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THE HEALTH | SEPTEMBER , 2021
| Innovation |
Quality assurance for the world
SIRIM enhances capabilities of Malaysia ’ s medical device manufacturers through proper certification and compliance
MEDICAL device manufacturers must demonstrate that their products have been appropriately certified and meet the required international standards .
It is significant because 90 per cent of all such medical devices manufactured in Malaysia are destined for the export market . SIRIM Berhad ’ s subsidiary SIRIM QAS International can provide this certification service ( SIRIM QAS ). SIRIM QAS , the country ’ s leading testing , inspection , and certification ( TIC ) centre , can audit and certify that a manufacturer complies with such standards . Furthermore , the Medical Device Authority ( MDA ) — an agency under the Ministry of Health ( MoH ) — has designated the organisation as a Conformity Assessment Body ( CAB ).
Being a CAB allows SIRIM QAS to audit and certify whether a manufacturer complies with ISO 13485 Medical Devices and Good Distribution Practice for Medical Devices ( GDPMD ), both management systems certifications .
ISO 13485 , for example , applies to any entity that designs , develops , or manufactures medical devices . It should be noted that under the Medical Device Act of 2012 , all medical device manufacturers must be ISO 13485 certified . At the same time , companies involved in the storage , distribution , installation , servicing , or disposal of medical devices are encouraged to become certified .
GDPMD , like ISO 13485 , is a critical certification for those involved in the medical device supply chain . It demonstrates that the holder can ensure medical devices ’ quality , safety , and performance under its care . This includes medical device importers and distributors , as well as foreign manufacturer representatives in Malaysia .
Performance and safety standards
SIRIM QAS also conducts tests to ensure that medical devices meet safety and performance standards . This is required for the product to be sold on both domestic and international markets . These include , but are not limited to , electrocardiogram ( ECG ) machines , incubators , and high-frequency surgical devices .
Because such devices are critical in diagnosing and treating various medical conditions , it is even more imperative to be free of flaws and malfunctions . Power surges and voltage spikes , for example , could not only damage the equipment but also cause serious injury to operators and patients .
Under the International Electrotechnical Commission ( IEC ), medical electrical equipment can be certified compliant with the IEC 60601 series . SIRIM QAS performs testing and certification for IEC 60601-1 , IEC 60601-1-2 , and IEC 60601-2-x .
This demonstrates the breadth of its expertise and reassures medical device manufacturers looking to set up shop in Malaysia that their products will be appropriately certified .
TO REPLACE diseased bones or joints , orthopaedic implants have become necessary . Procedures such as hip , knee , and shoulder replacements have resulted from the evolution of implants .
For this purpose , metals such as titanium alloys and stainless steel are commonly used . Metal implants are biologically inert due to their smooth surface .
This can result in the formation of a non-adherent capsule that does not adhere to the bone . Daily wear and tear can cause aseptic loosening when this occurs , resulting in a gap between the bone and the implant over time .
To address this problem , hydroxyapatite ( HA ), a bio-active material , has been identified as an ideal coating for use in cement-free implant fixations . It is primarily used to coat hip , knee , and even dental implants . The bio-active HA coating promotes bone formation around the metallic implant .
“ HA is referred to as a bio-active material due to its ability to form bonds with bone tissue . The HA coating in cement-less implant fixation promotes bone in-growth , which results in implant anchorage with bone ,” explained Dr Jamuna Thevi Kalitheertha Thevar , a Senior Researcher at SIRIM ’ s Industrial Centre of Innovation in Biomedical .
The use of hydroxyapatite ( HA ) coating is well known for promoting bone integration between the bone and various medical implants . Calcium and phosphorus make up the majority of HA . This composition allows the HA coating on medical implants to connect structurally and functionally with human bone .
“ As a result , it is ideal for patients with bone diseases or traumatic injuries , as well as the elderly ,” she said .
Global quality assurance
The Covid-19 pandemic has also highlighted the importance of ensuring the quality of all medical devices , particularly medical face masks and gloves . The latter is especially important in Malaysia , as the country is the world ’ s largest supplier of such products .
