BIS specifications for PPE kits

The personal protective equipment kits were mostly imported before the Covid-19 crisis

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Doctor
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The Bureau of Indian Standards (BIS) has released the national specifications for coveralls or bodysuits that healthcare workers need to wear while tending to patients with the coronavirus disease (Covid-19). Material used for the suits must be not only fluid-resistant but virus-resistant, said a BIS document. So far, the manufacturers have been making coveralls that are only fluid-resistant , following the guidelines laid down by the Union health ministry in an 11-page document on March 24.

“The personal protective equipment kits were mostly imported before the Covid-19 crisis. When there was a global shortage of the protective gear, the health ministry, along with the textile ministry, looked at various material that can be used to make the PPE kits with respect to the disease we are dealing with. Once, the material was in place, manufacturers were identified,” Lav Agarwal, joint secretary in the health ministry, said at a media briefing.

With the new specifications in place, manufacturers have begun a search again for materials that can be both fluid- and virus-resistant and yet are “breathable” to ensure that doctors workings during the summer months without air conditioning are comfortable.

“Initially, there was no clarity on what was needed, this is a very new disease and everybody is learning as they go {along}. However, after the health ministry guidelines came out, most manufacturers started using non-woven material and laminated it to make it fluid-resistant. But this lamination means that the material is not breathable,” said Rajiv Nath, founder and forum coordinator of the Association of Indian Medical Device Industry (AiMeD).

“… a lot of fast-paced research is happening and a few companies have found some breathable fabrics that just need to be certified.” said Rajiv Nath, founder and forum coordinator of Association of Indian Medical Device Industry (AiMeD).

Nath added: “Now, to make the coveralls viral -resistant, the seams would have to be taped, or glued, or sealed with heat; however the technology to do so is not available in India. But the machine used for sealing leather with heat or a glue developed by the Defence Research Development Organisations is being tested.”

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The new specifications will also help in standardising quality. “So far, all the different state governments or institutes like AIIMS {All India Institute of Medical Sciences} had different specifications for purchasing the PPE kits as there were no details mentioned in the health ministry guidelines. Now, with these specifications the manufacturers can work towards achieving a fixed standard,” said Nath.

To ensure that the PPE kits are of good quality, the government has now designated at least seven laboratories that can evaluate the kits. These labs check gloves for any leakages and tensile strength. The protective clothing is checked for the seam strength, resistance to fluids, resistance to punctures and tear and resistance to microbes. The masks and head-cover respirators are checked for functioning of inhalation and exhalation valves and field of vision, among other things.

Trustin Analytical Solutions in Chennai has been approved for testing gloves, and SGS India Private Limited, another company based in the same city, has been approved for testing gloves, plastic-based products, protective clothing and respirators. The Rubber Research Institute of India has also been approved for testing rubber-based materials.

This is apart from the four laboratories – the South India Textile Research Association, the Defence Research and Development Establishment, Heavy Vehicles Factory, and the Small Arms factory – that had already been designated by the ministry of textiles to perform such quality checks.

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“Our laboratory is NABL accredited and also recognised by the Central Drugs Standard Control Organisation as a centre for testing medical devices. For the current need in PPE, we have been asked to test medical gloves,” said Mahendran M, owner of Trustin Analytical Solutions. NABL is short National Accreditation Board for Testing and Calibration Laboratories. A certification from these bodies ensures that the PPE kits are safe to use.

“However, the implementation is patchy. The manufacturers are required to get certified from these agencies to sell their product to HLL {Lifecare Ltd}, which is the agency procuring for the central government. However, different state government follow different specifications and they do not necessarily ask for the certification,” said Malini Aisola, co-convenor of the All India Drug Action Network (AIDAN). This is the case in Delhi, which had floated a tender for 120,000 PPE kits through the Central Procurement Agency in March.

“This tender is being given to us as a piecemeal of about 3,000-4,000 kits a day. When we had floated the tender there were very few manufacturers who had come forward, and many did not necessarily have the certification. Even the ones with good products were not able to reach the only certification agency then – SITRA – in Tamil Nadu because of the lockdown. So, we started procuring the products after checking them for fluid-resistance ourselves,” said a senior Delhi government official.

To test, water was poured into the body-suit to check for leaks. For the next batch of procurement, the government will purchase kits from manufacturers that are certified, in case there are enough such manufacturers, according to the official, who requested anonymity.

“It is good that there is a national standard now, we have been procuring the PPE kits locally and there are several that do not match the health ministry standards. If all the kits already come certified from the government then we will not have to worry about the quality,” said a doctor from Lok Nayak Hospital on condition of anonymity.