Quality

Regulatory Perspective Of Testing Of Masks, Hand Gloves
And PPE In The Midst Of Covid-19

 

Dr. Manish A Rachchh Director (R&D) & CEO Accuprec Research Labs Pvt. Ltd.

Corona virus disease (Covid-19) is an infectious disease caused by a newly discovered coronavirus. WHO has declared Covid-19 as pandemic since 11 March 2020.1,2 The Covid-19 virus spreads primarily through droplets of saliva or discharge from the nose when an infected person coughs or sneezes, so it’s important that one also practice respiratory etiquettes (for example, by coughing into a flexed elbow). Further to prevent the spread of Covid-19, governments across the globe issued guidelines for public to wear face mask covering mouth and nose, maintain hand hygiene and follow physical distancing norms.

The COVID-19 pandemic is rapidly spreading across countries and regions, causing huge impact on people’s lives and communities. Till 31st May 2021, cumulative Covid-19 confirmed case was 281,73,883 & death was 331,911 in India.3 Starting as a health crisis, it now poses serious threats to the global economy, trade and finance with estimated economic impacts to range between $2 trillion and $4 trillion globally.

The World Health Organization (WHO) estimated that more than 45 million medical devices like masks and gloves are required for the COVID-19 response each month, along with 76 million examination gloves and 1.6 million medical goggles (WHO 2020). WHO itself has so far shipped nearly half a million sets of personal protective equipment (PPE) to 47 countries, but supplies are depleting rapidly. To meet rising global demand, WHO estimates that industry must increase manufacturing by 40% and urges governments to act quickly to boost supply.

This serious situation has provoked the manufacturing of the PPE (Personal Protective Equipment’s ) . Meanwhile to ensure the quality aspect the testing of the PPE has become an important prospective for keeping the corona worrier safe. As the spreading of the corona is controlled by the use of the PPE. The demand of medical devices like masks, gloves and PPE kits before the Covid-19 were very less as compared to current situation. The hand gloves, surgical masks and PPE were used mainly for surgery in hospitals, blood and other analytical tests in pathological laboratories and radiological centers and microbiological analysis in pharmaceutical industries. Due to Covid-19, medical device use has been drastically increased across the globe like N95 masks, surgical masks, hand gloves, PPE kits, face shield, sanitizers, etc. There are various standards published for the establishing the safety, efficacy and quality of these products. Every country has defined their requirements in the guidelines and follows accordingly to establish these quality, efficacy and safety.

In India, these products fall under the category of medical devices. India has defined requirements for medical devices as per Drugs and Cosmetics Act 1945 and Medical Devices Rules, 2017. As of now, CDSCO has not started regulation of such products but included in draft guideline document as a proposed products going to be regulated. Till that the MoH, GoI has published guidance document about quality standards that our PPE material shall complies.

There are countries that do not have specific requirements laid out in their regulations for PPE - products; such countries follow various internationally acceptable standards like ISO, ASTM (USA), AATCC (USA), EN (Europe) etc. In India, these medical devices are tested according to Bureau of Indian Standards and also internationally accepted standards.

Masks:

A surgical mask is a loose-fitting, disposable mask that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Surgical masks are not to be shared and may be labeled as surgical, isolation, dental, or medical procedure masks. They may come with or without a face shield. These are often referred to as face masks, although not all face masks are regulated as surgical masks. Performance testing of Surgical mask shall meet the requirements of IS 16289 or EN 14683.

If worn properly, a surgical mask is meant to help block largeparticle droplets, splashes, sprays, or splatter that may contain germs (viruses and bacteria), keeping it from reaching your mouth and nose. Surgical masks may also help reduce exposure of your saliva and respiratory secretions to others. While a surgical mask may be effective in blocking splashes and largeparticle droplets, a face mask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the mask and your face.

A triple layer/four layer medical mask is a disposable mask, fluid - resistant, provide protection to the wearer from droplets of infectious material emitted during coughing, sneezing, talking.

N-95 mask is a protective device with high filtration efficiency to airborne particles. To provide the requisite air seal to the wearer, such masks are designed to achieve a very close facial fit. Such mask should have high fluid resistance, good breathability (preferably with an expiratory valve), clearly identifiable internal and external faces, duckbill/cup-shaped structured design that does not collapse against the mouth. If correctly worn, the filtration capacity of these masks exceeds those of triple layer medical masks. Since these provide a much tighter air seal than triple layer medical masks, they are designed to protect the wearer from inhaling airborne particles. Performance testing of N-95 masks shall meet the requirements of ASTM F2100-19 or EN 149 guidelines.

WHO recommends Fabric masks should be made of three layers of fabric: Inner layer of absorbent material, such as cotton. Middle layer of non-woven non-absorbent material, such as polypropylene. Outer layer of non-absorbent material, such as polyester or polyester blend.