The challenging scenario of unsafe PPE KITSJune 9, 2021
Personal protective equipment (PPE) used in healthcare settings have gained much importance, public attention and market value worldwide after the outburst of COVID-19. It has now become one among the most critical components of infection control and protection protocols for the virus-caused pandemic, which continues to remain highly contageous and out of control.
However, as COVID-19 was a new pandemic experience even to those in the medical field, health workers, including doctors and nurses, often wondered whether the PPEs and practices are sufficient to prevent the new virus from infecting them. Certainly, there have been reports about rising incidences of health workers getting infected from across the country, despite using PPEs that were supposedly designed specially for COVID-19. Naturally, this led to general concern and demand for PPEs that followed strict compliance to specified quality standards.
Despite great concerns in the research field related to the quality assurance mechanisms for PPEs; they failed to evoke the due alertness from the government. Perhaps, the government and the hospitals did not have much prior knowledge or experience in the selection of quality-assured and suitable PPEs, or any idea about the stocks or supply-chains relating to it. Anyway, such concerns have had an impact in the market. Globally many manufacturers repurposed their facilities to produce more PPEs. However, they were still lacking proper knowledge on the design, the materials to be used, and the quality standards and regulations that are to be followed while manufacturing PPEs.
India lacked enough organised PPE production before February/March 2020. The sudden entry of many unrelated entrepreneurs into the industry made the scenario worse. There was not enough knowledge or understanding about PPEs from the part of the companies that turned to PPE production, who had earlier been focused on other medical devices or even garment making. At the same time, many questions regarding PPEs remained unanswered. These ranged from basic ones like what PPEs are, what types are most suitable for COVID-19, what ensures or increases the safety, how they can be made more comfortable and cost-effective and so on. The most important question that did not return even an echo as an answer was whether they can be used again and again, and if discarded, what will be the impact on the workforce, environment and the people.
It was this situation that triggered some independent as well as sponsored research on the quality standards to be followed for PPEs in healthcare and their utility. Much of the specifications for PPEs against SARS-CoV-2 needed redefining. The type of materials used in manufacturing and the details about the quality standards of the other accompanying wearables were researched. Gradually, the Indian industry and the government began to establish quality standards and innovations in their products to find suitable, cost-effective solutions for the people of India striving to fight off the pandemic. However, there is still a lack of stringent guidelines along with standard operating procedures regarding PPE issued in most of the hospitals or laboratories or recovery centres all over the country. This mainly stems from the lack of proper information or efforts to create awareness.
The Bureau of Indian Standards (BIS) classifies Surgical Gowns in 4 levels from Level 0 to 3 under IS 17334:2019. Body-coveralls come under IS 17423:2020 based IS 16546- Synthetic Blood Penetration Test (Procedure C) which is the same as ISO 16603:2003 Level / Class 3 (3.5 kPa). Both fabric and seams are to be tested. However, BIS demands no mandatory test for viral penetration. The stipulated standard IS 17423:2020 is lower than standards in USA/Europe, and resistance to viral penetration under pressure is not yet mandated. Thus, disposable gowns were often used when the patients are known to be Hepatitis B, C or HIV positive; that too only in tertiary hospitals where operation theatres for specialized surgeries exist. However, even there, reusable gowns made of woven fabrics are still used. These gowns, due to frequent washing and autoclaving, may not offer any protection and may get easily soaked with liquids or body fluids.
Healthcare workers must be made aware of these flaws in quality assurance protocols, say serious players in the industry who emphasize the use of medical grade material for foolproof PPE.
“For instance, many healthcare users do not even know that the normal spunbond fibre that is often found used for body-coveralls, a key component in the PPE kits available in market, is not medical grade and thus will not guarantee any protection from virus infection,” said Kora James, director, Careon Healthcare Solutions, one of the oldest medical disposables manufacturers in India.
Healthcare workers often get exposed to pathogens carried through blood, body-fluids, and other potentially infectious materials through direct/indirect contact of contaminated body-fluids or with non-intact skin, and mucous membranes. Protective clothing or gowns are inevitable for healthcare workers to create a barrier to eliminate or to reduce contact and droplet exposure. In healthcare, different grades or types of gowns are used according to the purpose, and these are to be made with different material, design and protective properties. These specifications are solely dependent on the level of exposure faced by a healthcare worker.
“Mainly there are five components in a PPE kit, which include the coverall suit, which protects the whole body; the goggles to protect the eyes; N95 mask or a 3 ply surgical mask; gloves (preferably the nitrile gloves); and the shoe cover. We mainly make body-coveralls and shoe covers in-house, and the rest we source from outside manufacturers, who comply with all quality certifications. There are different standards specified by BIS for these products, like the breathable or non-breathable laminated spunbond material or a more comfortable 3 layer SMS material for coveralls. There are similar standards for other components as well,” added James.
However, the major challenge in India is that most of the manufacturers, both the new entrants as well as existing players, are either not aware of these quality specifications or want to profiteer by using the cheaper non-standard material in the absence of a mandatory quality compliance mechanism.
Making quality standards mandatory is always the first solution. But in their absence, at least the PPE-manufacturers should be made aware of the quality standards to have their products tested for resistance to blood-borne pathogens/viral penetration. These quality standards should be maintained during manufacturing, packaging, storing and transportation. The companies must also include printed notices to be packed along with each PPE product, so that they will automatically create an awareness among the users as well. These notices can include
details about product specifications, principles of infection control and good practices for infection control. The users, especially healthcare workers dealing with COVID-19 patients or suspected positive cases, should ensure that the PPEs meet such quality specifications and check them for such label instructions. Finally, the users must also stick to the single-use regime and safe disposal of the same after use.
— with inputs from N S Arunkumar