Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to recalls. The document is intended to provide medical device manufacturers and other parties involved with additional clarifications regarding how recalls of medical devices should be performed in accordance with the applicable regulatory requirements.
The provisions of the document are non-binding in their legal nature and describe a suggested approach to be considered. In case of any discrepancies with the provisions of existing legislation, the latter should prevail. In particular, the guidance describes the recall process step-by-step, highlighting the most important aspects to which the parties involved should pay attention.
According to the applicable regulations, the manufacturer, importer, and distributor of a medical device shall each establish and implement documented procedures that will enable them to carry out an effective and timely recall of the device. The authority additionally emphasizes that the responsible party shall duly confirm the presence of the aforementioned procedures in order to be eligible for a Medical Device Establishment License (MDEL).
As it is stated in the guidance, a recall process, in general, could be divided into the following steps:
- Initiating a recall:
- Identify the need to initiate a recall;
- Develop recall strategy and scope;
- Conducting a recall:
- Notify and correct;
- Follow up;
- Review and close recall.
In most cases, a recall is initiated by a medical device manufacturer. At the same time, other parties involved, such as importers or distributors, are also allowed to initiate a recall. However, irrespectively of the party initiating the recall, each participant of the process should communicate the relevant information to parties down the distribution chain.
Identifying the Need
At the very first stage, a party initiating the recall should identify the need to initiate a recall. According to the guidance, a medical device manufacturer shall duly initiate a recall if it identifies certain issues associated with the medical device itself or its labelling, provided such issues:
- Expose patients to additional risks and hazards;
- Constitute a failure to meet the statements regarding the safety and performance of the device in question;
- Constitute a non-compliance with the regulatory requirements set forth by the applicable legislation.
There are many ways in which a medical device manufacturer could become aware of the aforementioned issues. For instance, the appropriate information could be communicating via a formal complaint triggering further investigation, an inspection carried out by an authorized person, or in the course of internal quality control testing. The issues could be related to:
- Design deficiencies;
- Component defects or failures;
- Labeling problems;
- Manufacturing problems;
- Software errors;
- Compliance issues (e.g. related to device licensing);
- Improper shipping, installation or servicing.
Depending on the nature of the issue identified, and also on the severity of actual or potential consequences thereof, the manufacturer shall issue a safety warning in order to notify about the risks, take necessary actions to correct the issue, or remove the device from the market.
As mentioned, each medical device manufacturer shall duly develop and implement a quality system and applicable policies regulating the way the safety- and performance-related issues should be identified and treated. These policies should prescribe the actions to be taken according to the risk associated with the issue identified and also the particular way such actions should be performed. Should the action determined by the manufacturer also need to be taken with regard to medical devices already distributed and thus being used for the intended purpose, such actions, in most cases, would fall within the scope of the definition of a recall.
Developing a Recall Strategy
At the next step, the responsible entity (usually the medical device manufacturer) shall develop a recall strategy describing the particular consequence of actions to be taken. According to the document, a recall strategy should cover the following aspects:
- Evaluation of risk,
- Evaluation of significant change to the medical device,
- Depth of the recall within the distribution chain,
- Recall communications,
- How to notify users who are not readily identifiable,
- Evaluation of the effectiveness of the actions taken,
- Initiation date, progress reports to Health Canada and anticipated closure date.
Additionally, the entity initiating the recall shall identify its scope – the devices subject to a recall. The approach described in a recall strategy should be based on the nature of the issue, the risks associated thereto, the ease of contacting the affected parties (e.g., customers or healthcare professionals using the device to be recalled), the level to which it is obvious for the customer that the device has a defect, and last but not least, the uninterrupted availability of alternative products that could be used instead.
If the party initiating a recall is a medical device manufacturer, it should request distribution lists from other parties involved in the supply of the affected device in order to plan the further steps regarding the way the customers should be notified. At this stage, the regulating authority should be duly notified about the planned recall as well.
In order to be able to plan the action in a correct way, the responsible entity should also carry out a risk evaluation, as the further actions to be taken would depend on the risks identified. In particular, it is necessary to consider the nature of the risks associated with the issue, specific aspects of the affected population, the competence of the ones using the product subject to recall and level of their awareness of the issue, adverse events that have already taken place, the probability of new cases, as well as the expected ability of an average device user to identify the issue.
Depending on the aforementioned evolution, the part initiating a recall should assign it to one of the following types:
- Type I. The issues identified could result in significant harm caused to the patient’s health;
- Type II: The adverse consequences that could be potentially caused by the device are temporary in their nature;
- Type III: The issues identified are not likely to cause any adverse health consequences.
The appropriate risk evaluation should be communicated to the regulating authority as a part of the recall notification to be submitted as described above. Once received, Health Canada would conduct its own risk evaluation on the basis of the information provided in order to validate the relevance of the decision taken by the party initiating a recall.
In summary, the present Health Canada guidance describes the most important aspects to be considered when making a decision to initiate a recall of medical devices already placed on the market, and also when planning the particular steps to be taken in this regard. The document outlines the scope of responsibility of the party initiating a recall, as well as the other parties involved in the distribution process.
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