Risks associated with the lay use of 'over-the-counter' medical devices. Study on infrared thermometers and wound care products
26 May 2012, PDF |
49 pages |
Hollestelle ML, Hilbers ESM, van Drongelen AW
RIVM Report 360050002
An assessment of the files on two types of 'over-the-counter' medical devices (infrared thermometers and wound care products) revealed major shortcomings in the risk analyses, available user information and post-market surveillance procedures. These three components are important for guarding the safe use of a medical device, especially in terms of reducing risks as far as possible in the design stage of the device, informing the user of residual risks and undertaking post-market surveillance activities. Particularly for over-the-counter medical devices, a rapidly growing market segment, information for the (lay) user is important. Application by lay users and potential errors when using the products were often not addressed in the risk analyses and were insufficiently covered in the user information. Moreover, the coherence between items addressed in the risk analyses and those stated in the user information was poor. The user information addressed more residual risks associated with the use of the product than the risk analyses. The comprehensibility of the user information was often compromised by poor readability and difficult phrasing. Appropriate user information is crucial for the safe application of self-care medical devices, even more so if the devices to be used are complex and/or relatively new to the consumer market. Files on 16 products eight infrared thermometers and eight wound care products were requested. These files contained the risk analysis, user information, post-market surveillance procedure and, if available, results of studies carried out with lay users. Files on all 16 products were received, but the documentation was often incomplete, notably for the thermometers. The absence of risk analyses and post-market surveillance procedures was remarkable as this information is an important requirement of the Medical Device Directive.