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OVER VIEW OF PPE FOR COVID-19

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covid19 / corona gear

The novel coronavirus is one of the deadliest pathogens to exist in recent times. With over 3.5 million cases and 2.5 Lac deaths all over the globe, this highly contagious pathogen causes severe illness and in many cases may even be fatal.
Amongst these fatalities, are healthcare professionals or health care workers which include doctors, nurses, ward boys, cleaners, police officers and many more of these frontline warriors. A war is being fought with a clinical armamentarium. Though the type and number of arsenal available to healthcare professionals may be limited, they are of the highest priority to them.

One of the most important is Personal Protective Equipment (PPE), which can protect and minimize the risk of transmission of Covid-19 to healthcare workers.
With this in mind, the aim should be to provide them with complete protection that provides maximum breathability, dexterity, comfort, minimum heat-associated stress and maintains the physiology of the healthcare workers. The coverall/protective suits should be designed to cover the whole body except for the hands, feet and face area, providing a barrier to airborne and fluid-borne contaminants and the pathogens, preventing from reaching the skin.
Aim has to be barrier effectiveness, functionality or mobility, comfort, cost, strength, fit, time to don and doff, biocompatibility, flammability, odor, and quality maintenance

The following core factors should be addressed to achieve maximum:

  • Fabric and its properties
  • Garment assembly and associated technology infrastructure.
  • Sterilization and safe disposal

PPE is divided into the following:

  • Surgical face masks Type IIR
  • Respirator masks FFP 2 and 3, N95, helmets and hoods and caps
  • Eye protection and goggles
  • Gowns -sterile, non-sterile and Thumb looped
  • Protective cover all
  • Nitrile gloves

There are multiple standards, specifications, directives and legislations. If we follow a combination of EU and ISO norms, we can manufacture a very good quality PPE.

Eg:

● PPE directives EU 2016/425.
● ISO 16604/ISO 16603 class3- resistance to penetration by blood and body fluids using synthetic blood with exposure pressure of 3.5 kPa and class 2- 1.75 kPa.
● EN 14126- resistance to penetration by infective agents and mechanical contact with substances containing contaminated liquid.
● ISO 22612- resistance to penetration by contaminated solid particles.
● ISO 22611- resistance to contaminated aerosols.
● These standards if applied they can filter the bacteriophages which are .027 Micron, While Covid-19 are .125 Micron.
● The fabric used should be passed by SITRA and the suit is to be passed by DRDE.
● All the products and packaging should be latex-free.
● All the products must be supplied with a minimum 3 years of shelf life from the date of manufacturing.
● As per guidelines set by the Ministry of Health and Family Welfare, Govt. of India the fabrication of body cover all and gowns must be carried out by adhesion/sewing /thermal/RF welding /ultrasonic welding or combination of technique.
● It should be followed by sealing of seams with hot air seam sealing machine, which is a special Technology.
● The gear should be of single stitch, so as to reduce the chance of any fluid penetration.
● Seams must be sealed with tape, minimum of 16mm in width, multi-layer adhesive using nozzle temperature between 250c to 300c.
● Sealed seam should undergo hydrostatic test assisted by compressed air.
● Sealing tape can be on the inner or outer side of the gear.

PPE categories as per EU 2016 /425:

● CATEGORY I: Simple PPE- Protects against minimal risk,
Above the neck products: sweatbands, cold weather hood system and sun capes.
● CATEGORY II: Intermediate PPE
Above the neck products: Safety Spectacles, Industrial Helmets and Bump Caps.
● CATEGORY III-Complex PPE. This prevents high risk and damage to the health.
Above the neck products: Respiratory PPE, Industrial helmet with hearing protection.

Coveralls Should Have Following Characteristics:

● Bodysuit from ankle to the top of head;
● Weather hood can be separate.
● Front zip extends enough into the perineum so that it is easy to wear and take off. The PPE should have a separate neck flap with tape tab to cover the neck;
● Hood should completely cover the head and half of the forehead;
● Sleeves are to be provided with a good flat elastic with thumb loop;
● Leggings with a flat elastic with the ankle loop;
● Shoe covers that extend just under the knee with good flat elastic; and
● A short apron with zip on the back.
Additional considerations:
● Must seal effectively around the ankles, wrists and face;
● Must be antistatic;
● Must be single use;
● Must be individually packaged; and
● Must be available in sizes S, M, L as a minimum.
● End users are the best judges of the barrier level required, based on experience and the potential of known exposure risk.
● CDC recommends that several gown sizes should be available in a healthcare facility to ensure appropriate coverage for staff members

Surgical Masks:

● Must conform to BS (British Standards) EN 14683:2019 or any equivalent standard
● Must have a splash resistance pressure equal to or greater than 120mm Hg;
● Must provide a bacterial filtration efficiency (BFE) of 98% or above;Must be single use;
● Each mask must dispense from packaging individually;
● Must be free from chemical smells, resulting from the manufacturing process, which
prevents the end user from breathing comfortably;
● Must have no residue left from the manufacturing process on the finished product which
may lead to irritations on the skin;
● Must be close fitting in order to prevent venting (exhaled air ‘escaping’ at the sides of the
mask);
● The noseband must deform when pressed to mould over the nose and cheeks and must
maintain its shape over time; and
● The noseband must not kink or break when adjusted.
Respirators:
● Must be single use;
● Must be of moulded, duckbill, flat folded or cone style;
● Must have integral straps/ties long enough to go around an adult head whilst wearing a surgical cap;
● Straps/ties must be adjustable for fit by the user;
● The upper strap/tie should sit at the crown of the head;
● The lower strap/tie should be positioned to allow it to be positioned behind the neck to hold the sides of the mask against the face of the user to prevent any gaping;
● The noseband must deform when pressed to mould over the nose and cheeks and must maintain its shape over time; and
● The noseband must not kink or break when adjusted.

