Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the investigation of reported problems associated with medical devices.
The latest version of the document was issued in March 2011. The authority explicitly states that the document should not be considered part of legislation since it does not introduce rules and requirements to be followed. Instead, it provides clarifications and recommendations regarding achieving and sustaining compliance with the applicable regulatory requirements. In the case of any discrepancies with the provisions of current legislation, the latter should prevail. The authority also mentions that the recommendations provided in the document do not represent legal advice on the matter.
The present Health Canada guidance is based on the applicable provisions of the Medical Devices Regulations dedicated to investigations of problems subject to reporting. In particular, it describes how the risk management principles should be applied and provides additional clarifications regarding the responsibilities of parties involved in operations with medical devices, including manufacturers, importers, and distributors. The document also provides additional recommendations regarding the procedures to be implemented by the entities operating in this sphere with regard to record-keeping as prescribed by the applicable legislation. By virtue of the guidance, the authority also intends to facilitate and streamline the regulatory procedures associated with incident reporting.
The scope of the guidance covers the following aspects:
- Internal rules and procedures,
- Mandatory reporting requirements in the context of the complaints handling process (the authority also mentions that the reporting requirements are addressed in detail in the appropriate guidance dedicated to the matter).
Health Canada emphasizes that the current regulatory requirements should be used as a basis for internal procedures to be developed and implemented by the responsible parties. However, the actual scope of such procedures could exceed the minimum requirements set forth by the applicable regulations. The particular way the requirements should be implemented will depend on factors specific to the company and product in question.
The regulatory requirements addressed in the document are applicable to medical device manufacturers and other parties conducting operations with medical devices, including importers and distributors.
In order to assist in interpreting the provisions of current legislation, the guidance also provides the definitions of the most important terms and concepts, including the following:
- Corrective action – an action to eliminate the cause of a detected nonconformity or other undesirable situation;
- Correction – an action to eliminate detected nonconformity including the repair, modification, adjustment, relabelling, or inspection of a device without its physical removal to some other location;
- Hazard – potential source of harm;
- Preventive action – an action to eliminate the cause of a potential nonconformity or other undesirable potential situation;
- Record – a document stating results achieved or providing evidence of activities performed;
- Reported problem – a communication from any source on a medical device that has been released for sale which indicates an actual or potential deficiency that may impact on the performance characteristics or safety of the device;
- Residual risk – a risk remaining after protective measures have been taken;
- Risk – a combination of the probability of occurrence of harm and the severity of that harm.
Apart from those listed above, the document also provides the definitions of such terms as “control number,” “distributor,” “establishment,” “harm,” “hazardous situation,” “health care facility,” “importer,” “manufacturer,” “medical device,” “nonconformity,” “person,” “recall,” and others. The document also provides additional clarifications regarding certain terms used in the context of problem reporting. For instance, the authority states that the scope of correction as a part of corrective action could include a recall of medical devices that create hazards for the patients or other persons using them. The authority also mentions that the main difference between preventive action and corrective action is in timing: the first one could be performed in advance, while the second always takes place when an incident has already occurred. Usually, it is performed to prevent further harm or mitigate newly identified risks. A recall should be initiated if it is identified that the medical device in question fails to comply with the applicable regulatory requirements or creates hazards for the persons using it.
According to the Health Canada guidance, identification and management of risks associated with a medical device should constitute an important part of the investigation process to commence in response to the problem reported. Risks subject to additional assessment may arise in the course of the use of the product for its intended purpose or as a result of defects impacting its safety. Thus, the problem investigation procedures employed by medical device manufacturers should be based on risk management principles. In this regard, Health Canada refers to the applicable international standards, such as ISO 14971 and ISO 13485. The authority also mentions that any and all medical device manufacturers shall comply with the latter as prescribed by the applicable legislation (except the manufacturers of class I medical devices which are low-risk products – in such a case, it would be sufficient to implement efficient risk management procedures).
In order to ensure the effectiveness of the procedures associated with problem report investigations, it is vitally important to ensure efficient cooperation among all parties involved in operations with medical devices, including medical device manufacturers and importers and distributors. It is recommended that all parties employ a similar approach to risk management in terms of requirements and terminology. For instance, it could be based on the aforementioned international standard ISO 14971.
According to this standard, the key stages in risk management shall include:
- Risk analysis;
- Identification of hazards and hazardous situations (root cause investigations);
- Estimation of risk;
- Risk evaluation;
- Risk control;
- Overall residual risk evaluation.
According to the guidance, the starting point for the process should be the moment when a responsible party receives a notification on a problem identified. The ending point is once all identified risks are duly mitigated. The information collected in the process could also be used in similar situations in the future.
Responsibilities of the Parties Involved
The guidance further describes in detail the responsibilities of all the parties involved, including medical device manufacturers, importers, and distributors. As mentioned, an effective collaboration plays an important role in mitigating the newly identified risks associated with medical devices already placed on the market.
In summary, the present Health Canada guidance provides an overview of the most important regulatory requirements related to problem reports and investigations associated thereto. The document outlines the main principles upon which the procedures to be employed by the parties should be based and describes in detail the responsibilities of medical device manufacturers, importers, and distributors.
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