4^th September, 2021; 11am-12pm

Key points of HCFI Expert Round Table

• Many people buy N95 masks to reduce their risk of getting Covid-19. But, health regulatory authorities recommend that the use of N95 masks be limited to healthcare workers.
• There are several counterfeit brands sold in the market, particularly in the developing countries. This raises safety concerns.
• Only patented technologies which have international certification and are based on peer reviewed evidence should be used.
• Nonwoven masks are manufactured using plastic variants such as polypropylene to provide protection against infections.
• Asia Pacific has emerged as the largest market for disposable face masks in 2019. India including China is among the largest manufacturer of disposable face masks. Hence, adherence to quality of masks is essential.
• Face masks are a ticking bomb; every minute, 3 million masks are thrown out and act as a source for other infections and toxicants in the environment.
• Certifications or patents are not enough to determine credibility. Stricter regulations on product testing for claims of manufacturers are essentail to ensure the effectiveness of the product advertised.
• Washable and reusable masks are favored. Face masks in esthetically appealing designs and prints to attract the consumer are available in the market.
• Silver has antimicrobial properties, which have been well-documented. The potential antiviral mechanisms of silver nanoparticles are binding interaction with viral envelope proteins and inhibiting the virus from binding to the host’s cell membrane. Size of nanoparticles has been thought to influence their antiviral efficiency.
• It is necessary to implement well-defined evaluation parameters and quality control protocols to improve product quality and consumer trust.
• Reusable face masks can be laundered for reuse (maximum 50 cycles).
• ASTM Level 1 masks are for procedures in which there is low risk of fluid exposure (no fluid, splashes or sprays expected).
• ASTM Level 2 is for procedures in which there is moderate risk of fluid exposure (aerosols, splashes or sprays).
• ASTM Level 3 is for procedures in which there is heavy exposure to fluid (aerosols, splashes or sprays)
• Consumer Product Safety Commission (CPSC) under the Consumer Product Safety Act is charged with protecting the public from unreasonable risks of injury or death associated with the use of different types of consumer products under its jurisdiction.
• A face mask should have at least three layers: Inner absorbent layer made of a coated/absorbent cotton, middle filter layer made up of nonwoven material and outer fluid repellent layer.
• ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), NIOSH (National Institute for Occupational Safety and Health), SITRA (South India Textile Research Association), INMAS (Institute of Nuclear Medicine Allied Sciences) provide certifications to ensure the validity of claims of the manufacturer.
• Two innovations by IIT scientists have created a coating for masks that kill viruses within minutes: Nano coating system and a cloth mask coated with a biodegradable biocompatible and non-irritant system.
• Antibacterial properties of silver are known for a long time. Use of silver in larger concentrations is harmful.
• Apart from size, concentration of silver used, coating on which layer of the mask, is there a direct contact with hands also matters. A nanoparticle is less than 100 nm.
• Silver nanoparticles can have adverse effects on health in both animals and humans via dermal, respiratory and oral routes. Some airborne particles are released from nanoparticle impregnated products, even when nanoparticles are embedded inside the fibers.
• NIOSH has suggested an exposure limit of 0.9 mcg/m3 over 8 hours exposure for respirable silver particles that are less than 100 nm in size.
• EPA prohibits manufacturers from advertising antimicrobial claims without proper registration of the product as a pesticide.
• Antiviral or antibacterial claims on products are also not allowed in accordance with Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
• IIT Mumbai has developed a coating technology called Duraprot (durable+protection), which has been patented. Every nanotechnology that is developed is first evaluated for toxicity. The silver coating technology was also evaluated for any toxic or mucosal irritant effect.
• The coating material is a nanoemulsion of several biobased materials. All ingredients are FDA GRAS approved materials, they are natural or naturally derived. The material is biodegradable, biocompatible and non-irritant.
