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Session: Poster session II
Session starts: Thursday 24 January, 16:00

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Vera Lagerburg ()
Bertjan Arends ()

Abstract:
Introduction: The use of medical equipment is subject to regulations, among which the most important ones are the medical devices law [1] and the medical devices directive [2]. In this case study the regulations that apply to a customized medical device will be addressed. On the initiative of our hospital a chair is being developed for the paediatrics department, to offer patients comfort and distraction during the administration of cytostatic drugs. This chair has a child friendly design and incorporates various electronic devices, such as a gaming computer. The chair is especially designed and produced for our hospital and is developed in collaboration with several companies and organisations. Regulation: The first question to be addressed is which regulations apply to this chair. Therefore it must be determined if this chair is a medical device. Article 1a of the medical devices law states the definition of a medical device [1]. Because the chair is custom designed for the paediatric oncology department to give comfort to the patient and thereby alleviate their treatment, this chair is a medical device and therefore should fulfil all the requirements of the medical device regulations. The second question that has to be answered is whether this device needs CE marking. Article 7 of the medical devices directive [2] states that all medical devices being placed on the market, should have CE marking, except custom-made devices and devices intended for clinical investigation. Because only one single copy will be made, and the chair will not be marketed, it is not required to have a CE marking. The chair is not used for research, so conformation to the requirements for research purposes is not necessary either. The directive states that ‘custom-made’ devices are intended for the sole use of a particular patient, which is not the case for this chair. This means that the chair does not have to meet the regulations regarding the medical devices directive, although it is a medical device. Practical approach: Still the hospital must ensure the safe use of the chair [3]. We decided to use the IMDD (Investigational Medical Device Dossier) as a checklist to cover the most essential safety aspects of the chair. The IMDD is used by the CCMO (Central Committee on Research inv. Human Subjects) and is written for non-CE-marked medical devices intended for clinical investigation. Not all the parts of the IMDD will apply to single copies, but certain parts are without doubt relevant, such as instructions for use and a risk analysis. The manufacturer has to fill in the IMDD. Based on this a clinical physicist will decide whether the chair can be safely used at the hospital. Subsequently, the medical technology department will perform some acceptance checks, among which an electrical safety test. Preliminary conclusion: This case illustrates that, under certain conditions, it may be possible to safely use non CE-marked equipment. The product safety of the equipment is the responsibility of the hospital and may be checked in a structured way using the IMDD.