and operators who are utilising the medical equipment .
Nowadays , there are two frequently used standards for electrical safety tests developed by the International Electrotechnical Commission — IEC 60601 and IEC 62353 . Even though the objective of these two standards is the same — to prevent the occurrence of electrical shock — each standard applies different approaches to achieve it .
Competent technical personnel would be able to distinguish between the two standards and apply them accordingly to different situations . They also would have a deep knowledge of each testing parameter function and understand the consequences of skipping any of the parameters — we wouldn ’ t want to see patients or operators electrocuted due to unsafe medical equipment , would we ?
TECHNICAL EXPERTISE
According to Malaysian Medical Industries , in 2019 , the export of medical devices by Malaysia was valued at USD5.6 billion [ 4 ]. Exports were mainly for devices that are made from rubber . As we know , Malaysia is among the top seven biggest producers of rubber in the world , recording 515,000 metric tonnes in 2020 [ 5 ]. However , 88 % of the medical equipment used in Malaysia is imported from other countries , primarily active and high-technology medical devices [ 6 ]. This shows that Malaysia is a medical device producer but not a medical equipment producer .
A lot needs to be done before Malaysia gets recognised as a medical equipment producer and one of them is having competent biomedical personnel . This will encourage the transfer of technology to Malaysia , and at the same time encourage the growth of technical expertise in the Biomedical Engineering field .
MAINTENANCE PROGRAMME
At MOH , the maintenance of medical equipment is known as Biomedical Engineering Maintenance Services ( BEMS ). It is carried out by companies appointed by MOH , bonded through an official contract agreed to by both parties .
There are two types of contracts that govern BEMS : one is for the hospital , which is known as Hospital Support Services ( HSS ), and the other is called the Medical Equipment Enhance Tenure ( MEET ), applied mainly to health clinics . In the HSS contract , under the Technical Requirement , it is stated that “ The company shall provide qualified and competent personnel to witness and advise installation , T & C , manage maintenance and disposal of biomedical equipment ”, and in the MEET under Appendix V1 , Clause 13 , General Duties , 13.2 Competency , it is stated that “ The Company shall provide and perform its obligations under this Agreement and take all appropriate measures expected of a competent company ” — both contracts emphasise the requirement of having competent Biomedical Technical Personnel ( BTP ) in handling the maintenance of medical equipment .
HANDBOOK ON COMPETENCY
It is clear now that it is very important to ensure that the maintenance of medical equipment is handled by competent BTP . But how do we distinguish between a competent and an incompetent BTP ? What types of assessments need to be carried out ?
In 2019 , MOH published a book titled “ Handbook on Competency in Biomedical Engineering Maintenance Services ( BEMS ), Ministry of Health Malaysia ”. This book has been used by MOH to assess the competency levels of BTPs who are working under contract with MOH .
According to the book , there are two important bodies involved in the assessment : i . Ministry of Health Biomedical Engineering Maintenance Services Competency Committee ( MBCC ); and ii . Ministry of Health Biomedical Engineering Maintenance Services Competency Board ( MBCB ).
MBCC is a committee that conducts competency assessments on BTPs . The result of the assessment needs to be endorsed by the MBCB before the BTP ’ s competency level is officially recognised . How do we determine the competency level ? Before any BTPs can be assessed , they must first complete the compulsory competency module
29