Effective Date: October 3, 2011
Supersedes: January 2011
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Guidance documents are meant to provide assistance on how to comply with governing statutes and regulations. They also serve to provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.
Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of marketed health products. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read in conjunction with relevant sections of other applicable guidance documents.
The purpose of this guidance document is to assist manufacturers and importers in understanding and complying with the Medical Devices Regulations concerning mandatory problem reporting (sections 59 through 61.1(2)).
The mandatory problem reporting provisions in the Regulations are intended to improve monitoring and reduce the recurrence of incidents related to medical devices in Canada, and to ensure that the risk to Canadians of problematic devices is managed appropriately. Since Health Canada and its regulatory partners have similar reporting requirements, the Regulations enable Health Canada's participation in international alert systems.
Health Canada, along with its international partners in the Global Harmonization Task Force (GHTF), has developed agreements and documents to promote a harmonized approach to medical device regulation around the world. One of the study groups within the GHTF has produced a document entitled " Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices" (N54) which sets out criteria for adverse event reporting. In discussing the mandatory reporting requirements of the Regulations, this document is also intended to illustrate Health Canada's support of the general principles of harmonization and the goals of the GHTF.
This guidance document is intended as a supplement to the Regulations, to aid in the interpretation of the mandatory problem reporting requirements.
The following definitions are set out for the purposes of interpretation of this document.
For the purpose of this document, the manufacturer and the importer (subject to section 61.1 of the Regulations) are considered to be reporters of the incident to Health Canada. The complainant is the patient, user, or other person who initially brought the incident to the attention of the reporter.
A mandatory problem report is required under the Regulations for any incident involving a medical device that is sold in Canada when the incident:
The manufacturer and importer are each required to make both a preliminary and a final mandatory report, unless the manufacturer provides the Minister written authorization to permit the importer to report on its behalf (see section 61.1(1)-61.1(2) of the Regulations). Manufacturers remain responsible for ensuring that the information in the incident report is both complete and accurate.
A mandatory problem report is required under section 59(2) of the Regulations for any incident occurring outside Canada (foreign incidents), but involving a medical device that is also sold in Canada, only if the manufacturer has informed the regulatory agency in the country where the incident occurred that corrective action is necessary, or when this regulatory agency has requested the manufacturer to take corrective action.
Note: A manufacturer or importer of a radiation emitting device who sends a report to MHPD for the Mandatory Medical Device Problem Reporting Program which concerns a matter within the scope of section 6 of the Radiation Emitting Device Act does not have to be re-submit it to the Consumer and Clinical Radiation Protection Bureau (CCRPB) in order to fulfil the notification requirements set out in that section.
In accordance with section 59 of the Regulations, any incident which meets all of the three basic reporting criteria described in sections 2.4.1 through 2.4.3, below, is considered a reportable incident and must be reported to Health Canada.
Note: When a manufacturer, or importer, receives a complaint about a device which meets the three basic criteria described in sections 2.4.1 through 2.4.3, it must be reported even if the device no longer holds a market authorization in Canada.
It is possible that the reporter will not have enough information to decide on the reportability of an incident. In such a case, the reporter should make reasonable efforts to obtain additional information to aid in the decision. Where applicable, the reporter should consult with the medical practitioner or the health professional involved, and make all reasonable efforts to retrieve the device for evaluation.
Foreign incidents must be reported in accordance with section 59(2) of the Regulations.
Foreign incidents which occurred prior to the specific incident which resulted in the decision to report a corrective action to a foreign regulatory authority (or to the request by the foreign regulatory authority for a corrective action to be undertaken) need not be reported to Health Canada. These incidents should, however, be considered in the rationale for undertaking any future corrective action(s).
The specific foreign incident which resulted in the decision to undertake a corrective action should be reported to Health Canada.
Foreign incidents occurring after the decision to undertake a corrective action, and having the same root cause as the incident which precipitated that decision, need not be reported to Health Canada, unless they result in another, separate corrective action.
Note: Guidance on the timing of reporting foreign incidents to Health Canada is found in section 2.9.2.
The reporter becomes aware of information regarding an incident which has occurred with its device. This may include information from device testing performed by the manufacturer, user or other party.
In assessing the link between the device and the incident, the reporter should take into account:
This judgment may be difficult when there are multiple devices and drugs involved. If, after becoming aware of a potentially reportable incident, there is uncertainty about whether it is reportable, the reporter should submit a report within the timeframe required for that type of incident.
When the first two criteria to determine whether an incident is reportable (section 2.4.1 and 2.4.2) are met, and when death is the result of an incident, a report to Health Canada must be submitted within 10 calendar days, in accordance with section 60(1)(a)(i) of the Regulations (see section 2.9.1, below, for more details).
