report has been agreed upon with the manufacturer, the regulatory affairs team submits the initial report to the regulatory agency. In addition, the manufacturer is to be provided with a copy of the initial investigation report.

If communication or a request for further information is received from a regulatory body, such communication must be forwarded immediately to the relevant legal manufacturer.

All responses must originate from or be vetted by the manufacturer before submission to the regulatory agency. Subsequent communication must also be processed in the same manner.

Evaluation of samples

If a sample of the device involved in the adverse event is available for evaluation, the regulatory affairs team should send it to the manufacturer.

Any samples being sent for evaluation must be processed to ensure they have been adequately decontaminated and certified.

Issuing safety alerts for adverse events

Safety alerts may be instigated by the manufacturer or upon the recommendation or request of a regulatory body.

A safety alert issued by the manufacturer is information released to the public domain that will help device users use them safely or more effectively.

Safety alerts requested by regulatory bodies may result from receiving information about an adverse incident in which they feel the manufacturer should make a public announcement to mitigate a potential safety issue.

Every safety alert issued to customers includes an acknowledgment form. The customer must sign and return the form to acknowledge receipt of the information.

You must retain all distributed alert records and all completed acknowledgment forms received.

Issuing customer information bulletins

A customer information bulletin (CIB) is typically a document containing information similar to that within a safety alert but of lower significance in its ability to negatively affect the user’s health, safety, or well-being.

The information in a CIB is typically related to a particular operating characteristic, labeling, and operating instruction.

The CIB is communicated to the public to improve their understanding of the product. Acknowledgment forms are generally not included with the release of CIBs.

Initiating product recall for adverse event

Generally, the regulatory affairs and quality assurance teams coordinate the product recall in consultation with senior management.

The applicable regulatory body will also appoint a nominated recall coordinator as a point of contact for the company.

A product recall team should be established by senior representatives from regulatory affairs, quality assurance, logistics, sales and marketing, and customer service, as applicable.

The product recall coordinator is responsible for inter-site liaison and ensuring that all details are communicated and appropriate approval for initiating a major product recall is obtained by the regulatory affairs and quality assurance. This approval must always be obtained in writing.

The product recall coordinator must also provide the regulatory affairs and quality assurance with the documented rationale for not conducting any recall, correction, or removal actions in cases where this has been considered but decided against.

In cases where a manufacturing site initiates the product recall, the appropriate manufacturer will provide formal notification to the sponsor company of the reason, products affected, and actions to be taken.

Types of product recall

There are generally three types of product recall:

a. Product withdrawal

The product type or model is permanently withdrawn from supply because it poses a known or suspected unacceptable risk to the safety and well-being of the public.

This recall may be voluntary by the product’s sponsor or may result from a directive from a regulatory body.

b. Batch (product) recall

A nominated amount of a product type or model is recalled from customers or from the manufacturer’s stock due to a known quantity having a defect that is known to pose or suspected of posing an unacceptable risk to the safety and well-being of the public.

In this category, the known quantity is typically quantified by serial number range, manufacturing lot number, manufacturing date, or other means of identifying the affected products. In these cases, only the affected products need to be recalled.

This recall may be voluntary by the product’s sponsor or may result from a directive from a regulatory body.

c. Recall for product correction

This category applies where it has been identified that a product currently being supplied to the public could have modifications to the device itself or amendments made to any written information related to the device, such as operator’s manuals, instructions for use, and product labeling, and that such modifications may improve the safety and efficacy of the product.

I’d like to point out that requirements for product correction are undertaken with close communication between the sponsor and the customer to ensure that the minimum amount of customer disruption is incurred while the product is undergoing modification.

Regulatory Bodies permit such product modifications to be undertaken progressively at the customer’s or the sponsor’s premises or at a location agreed upon by both parties.

The sponsor may make this recall voluntary or follow a directive from a Regulatory Body.

How to communicate product recall activities

Effective and timely communication between stakeholders must be maintained, especially between the manufacturer and regulatory body.

a. Communication with regulatory bodies

Each regulatory body has its format for communicating the full details of the incident or product recall (e.g., a uniform recall procedure for therapeutic goods).

This document stipulates the actions to be undertaken, the documentation to be raised, and the time frames involved for the company to meet its regulatory reporting requirements on product recalls.

Some regulatory agencies have established contact lists for device sponsors to reference when issuing safety alerts or product recall notifications.

The list contains the names and e-mail addresses of key hospital/health authority personnel, and sponsors must ensure that electronic copies of regulatory announcements are sent to these individuals via email in addition to any postal communication.

b. Quality records

All documentation raised during the processes related to adverse events and product recalls is to be considered quality records and processed and archived in accordance with quality procedure.

Conclusion

In conclusion, this article briefly overviews managing patient incidents, adverse events, safety alerts, and product recalls.

During adverse event notification and product recall, it is important to ensure that all actions comply with regulatory requirements and within the necessary timeframes by clearly defining the responsibilities of key individuals and the reporting and communication processes.

Use a risk-based approach to determine if a patient incident is categorized as an adverse event and if a product recall is necessitated. Please always maintain effective and timely communication with the regulatory authority.

ISO 9001 and ISO 13485 standards provide frameworks for post-market surveillance and control mechanisms for managing adverse events and product recall. This ensures that product recalls are handled efficiently and effectively to safeguard public health.

Author: Kazi Hasan

Kazi is a seasoned pharmaceutical industry professional with over 20 years of experience specializing in production operations, quality management, and process validation.

Kazi has worked with several global pharmaceutical companies to streamline production processes, ensure product quality, and validate operations complying with international regulatory standards and best practices.

Kazi holds several pharmaceutical industry certifications including post-graduate degrees in Engineering Management and Business Administration.