FEATURE
INGENIEUR
FEATURE
INGENIEUR
Leveraging Legislation in High-end Medical Device Delivery for Radiology
By Ir . Ts . Dr Mohd Effendi bin Amran Senior Principal Assistant Director Engineering Service Division Ministry of Health Malaysia
Practising engineers must be flexible , aware of applicable laws , rules , and guidelines , able to retrieve specifications and other important data , and focus on compliance throughout the entire engineering and development process . Particularly when it comes to the procurement and installation of medical devices , healthcare engineers should always be alert to established laws and regulations , together with amendments that relate to the healthcare sector . In the case of radiology , there are several legal requirements concerning the devices , systems , and department facility ’ s compliance that necessitate engineers to be in the co-supervision .
Radiology is the area of medicine that uses radiation , high-frequency sound waves , or extremely strong magnetic fields to create images of the body that are used for diagnosing diseases and treatment . In Malaysia , including Sabah and Sarawak , the radiology department is usually designed to cater to all clinical disciplines and subspecialties for all inpatients , outpatients , emergency services , and other Ministry of Health ( MOH ) hospitals and clinics in the vicinity of the hospital . Along with the Radiology Information System ( RIS ) and the necessary digital devices and computers for image capture , processing , post-processing , reporting , printing , distribution , and storage / archiving , it is also completely ITequipped . Furthermore , in compliance with the Hospital Information System ( HIS ), the aforementioned system is fully integrated with the main hospital IT network and PACS in the Radiology Department . Additionally , the department serves as a mastery programme for medical imaging and diagnostics as well as a training ground and attachment training centre for other radiologists , medical officers , radiographers , trainees in radiology , and trainees in other clinical and allied disciplines .
Medical imaging is the art and science of producing visual depictions of an organ or tissue ’ s function inside the body for clinical studies and medical intervention . It plays a crucial role in modern medicine , allowing healthcare professionals to visualise and analyse the internal structures and functions of the human body without invasive procedures . Besides , medical imaging is essential for diagnosing and monitoring various medical conditions , guiding treatment plans , and facilitating surgical interventions . Advances in technology continue to enhance the capabilities of medical imaging , leading to more accurate and non-invasive diagnostic procedures .
In a nutshell , the discipline of medical imaging is adaptive and diverse , with uses beyond clinical diagnosis . It is a vital instrument in modern healthcare and other fields , having an impact on a wide range of scientific , research , and industrial sectors . Hence , to meet the functional needs , a modern radiology department must be well-equipped with the necessary high-end ,
36 VOL 98 APRIL - JUNE 2024