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Accreditation ensures the quality of medical devices

In recent past, we have witnessed unprecedented challenges in catering to the needs of health and safety of the citizens. The awareness in common man about health, safety, quality in testing and how to look for trust in products/services has grown exponentially. The increased expectation of quality in every sphere of life has forced us to demand products and services that have attested credentials. Accreditation provides confidence in delivery of a competent service related to testing of products and materials intended to be used in diagnosis and treat­ment of patients in various laboratories and hospitals.

The role of NABL has been underlined in the recent fight against COVID pandemic, where the accreditation granted to laboratories for testing of medical devices, PPE, masks, ventilators, patient monitoring units, etc., played a major role in ensuring the health and safety of citizens.

NABL has established its management system in accordance with ISO/IEC 17011:2017 and is signatory to International Laboratory Accreditation Co-operation (ILAC) and Asia Pacific Accreditation Co-operation (APAC) Mutual Recognition Arrangements. Such MRA reduces technical barrier to trade and facilitates acceptance of test/calibration results among countries, which MRA partners represent.

We at NABL, as an accreditation body, have always strived to ensure that the end user/common man gets the best of services and can trust a product/material testing in NABL accredited laboratory through NABL symbol on test reports.

NABL-accredited laboratories are catering to testing needs of medical devices and accessories like gloves, catheters, bronchoscopes, solutions and blood-administration sets, transfusion sets, drainage sets, oxygenators, extracorporeal oxygenator tubings, drug delivery catheters, sutures, needles, tubes, blood bags, etc. Equipment like ventilators, pulse oximeters, oxygen concentrators, and various medical electrical equipment can also be tested in NABL-accredited laboratories. NABL accredited calibration laboratories are ensuring traceability in measurements of various measuring equipment like patient monitors, ventilators, discharge equipment, oximeters, oxygen concentrators, defibrillators, BP apparatuses, ECG machines, nebulizers, radiant warmers, blood gas analyzers, Bipap, etc., that are critical to the healthcare sector.

It is well known that the hospital and laboratory personnel run the risk of getting infected due to their proximity with infected subjects. The shortage of assured quality-protective gear can jeopardize the entire battle against COVID-19. The hospitals and nursing homes have to insist on product quality in their procurements, which will ensure better and reliable patient care. This is possible by using products that can be trusted to meet the requirements by being tested in NABL-accredited laboratories.

NABL has proactively put up the list of accredited laboratories for testing products like PPE, sanitizers, gloves, masks, and medical devices. NABL has reached out to the industry through various platforms and disseminated information about the tests being offered for these products by NABL-accredited laboratories in various regions. This has helped the industry in speeding up supply of assured quality products to hospitals.

NABL has encouraged laboratories to ensure use of NABL symbol in the test reports containing only accredited parameters, which provides trust in the test report to end-users. This ensures that the results are valid and metrologically traceable, hence can be relied upon by the customers.

The laboratories of manufacturing units can also obtain NABL accreditation for testing of their products. The application for NABL accreditation in accordance with ISO/IEC 17025:2017 can be submitted online through our website www.nabl-india.org. The application for medical equipment can be submitted under the group of medical electrical equipment in electronics testing. Medical devices, in which biological parameters are being tested, can be applied under the groups of toxicology and medical accessories and surgical products.

NABL welcomes the inputs from the industry on the need for accredited testing facility in various products. Such inputs help us to make the accredited laboratories aware of the requirements of the industry, which in turn help the laboratories offer accredited testing facility to serve the industry.

To conclude, it is evident that accreditation has a very vital role in instilling the required confidence, and NABL is contributing its part in nation building at every step. However, the onus is also on the industry to make use of accreditation infrastructure available in the country to assure their customers about the quality of products.

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