Authors (including presenting author) :
Chan Oliver(1), Mak MH(1), Li Deo(1), Chan KK(1)
Affiliation :
(1) Biomedical Engineering Services Section, Business Support Services Department, Hospital Authority Head Office
Introduction :
The efficacy of diagnosis and treatment of disease cannot be assured without using well-functioning medical devices. In addition to fulfilling the acceptance test requirement before they are put into clinical service, regular (re)calibration is often required to confirm that accuracy is being maintained. Generally, this is performed in a suitably controlled environment (e.g. laboratory), and the staff should be confirmed competent to perform such calibration. During the coronavirus pandemic, significant challenges are being encountered by supply chains and transportation. There is a risk of delayed calibration by external service providers if no in-house technical team is readily set up to provide a “safety net” as a contingency measure.
Objectives :
This article aims to report (1) the technical standard adopted for the establishment of an in-house Medical Equipment Calibration Laboratory, (2) the scope of calibration services, and (3) result of a users’ satisfaction survey.
Methodology :
The laboratory was officially accredited by the Hong Kong Laboratory Accreditation Scheme (HOKLAS) in 2014. The laboratory was established according to ISO/IEC 17025 – “General Requirements for the Competence of Testing and Calibration Laboratories”. Currently, the laboratory is competent to calibrate i) audiometers with earphone, ii) audiometers with bone vibrator, iii) digital thermometers, and iv) temperature recorders/loggers. Measurement uncertainty is crucial information for some clinical users, and is evaluated based on ISO/GUM. An annual users’ satisfactory survey has been performed since 2014 as a continual practice of review.
Result & Outcome :
The laboratory issued around 40 calibration certificates in 2017, and there was around a 25% increase in service requests in 2020. Our laboratory is able to keep the measurement uncertainty to around 2dB for acoustic measurement, and around 0.2oC for temperature measurement, which are considered sufficient for clinical application. A survey confirmed that a satisfactory calibration service is being provided to our clinical users, e.g. with ratings of 59.5% (Good), 40.5% (Very good, which is the highest rating) for acoustic calibration services. For benchmarking, our laboratory is one of the 28 recipients of the “Testing and Certification Manpower Development Corporate Award” organized by the Hong Kong Council for Testing and Certification (HKCTC) in 2021. Conclusions: This article demonstrates that a high-standard in-house calibration service is available for selected medical devices in the Hospital Authority.