When the first two criteria to determine whether an incident is reportable (section 2.4.1 and 2.4.2) are met, and when serious deterioration in health is the result of an incident, a report to Health Canada must be submitted within 10 calendar days, in accordance with section 60(1)(a)(i) of the Regulations (see section 2.9.1, below, for more details).
Under the Regulations, a serious deterioration in health means a life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage.
The interpretation of the term "serious" should be made in consultation with a medical professional, when appropriate. The term "permanent" means irreversible impairment or damage to a body structure or function, and necessarily excludes minor impairment or damage.
Medical intervention is not in itself a serious deterioration in health. The reason that motivated the medical intervention should be used to assess the reportability of an incident.
Not all incidents lead to a death or to a serious deterioration in health, either owing to circumstances or to the timely intervention of health care personnel, for example. These situations are known as near incidents. If the incident, in the case of recurrence, could lead to a death or to a serious deterioration in health, a report to Health Canada must be submitted within 30 calendar days, in accordance with section 60(1)(a)(ii) of the Regulations (see section 2.9.1, below, for more details).
This requirement also applies if the examination of the device, or a deficiency noted in the information supplied with the device, or any information associated with the device, indicates some factor which could lead to an incident involving death or serious deterioration in health.
In the report to Health Canada, it is recommended that all relevant information that might impact the understanding or evaluation of the incident be included. For example, "the patient was confused prior to becoming trapped in the bedsides"; "the patient was a very low birth weight premature delivery and had a central line placed three days before onset of cardiac tamponade"; "the X-ray machine was over 20 years old and had been poorly maintained at the time of the incident ", etc. This information should also include an explanation of how this incident could have led to a death or to a serious deterioration in health.
Reportable incidents involving a medical device that affected one or more patients, users or other persons, on the same, or different, dates are to be reported to Health Canada as separate incidents, because each incident was a separate event. However, in the case of a medical device, such as an automated chemistry analyzer, a reportable incident concerning a particular run or rack of analyses (containing samples from one or more patients) should be reported to Health Canada as a single incident, because the entire rack of analyses represent a single event.
As with all reported device complaints, all potential use error incidents must be evaluated by the reporter (see Appendix A for examples). The evaluation should include principles of risk management, usability engineering, design validation, and corrective and preventive action processes. Importers may need to coordinate their evaluation with the manufacturer, in order to ensure that these elements are addressed. Results should be available, upon request, to Health Canada. Please refer to section 2.8.4, below, for guidance on abnormal use ("off-label" use).
There is increased international focus on errors in the use of medical devices. Incidents associated with use error must be evaluated by the reporter and the results documented. These types of incidents can be controlled by the manufacturer's quality systems corrective and preventive action requirements, design validation, usability engineering, and risk management processes. By their nature, incidents involving use error usually involves a degree of uncertainty as to the root cause, but the risks can be managed by the manufacturer through consultation with Health Canada.
Use errors related to medical devices, which did result in death or serious deterioration in health, must be reported to Health Canada, providing the criteria specified in sections 2.4.1 and 2.4.2 were also met.
Use errors related to medical devices, which did not result in death or serious deterioration in health, but which have the potential to result in death or serious deterioration in health, also need to be reported to Health Canada, providing the criteria specified in sections 2.4.1 and 2.4.2 were also met.
Deficiencies of devices that would always be detected by the user, and where death or serious deterioration in health has not occurred, do not need to be reported, because they do not meet requirements of section 59(1)(b) of the Regulations. In these situations, "always" means that even if the incidents were to recur, the user would, again, always detect the defect or malfunction prior to use.
Examples of non-reportable incidents:
When the reporter has information that the root cause of the incident is definitely due solely to a patient's condition, the incident does not need to be reported, because it does not meet the requirements of section 59(1)(a) of the Regulations. These conditions could be pre-existing or occurring during device use.
To justify not submitting a report, the reporter should have documented information available to conclude that the device performed as intended and did not cause, or contribute to, death or serious deterioration in health. A person qualified to make a medical judgment would accept the same conclusion.
Examples of non-reportable incidents:
Incidents which did not lead to a death or to a serious deterioration in health because a design feature protected against a malfunction becoming a hazard, do not need to be reported, because they do not meet the requirements of section 59(1)(a) of the Regulations.
Examples of non-reportable incidents:
Abnormal use includes intentional use for a non-approved purpose ("off-label" use). It should not be confused with use error (see section 2.7). As with all reported device complaints, all potential abnormal use incidents must be evaluated by the reporter (see Appendix A for examples). Abnormal use need not be reported to Health Canada under mandatory reporting regulations. Abnormal use should be managed by the health care facility and the appropriate provincial or territorial departments of health under specific and appropriate schemes not covered by this document.
