In clause 7.3.2—Design and development planning, the organization is required to maintain a plan to control the design and development of the medical device. This plan will include process elements like a systematic process plan for the design and development of the product, defined method to control the progress of the design and evelopment, planned review and updating of relevant and maintaining supportive documentation and documenting the necessary process stages of design and development. There is more requirements but then we will divert form the issue which I would like to discuss – integrated risk management during the design phase.You may review the following document, for more information about the ISO 13485 Standard requirements for design and development.
Why does the risk management is given so much weight during the design phase? Medical devices are becoming more sophisticated, they increase in complexity and their response to user inputs, environmental inputs, and component failures aren’t as predictable as it used to be. This is why a systematic approach to device safety is critical and must be implemented during the design phase.
Scope of responsibility
Many developers of medical devices refuse to believe, that the risk management is under their responsibility. Well, it is. Let us take an example; when a new risk was identified during the use of a marketed medical device, let us say during service in the hospital, a risk of infection was detected and reported – the developer bears the responsibility to participate in the management of this risk just like any other party that was involved in the realization of the product. In order to manage it you must have a risk management system. In the practice it requires to include risks management activities in the design and development plan.
Risks management plan integrated in the Design and development plan
Integrating effectively the risk management system in the design phase requires its implementation during the product definition phase.A risk management system may be effective (only) when a well-defined plan is in place. And requested logical conclusion is that a correlation and integration between the two plans must exist. In other words, risks management activities, that are included in the plan must ne also integrated in the planning of the design and development. There are several strategies of integrating risk management in the design phase with which risks of the intended use of the medical device may be submitted to risks management:
- Inherent safety by design – where the medical device will be designed with integrated measures or functionalities that will reduce risks and includes a feature or a function that controls a certain or a group if risks. For example, the user of the medical device is blocked from using it as long as it was not cleaned or sterilized after use.
- Protective measures – measures that are incorporated within the medical device like safety mechanism. Basically, the protective measures shall protect those elements that are exposed to risks from other aspects of the system.
Development Team
The risk management is not the issue of the quality manager but is an issue of the persons that develop the medical device. As soon as you adopt this approach the sooner you will implement an effective risk management system. As the first step you must identify the personnel in the organization, that are involved in the design of the medical device (including external third parties). In the second step will be to train them in the arts and practices of the risk management and apply to them the responsibility to the safety of the medical device. Training of the development team must be:
- Programmed – what will be trained: qualification program, further training and education
- Planned – when, in which point of time which; when employing the employee and according to the training plan as required from the ISO 13485-chapter 6.2 Human resources
Participating in post market phase
The post market phase is a critical phase concerning the risk management. This phase refers to the life-cycle stage of the product after the design has been completed and the medical device has been manufactured and includes processes and activities used to monitor the performance of a medical device after is was released for manufacturing and delivering for the customers (for example hospital) and the final user (for example a patient). The goal of this phase is to detect and manage problems and accurately characterize the real-world device behavior of the medical device under clinical conditions. In the post market phase data regarding the use of the medical device is being gathered; complaint data, vigilance reports, literature, performance of similar devices (such as from competitors) and production and manufacturing information. These types of data will deliver you important information regarding the safety of the medical device.
The activities regarding the post market phase shall include an established, documented and maintained ongoing process for estimating and evaluating the associated risks, that were identified and gathered during the post-production phase and controlling these risks, and monitoring the effectiveness of the controls that were gathered during the post-production phase. The development team must (!!!) receive systematically this data using
- a defined method of mechanism by which information is generated by the operator, the user, or those accountable for the installation regarding use and maintenance of the medical device
- and in place processes and activities to analyze this information.
In the practice the organization may manage one process for all parties involved, but with specific reference to the design issue. When new risks were identified or where residual risks are increased the development must react. The reaction will be defined in process and a procedure; how the data was received, how it was analyzed and by whom, what are the results of the analysis and which measures have taken. These processes and activities shall be included in a designated risk management plan.
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