The ongoing COVID-19 pandemic has made it painfully clear how crucial our healthcare system is, and how much want there is for personal protection equipment (PPE) for frontline workers. As of May 6, 548 doctors, nurses and paramedics had reportedly been infected by the novel coronavirus, and on June 3, 479 workers at All India Institute of Medical Sciences were reported to have COVID-19. And recently, Hyderabad’s Nizam’s Institute of Medical Sciences (NIMS), saw 12 medical staff contract the virus.
There has been increasing demand for robust PPE including coveralls and masks for healthcare workers. There have also been allegations of sub-standard PPE being provided to frontline workers at hospitals and testing labs. An AIIMS doctor, Dr Srinivas Rajkumar, was even expelled from the Resident Doctors Association and served a show cause notice by the hospital for questioning the quality of N95 masks being provided. Dr Srinivas has stood by his statement.
Dear all,
— Dr. Srinivas M.D (AIIMS) (@srinivasaiims) June 4, 2020
I stand by my statement given. It is true.
The threat was related to resident welfare activities. Original message to New Indian Express is Shared .
During pandemic we should be careful while presenting sensitive facts. Thank you.
Dr. Srinivas pic.twitter.com/C3myBSEEa0
Another aspect emerged when TNM looked into the matter – there is a lack of uniformity in PPE kits, and healthcare workers are often unaware if they are getting the right masks.
Ideally, healthcare and frontline workers should be getting N95 respirators. The major difference between a face mask or surgical mask and N95 respirator is how the latter fits. It is possible to achieve N95 like filtration (>95%) with certain cloth masks also. However, while these face masks prevent particles escaping from the wearer’s nose and mouth, N95 respirators fit snugly, creating a seal, and therefore preventing exposure to the virus expelled by another person.
Dr Sameer Agarwal of Rajasthan-based Practicing Pathologists Society (PPS) tells TNM that while face masks or a three-ply mask are appropriate for the public, healthcare workers need N95 respirators because they are in close contact with COVID-19 patients and those suspected to be infected by the novel coronavirus. The risk of contracting the virus increases when air comes in through the gap between the mask and the face. Dentists, surgeons and those collecting samples such as nasal swabs for COVID-19 testing need N95 surgical respirators, which provide some additional protection against fluids as well, Dr Sameer adds.
However, conversations with several healthcare workers in different parts of India revealed they are not always given the right kinds of masks.
Dr Kadali Vishnu, President of the Telangana Junior Doctors Association (TJUDA) and paediatrician at the Niloufer Hospital in Hyderabad, tells TNM that while they receive PPE from the government, the same type of mask doesn’t come in the kit each time. “Many times, we have been given the surgical mask (three-ply). Sometimes, we are given N95 respirators which do not have NIOSH stamps,” he alleges. He adds that sometimes, his hospital procures N95 respirators separately from the PPE kits.
The National Institute for Occupational Safety and Health or NIOSH is a US-based institute that certifies N95 masks and respirators. Some of the well-known manufacturers that have NIOSH certification are 3M (an American company), Venus and Magnum. Including the latter two, in India, only three manufacturers have NIOSH certification for their N95 masks, says Dr Sanjiv, Chairperson of the Preventive Wear Manufacturers' Association of India (PWMAI).
Similarly, Megha, a nurse working at Hyderabad’s Gandhi Hospital, where COVID-19 patients are being treated, says that though they are being provided PPE, the N95 respirators are often procured separately by the hospital. The photo she sent below show the masks that they are using.
However, Dr Sameer says, “While these look like N95 respirators, it appears that they have a valve. Healthcare workers in proximity with COVID-19 patients or in COVID hospitals should not be using face masks or respirators with a valve.”
He also says that for lab specialists working where RT-PCR tests – especially swabbing – are done, N95 respirators are must. “For those dealing with blood samples, an N95 or N95 equivalent face mask (one that doesn’t fit as tightly) or surgical mask would also do. But those handling and opening mouth, nose or throat swab samples should have N95 respirator protection,” Dr Sameer says.
However, Arun Sankar, advisor to the Clinical Laboratory Professionals Association India, who works at a government facility in Valapad, Kerala, says that in his experience, lab technicians are only using three-ply surgical masks and gloves.
Experts like Dr Sanjiv and Dr Sameer note that healthcare workers are often not aware that they need to seek tight-fitting N95 respirators, not a loose-fitting N95 mask or surgical mask.
