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 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 acquire accreditation.
“Because our laboratories are ISO-certified 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.
