COVER FEATURE
INGENIEUR
COVER FEATURE
INGENIEUR
Competency of Biomedical Technical Personnel : Are We Ready ?
By Ir . Azrulazhar bin Jamaludin , P . Eng Senior Principal Assistant Director Biomedical Sector Engineering Services Division Ministry of Health Malaysia
Disposal
Planning
Procurement
Biomedical Engineering , according to Michigan Technological University , is the application of engineering principles and problemsolving techniques to biology and medicine [ 1 ]. An engineer ’ s role is to study the current situation or problem — in this case , problems related to clinical situations — and design a solution for it through engineering practices . One can say that it is a fusion between engineering and the clinical field .
In Malaysia , especially at the Ministry of Health ( MOH ), Biomedical Engineering mainly focuses on the well-being of medical equipment . The aim is to ensure that the clinical side possesses sufficient medical equipment that is in an optimal and safe condition .
Clinical staff must be able to carry out clinical functions efficiently . To ensure that , a biomedical engineer is heavily involved in the life cycle of medical equipment , starting from planning , procurement , testing and commissioning , maintenance , decommissioning , and finally , to the disposal of medical equipment ( Figure 1 ).
Every step has to be carried out efficiently , according to regulations , guidance documents , and good engineering practices .
REGULATORY
Act 737 Medical Device Act 2012 was gazetted on February 9 , 2012 . After a series of postponements , the Act finally came into force on January 1 , 2018 [ 2 ]. However , the enforcement of the Act was limited to pre-market at the time . This
Maintenance
Testing and Comissioning
Figure 1 : Life cycle of medical equipment
means all medical devices that are manufactured , imported , and distributed in Malaysia must beforehand be registered with the Medical Device Authority . Through the Certified Assessment Body , the medical device safety is assessed for its intended use .
In the Act , under Chapter 4 , General Duty , Section 43 , Usage , operation , maintenance , etc ., of medical devices , it says “ A person - installing , testing , commissioning , maintaining , and / or disposing of medical devices must have the qualification and competency as prescribed by the minister ” [ 3 ]. This statement refers to the post-market activity of medical devices , which is not yet fully regulated . However , it is an undeniable fact that it is important to regulate post-market activity , especially regarding the competency of technical personnel .
Technical personnel play a significant role in the maintenance of medical equipment . It is essential to have maintenance carried out by competent technical personnel . This is extremely important to ensure the safety of patients
28 VOL 95 JULY-SEPTEMBER 2023