Revision Study on Medical Device Management within Health Quality Standards

摘要

The "Health Quality Standards (HQS)", established by the Quality and Accreditation Department in Ministry of Health for the evaluation of the quality of health services, guides the auditor health professional in hospital audits. The evaluation criteria under the standards form the rating criteria of the auditor. Performing of the calibration, labeling and certification in according to the international standards and the examination of the competence of the companies that make the calibration of the medical devices are the points that must be taken into account in the quality studies. However, it is observed that there are nonstandard calibration studies in the sector because of the insufficient control mechanism. It is emphasized that calibration should be made in the HQS evaluation criteria, but there is no detailed guidance information on the quality and adequacy of these measurements. Calibration studies carried out only on the label, which are out of standard, pass the inspection according to the currently used "Medical Device Management" evaluation criteria. Performing the auditing mechanism required for the calibration on the HQS evaluation criteria will increase the quality of the calibration service received from the health institution from outside and thus the quality of the health service. Such an inspection mechanism can only be achieved by revising the current HQS "Medical Device Management" standard and evaluation criteria. In this statement, HQS "Medical Device Management" standards and evaluation criteria were examined and necessary points for revision were determined.