Medical disposables and accessories used in hospitals do play a vital role in preventing hospital acquired and surgical site infection, two of the most serious medical challenges. But, why is the medical disposable market in the country crowded with unsafe products?
Most of the medical accessories such as surgical drapes and packs, general care products, including medical apparels, surgical gowns, surgical sheets etc., which keep the patients and healthcare workers safe and infection free, were not under the ambit of any strict quality regulations in the country. Most of the general quality certifications were either voluntary or merely part of some guidelines. So, there was no mechanism to control or penalise the offenders who are not in compliance with the supposed-to-be patient safety parameters. Even after the government introduced rules to make the registration of medical devices, disposables and accessories mandatory under the provisions of Drugs and Cosmetics Act, not all products were included in it. Now, even with the recent amendments to medical devices rules introduced last year to bring more products under the registration rules with quality norms equivalent to drug products, there is strong resistance from the industry. Therefore, this scenario has been exploited by the manufacturers, and the user industry, which is often under cost pressure, found it convenient to cut costs on these items knowingly or unknowingly.
Has this scenario, like the absence of regulations and lack of awareness, created challenges for quality manufactures?
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