The current crisis of PPE

Dr Sona Pungavkar, Senior Consultant Radiologist, Global Hospital, Mumbai, gives an insight on the types of PPE used in different states and the challenges faced while treating COVID-19 patients 

Personal protective equipment (PPE) has been primarily designed to act as a barrier to an external harmful agent.  Besides, healthcare industry, it is also used in other hazardous areas, such as chemical factories, welding factories, construction areas, laboratories etc. A technical committee (TC) in ISO, called ISO TC/94 has been set up with a scope of standardisation of the performance of personal protective equipment designed to safeguard wearers against all known possible hazards.

In case of a healthcare worker in the current COVID-19 crisis, it includes a set of components, which protects the worker, in a covering, which can prevent harm from the virus and it’s entry upto the skin and the insides of the body, such as lining of the nose and mouth etc. So the mention of PPE, the terminology, could include anything from a set of mask and gloves to an entire bodysuit and added covering such as shoe covers and face shield etc.

PPEs are required at various areas such as airports, isolation areas in airports and community, for administrative staff entering the field to arrange quarantines, nasal swabs, staff working in laboratories, police staff, ambulance workers, people at mortuaries, hospitals catering to Covid patients, hospitals not catering to Covid cases, but may have an asymptomatic patient presenting for another condition, which requires surgery etc. Also, in every hospital, there are different areas where PPEs are required. For the family of asymptomatic or mildly symptomatic people who are in home isolation or quarantine, different kinds of PPE can be recommended. 

These areas are designated as low risk, moderate risk and high risk. Hence, there are several types of kits available on the basis of the risk assessment for the worker. For instance, a person managing the reception desk at a hospital is, not at the same risk, as a doctor intubating a COVID-19 positive patient in the ICU. Both these people require PPEs, though the contents of the PPE may be different. The patient also has to be provided with a certain type of PPE ranging from mask to full PPEs.

The Government of India has set standards for the minimum quality parameters of PPEs for these areas of differential risks. 

Low risk areas include reception areas and other OPDs. Moderate risk areas include fever clinics, isolation areas etc. High risk areas include COVID-19 wards and COVID-19 ICUs.

Low risk areas can usually have a surgical mask and gloves. Moderate risk areas can have N95 or equivalent masks and gloves, as per MoH&FW. However, CDC 2020 has  three types of PPE called as standard, full and enhanced PPE. 

The kit, which has to be used for high risk exposure, includes contact and airborne exposure. The contents of the kit include:

1. Coverall suit on the body with a head cover, with a material conforming to the norms. It, ideally, needs a two-way zipper, which helps the person to be comfortable in the suit, while sitting. The zipper needs a covering.
2. Shoe Covers with leggings made of the same material as the coverall.
3. A pair of goggles, with an adjustable band and which can accommodate the prescription glasses and /  or a face shield.
4. A pair of nitrile gloves, which are powder free and resistant to chemicals and do not tear easily.
5. N95 or an equivalent FFP2 mask, which has an accepted filtration capacity.

A disposable bag and apron can also be included, the latter, especially for the people who are intubating. 

Considering the rapid spread of the COVID-19 disease and the healthcare and manufacturing sectors having limited prior experience, PPE shortages are currently posing a tremendous challenge to the Indian healthcare system because of the pandemic. Also, there in my discussion, with several doctors leading the campaign in the frontline in the municipal hospitals, the general consensus has been that the kits need not be sterilised except, when being used in an operation theatre, COVID-19 wards or COVID-19–ICU, as per the protocol of the establishment. Getting the kits sterilised, when not necessary increases the cost and time between production of the kits and delivery. 

There is a scarcity of coveralls, and having assessed the risk versus benefit ratio,  an emergency temporary measure has been implemented in larger public interest, in present given circumstances by the Directorate General of Health Services, MoH&FW. The coverall fabric that passes ‘Synthetic Blood Penetration Resistance Test’ (ISO 16603) and ‘Resistance to penetration by biologically contaminated solid particles (ISO 22612:2005) may be considered as the benchmark specification to manufacture Coveralls.” 

