Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the investigation of safety- and performance-related issues associated with medical devices. Apart from other aspects, the document highlights the most important points related to the corrective and preventive actions (CAPA) and their evaluation.
The document is intended to provide medical device manufacturers and other parties involved in operations with medical devices with additional clarifications and recommendations to be considered to achieve and sustain compliance with the applicable regulatory requirements. The authority also reserves the right to modify the guidance and recommendations provided therein, should it be reasonably necessary to reflect the changes to the applicable legislation. The provisions of the guidance are non-binding in their nature and should not be construed as legal advice of any kind.
Corrective and Preventive Actions
According to the guidance, additional actions could be required to mitigate new risks identified. As it is stated by Health Canada, risk control measures necessary to address the identified root cause of a problem may involve changes in the design, production methods, testing, components, packaging, labeling, or other aspects of a finished device.
Once the issue related to the safety or effectiveness of a medical device already placed on the market has been identified, the manufacturer shall duly develop and implement the appropriate measures to address these problems. In particular, the appropriate CAPA plan should be developed by a responsible person having the necessary qualifications. Such a plan should describe the approach to be applied to eliminate the newly identified risk or reduce it to a level that is deemed acceptable. The changes to be implemented under the CAPA plan should be aligned with the quality system employed by the medical device manufacturer. The authority additionally emphasizes that such a plan should require an assessment in the case of Class III or IV devices, to determine whether any of the changes meet the definition of “significant change”, and if so, compliance with the applicable requirements of the Regulations before the sale of modified devices. It is also important to mention that in case the changes introduced to the medical device in question in the course of corrective and preventive actions would impact production and supply of the device, other parties involved in the supply of such device should be duly notified. Moreover, a party that has initially informed the manufacturer about the issue should be notified about the actions taken by the manufacturer to address the problem. Once finalized, a CAPA plan should be subject to approval by the senior management of the medical device manufacturer.
The appropriate written procedures developed by the manufacturer should prescribe that a CAPA plan should be implemented without undue delay, while all the measures taken should be duly recorded in the problem report file.
As it was mentioned before, the manufacturer shall communicate information about the root cause of the problem, as well as the measures are taken to address it to the entity that has initially reported the problem (e.g., importer or distributor), while the latter requires such information to comply with the appropriate record-keeping requirements it is obliged to follow.
Evaluation of Corrections and CAPA
The present Health Canada guidance not only describes the particular procedure to be followed by a medical device manufacturer when developing and implementing a plan of corrective and preventive actions but also provides additional recommendations regarding the evaluation of the actual effectiveness of such actions. In this regard, the authority explicitly states that the manufacturer’s procedure should require that the result of corrective and preventive actions and corrections be evaluated by a qualified individual or group to determine whether the residual risk(s) is acceptable and that the actions were effective. For this purpose, the manufacturer shall duly collect and evaluate sufficient information regarding the performance of medical devices subject to correction. For instance, the review could include a statistical analysis of problem trends.
Should the level of residual risk exceed the acceptable threshold, an additional risk/benefit analysis would be required to determine whether the medical benefits of the device outweigh the residual risk. Should this be confirmed, the medical device in question should be allowed for further marking and use in Canada. At the same time, should the residual risk(s) be found unacceptable, the whole procedure should be performed one more time from the very beginning, including such stages as the development of a plan of corrective and preventive actions, its implementation, and further evaluation of their effectiveness. The authority additionally emphasizes the importance of keeping records of such an evaluation to be conducted by a medical device manufacturer in the course of an investigation of a problem reported.
The guidance also covers the most important aspects regarding the record-keeping requirements the parties involved shall comply with. In this regard, the authority refers to Section 57 which prescribes that:
The manufacturer, importer, and distributor of a medical device shall each maintain records of the following:
- Reported problems relating to the performance characteristics or safety of the device, including any consumer complaints, received by the manufacturer, importer, or distributor after the device was first sold in Canada; and
- All actions taken by the manufacturer, importer, or distributor in response to the problems referred to in paragraph (a).
The appropriate written procedure to be duly developed and implemented by the aforementioned parties should prescribe the particular way the records should be maintained. In particular, a unique number could be assigned to each report to ensure transparency and traceability. Additionally, the parties involved in operations with medical devices could employ problem report logs to record detailed information about the investigation carried out in response to the problem reported. Apart from this, the procedure should provide additional details regarding the documents to be created in the course of an investigation and further corrective actions taken to mitigate the risks identified.
Existing legislation does not provide specific requirements for maintaining such records. However, the aforementioned procedure should cover such aspects as:
- The scope of persons or functions responsible for record-keeping;
- Indication of the particular way the records should be kept;
- Clarifications regarding the way existing records could be navigated through;
- References to the access control and other measures to be implemented to ensure the integrity of records;
- Details regarding archiving and retention of records related to the investigation of reported problems and actions taken in response.
In summary, the present Health Canada guidance provides an overview of the existing regulatory framework for corrective and preventive actions to be taken by medical device manufacturers to address the risks associated with the products they are responsible for. The document also clarifies the most important aspects related to cooperation between the parties involved in supplying medical devices.
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