Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the investigation of reported medical device problems. Apart from other aspects, the document describes key activities in a problem report investigation. The guidance is intended to provide medical device manufacturers with additional clarifications and recommendations to be considered in order to ensure compliance with the applicable regulatory requirements related to the investigation of incidents associated with medical devices for which they are responsible.
According to the guidance, the process commences once the manufacturer becomes aware of an incident that has already occurred, or a potential issue. It is stated that under the general rule, the actions to be performed by medical device manufacturers include:
- 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 (correction, corrective and preventive actions);
- Evaluation of effectiveness of risk control measures;
- Final mandatory reporting, as applicable;
- Closure; and
- Ongoing trend analysis.
The documented procedure developed and implemented by the medical device manufacturer could contain flowcharts intended to provide additional clarifications, provided the detailed instructions are provided as well.
Receipt and Recognition of Medical Device Problem Reports
As mentioned, the process starts when the medical device manufacturer receives information about the potential safety and/or performance issue associated with a medical device for which it is responsible. Such information could be received in any form, including various types of written correspondence. At the same time, most of such communications initially do not contain precise information about the issue. The authority additionally emphasizes that any and all notices related to the safety and performance of medical devices should be subject to a rigorous investigation – for instance, the reports of alleged incorrect use. It is stated that the written procedure should prescribe the particular way the issues should be identified, including how the information provided orally should be recorded. The sources of the reported problems include all the parties involved in operations with medical devices, e.g., customers, healthcare professionals, importers, and distributors. Sometimes information about the issues requiring additional assessment and investigation could be provided by the regulating authority. In some cases, the manufacturer could identify issues related to medical devices already placed on the market in the course of its day-to-day activities, such as:
- Receiving inspection;
- Product demonstration;
- Processing of returned goods;
- Service or repairs.
As in the case with other sources of information, the information deriving from these sources could be incomplete and trigger further investigation.
In order to ensure that the safety and performance-related information deriving from any sources is duly received and processed, medical device manufacturers should develop and implement the appropriate procedures covering the aspects related to complaint handling.
According to the Health Canada guidance, valuable information related to safety and performance issues could be obtained by analyzing information about medical devices provided for repairing and service, other than ordinary maintenance. For this purpose, the manufacturer should analyze service reports on a regular basis, and the particular way they should be performed should be prescribed by the appropriate procedure.
The authority additionally emphasizes that all the employees of a manufacturer should take the steps necessary to ensure information about potential issues they have received will be duly communicated to the relevant departments for further investigation. As stated in the document, the procedure should identify those responsible for initially receiving a problem report, provide clear instructions on how to respond and establish a time frame for communication of the report to the individual or group function responsible for evaluating it. It is important to mention that since, at this stage, the risk associated with the issue remains unclear, further steps should be taken without undue delay, as in cases with the highest level of risk.
Collecting Additional Information
The document further describes the steps to be taken in order to gather additional information about the potential issue. Health Canada states that successful determination of the root cause of a problem relies to a great extent on the quality of the information gathered on the original incident. Thus, all the parties involved in operations with medical devices should take all the steps necessary to ensure the timely collection of complete and accurate information about the issues. For this purpose, a responsible person should be designated to coordinate the processes. This person should be responsible for receiving problem reports received from other parties. It is stated that the information to be collected should cover the following aspects:
- Complete identification of the device;
- Information about the manufacturer, importer and distributor;
- Details of the incident and other relevant factors, such as patient condition, environmental conditions, ancillary equipment and medical personnel involved.
The documented procedure to be adopted by the manufacturer should prescribe the particular way the information should be collected and recorded. Should several parties be involved, the procedure should describe the expected input of each party.
Problem Report Forms
In order to ensure completeness of the information regarding the issue, the manufacturer could use a standardized report form and/or a database. Moreover, the forms used could be customized according to the expected failures. Other parties involved, such as importers or distributors, are also allowed to develop their own reporting forms, provided that the requirements regarding the information to be collected, established by the manufacturer, are met. The manufacturer shall communicate its reporting form to the parties involved and also provide the updated versions in a timely manner. All the employees involved in the process should be familiar with the form and how it should be filled in. The written procedure implemented by the manufacturer should also provide information about the forms used, as well as recommendations on the way they should be filled.
As mentioned, additional information about the incident could be obtained by analyzing the medical device in question. For this purpose, a rigorous examination and testing should be performed. In order to ensure the accuracy of the information collected in such a way, it is necessary to either identify and isolate the device in question or use a sample from the same batch. Depending on the particular situation, the device could be retrieved from the user or taken from devices that were not supplied. Additionally, samples from the same lot can be used for testing or to try to recreate the problem. In this regard, the written procedure should prescribe the particular way the device in question should be identified and isolated for further assessment. It should also describe how the manufacturer may request samples of the device for its internal examination and testing.
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