All reporting time frames refer to when Health Canada must first be notified. This notification may be in the form of a preliminary report, or a combination of a preliminary and final report. The choice of report type depends on whether all the required information is available within the appropriate report timeframe. The Mandatory Medical Device Problem Reporting Form for Industry can be used to report preliminary, updates, final, or preliminary and final reports to Canada Vigilance - Medical Device Problem Reporting Program.
Note: The date that a representative of the reporter is notified of the issue ("awareness date") is considered by Health Canada to be day zero.
Section 60(1)(a) of the Regulations requires that if the death or serious deterioration in health of the patient, user or other person has occurred, a report must be submitted to Health Canada within 10 calendar days. If death or serious deterioration in health did not occur as a result of the incident, but might if the incident were to recur, then the report must be submitted to Health Canada within 30 calendar days.
If, after becoming aware of a potentially reportable incident, there is uncertainty about whether it is reportable, the reporter should submit a report within the timeframe required for that type of incident.
When the decision has been made to report a foreign incident to Health Canada (see section 2.3.2 above, for the criteria), section 60(1)(b) of the Regulations requires that a preliminary report be submitted as soon as possible after the manufacturer has informed the foreign regulatory agency of the intention to take corrective action, or, as soon as possible after the foreign regulatory agency has required the manufacturer to take corrective action.
Note: In this case, Health Canada interprets "as soon as possible" to mean within 48 hours after the decision.
A combined preliminary and final report may be submitted to Health Canada if the incident investigation is complete.
Section 60(2)(h) of the Regulations requires, as part of the preliminary report, that the reporter propose a timetable for carrying out any corrective actions and for submitting the final report. Health Canada will review the proposed timetable to ensure that it does not jeopardize the safety of patients and users. The reporter should provide a final report as soon as the information is available, or as requested by Health Canada.
The timetable should include proposed dates relating to the action plan for resolving the issue, and should not merely include the proposed date for submission of the final report. If the investigation is still in a very preliminary state (e.g.: for a 10-day report), it may be that the timetable only indicates the immediate actions taken (or to be taken) and the proposed date(s) for any updates and for the final report.
Note: A report that contains the information required for a combined preliminary and final report may be submitted to Health Canada, provided that the results of the investigation are available within the 10-calendar-day or 30-calendar-day timeframe for submitting a preliminary report.
The purpose of a preliminary report is to inform Health Canada that, 1) a reportable incident has taken place, and 2) the reporter has begun the investigative process required to determine the root cause.
Section 60(2) of the Regulations sets out the information requirements for a preliminary report. The required information is listed below by section number, with a brief explanation where necessary. References made to the reporter mean the reporter of the incident to Health Canada, and not the complainant.
Section 60(2)(a) requires the reporter to submit information which will allow for ready identification of the device involved in the incident. This shall include 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.
Sections 60(2)(b)(i) and (ii) require the reporter to specify the manufacturer and the importer (as appropriate) of the device involved in the incident. Information required includes the name and address of the manufacturer and of the importer of the device (as appropriate). Additional information includes the name, title, telephone and facsimile numbers of the reporter, in order to facilitate contact for any additional information concerning the incident that may be requested by Health Canada.
Section 60(2)(c) requires the submission of the incident awareness date, which is the date the incident came to the attention of the reporter.
Section 60(2)(d) requires the submission of the details known in respect of the incident, including the date the incident occurred and the consequences for the patient, user or other person. The details may include but are not limited to the following:
Consequences referenced in section 60(2)(d) are the details of any harmful health effect(s) from the incident, the severity of the effect(s) and any treatment required.
Section 60(2)(e) requires the reporter to submit the name, address and telephone number, etc, if known, of the person who reported the incident to the manufacturer or importer.
Section 60(2)(f) requires the reporter to submit the identity of any other medical devices or accessories involved in the incident, if known. This refers to any other equipment that was used with the device or in the vicinity of the device. It is also useful to include information concerning drugs used concomitantly with the device.
Section 60(2)(g) requires the reporter to submit their preliminary comments with respect to the incident. The comments should include a discussion of the preliminary findings of the investigation and an assessment of the risk to patients/users.
Section 60(2)(h) requires the reporter to submit their course of action in respect of the incident, including an investigation, that they propose to follow and a timetable for carrying out any proposed actions and for submitting a final report. This should also include a discussion of whether the device was repaired or replaced following the incident and the details of the repair or replacement, if available when submitting the preliminary report.
Section 60(2)(i) requires the reporter to submit a statement concerning the submission of a previous report for the device and the date of that report. This is interpreted to mean the last incident with the same root cause for the device. This statement should include both the reporter's and Health Canada's file number for that incident.
