The ISO 13485 standard requires the evaluation of feedback regarding the use of the medical device; the organization is to continually and systematically evaluate whether the medical device meets the requirements throughout its life-cycle:
- Does the medical device meet the intended use requirements?
- Does the medical device meet the regulatory requirements?
- Are residual risks still controlled, and have new risks been identified?
Feedback methods
Feedback refers to the monitoring of gathered information relating to whether the organization has met customer requirements. The goal of the feedback, simply put, is to define, document, and implement methods for monitoring and controlling the product using data that were collected in the postproduction phase or by means of postmarket surveillance in order to detect quality problems. Once quality problems are detected, they are handled: analyzed, evaluated, and submitted to further quality processes and controls.
The tactic is to plan systematic methods that will provide early identification of quality problems and warnings related to the medical device. The idea is to detect the problem before the medical device may harm a patient or a user. By measuring feedback, importance is given to the fulfillment of the medical device’s requirements rather than the perception of the customer as to whether the organization has met their requirements. Customer satisfaction is a subjective matter, whereas achieving medical device or regulatory requirements are objective issues that can be assessed and measured. A customer satisfaction survey may turn out to be diverted, and therefore may provide inaccurate results. However, the feedback will indicate the status of the medical device compared to its requirements. Feedback could be positive or suggestive—it need not be only negative regarding the medical device. Feedback may be referred or compared to postmarketing surveillance (PMS), that is, the search for and detection of problems in the medical device that were not identified or recognized before submission for marketing.
How can one measure customer feedback? Feedback consists of a systematic gathering of information related to the use of the medical device and its effect on users or patients in the postproduction phase, for example, transportation activities, storage, installation, service, and use. The information shall be collected in various ways (which will be detailed later). Bear in mind that the data collected via feedback methods are to be used at later stages as inputs for processes of analysis of data (clause 8.4) and improvements, for example. Thus, it is recommended that when you plan the gathering activities and characterize the types of data to be collected, you should consider future activities, for example, analysis; the objective of the analyses is to demonstrate the suitability and effectiveness of the quality management system and to evaluate whether improvements of the effectiveness of the quality management system are needed.
Potential input for improvement processes
Another objective of feedback is to assist the manufacturer in implementing improvements in the medical device or in the realization processes that, in the end, will allow the product to meet its requirements optimally (and customers’ as regulatory). This will be achieved through five subobjectives:
- Early identification of problems concerning quality, performance, functionality, and safety
- Creating communication channels, allowing data to flow
- Defining and collecting appropriate data that will support the analysis of the root causes
- Initiating an interface between the problems and related data and the improvement processes for analysis, treatment, and correction
- Improving quality management system performance
Using defined systematic methods to collect data regarding the use of the medical device, the manufacturer will identify—in advance—quality problems related to its functionality, performance, intended use, and safety, and will submit them to a controlled process for handling. The purpose is to detect these problems before they can cause harm to anyone. The source of these problems may originate in the design of the medical device or the realization processes.
The following issues are dealt in chapter 8.2.1 – Feedback:
- Developing methods for Feedback throughout the life-cycle of the medical device
- Developing Documented procedure
- dentifying Inputs for feedback
- Research, postmarket clinical evaluation
- Postmarket clinical follow-up
- Customer complaints
- Return of medical devices
- Product reviews and audits
- Published literature, journals, and article reviews
- Service calls
- Customer surveys
- Applicable regulatory requirements
- Relation between feedback and further quality activity
This webpage contains only a fragment of the chapter 8 – Measurement, analysis and improvement from the book:ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition published by:
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