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THE HEALTH | NOVEMBER-DECEMBER , 2021
| Innovation |
Safety and quality guaranteed
It is critical for medical devices to follow the guidelines put forth by various medical device authorities
IN THE medical device industry , conducting microbiology , chemical and toxicity tests are essential . Why is this so ? SIRIM explains that when it comes to medical devices , rigorous testing should be a requirement . Manufacturers will be happy to know that SIRIM ’ s Industrial Biotechnology Research Centre ( IBRC ) provides three critical testing services , namely microbiology , chemistry and toxicity testing , to ensure that medical devices are safe .
Microbiology testing is critical , especially in the medical device business , where microorganisms such as bacteria can have a severe impact on goods , processes , and human health .
Chemical and toxicological tests are also crucial . The former entails testing the chemical qualities of medical equipment , while the latter involves testing for harmful chemicals in the devices .
Detailed process
“ We need to be able to eradicate or at least lessen the possibility of these devices causing harm to the end-user in compliance with ISO 13485 standards ,” noted Mohd Mahayuddin Hussin , a Researcher at IBRC .
“ It is critical for medical devices to follow the guidelines put forth by various medical device authorities . Microbes should not be present in sterile devices , for example . Patients with compromised immune systems could be harmed by even the tiniest amount of contamination ,” he said .
Prior to testing , the medical device ’ s material characterisation should be completed , according to Part 1 of ISO 10993 . Dr Nur Ellina Azmi , a Senior Researcher at SIRIM ’ s IBRC who works in analytical chemistry and chemical testing , explained the process .
“ We need to know the properties of the materials , so we ’ ll conduct a chemical analysis to assess the stability and chemical features of the sample presented . This helps scientists to learn more about the compounds , such as if they are harmful and the level of safety required to perform future research .”
After gathering the appropriate information , the sample will be tested for biocompatibility .
“ Biocompatibility testing is an important element of toxicity testing
Pharmaceutical compound analysis using LCMSMS .
and is carried out in line with the international standard ISO 10993 on Biological Evaluation of Medical Devices requirement explained Noor Rabihah Aid , a Researcher at the IBRC Toxicology Laboratory .
There are a variety of medical device related requirements that we must adhere to in order to verify that the medical devices are biocompatible and safe for human use .
SIRIM ’ s expertise
SIRIM , as Malaysia ’ s leading industrial research and technology organisation , can provide a wide range of testing and evaluation services , as well as other complementary services such as customised testing and evaluation , regulatory consultation and advice . It can even do research and development to help companies advance to the next stage .
The organisation has a wide range of facilities , the majority of which have been appropriately accredited with the ISO and Good Laboratory Practice ( GLP ) standards . The laboratories are equipped with high-tech and specialised equipment , as well as the most up-to-date procedures for evaluating and validating medical devices .
SIRIM ' s team of highly qualified employees is another plus point . Nur Ellina said : “ In fact , we must be registered with the relevant authorities and audited by the Department of Standards Malaysia to be an approved signatory for the tests ; for example , chemists must be registered with Institut Kimia Malaysia .”
She pointed out they needed the necessary expertise and experience . An organisation must have adequate buildings , systems , and staff in place to
Viral Penetration Test for personal protective equipment .
Chemical analysis of medical device . acquire accreditation . “ Because our laboratories are ISOcertified and have GLP status , your test results will be accepted internationally ,” Noor Rabihah remarked .
SIRIM has also made major investments in improving its capabilities . “ We continue to expand as industry leaders with constant investment in our facilities , equipment , and technological capabilities ,” said Mohd Mahayuddin .
Boosting public awareness
SIRIM is now focusing on glove makers , with ambitions to expand its customer base soon to include dialysis centres and intravenous solution providers . In addition , it is helping to raise knowledge of the regulations and procedures that medical device manufacturers must follow .
The team attends related trade shows , arranges industry engagement days where they hold training sessions to explain the many types of testing SIRIM offers , and visits potential clients to discuss collaboration opportunities .
“ We also collaborate with organisations such as the Malaysian Rubber Glove Manufacturers Association ( MARGMA ) to host events on rubber-related medical equipment and invite their members to tour our facilities ,” Mohd Mahayuddin added .
As the medical device business expands , so will the demand for medical device testing , and SIRIM stands ready to assist industry companies in expanding globally . Global regulators require greater in-depth testing and evaluation of medical devices , including long-term testing , and SIRIM is constantly improving its services to guarantee industry fulfils these tough regulatory criteria .
“ When compared to the US , for example , our costs are very reasonable . Our test reports are also accepted internationally , including important markets like the US and Europe . This demonstrates that our capabilities are comparable to those of our foreign counterparts ,” Noor Rabihah commented . — The Health
For organisations interested in obtaining IBRC services , please visit www . sirim . my , contact + 603-5544 6000 or e-mail us at web @ sirim . my .