New approaches to maintenance procedures of medical devices with measuring functions

Abstract

Medical devices with measuring functions play a crucial role in diagnostics and treatment of patients is health care establishments. Both the testing and manufacturing guidelines laid out in the medical devices directive MDD 93/42, as well as the recommendations for electrical medical equipment in IEC 60601 and IEC 62353 are largely not implemented. The majority of the guidelines that are being followed are those relating to the manufacturing and selling (as well as obtaining of the CE mark), while the precision and accuracy of medical devices in the subsequent period of use are not sufficiently monitored. The manufacturers, distributors and servicing companies do provide yearly service to those contracted establishments. However, while the aforementioned service includes part replacement, it does not include measurements of output parameters which are of vital interest to the patients. Part of the reason for the lack of focus on exit parameters by the servicing companies is that they do not possess the necessary equipment needed to perform said tasks, thereby compromising the entire process of preventative maintenance. Due to the aforementioned, in order to regulate this domain, state agencies and the affiliated measurement laboratories ought to perform independent inspection (verification) of medical devices with measurement functions according to ISO 17020 standards. This would effectively abolish the lobby and monopoly that manufacturing companies hold over medical device repair and thereby not only lower the cost due to unnecessary servicing, but it would ensure an increase in medical device reliability and safety and ultimately patient diagnosis and treatment.