Eye Protection:

A face shield or visor is a device worn on the head for covering the whole of the face and providing
a barrier to liquid splashes. They must be:
● Optically clear;
● Resistant to fogging; and
● With an adjustable headband

Must be single use;

● Each mask must dispense from packaging individually;
● Must be free from chemical smells, resulting from the manufacturing process, which
prevents the end user from breathing comfortably;
● Must have no residue left from the manufacturing process on the finished product which
may lead to irritations on the skin;
● Must be close fitting in order to prevent venting (exhaled air ‘escaping’ at the sides of the mask);
● The noseband must deform when pressed to mould over the nose and cheeks and must maintain its shape over time; and
● The noseband must not kink or break when adjusted.

Respirators:

● Must be single use;
● Must be of moulded, duckbill, flat folded or cone style;
● Must have integral straps/ties long enough to go around an adult head whilst wearing a surgical cap;
● Straps/ties must be adjustable for fit by the user;
● The upper strap/tie should sit at the crown of the head;
● The lower strap/tie should be positioned to allow it to be positioned behind the neck to hold the sides of the mask against the face of the user to prevent any gaping;
● The noseband must deform when pressed to mould over the nose and cheeks and must maintain its shape over time; and
● The noseband must not kink or break when adjusted.

Eye Protection:

A face shield or visor is a device worn on the head for covering the whole of the face and providing a barrier to liquid splashes.

They must be:
● Optically clear;
● Resistant to fogging; and
● With an adjustable headband

Eye Shields/safety glasses are devices for protecting the eyes against exposure to liquid droplets.
They must be:
● Be resistant to fogging
● Must be optically clear

A Few More Concerns Which Should Be Looked Into:
● Face shield should not hamper the neck movements;
● Face shield design should allow the use of the stethoscope;
● Eye shades should fit snugly to prevent spillage into the eyes and should be fog free;
● The only PPE disposal after the hypochlorite treatment should be incineration; and
● PPE designs should vary according to the healthcare workers build and profile.
There are few innovations which must be adopted since the healthcare professionals use these articles for 8 to 10 hours, which makes it uncomfortable and involves physiological stress too.
● The most important concerns to be addressed are hydration and urination.
● Hydration can be achieved by providing hydration devices which are bottles fitted with siphoning tubing.
● Urination can be answered by using the diapers with odor removing chemicals or condom catheters.
(Recently, doctors in one of the New York hospitals had to use diapers.)

What are the challenges:

● There should be good fabric regulation;
● An understanding of sealing tapes and it’s technology.

● Government agencies should monitor the process and end product.
● Good planning from the manufacturer.

Here is my take on the matter:

PPE is the most important mechanism for the protection of healthcare workers from this virus. It has been in use in other spheres of healthcare for many years. This crises has just highlighted the importance of precautionary and protective gear more than ever. The lives of healthcare professionals are at stake.Let all of us stakeholders come together and understand the importance of providing a quality product.
Let us erase all the ambiguity regarding the raw material used and its specification. Universalize the nomenclatures and simplify them. Use generic terms that make the process easy to understand and not terms such as SMS, SMMS, SMMMS SMMSS, TUP, PUC, PVC, SPUNBOND, MELTBLOW, GSM etc.
The basic raw materials typically used for disposable PPE are various forms of synthetic fibers (e.g. polypropylene, polyester, polyethylene) The most commonly used nonwoven fabrics for isolation gowns are spun bond and spun bond / melt blown / spun bond technologies. Today there is question mark about suitability of SMS. There is recommendation of breathable viral barrier fabric which is lightweight tri laminate.
The list is very long and confusing for most clinicians. Clinicians should be absolutely clear about the usage of the products as soon as they look at the packages and be assured that it clears all safety measures. It’s the moral responsibility of society to be a part of this war against this pathogen and do everything possible to save our healthcare professionals. Please do not promote anyone involved in this trade without educating them.
.

References: DRDO, WHO, NHS, MANUFACTURERS, PUB MED.
Dr. Shahaji Deshmukh
Dean
Bharati Vidhyapeeh (Deemed to be University)
Medical College & Hospital,
Sangli, Maharashtra.

2 Comment

  1. Gautam Taralekar

    This is perfect! We need to simplify things to make them available and improve their efficiency. I really appreciate your efforts to have made things easier to understand! I hope the society contributes in this war against this pathogen. Fingers crossed !
    # Stay safe # Stay healthy # Stay Motivated!

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