Also, there is confusion in the standards, as in view of the urgency and different certifications are being required for on short notice. Earlier SITRA (ISO 16603) was the norm. A new certification by Haffkine has also been recently introduced to avoid flooding of the market with low quality material. Another certification has been issued by DRDE, which is identical to SITRA and those fabrics which have SITRA certificates need not have DRDE, but the purchasing authorities, who may not be from the medical background, cannot distinguish between the same and insist that the manufacturers should have both. So it leads to unnecessary pressure on the manufacturer. Another certification is ATIRA. Also, the authorities and healthcare workers may not be aware of the grading of the masks etc. As an example, there is a craze and a panic-based obsession to use N95 leading to scarcity for the use in the high-risk areas. An equivalent mask such as FFP2, N99 or KN95 will also perform the same or better function of filtration, as an N95. By and large, civilians do not need an N95 mask. A surgical mask is sufficient. 

The states bordering Maharashtra have different directives from their governments, which adds to the confusion. So a manufacturer confidently producing a kit in Gujarat with a set of specifications faces an issue with the same kit in Maharashtra, due to differing guidelines.

The shortage of PPE is being experienced by other affected countries, across the world. Centres for Disease Control and Prevention, USA, is also working on optimisation of use of PPEs in the current scenario. They have suggested prioritising the use of PPEs, for example, reserving respirators (N95 masks or equivalent) for aerosol generating procedures, rather than routine surgeries. Practices allowing extended uses of N95 are being adopted. These decisions need to be made by the individual health workers who are heading the committee looking after the supplies of the PPE materials. Some manufacturers recommended re-using the kits if the necessary decontamination and sterilisation processes can be performed.

A spreadsheet-based model that will help healthcare facilities plan and optimise the use of PPE for response to Coronavirus disease 2019 (COVID-19) (ref below). Non-healthcare facilities such as correctional facilities may also find this tool useful.

The need of the hour is to provide the PPEs as fast as possible, with as high quality. However, to optimise the resources it is imperative to educate health workers what they need to use in areas corresponding to the risk involved, to educate manufacturers what they should make, to educate traders what they should be offering to the doctors and institutes, to create a code for transport of urgent materials required for making various types of PPEs via transportation systems and couriers and giving options to the government officials making decisions. We cannot overlook the fact that the traders are also needed to cater to the small private set ups, clinics and diagnostic centres. Every manufacturer cannot cater to thousands of clients as the production, which has its own challenges, then suffers.

Keeping this in mind, it would be fair that the manufacturers and traders are not discouraged, but encouraged to work with doctors and set the correct standards. Most of these people are micro, small and medium sized enterprises who are rising to the occasion at the risk to their own lives and facing the challenges of production and delivery in times of lockdowns. Mumbai and Maharashtra are suffering the most. Hence, there is a need for teamwork between government and private doctors, medical institutions, manufacturers, traders, courier services, transport and government officials from health and industry ministries.

References

1.Ministry of Health and Family Welfare Directorate General of Health Services [Emergency Medical Relief]. https://www.mohfw.gov.in/pdf/GuidelinesonrationaluseofPersonalProtectiveEquipment.pdf

2.WHO Disease Commodity Package (Version 4.0)

3.Centre for Disease Control and Prevention – https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html

4. ISOTC/94 Personal safety – Personal protective equipment. https://www.iso.org/committee/50580.html

5. Geneva World Health Organization; 2014. Infection prevention and control of epidemic- and pandemic-prone acute respiratory infections in health care. 

6.https://www.ncbi.nlm.nih.gov/books/NBK214342/#_ncbi_dlg_citbx_NBK214342

6. CDC 2020 – PPE Burn Rate calculator – https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/burn-calculator.html