Medical Device Vigilance
What is a Complaint?
FDA provides a precise definition of complaint in the section 21 CFR 803 (b):
Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
The key characteristic for a complaint is the presence of an allegation against a specific device. This is very important as it will be useful to determine if a specific communication received from the customer can be considered a complaint or not.
Overview of Complaint Handling Process
The process for complaint handling can be summarized in the scheme here ☛
Medical Device Vigilance Services
Any information related to the involvement of the patient in the specific event and, in case, the consequences of the event on the patient, user or any other person involved. If there were consequences, it is often necessary to know whether there was medical intervention.
This is the minimal information necessary to open the complaint and perform an initial evaluation. If this information is not available, it is necessary to contact the customer to collect missing information.
It is essential to collect all the necessary information to perform an adequate evaluation of the reportability of the event.
In another article, we have discussed the techniques for root-cause analysis. In the context of complaint handling, technical investigation can be quite different depending on the type of events and type of potential failures. However, in general, technical investigation may contain the following items:
- The root-cause of the event, if it is related to a specific failure of the device, use error, or any other reason.
- For root-cause analysis, it is necessary to evaluate the sample involved in the specific complaint, the results of sample analysis shall be clearly documented or referenced in the complaint record.
- Review of the history for the device involved in the event to check if any deviation potentially related to the specific event has been recorded in manufacturing documentation. Sometimes it is necessary to check device history record of devices manufactured in the same period as the one involved in the event (for example previous and subsequent lot or serial numbers).
- Complaint data history: it is often necessary to provide an overview of how many similar events have been received within a specific timeframe.
- If medical investigation had to be performed because the event imparted a consequence of a patient, the results shall be included in the complaint investigation. Often medical investigation is needed to evaluate the seriousness of the event (serious injury or not) and thus perform appropriate reportability evaluation.
Once the root-cause of the event is determined, it is important that a risk assessment is performed to ensure the risk is considered acceptable. Unacceptable risks for a marketed medical device necessitate field safety corrective action or field safety notice to be implemented.
- Evaluation of the need to implement corrective action
- Once the root-cause is determined, the necessity to implement corrective action shall be evaluated. If no specific actions are taken, appropriate justification shall be documented.
Response to customers with a summary of the complaint received and the results of the investigation shall be provided under the following situations:
- The customer specifically requires a response
- A competent authority asks the manufacturer to provide a response
Design your PMS plan:
Research – including:
- Indications for use
- Regulation history, and device background
- Build and develop schedules for follow-up assessment procedures
- Data collection and statistical analysis
- Guidance on Notified Body Interactions
- Make sure your organizations meet interim and final data analysis requirements
- Writing services related to Post Market Clinical Follow-up, Periodic Safety Update Report, Summary of Safety and Clinical Performance, Risk Management Plan and Report, Post Market Surveillance Plan and Report
Requisite MDR PMS Revisions:
- Updating the benefit-risk determination
- Updating the design and manufacturing information, the instructions for use, labeling etc.
- Post Market Clinical Follow-up Plan and Report
- Identify needs for preventive, corrective or Field Safety Corrective Action for the device
- Contribute to the PMS of other devices (when relevant)
- Detect and report trends as specified in Article 88
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