Risk assessment of medical devices in potentially explosive atmospheres

Status:

completed 06/2022

Aims:

The question to be answered is under which conditions medical devices such as hearing aids, insulin pumps, etc. are to be regarded as an ignition source in the sense of explosion protection. Based on a publication that was produced together with PTB and in which certain operating voltages for hearing aids and cochlear implants are mentioned as obviously uncritical, a safety-related assessment of such devices is to be drawn up, which will support the employer in deciding within the framework of his risk assessment whether and, if so, under which conditions wearers of such devices can work in potentially explosive atmospheres.

Activities/Methods:

In cooperation with the German Social Accident Insurance Institution for the raw materials and chemical industry (BG RCI), specific medical devices were examined for their ignition sources. For this purpose, individual samples were procured.

Results:

The employer has received an up-to-date guide for assessing whether the operation of medical devices within potentially explosive atmospheres is an effective source of ignition. This is limited with regard to the possibly necessary consideration of device errors and malfunctions due to a lack of knowledge of the structural design of the medical devices. Decision-making tools for risk assessment for cochlear implants and hearing aids as well as for glucose sensors in hazardous areas, which indicate the boundary conditions under which these devices can be worn in zones 2 and 22 or 1 and 21 without fear of explosion were published.

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