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 medical device problems. The document is intended to provide medical device manufacturers and other parties involved in operations with medical devices with additional clarifications regarding existing regulatory requirements in terms of problem report investigation.
According to the Health Canada guidance, the activities to be performed by the entity responsible for a medical device with regard to issues associated with the said medical device include the following:
- Receipt and recognition of medical device problem reports;
- Gathering of detailed information, obtaining subject device;
- Identification of safety and performance issues;
- Preliminary risk analysis;
- Interim risk control measures;
- Preliminary mandatory reporting, as applicable;
- Root cause investigation;
- Complete risk analysis;
- Risk evaluation;
- Risk control measures (corrections, corrective and preventive actions);
- Evaluation of effectiveness of risk control measures;
- Final mandatory reporting, as applicable;
- Closure; and
- Ongoing trend analysis.
It is also stated that medical device manufacturers should duly develop and implement the appropriate written procedures (policies) describing how the medical device problem reports should be treated. Such procedures could include a flowchart describing the particular actions to be performed and key persons or divisions responsible for undertaking these actions, as well as supporting documentation providing additional clarifications and instructions.
Evaluation of Problem Report Information
Once the information about the potential problem is received, it should be subject to a rigorous assessment in accordance with the written procedure on problem report investigation in order to:
- Determine whether it meets the scope of this procedure;
- Estimate the associated risk;
- Determine whether mandatory reporting requirements apply.
First, it is necessary to evaluate whether the information received contains any references to the potential safety and performance issues associated with a medical device. If it does, an investigation should be commenced in accordance with the appropriate written procedure developed and implemented by the party responsible for a medical device. If an investigation has not been initiated, the appropriate justification should be duly documented. According to the guidance, the written procedure on problem report investigation should also prescribe specific timeframes for the abovementioned actions.
Once it is determined that the communication received contains information about the potential problem, a preliminary risk analysis should be carried out by:
- Reviewing and analyzing available information on the incident;
- Identifying the hazard(s) involved; and
- Estimating the risk(s) associated with the identified hazard(s).
Should it be identified that additional information is required, such information should be obtained within the shortest possible period of time. Using the information available, the entity responsible for the medical device in question should determine the level of risk, e.g., high, medium, or low. The authority additionally emphasizes that the written procedure on problem report investigation should directly specify the person or division responsible for carrying out a preliminary risk analysis.
Mandatory Problem Reporting
According to the Health Canada guidance, medical device manufacturers and importers are obliged to ensure compliance with the appropriate regulatory requirements on reporting set forth by the applicable legislation. In particular, any and all reports containing information about potential safety and performance issues should be subject to a rigorous evaluation in order to determine whether it is a serious incident requiring mandatory problem reporting to Health Canada. Should the reporting threshold be reached, the appropriate report should be prepared and submitted to the regulating authority in accordance with the applicable regulatory requirements. In this regard, the authority refers to its guidance document for mandatory problem reporting for medical devices. The written procedure on problem report investigation should prescribe the particular way the information should be evaluated in order to determine whether it meets the reporting criteria.
As mentioned, in the case of mandatory problem reporting, time is of the essence. According to the guidance, before the actual risk level is determined, any potential problem should be treated as the one associated with the high risk, which means that any and all activities should be carried out within the shortest timeframe possible. The main reporting timeframes are set forth by the applicable legislation on mandatory medical device reporting. For instance, if there was a serious deterioration in the state of health, the entity responsible for a medical device should submit the appropriate preliminary report no later than 10 days from the date the information about the potential problem was initially received. If such significant harm has not been caused but still could be caused if a similar situation were to occur, the timeframe for the preliminary report submission will be 30 days. Under the general rule, for the purpose of calculating the timeframes described herein, a manufacturer or importer is considered to be aware of an incident when an employee has acquired information concerning the device and the outcome.
According to the current legislation, distributors are not subject to mandatory reporting. At the same time, the written procedures on problem investigation they should develop and implement should also specify the appropriate time limits based on the level of risk associated with the problem.
Root Cause Investigation
In certain cases, the medical device manufacturer is the only party having sufficient information to identify the root cause of the incident. Hence, upon completion of an investigation, the manufacturer should duly communicate its results and conclusion to other parties involved in operations with the medical device, including importers, distributors, or private label manufacturers (where applicable).
According to the guidance, a root cause investigation should be carried out in order to:
- Establish a relationship between the problem and the device involved;
- Determine the exact nature and extent of the root cause of the problem; and
- Provide valuable input for risk analysis and subsequent risk control decisions.
In order to achieve the aforementioned goal, the entity responsible for a medical device should perform the appropriate actions, including rigorous analysis of the information related to the problem report, additional testing of the medical device in question, and a review of the instructions for use or labeling of the product. The authority additionally emphasizes that the person carrying out the aforementioned activities should have sufficient knowledge regarding the medical device subject to investigation, its functions, and features, as well as the risks associated thereto.
In summary, the present Health Canada guidance addresses the aspects related to the evaluation of information associated with the problem reports and regulatory requirements in the sphere of mandatory problem reporting. The document also describes the most important points to be considered with regard to the root cause investigation to be carried out by a medical device manufacturer in order to identify the reasons behind the incident.
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