As a result , SIRIM QAS has broadened its testing and certification services to include medical face masks and gloves manufactured , imported into , or sold in Malaysia . With the current global health situation , this service helps protect public health . It ensures that Malaysia has a positive reputation as a source of such equipment .
Currently , SIRIM QAS is providing a 20 per cent rebate to manufacturers of face masks under the package service for testing and certification till Dec 31 , subject to terms and conditions .
Leading the way in 5G medical devices
In addition , as the Internet of Things ( IoT ) becomes more prevalent , an increasing number of medical devices include wireless connectivity features .
People with Type 1 diabetes , for example , may have insulin pumps that record the time and level of dosage . It then sends the reports via Bluetooth to their mobile devices , allowing them to track
Adding value to orthopaedic implants
To enable it to adhere to the metal implant , HA is used as a raw material in powder form for coating applications using an atmospheric plasma spray system at high temperatures .
Properties such as roughness , crystallinity , and thickness are evaluated according to ISO standard specifications to ensure that the coatings are suitable for medical applications ( ISO 13779 ).
Taking the innovation further
Even though the HA coating is still in the research and development stage , local medical device manufacturers have expressed interest . SIRIM encountered a company looking for a service provider offering coating services during a recent technology audit programme .
“ This has been a fantastic opportunity for SIRIM . We look forward to taking this innovation even further as it enters the clinical trial phase before being commercialised ,” Dr Jamuna said .
She is confident the HA coating service will benefit the medical device industry , elevating Malaysia ’ s position as a regional leader in medical device manufacturing . Local medical implant manufacturers will add value to their products by producing finished products with the help of the HA coating service . Local dental implant manufacturers have taken notice of this coating service .
“ This service will strengthen Malaysia ’ s capability to produce highend finished medical products for the global market ,” she stated .
Commercialisation prospects
There is a transition period their medication .
In Malaysia , the Malaysian Communications and Multimedia Commission ( MCMC ) regulates connected devices with communication capabilities . SIRIM QAS is the designated certifying agency for such devices . It performs testing and certification to determine if they meet Malaysia ’ s spectrum plan , regulatory requirements , and technical requirements covering radio frequency ( RF ), interoperability , safety , electromagnetic compatibility ( EMC ), and specific absorption rate ( SAR ), if applicable .
One of Malaysia ’ s 5G verticals ’ goals is to grow the digital healthcare industry . As a catalyst to accelerate the adoption of 5G related technologies in the local healthcare industry , MCMC ’ s 5G Demonstration Project has provided a platform for collaborations between the healthcare industry and telcos .
An example is a collaboration between the Hospital Sultanah Maliha , Digi and CREST . It showcases 5G-connected ambulances that enable real-time medical data transfer between paramedics attending to emergency cases and the hospital .
Another strategy for boosting the industry is to increase the capacity of the medical device manufacturing sector to produce connected medical devices . As a result , SIRIM QAS plays a vital role in elevating Malaysia to that level . — The Health
between research and development and commercial production , according to Dr Jamuna .
“ For starters , the company must be capable of producing large quantities on a large scale in an efficient manner . As a result , the coating properties are being improved per the manufacturer ’ s standard specifications . Meanwhile , it must improve production capability , achieve low production costs , and deliver coated implants of unrivalled quality .”
Furthermore , because the implants are medical devices , they must adhere to stringent medical standards . All of this can be timeconsuming .
Dr Jamuna , on the other hand , sees room for expansion in this sector .
“ In the northern region , we are surrounded by medical device manufacturers . Our market-driven research approach has created market solutions for potential users or buyers through value chain product innovation ,” she explained .
Dr Jamuna was confident that SIRIM could provide innovative solutions to the country ’ s medical device industry because research and development are the organisation ’ s core strengths .
She used the current collaboration with a medical implant manufacturer as an example , noting that the manufacturer could not find a coating service provider locally before contacting SIRIM .
“ However , to remain competitive on a global scale , we must continue to improve and grow in the medical sector . We must be able to continue to improve technological innovations in response to global trends .”