Health Canada, the country’s regulating authority in the sphere of medical devices, has published updated guidance on incident reporting for medical devices. The present document supersedes the previous version issued by the authority earlier in October 2011.
Due to its legal nature, Health Canada does not introduce any rules and obligations the parties involved should follow but instead provides additional clarifications and recommendations to be considered. Moreover, it is also allowed to apply an alternative approach, providing that such an approach complies with the respective regulatory requirements, and there is a sufficient justification in place. The medical device manufacturer intended to apply an alternative approach should discuss it with the regulating authority in advance to avoid non-compliances in the course of its actual implementation.
The regulating authority additionally mentions that it is entitled to request documents or introduce the requirements other than outlined in the present guidance, should it be necessary to ensure the safety and effectiveness of the medical devices intended to be marketed and used in Canada. However, all such requests would be duly justified, and the decisions based thereon should be duly documented.
Regulatory Background
The present guidance is intended to provide medical device manufacturers and other parties involved in operations with medical devices with additional clarifications and recommendations to be considered in order to achieve and sustain compliance with the applicable regulatory requirements set forth by the Medical Devices Regulations with regard to the incident reporting obligations.
According to the aforementioned Regulations, incident reporting plays important role in the reduction of the number of incidents associated with medical devices, as well as the overall improvement of the quality of medical devices in general. It also constitutes an important part of the risk management process. Nowadays the Canadian regulating authority is taking steps towards further harmonization if the regulatory framework with the best practices adopted in other jurisdictions, as well as with the ones developed by the Global Harmonization Task Force (GHTF) – for instance, the “Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices” – the document that outlines the regulatory requirements in terms of adverse event reporting.
As it was already mentioned before, the present Health Canada guidance does not introduce regulatory requirements itself, it only describes in detail the ones prescribed by the applicable Regulations, and also suggests the approach to be followed by the medical device manufacturers to ensure continuous compliance thereto.
The document provides the definitions of the most important terms and concepts used in the context of adverse event reporting. These definitions include, inter alia, the following ones:
- Abnormal use – an act, or omission of an act, by the user of a medical device as a result of conduct that is beyond any reasonable means of risk control by the manufacturer. According to the guidance, it also includes intentional use for a non-approved purpose.
- Correction – an action to eliminate a detected nonconformity including the repair, modification, adjustment, relabelling, or inspection (including patient monitoring) of a device without its physical removal to some other location. Such a correction could take place in the course of the appropriate corrective action. At the same time, this concept also includes recalls initiated to withdraw certain medical devices from the market.
- Incident – for the purpose of the guidance, an incident stands for the event subject to reporting under the applicable reporting requirements.
- Malfunction or deterioration – a failure of a device to perform in accordance with its intended purpose when used in accordance with the manufacturer`s instructions.
- Preventive action – action to eliminate the cause of a potential nonconformity or undesirable potential situation.
Besides the ones listed hereabove, the guidance provides the definitions of such terms as “radiation emitting device,” “recall,” “serious deterioration in the state of health,” “user error,” “serious risk of injury to human health,” as well as the definitions of the terms related to the parties involved in operations with medical devices, such as manufacturer, user, and reporter.
Incident Reporting: the Basics
The present document describes in detail the regulatory requirements on adverse reporting for medical devices intended to be marketed and used in Canada. As it was already mentioned before, it provides additional clarifications with regard to the applicable provisions of the Regulations addressing such issues.
According to the general rules, the medical device manufacturer, importer, and authorization holder are responsible for reporting incidents associated with medical devices to Health Canada. At the same time, the person using the medical device (e.g. patient or healthcare professional) may file a complaint to bring the attention of the regulating authority to the incident.
When considering whether the particular event should be reported as an accident, the responsible party should consider the following criteria:
- It has occurred in Canada;
- It took place, not in Canada (for Class I medical device);
- It is related to a failure of a medical device, or certain deviations from the way it should operate, or any similar issues related to its labeling and indications for use; and
- Has resulted in serious consequences for the patient`s health.
Should such a situation occur, both medical device manufacturer and importer are obliged to submit two reports – preliminary and final. However, the medical device manufacturer may also authorize the importer to act on its behalf. Anyway, the medical device manufacturer remains to be the party responsible for the completeness and accuracy of the information submitted.
As it was mentioned before, the foreign incident reporting requirements are different depending on the class of a medical device in question under the risk-based classification. According to the current regulatory requirements, foreign incidents should be reported only when related to Class I medical devices, while for the ones assigned to higher classes another approach should be applied – such devices are subject to foreign action notification to be provided in case of serious risks identified.
Health Canada additionally mentions that in the case of radiation-emitting devices separate notice to the respective authority is not required – it would be sufficient to submit a general report for a medical device.
Additional Incident Reporting Criteria
In order to assist medical device manufacturers and other responsible parties in complying with the regulatory requirements described herein, the present Health Canada guidance provides additional clarifications regarding the criteria to be considered when determining whether the particular incident should be reported. Under the general rule, any incident should be reported in case if it meets all three of the criteria listed below. The authority additionally emphasizes that the appropriate report should be submitted even if the device is no longer available on the market.
Reporting criteria to be considered:
- An incident actually took place;
- There is a connection between the incident and a particular medical device;
- The incident resulted in severe negative consequences for the patient or other person using the medical device.
Should all these criteria be met, such an incident should be reported to the regulating authority in accordance with the applicable regulatory requirements.
Summarizing the information provided hereinabove, the Health Canada guidance on incident reporting provides an in-depth review of applicable regulatory requirements set forth under the current framework. In particular, it provides clarifications regarding the criteria to be considered by the responsible party when determining whether the incident associated with the medical device should be subject to reporting.
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