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Experts rue health ministry’s guidelines on PPEs not specifying BIS certification except for 3-ply masks

Shardul Nautiyal, Mumbai
Saturday, November 7, 2020, 08:00 Hrs  [IST]

Experts in the field rue that the Union health ministry’s guidelines on personal protective equipment (PPEs) do not specify the need to get the Bureau of Indian Standards (BIS) certification except for 3-ply masks. Health authorities therefore need to notify BIS guidelines for all PPEs in the interest of domestic industry and patient safety.

BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods for minimizing health hazards to consumers.

Experts have argued that health ministry guidelines only specify standards for PPEs and give BIS only for 3-ply masks which is not in compliance to new Medical Device Rules – 2017 (MDR- 2017).

Main components of PPE are goggles, face-shield, mask, gloves, coverall/gowns (with or without aprons), head cover and shoe cover.

“Though there is no mandate for BIS certification. It is recommended to add BIS in health ministry guidelines. This will give industry choice and adherence to compliance levels based on certification by notified bodies until new MDR regulations are effectively implemented. Since MDR 2017 uses the concept of notified bodies, certificates of conformity from any notified body of the Central Drugs Standard Control Organisation (CDSCO) should be acceptable,” according to an expert in the field.

As of today, PPEs are not being effectively regulated as medical devices as manufacturers have yet to get themselves registered voluntarily on the portal-cdsco mcdonline.gov.in as per the mandate of new MDR -2017.
To regulate the production of PPEs among Indian manufacturers in line with the specifications of the World Health Organisation (WHO) and the Union health ministry, the Government issued a notification on April 6, 2020. Conformity to BIS as per MDR 2017 will complement the government’s self-reliant and Make in India campaign to boost domestic industry in the wake of COVID-19 crisis.

Coronaviruses target mainly the upper and lower respiratory tracts. Hence protecting the airway from the particulate matter generated by droplets/aerosols prevents human infection. Contamination of mucous membranes of the mouth and nose by infective droplets or through a contaminated hand also allows the virus to enter the host.

Hence the droplet precautions/airborne precautions using masks are crucial while dealing with a suspect or confirmed case of COVID-19/performing aerosol generating procedures. Masks are of different types. The type of mask to be used is related to a particular risk profile of the category of personnel and his/her work.

There are two types of masks which are recommended for various categories of personnel working in hospital or community settings, depending upon the work environment - Triple layer medical mask and N-95 respirator mask. It was also recommended to the government to allow industrial mask manufacturers to produce indigenous N95 masks as per the standards approved by BIS.

There are only a few N95 mask manufacturers in the country which are approved by the National Institute for Occupational Safety and Health (NIOSH). As per official estimates, there is availability of only 25 lakh N95 masks in the country and there is a demand for around 2.5 crore such masks.

Evidence shows that people can spread the coronavirus before they are even showing symptoms of infection. To stop the transmission everybody should wear a mask.

NIOSH is a US Federal agency responsible for conducting research and making recommendations for the prevention of work-related disease and injury in healthcare among others.


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