INGENIEUR
INGENIEUR
Level 2 BTPs are expected to be capable of second-line repair , where they should be able to identify the intermediate corrective actions required for the corrective maintenance of the specific medical device up to module / board level at maintenance workshops either internally or externally [ 7 ]. Besides the scope of repair in Level 1 , a Level 2 BTP is expected to be capable of doing the scope of repair such as :
● Repair and replacement of equipment modules assembly or boards ( PCB )
● Ensure equipment requiring calibration is calibrated before use on a patient
● Repair and replacement of component or subcomponent of the equipment ( PCB ) [ 7 ]
In Level 3 , the BTP should be able to identify advanced corrective actions required for the breakdown maintenance of the specific medical device up to component level as well as complete overhaul at specialised or manufacturer facilities [ 7 ]. Besides the scope of repair for all previous Levels , a Level 3 BTP should be able to perform the scope of the repair as below :
● Complex maintenance tasks that call for special skills , tools or equipment
● Software reprogramming of medical devices
● Specialised verification of medical device
● Modification and upgrading of medical device system and software
● Total overhaul or refurbishment of medical devices [ 7 ]
A BTP at this level is recognised as equivalent to a Product Technical Specialist ( PTS ).
ASSESSMENT
Several key factors in the assessment decide the competency level of the BTP and they are :
● Career position
● Academic qualification
● Technical training
● Work experience
● Yearly hands-on hours
● Maintenance skill
● Repair skill
● Customer feedback assessment Biomedical maintenance has existed in the industry for quite some time . Some engineers have more than 20 years of industry experience . We would not want to create an assessment system that disqualifies the more experienced engineers . What we want to do is to endorse qualified engineers and distinguish them based on their expertise so that the right engineer will handle the right level of maintenance needs .
ARE WE READY ?
Biomedical engineering is a fast-growing field in Malaysia . With more advanced and sophisticated medical equipment entering the market , we would like to have the right person to handle the equipment . Not only for the sake of the equipment but , more importantly , for the safety of the patient and operator . Since 2019 , MOH has established a system to identify competent BTPs and group them according to their expertise level . This has been done to ensure that we are ready when the regulation of post-market activity is fully regulated . The question is , ARE YOU READY ?
REFERENCE
[ 1 ] https :// www . mtu . edu / biomedical / department / what-is /
[ 2 ] https :// www . mda . gov . my / doc-list / legislation . html
[ 3 ] Laws of Malaysia Act 737 Medical Device Act 2012 .
[ 4 ] Ayman Falak Medina , “ Malaysia ’ s Healthcare Sector : A rising giant in ASEAN ”, 2020 . https :// www . aseanbriefing . com / news / malaysiashealthcare-sector-a-rising-giant-in-asean /
[ 5 ] https :// www . statista . com / statistics / 275397 / caoutchouc-production-in-leadingcountries /#:~: text = Natural % 20rubber % 20 production % 20worldwide % 20 2020 % 2D2021 % 2C % 20by % 20 country & text = Thailand % 20produced % 20 4.83 % 20million % 20metric , leading % 20 natural % 20rubber % 20producing % 20country .
[ 6 ] https :// www . trade . gov / country-commercialguides / malaysia-healthcare
[ 7 ] Ir . Dr Syed Mustafa Kamal Bin Syed Aman and Siti Hajar Binti Abdul Aziz , “ Handbook on Competency in Biomedical Engineering Maintenance Services ( BEMS ), Ministry of Health Malaysia ”.
32 VOL 95 JULY-SEPTEMBER 2023