Think back, before the news of the pandemic loomed closer in Malaysia, how frequently did you use face masks and hand sanitisers back then? Let us be honest then, Malaysians before the pandemic was not aware of the benefits of face masks and hand sanitisers beyond the usage of a preventive measure of combating COVID-19.
When the pandemic was prevalent in the country, there was high traffic at every pharmacy, convenience store and even at your nearest shops scouring for any face masks and hand sanitisers in these shops. Only then the nation realised the utmost importance of PPEs such as hand sanitisers, face masks and even gloves to be measured and tested to the highest standards to combat COVID-19.
And this is where TÜV SÜD comes in. Being a pioneer for safety, security and sustainability solutions over the past 150 years, they provide immense value to their clients through a comprehensive portfolio of testing, certification, auditing and advisory services. Now more than ever, TÜV SÜD are in high demand in supporting the medical industry during COVID-19.
The medical device market is governed by different national and international standards and regulations, which companies must fulfil. Their dedicated team ensures you do just that, by accompanying you through the complex medical device regulatory requirements for your product's target markets.
TÜV SÜD is a Notified Body (ID number 0123) for European Regulation, a mandatory requirement for all products entering the EU. The services include quality management system auditing, design dossier review, product testing and verification according to the required EU Medical Device Regulation 2017/745 & the In Vitro Diagnostic Device Regulation 2017/746
TÜV SÜD is also authorised to work with clients who would like to participate in the Medical Device Single Audit Program (MDSAP). The objective of the MDSAP is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a Medical Device manufacturer, conducted by an MDSAP recognised auditing organisation, to satisfy the needs of multiple regulatory jurisdictions.
The MDSAP program includes 5 participating regulatory authorities:
Therapeutic Goods Administration of Australia
Brazil’s Agência Nacional de Vigilância Sanitária
Health Canada
Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
U.S. Food and Drug Administration
Other services such as the ISO 13485 audit along with the Good Distribution Practices for Medical Device (GDPMD) audit are immensely crucial in maintaining and improving quality assurance throughout the distribution chain. Also, it is a requirement by the Medical Device Authority of Malaysia to have all medical devices to be registered and all stakeholders, including manufacturers, importers, exporters, distributors and service providers, to be licensed.
TÜV SÜD also goes above and beyond for its clients by providing on-site training, virtual training and e-learning on all things related to ISO 13485, which promises to keep participants enabled, engaged and empowered by the end of the session. TÜV SÜD also provides more in-depth pieces of training, from Sterilization Training to Risk Assessment Training.
Other crucial services in which the medical industry see great value are the pre-shipment inspection, whereby visual inspections are done on PPE gloves as per the requirement from customers themselves, along with testings on all forms of PPEs, ranging from gloves, face masks to even medical gown itself.
The International Standard whereby TÜV SÜD can test on for gloves can be seen below:
– Foodservice gloves: ASTM D7329
– Nitrile examination glove: ASTM D6319
– Polyvinyl chloride examination glove: ASTM D5250
– Polychloroprene examination glove: ASTM D6977
– Rubber examination glove: ISO 11193, ASTM D3578
– Surgical rubber glove: ISO 10282, ASTM D3577
– Protective glove for standard use: EN 374-1 (chemical risk), EN 374-5 (microorganisms risk), EN 374-2 (Penetration), EN 374-4 (degradation), EN 16523 (Permeation), ISO 16604 (protection against the virus), EN 388 (mechanical risk), EN ISO 21420 (General)
– Medical glove testing: EN 455-1 (freedom from holes), EN 455-2 (Physical), EN 455-3 (Biological)
– Medical glove shelf life testing: EN 455-4, ASTM D7160
– Medical glove testing: ASTM D5151 (Detection of holes) / D6124 (Powder-free) / D7102 (Endotoxin)
The tests above can save lives, as they can test the nitty-gritty effectiveness of these gloves such as biocompatibility, biological chemical testing, shelf-life study and even food contact testing.
The key PPE of COVID-19, the face mask, needs to be tested to ensure it is safe for use by medical practitioners. With the ASTM F2100 and EN 14683, TÜV SÜD can ensure that medical face masks can meet the following requirements:
• Bacterial Filtration Efficiency (BFE)
• Synthetic Blood Penetration / Fluid Resistance / Splash Resistance
• Sub-micron Particle Filtration Efficiency (PFE)
• Differential Pressure / Breathability
• Flammability
• Microbial Cleanliness / Bioburden
TÜV SÜD is also able to conduct testings on medical gowns, as per AAMI PB70 guideline, along with testings on hand sanitisers according to the BS EN 1040 and BS EN 1275 standards which in both the short and long run can save lives of medical practitioners.
In moments of uncertainty, and moments where civilians need the medical industry more than ever, third-party TÜV SÜD is coming to the rescue. Malaysians can be certain the PPEs in the country are safe to use, thanks to the expertise and experience of TÜV SÜD when it comes to testing.
For further information, do reach out to TÜV SÜD Malaysia at [email protected] to learn more.
This content is provided by TÜV SÜD.
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