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Regulatory Perspective
Of Testing Of Masks, Hand Gloves
And PPE In The Midst Of Covid-19
All of these masks have different
protection efficacies.
Gloves:
When a person touches an object/surface
contaminated by COVID-19 infected person, and then
touches his own eyes, nose, or mouth, he may get exposed
to the virus. Although this is not thought to be a
predominant mode of transmission, care should be
exercised while handling objects/surface potentially
contaminated by suspected/confirmed cases of COVID-19.
Nitrile gloves, latex surgical gloves, non-latex
surgical gloves, non-latex examination gloves, radiation
protection gloves, nonpowdered surgeon gloves, etc. are
various types of gloves available in the market with
various types of intended use. Covid- 19 disease has
increased the use of gloves also. General public have
started using cotton/fabric gloves which are re-usable
and economic and further help the prevention and spread
of the disease.
Nitrile gloves are preferred over latex
gloves because they resist chemicals, including certain
disinfectants such as chlorine. There is a high rate of
allergies to latex and causes contact allergic
dermatitis among health workers. However, if nitrile
gloves are not available, latex gloves can be used . Non
powdered gloves are preferred to powdered gloves.
Medical gloves are used by health care personnel to
prevent the spread of infection or illness.
Performance test of these gloves shall
meet requirements of either EN ISO 374 Part 1 to 5, EN
455 Part 1 to 4, ASTM D6319 - 10 , EN 21420 : 2020 or
ASTM D3578:2019 depending on type and intended target
market of the gloves.
Personal Protective Equipment (PPE): The
term “Personal Protective Equipment” encompasses the
specialized clothing or equipment worn by workers for
protection against health and safety hazards. For
healthcare personnel, PPE may include respirators, face
masks, gloves, eye protection, face shields, gowns, and
head and shoe coverings. PPE kit protects healthcare
workers and other personnels at health care facilities
that provide care to a patient with confirmed Covid-19
disease or any other communicable disease and during
surgery. Performance of the PPE shall meet the
requirements of either IS 16546:2016/ISO 16603:2004, EN
13795-1:2019, AAMI Level I to IV or AATCC standards.
The last year has witnessed a colossal
surge of COVID-19 cases all over the world and donning
basic shields of face masks has become the ‘New Normal’
nowadays when stepping out for work or travel. However,
the healthcare community across the globe, who have been
toiling day and night to treat infected patients, are at
a significantly higher risk of contracting the
SARS-CoV-2 viral strain and falling sick with corona
virus disease. Thus, they certainly require enhanced
safeguarding gear in the form of a PPE kit. Moreover,
even common people, in particular situations such as
caring for corona positive family members in hospitals
or having to travel for long distances by bus, train,
flight need to cover themselves in PPE to stay safe from
COVID-19.
The government has mandate the use of
face mask when out in the public or at work place. This
sudden increase in the demand of these precautionary
items has resulted into rise in many indigenous
production units. All these units did not have testing
facility which is required to release the efficacious
and quality product into the market.
Further, there were couple of labs only
in entire country who has the capacity to do testing of
such type of PPE products. That means, one side there is
a hug demand of PPE products to safe guard front line
workers and individuals involved in care of Covid- 19
patients and on another side, our country was facing
challenge of limited quality testing lab who can provide
testing of PPE products. Our team of R&D has took up
this challenge, work hard with engineering team to set
up testing facility for PPE products in early April 2020
(during lockdown) and by mid of May 2020, completed all
necessary validation of various test procedures to test
and qualify mask (including N95), gloves, PPE kits and
like products. Ours was the first testing facility in
entire western region and of course in Gujarat who has
started offering quality testing services for various
PPE products.
We are happy to share that majority of
tests required for qualification of surgical masks, N95
masks, gloves and PPEcoverall were also accredited under
ISO/IEC 17025: 2017 through NABL and 100+ Indian as well
as International clients are taking benefits of
professional testing service from our company. Various
tests are summarized.
Recently, every one of us has pass
through turbulent 2nd wave of Covid-19 which directly or
indirectly affected our family and friends. Though the
2nd wave effect has been significantly reduced but we
cannot eliminate probability of 3rd wave which some of
the countries have already started facing. Our
Government of India is working very hard for ‘Covid-19
vaccination’ drive and we should have to participate as
a citizen of this country in this drive. We have to
fight and have to win this battle against Covid-19 by
adopting MASDIV that means, wearing Mask (MA), Sanitize
(S) our hands frequently, Distance (DI) during social
gathering and Vaccinate (V) our near and dear ones.
References:
1. https://www.who.int/emergencies/diseases/novel-coronavirus-2019
2. https://www.who.int/news
3. https://www.covid19india.org/
4.
https://www.freepik.com/free-vector/protective-mask-efficacy_9058350.htm
Dr. Manish A Rachchh
Director (R&D) & CEO, Accuprec Research Labs Pvt. Ltd.
Ahmedabad, Gujarat, India.
Email:
manish.rachchh@accuprec.com
Contact: +91 90999 81023
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