Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for the investigation of reported medical device problems. The document provides additional clarifications regarding the responsibilities of medical device manufacturers and other parties involved in operations with medical devices, as well as recommendations to be considered in order to achieve and sustain compliance with the applicable regulatory requirements set forth by existing legislation. Among other aspects, the document highlights the main points related to root cause investigation, risk analysis, and risk evaluation.
It is also important to mention that the provisions of the present guidance are non-binding in their legal nature and describe the approach suggested by the authority. However, in the case of any discrepancies with the provisions of current legislation, the latter should prevail.
Complete Risk Analysis
According to the document, a complete risk analysis should be duly performed if the investigation identifies significant safety-related issues. Such an analysis should be carried out in order to:
- Verify the results of the preliminary risk analysis;
- Ensure that all the potential hazards and hazardous situations associated with the problem are identified;
- Estimate the risk(s) for each identified hazard;
- Define the scope of the problem (to which particular devices it applies and how many). This information is used to identify any risk present with devices currently in distribution.
Health Canada states that due to the use of numerous sources of information, the results achieved through complete risk analysis are much more comprehensive and reliable in comparison to those achieved through preliminary risk analysis conducted by the responsible party once information about the potential safety-related issues has been received. In this context, the guidance also refers to the international standard ISO 14971 as the one to be applied.
Thus, the appropriate written procedure on medical device problem investigation, developed and implemented by a medical device manufacturer, should prescribe a complete risk analysis in response to any potentially unacceptable risks identified.
As the next step, a medical device manufacturer should evaluate the risk in order to determine whether it is acceptable or not. Such a determination should be based on the results of a complete risk analysis carried out as described above. According to the recommendations provided by the applicable standard, the risk evaluation should be based on comparing the new risk to the acceptance criteria used during the initial device development stage. Further actions to be taken by a medical device manufacturer should be based on the results of such evaluation. Should the risk be found acceptable, no actions would be needed. Otherwise, it would be necessary to develop and implement additional measures in order to mitigate the risk.
The aforementioned written procedure on the investigation of medical device problems should prescribe that risk evaluation be carried out by a responsible person having the necessary knowledge and qualifications. The decision taken, as well as its justification, should be duly documented.
Risk Control: Roles, Corrections
As mentioned, risk control measures are those introduced by a medical device manufacturer in order to, depending on the nature of the risk and its specific features, either eliminate the risk completely or reduce it to an acceptable level. According to the guidance, such measures could include:
- Corrections, aimed at eliminating or minimizing an unacceptable risk associated with device in distribution;
- Corrective actions aimed at eliminating the root cause and preventing recurrence;
- Preventive actions aimed at preventing occurrence, where a potential risk is confirmed but a related incident has not yet occurred.
Health Canada also states that depending on the particular situation, the aforementioned corrections could take place either before usual corrective and preventive actions or simultaneously.
Role of Manufacturer, Importer, and Distributor
The guidance further describes in detail the spheres of responsibilities of all the parties involved in operations with medical devices, including medical device manufacturers, importers, and distributors.
Under the general rule, a medical device manufacturer should be the one initiating a correction. However, efficient cooperation with other parties involved in supplying medical devices on the market is vitally important in order to ensure the effectiveness of such actions in general.
In certain cases, importers and distributors may also initiate a correction. In such a case, it would be necessary to consult with the medical device manufacturer as the party possessing the most comprehensive information about the medical device in question and risks associated thereto in order to ensure that risk is fully addressed.
Corrective and preventive actions are to be carried out mostly by a medical device manufacturer, as certain changes are usually needed to be made to the design of a medical device in question or its manufacturing process.
According to the guidance, risk control measures necessary to address the risk(s) associated with devices that have been distributed may involve ceasing the sale of the device pending identification and elimination of the root cause, advising users and patients, providing additional instructions for use, modifying the devices that have been released or removing them from use.
Health Canada additionally emphasizes that in order to avoid undue delays, a manufacturer responsible for a medical device in question should consider the option to implement intermediate corrections even before a comprehensive investigation is completed. The primary purpose of such measures is to prevent new incidents from occurring. Consequently, such actions could take place in the form of ceasing distribution of medical devices to customers and/or requesting the customers to abstain from using medical devices they already have until further notice. Later, when a complete risk control plan is developed by the manufacturer, these actions could be reviewed.
In order to ensure the efficiency of the mechanisms described above, they should be governed by the appropriate internal written procedure to be developed and implemented by all the parties involved. In particular, such a procedure should prescribe the expedited pathway for immediate implementation of corrective actions approved by the senior management. It should prescribe that once approved, the corrections should be implemented within the shortest period possible in accordance with other related procedures, while all the actions taken should be recorded in the problem report file.
In summary, the present Health Canada guidance describes the main principles of risk control. The document highlights the main points to be considered by medical device manufacturers and other parties with regard to corrections and corrective and preventive measures to be implemented in order to mitigate the risks associated with the safety-related issues identified.
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