TEMAS News Ticker

Medical Devices Instruction for Use: training and risks reduction

Keywords: Medical Devices, IFU, Training, Complaints

The EU MD Regulation introduced a novel requirement on the Instruction for Use (IFU): the information provided has to be developed taking into account the level of knowledge and the proficiency of the actual user (e.g. medic, nurse, patient). To decide the level of details that the IFU have to include is certainly a matter of experience, and sometimes past experience is sufficient to properly cover this need. However, with the new Regulation requirement the IFU in the MD validation acquires a greater importance.

In cases where experience is not enough, especially for innovative MDs, formal training of the users can be a learning process for both the user and the producer. In essence, to have a valid(ated) IFU, you need to assess if the training based on the IFU is effective enough to reduce/avoid misuses and risks. To build an effective formal training, according to a piece on Med Device online, 6 steps are required, and all of them can be linked to a proper IFU development. The first step is to build the training having in mind the skills and knowledge needed to operate the MD in a safe way. The second step is to consider the characteristics of the learner (i.e. the user/s) and target the training to the specific conditions (an ER nurse can have different needs than a ambulatory doctor). Other steps relate to the way learning is done: it is important to engage the learners, make the training practical, and use a fail-learn approach. The final step is assessment and validation, and this is where the feedback for the development of the IFU improvement is coming from.

The IFU should be built having in mind the lesson learned during training program development and testing, to convey the right instructions in an understandable way, and alerting of likely mistakes. While training should not be the main risk management measure, the interaction between training and IFU will assure that operator and patient safety is achieved.

For more information on this topic send an email to Christian Micheletti, TEMAS AG, CH-8048 Zürich, christian.micheletti@temas.ch

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