Part of the problem is the confusion and ambiguity around the certification, which prevents frontline workers from finding the authentic product or verifying if they are using one. Generally, N95 masks and respirators are certified by NIOSH or equivalent Chinese KN95 standard, or the European FFP2 standard, among others.
In May, seeing the shortage of N95 masks, the Bureau of Indian Standards (BIS) pushed through a relaxation for domestic manufacturers wanting to make them. Manufacturers could now test the products in any BIS-recognised lab or testing facilities of other BIS-license holders and apply for the license. However, the deadline for licensing and registering with the Drugs and Controller General of India was set at October 1, 2021, creating a transient period, which some manufacturers are using to sell substandard and unlicensed PPE, Dr Sanjiv told Pharmabiz.
In another development, medical devices were now being classified as ‘drugs’ as a result of the Medical Devices (Amendment) Rules 2020, which came into effect in April. This, coupled with a gazette notification by Central Drugs Standard Control Organisation (CDSCO) which defined medical devices as anything that helps disease prevention, made masks a medical device, and hence, a 'drug'. This was seemingly done to ensure quality control.
However, despite all this, Dr Sanjiv and Dr Sameer both allege that some manufacturers have started selling PPE, including N95s, with fake NIOSH stamps or BIS stamps. BIS, which is a regulatory body, can only act when the BIS mark is misused, and CDSCO does not have authority to take action yet as manufacturers aren’t bound to take license immediately, Dr Sanjiv says.
Dr Rohit Jain, Secretary of PPS, tells TNM that they have received several complaints about PPE with fake stamps. Not all of them are verifiable, simply because there is not clarity on which manufacturers they can trust when it comes to masks. “It would really help if the government can publish a list of manufacturers that are making N95 masks so that all healthcare workers, even private players, know where they can buy from,” he says.
Below are some of the photos that Dr Sanjiv and others have received of masks floating in the marker, that claim to be N95 certified by NIOSH, KP95 or as FFP2, but are allegedly fake.
HLL Lifecare Limited, the government’s procuring arm, has a public list of verified manufacturers for coveralls. It has also put out a tender for the manufacture of N95 masks with/without an expiratory valve. Multiple attempts to reach T Rajasekhar, Director – Marketing of HLL went unanswered.
It is not just government hospitals or COVID hospitals that are facing challenges with PPE. St John’s Medical College in Bengaluru, which has been a first responder since February this year, has allegedly not received any PPE kits from the government. The hospital houses patients with Severe Acute Respiratory Infections (SARI), a category vulnerable to COVID-19.
Dr Sanjiv Lewin, Chief of Medical Services at St John’s Hospital, tells TNM that earlier, when they tried to get PPE kits in the market, they were quoted a price of Rs 4000 per kit, which was not affordable. They managed to get some stocks of PPE from some government-aided organisations, but ultimately started manufacturing their own coverall gowns with the materials they had available.
“We have 800 patients and have screened 1400 people. 180 are Intensive Care Unit (ICU) patients. The total coronavirus positive rate at the hospital has been 6%. I am trying to look after 1,500 clinicians here running COVID and non-COVID services, and we have been facing challenges getting N95 respirator masks. So much so that some days back, at 3.45 pm we were reduced to just 18 N95s. There is a lot of fear when there is a shortage of PPE, and that makes it hard for us to continue providing services,” Dr Lewin says.
“Due to the lack of supplies, we have even had masks with spurious material reach us. Many private hospitals with deep pockets have hoarded PPE including N95 masks,” he alleges. “I don’t blame the hospital, but the system is at fault. There is little quality control and problems with distribution are most unfortunate.”
While the government acknowledged and directed against differential pricing and hoarding of N95 masks earlier too, it only capped prices on June 3. In comparison, the cost of two and three-ply surgical masks were capped in March to address price gouging and black marketing. N95 mask prices from four manufacturers have now been capped between Rs 95 to Rs 165 as opposed to Rs 150 to Rs 250 earlier.
Experts TNM spoke to said that there needs to be uniformity in pricing, supply, distribution and quality of PPE for healthcare workers. Some also say that N95 respirators should be reserved for healthcare and frontline workers only, and not be sold over the counter.
A coordinator from a quarantine centre in Mahbubnagar district in Telangana, who also reported that they did not initially receive N95 respirators, says, “We also need to focus on reuse of N95, rational use of N95, the supply chain, and who controls who gets N95 masks etc.”