Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to incident reporting for medical devices.
The document is intended to assist medical device manufacturers and other parties involved in operations with medical devices in ensuring compliance with the applicable regulatory requirements for reporting adverse events associated with medical devices allowed to be marketed and used in Canada.
Recommendations provided in the guidance are non-binding in nature, so an alternative approach could be applied, provided such an approach complies with the current legislation and has been approved by the authority in advance. The regulating authority is also entitled to request additional information and documentation beyond the scope of the present guidance, should it be reasonably necessary for the authority to assess the safety and effectiveness of medical devices.
Content of an Incident Report
Health Canada further describes in detail the scope of information about the adverse event itself, as well as the medical device involved, to be provided by the responsible party to the regulating authority. As the very first step, a preliminary report should be submitted. According to the guidance, a preliminary report is intended to inform the authority that:
- A reportable incident has taken place, and
- The reporter has begun the investigative process required to determine the root cause.
It is important to mention that for the purpose of this guidance, a “reporter” stands for the one who is responsible for reporting to the regulating authority under the applicable legislation (e.g., medical device manufacturer), and not the one who files the initial complaint (a complainant, who can be a patient, a healthcare professional, or any other natural or legal person).
The particular scope of information to be included in such a report is prescribed by the applicable regulations. The authority provides references to the particular provisions to be applied and also clarifies the reporting requirements set forth therein.
According to Section 60(2)(a), the reporter shall provide details sufficient to identify the device involved in the adverse event in question, including the name of the device (for example, the trade name), the medical device identifier, the device catalogue number, device license number, the model number, serial number, lot number, etc.
According to Sections 60(2)(b)(i) and (ii), the reporter shall also provide information about the manufacturer and importer of the device in question, including the name and address. The authority reserves the right to request additional information, such as contact details.
According to Section 60(2)(c), the reporter shall indicate the date it became aware of the incident.
According to Section 60(2)(d), the reporter shall provide all information about the adverse event which is available at the moment of reporting, such as the exact date and the effect caused to the person involved. The scope of information to be provided may include the following points:
- What happened (where, when, how, to whom)?
- Is this the first time the device was used by the hospital/healthcare worker/patient/user?
- If not, how long has the device been in use? When it was used previously?
- Have there been any previous problems with the device? If so, how often have these problems occurred?
- Was the device used according to directions?
- What were the environmental conditions surrounding the incident (if applicable)?
- What were the parameters or control settings at the time of the incident?
- How many other units of the device were involved in the incident?
- Was the device misused in any way (for example: reuse of a single-use device)?
- What method was used to clean, sterilize or re-sterilize the device? Was this consistent with the manufacturer’s recommendations?
- How was the product stored or maintained?
Apart from the aspects listed hereabove, the reporter shall provide detailed information about the negative consequences faced by the person involved in the incident (e.g. patient or user), if any, including the information about the treatment such person would require to overcome the consequences.
According to Section 60(2)(e), the reporter shall also provide information about the initial claimant, i.e., the one who has informed the reporter about the incident.
According to Section 60(2)(f), the reporter shall provide information about other medical devices, equipment, or drugs involved in the incident.
According to Section 60(2)(f), the reporter is obliged to supplement the report with comments regarding the adverse event that occurred, including the plan and timeframes for further actions the reporter will take in the course of an investigation. If the device has been replaced, this should be indicated in the report as well.
According to Section 60(2)(i), the reporter shall provide details about the previous report dedicated to the same matter.
The reporter shall also provide information about any actions it will take to mitigate the risks identified. For instance, depending on the risks and severity of potential consequences, the reporter may issue a special notice to communicate important information to users or initiate a recall. The reporter will be responsible for continuous monitoring to be performed in order to ensure the measures taken are efficient enough in mitigating the risks associated with the device in question.
As mentioned, a preliminary report to be submitted to Health Canada by the reporter shall contain information about the actions it is going to take. In this regard, the authority states that it will assess the adequacy of the measures described in the plan provided by the reporter, as well as of the timeframes indicated therein. In particular, the authority will assess whether the actions proposed by the reporter consider all the important aspects associated with the incident and the medical device itself. It will also assess the potential impact the actions suggested by the reporter would cause on the safety of patients. Thus, the authority will pay the most attention to the risks associated with the device and interim actions the responsible entity is going to take during the investigation in order to mitigate the risks before additional information about the incident is available. Additionally, the authority will evaluate justifications for all gaps in the timetable suggested by the reporter in order to ensure there would be no undue delays in the implementation of measures reasonably necessary to reduce the risk of new adverse events having the same roots.
The authority will assess the adequacy of the actions suggested by the reporter using numerous criteria, including the following ones:
- Significance of risk associated with the device;
- Information that will be communicated to the parties involved (whether it is sufficient to mitigate the risk);
- Effectiveness of communication methods the reporter is going to use.
In summary, the present Health Canada guidance provides additional clarifications regarding the county’s regulations on incident reporting. The document also contains recommendations on the content of the report to be submitted by the responsible entity and describes the approach the authority will apply when assessing it and measures described therein.
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