• It is cross linked to the fibers of the mask and retains its efficacy for until 20 wash cycles. Can be coated on cotton, polyester viscose and rayon. Easy to make and easy to coat process.
• It has charge based attraction and killing mechanism. Its anti-SARS-CoV-2 activity has been demonstrated by RT PCR method. The swab (viral transport medium) swab was coated with the nanoemulsion.
• Any product which has health implications is supposed to be regulated i.e., product standards have to be specified by law.
• Medical devices were earlier regulated as drugs by CDSCO. All masks used for medical purposes are medical devices. Until February 2020, the Government had regulated or notified 37 categories of medical devices as drugs. In February 2020, CDSCO notified the definition of medical device. Any product, including masks, which falls under the definition would deem to be regulated by the rules.
• From April 2020, all manufacturers of non-notified medical products/ devices were given an option to register voluntarily along with ISO 13485 certification, which is for quality management. This period of voluntary registration ends on September 30. After this registration becomes compulsory. All products used during Covid – masks, PPE, oxygen concentrator, pulse oximeter, ventilators are therefore unregulated as on today. However, product certification does not require product compliance yet.
• For Class A and B products, the CDSCO has given one year time to comply with the legal requirements for the product.
• The standards prescribed are the Bureau of Indian Standards (BIS) standards. From August 2022, compliance to BIS standards would be mandatory in order to sell a product in the market.
• The Health ministry guidelines for PPE kits still talk of foreign standards and not BIS standards. The Textile ministry however is advising every manufacturer to get certification from BIS.
• The only assurance for quality is the ISI mark. Look at ISI mark when buying masks.
• At the request of the government, BIS put a condition for the manufacturers that products would be sold to the government first. So, masks with ISI mark may not be available in the open market.
• As of today, there is no legal compliance expected from mask manufacturers; legal compliance (to some extent) starts from 1^st October; product compliance gets effective from August 2022.
• Two Indian standards are available for masks: IS 16829:2014 for surgical face mask and IS 9473:2002 for N95 masks in line with the ASTM and BS standards.
• These standards require the bacteria filtration efficiency, particle filtration efficiency, splash resistance and breathability.
• At present, 56 licenses have been granted from IS 16829. This list is available publicly on BIS website and is updated in real time.
• Coating of masks (with silver nanoemulsion) is not specified as a requirement, but may be given as optional requirement.
• The resistance to inward leakage of surgical masks is poor. Therefore, all frontline workers use N95 and FFP2 masks.
• N95 mask is a 5-layer mask; it has very good resistance to inward leakage.
• The fit of surgical mask and N95 vary greatly.
• BIS is converting respirators to medical respirators. Apart from filtration efficiency and inward leakage, requirement of bacteria filtration efficiency and splash resistance is also being specified.
• There should be a standard for the barrier masks for use by the general public, which provide only breathability and particle filtration efficiency, apart from design and reusability requirements.
• ASTM, AFNOR, Ireland have already brought standards for barrier masks. BIS is working on standards for the barrier mask and will soon bring out a mask for the general public with a caveat that these masks are not suitable for the medical professional.
• A strong redressal mechanism is available online.
• 261 licenses for N95 masks have been granted as on today.
• N99 and FFP3 masks are also now being provided.
• As of today, there are no regulations. In future, CDSCO will be the regulatory authority. States have drug inspectors etc. If there is any misuse of BIS marks (fake ISI marks), BIS has the power to raid such premises and search. It can also act if somebody who holds a BSI license gives substandard quality.
• The breathability is a prime requirement of masks – it is 29.4 Pascals, which is equivalent to 3mm of water column.

Participants

Dr Ashok Gupta

Dr Suneela Garg

Dr DR Rai

Mr JK Gupta, BIS

Mr Anil Jauhri, Ex CEO NABCB, QCI

Prof Naveeen K Navani, IIT Roorkee

Mr Kapil Punjabi, IIT Mumbai

Dr Anita Chakravarti

Dr Arun Jamkar

Dr KK Kalra

Dr Anil Kumar

Ms Ira Gupta

Ms Priyanka Bapna

Dr S Sharma