Inspection process of medical devices in healthcare institutions: software solution

Abstract

With increased sophistication of electrical medical devices and more dynamic working environment conditions, safety and accuracy requirements are becoming more strict. Healthcare institutions are challenged in keeping their electrical medical devices safe to use, accurate and reliable in terms of measuring and monitoring of vital parameters. In healthcare institutions maintaining overall operating functions at the required level of performance can be achieved through periodical safety performance inspections. International guidelines, such as Directives IEC 60601, ISO 62353 and MDD 93/42, define how healthcare institutions should perform these periodical checks. In countries, where those guidelines are not adopted, medical device safety and performance inspections are conducted in accordance to Directives of new approach. This paper presents the software solution for tracking the inspection process of medical devices in public and private healthcare institutions. The software is implemented in Oracle Application Development Framework Technology (ADF) and it is used to facilitate gathering of documents such as Inspection Certificates, Working Orders, Measurement Reports, Calculated Errors, and also to keep track of dates for next inspection. The software can be accessed online via Inspection Laboratory website, and all clients, as well as professional laboratory staff can login using their own username and password which makes all inspection data confidential. The software solution is validated in private and public healthcare institutions in Bosnia and Herzegovina (BH). Out of 331 public and private health care institutions in BH, software solution was validated in 218 institutions and more than 1800 inspection tests reports were imported in software by the date that this paper was written.