The Need to Develop Ventilation Standards in India, Health News, ET HealthWorld



By Ashok Patel

The quality of care is directly proportional to the quality of the tools and instruments used to deliver the care in tandem with the skills and expertise of the caregiver and the training and experience of the attendants – who use these tools and instruments. This is particularly relevant for a device such as a mechanical ventilator which has saved the lives of millions of people around the world. The role of ventilators has been magnified several times during the ongoing Covid-19 pandemic when widespread projections of a shortage of the lifesaving device in the country, also due to reduced supplies from abroad. , were resolved by swift action and massive increase in domestic production. From traditional fan makers and power supplies, to automakers, research organizations and start-ups and last but not least, the government – the country as a whole has “risen” to the challenge. the impending challenge. Within a few months, the production of ventilators had increased considerably. By July, production had grown from 300 per month by 8 manufacturers to over 30,000 fans per month by 16 manufacturers.

However, this phenomenal increase in quantity must also be complemented by an improvement in the quality of these rescue machines. And quality can only be guaranteed by prescribing a full set of standards for these critical machines.

Regulation of medical devices
In India, medical devices are regulated by the Drugs and Cosmetics Act of 1940 and the Medical Device Rules 2017. It was not until February of this year that the government tightened the regulatory regime for medical devices by redefining them, expanding the list to include all medical devices and making it subject to the Drugs and Cosmetics Act 1940 and Medical Device Rules 2017. This was a huge development from the previous regulation of only 37 categories of medical devices.

Fans classified in risk class C
In the classification of medical devices in Annex M-III of the Drugs and Cosmetics Rules 1940, medical devices are divided into four classes according to their level of risk and ventilators fall under class C which covers moderate to high risk devices. (bone fixation plates are also in the same class), a lower grade than high-risk devices such as heart valves and implantable defibrillators.

Actions Taken So Far: Six Technical Specifications Recommended by the DRDO Technical Committee
During the first discussions on identifying standards for ventilators to be produced in the country, the DRDO technical committee had defined some essential technical characteristics as it had met periodically following the battle of Covid-19. These characteristics were as follows: First, the machine should be turbine / compressor based as the installation sites might not have central oxygen lines. Second, the machine must have invasive, non-invasive, and CPAP features to make them versatile. Third, the machine should be able to deliver a tidal volume of 200-600 ML while having a display of lung mechanics. Fourth, the machine must be able to monitor platen pressure, oxygen concentration, inverse ratio (I: E) while enabling positive expiratory pressure therapy (PEP) and pressure support (PS). Fifth, the machine must be available in pressure, volume and pressure assist modes. And six, the machine should have the working capacity for 4-5 days continuously without backup power.

Need to develop standards for the whole spectrum of diseases and not just for Covid
However, these technical guidelines are only minimum essential specifications and have been confined to the context of the government’s overdriving of government purchases to rule out any shortage of ventilators in the country for Covid patients. In fact, until Covid-19 hit, ventilators were not regulated medical devices in the country, neither under Bureau of Indian Standards (BIS) certification nor under Central regulation. Drugs Standard Control Organization (CDSCO). Significantly, during the third week of June, the Bureau of Indian Standards notified Indian standard IS 17426: 2020 for intensive care ventilators to be used in the Covid-19 specification by posting in the India Gazette. . This is not sufficient for two reasons. First, given the involvement of a wide range of actors involved in the manufacture of an end fan and accessory product throughout the value chain, a comprehensive set of specifications and standards must be developed. . Additionally, considering that ventilators are also used for many other pulmonary complications, specific standards for a particular lung condition as well as general standards should be developed with the long term in mind. And second, now that there has been a large-scale involvement of domestic manufacturers in manufacturing fans, it argues for a local set of standards and specifications. Previously, as most of the ventilators used in the country were imported, FDA or CE standards were applicable. From now on, according to Medical Device Rules 2020, ventilator manufacturers must adhere to ISO 13485 quality management standards. In addition, they must comply with general requirements for basic safety and essential performance of medical electrical equipment. under IEC60601-1-12, and in particular basic safety and essential performance requirements for intensive care ventilators in accordance with IEC60601-2-12, the two global standards.

Related equipment such as catheters have been regulated previously
In particular, similar medical devices have already been regulated. Under the Medical Devices Rules 2017, the government had listed the names, risk class and general uses of certain catheters – a device related to ventilators – whose quality and safety aspects are equally important to patients, although than classified in Class B, a notch below the riskiest fans. Some of these catheter devices were as follows. Tracheal tube: which is used to obtain a closed circuit for ventilation; Esophageal Obturator: which facilitates ventilation by blocking the esophagus, thus allowing positive pressure ventilation through the trachea; Tracheobronchia suction catheter: which clears the airways of mucus, pus, or aspirated material to improve oxygenation and ventilation.

It is understandable that the government allowed the manufacture of essential lifesaving devices without a license and with minimum specifications in response to the demanding nature of the times. Just a few weeks ago, the government announced that it had delivered 36,433 ventilators to public hospitals across the country in less than a year with an average cost of between 2 and 10 lakh. This must be applauded. However, this increase in quantity must be followed by regulation and quality standards. Keep in mind that there has been an outcry over home fans not being BiPAP compatible, forcing the government to clarify the same. A detailed fan standards plan would eliminate the need for such doubts and clarifications while establishing more clarity. In addition, given the criticality and intrinsically risky nature of these devices, non-negotiable quality must go hand in hand with quantity. After all, it is a matter of patient safety and life.

By Ashok Patel, Founder and CEO, Max Ventilator

(DISCLAIMER: Opinions expressed are those of the author and do not necessarily subscribe to it. will not be responsible for damages caused to any person / organization directly or indirectly.)


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