The proposed interim correction(s) and corrective action(s) must reduce the risk of the device to patients, users and other people to acceptable levels. Proposed interim actions may include a temporary stop-sale or recall, including communication of information about the risk to all users. The situation should be monitored to confirm that the interim actions have reduced the risk to acceptable levels.
In general, Health Canada will use the following criteria:
In general, Health Canada will use the following criteria based on all information available:
The purpose of a final report is to inform Health Canada of, 1) the results and conclusions of the investigation, and 2) the corrective actions and preventive actions (as appropriate) that have been, or will be, undertaken.
Section 61 of the Regulations sets out the information requirements for a final report. The required information is listed below by section number, with a brief explanation where necessary. References made to the reporter, mean the reporter of the incident to Health Canada.
Section 61(2)(a) requires the reporter to submit a description of the incident, including the number of persons who have experienced a serious deterioration in the state of their health or who have died. All new information obtained since the submission of the preliminary report must be included so that the description of the incident in the final report is unambiguous and complete. This would also include a discussion of whether the device was repaired or replaced following the submission of the preliminary report, and the details of the repair or replacement.
Section 61(2)(b) requires the reporter to submit a detailed explanation of the root cause of the incident and a justification for the actions taken in respect of the incident. The explanation should be clear, scientifically sound, and consistent with the data provided and other relevant available information. The justification should present evidence that the proposed course of action will resolve the problem and mitigate the risk of its recurrence.
Note: If no corrective actions are to be undertaken, a detailed rationale must be included in the report.
Section 61(2)(c) requires the reporter to submit any actions taken as a result of the investigation, which may include, (i) increased post-market surveillance of the device, (ii) corrective and preventive action respecting the design and manufacture of the device, and (iii) recall of the device.
Note: Section 61(2)(c)(ii) is interpreted to mean the following: corrective action on the device to prevent recurrence of the issue respecting the design and manufacture of the device, and may also include preventive action taken on similar product lines / devices to prevent occurrence of the same issue.
If increased post-market surveillance is required, the final report must present an action plan for increased monitoring and trending of incidents associated with devices already on the market, including the following details:
If there is a need to provide information to users of the device, the final report must include details of the risk communication plan. This may be done by referring, in the final report, to the recall notification which was already submitted to Health Canada.
Although the Regulations refer to preventive actions in section 61(2)(c)(ii), it should be noted that if an incident has occurred, it is not possible to take a preventive action. The manufacturer should always look across its product lines to evaluate whether the issue that resulted in an incident with one product may also occur in another product line, if no action is taken. In this case, since the other product lines have not yet experienced the issue, any action taken is considered to be preventive. This is documented in the manufacturer's quality management system. It is not reported to Health Canada under the mandatory problem reporting provisions of the Regulations.
If a correction is required for any units of the device still in use, the final report should include a detailed action plan and timetable for carrying out the correction. If the investigation indicates that there is a design or manufacturing defect, the final report must include a detailed plan of action and timetable to correct this defect and to prevent its recurrence.
Note: Trending is not considered to be a corrective action, but is part of a post-market surveillance program.
Corrections and corrective actions fall under recall activities.
It should be noted that in the event a device is not returned for evaluation, an investigation into the root cause of the incident must still be conducted to the extent possible. This investigation may include the evaluation of retained samples from the same lot, and from earlier and later lots of production from the device in question, as well as the evaluation of all related or similar incident records for that lot, for example.
In general, Health Canada will use the following criteria based on all information available:
In general, Health Canada will use the following criteria based on all information available:
It should be noted that absences from a mandatory problem report of any elements outlined in this guidance document may necessitate additional questions, requests for information and compliance verifications by Health Canada. Submission of inadequate mandatory problem reports by reporters, for which Canada Vigilance - Medical Device Problem Reporting Program is consistently required to request additional information, will result in the forwarding of this information to the Health Products and Food Branch Inspectorate, to determine regulatory compliance.
If there are any questions relating to the device or the incident in the report, Health Canada will contact the reporter/manufacturer/importer listed on the mandatory problem report.
Mandatory problem reports may be submitted to Health Canada using one of the following methods:
Once the report has been received and entered into our database, a letter confirming receipt of the report will be sent to the reporter. This letter will contain information concerning the name of the device in the incident, the reporter's file number, Health Canada's file number and the date the report was received by Health Canada. Please ensure that Health Canada's file number and the Reporter file number is included on all further correspondence concerning the incident.
Complaint reports received of incidents occurring despite adequate instructions and design according to manufacturer's analysis. Examples include the following:
Potential abnormal uses include complaint reports received of incidents occurring despite proper instructions; proper design; or proper training, and are, according to manufacturer's analysis, determined to be beyond any reasonable means of the manufacturer's risk control. Examples include the following: