Medical Device: Standards for ventilators must be defined in India

This is particularly relevant for a medical device such as a mechanical ventilator which has been responsible for saving the lives of millions across the world.

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Last Updated on November 9, 2021 by The Health Master

Standards for ventilators must be defined in India

Quality of care is directly proportional to the quality of the tools and instruments used in dispensing care, in tandem with the skill sets and expertise of the caregiver and the training and experience of the attendants who are using those tools and instruments.

This is particularly relevant for a medical device such as a mechanical ventilator which has been responsible for saving the lives of millions across the world.

The role of ventilators has been amplified several-fold during the ongoing C-19 pandemic when the widespread projections of a shortage of the life-saving medical device in the country, also on account of the curtailed supplies from abroad, were addressed through a rapid and massive scaling up of domestic production.

From traditional ventilator manufacturers to PSUs to automobile companies to research organisations to start-ups and last but not the least, the government, the country as a whole has ‘stood up’ to meet the impending challenge.

In a matter of months, the production of ventilators had shot up considerably. By July itself, the production had been augmented from 300 per month by 8 manufacturers to over 30,000 ventilators per month by 16 manufacturers.

However, this phenomenal increase in quantity also needs to be complemented with improvement in quality of these lifesaving machines. And quality can only be ensured by way of prescription of a comprehensive set of standards for these critical machines.

The regulation of medical devices

In India, medical devices are regulated under the Drugs and Cosmetics Act of 1940 and Medical Device Rules 2017.

Only in February this year, the government tightened the regulatory regime for medical devices by redefining them, expanding the list to include all medical devices and subjecting them to the rules under Drugs and Cosmetics Act of 1940 and Medical Device Rules 2017.

This was a huge development from the earlier regulation of only 37 categories of medical devices.

Ventilators classified as Class C risk

Under the classification of medical devices, these are divided into four classes according to their risk level and ventilators fall under Class C that covers moderate-to high-risk devices (bone fixation plates are also under the same class), one grade lower than the high-risk devices such as heart valves and implantable defibrillators.

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Steps taken so far: Six technical features recommended by the Technical Committee of the DRDO

In the course of the early discussions on identifying standards for the ventilators to be produced domestically, the Technical Committee of the DRDO had laid down certain essential technical features as it had convened periodically in the wake of the C-19 battle.

These features were as follows:

One, the machine should be turbine/compressor based because the installation sites might not have central Oxygen Lines.

Two, the machine should have Invasive, non-invasive and CPAP features to make them versatile.

Three, the machine should be able to provide 200-600 ML tidal volume while having Lung Mechanics Display.

Four, the machine should be able to monitor the Plateau Pressure, oxygen concentration, inverse ratio (I:E) while allowing Positive-end Expiratory Pressure Therapy (PEEP) and Pressure Support (PS).

Five, the machine should be available in pressure, volume and pressure support modes.

And six, the machine should have the working capability for 4 to 5 days continuously without power back-up.

Need to develop standards for the entire spectrum of diseases and not C-19 alone

However, these technical guidelines are merely minimal essential specifications and have been confined to the context of the government’s procurement overdrive to rule out any shortage of ventilators in the country for C-19 patients.

In fact, until C-19 struck, ventilators were not regulated medical devices in the country, neither under the Bureau of Indian Standards (BIS) certification nor under the Central Drugs Standard Control Organisation (CDSCO) regulation.

Significantly, in the third week of June, the Bureau of Indian Standards notified the Indian standard IS 17426: 2020 for ICU ventilators for use in C-19- Specification by publishing in the Gazette of India.

This is not enough for two reasons. First, given the involvement of a wide range of players involved in the manufacturing of a final ventilator product and accessories through the value chain, a comprehensive set of specifications and standards must be thrashed out.

Additionally, mindful of the fact that the ventilators are also used for a whole lot of other lung-related complications, specific standards in relation to a particular lung condition as well as broad standards have to be evolved keeping the long term in view.

And second, now that there has been a large-scale involvement of domestic manufacturers in making ventilators, it makes the case for an indigenous set of standards and specifications.

Earlier, since the bulk of ventilators used in the country were imported, the FDA or CE standards used to be applicable. As of now, according to Medical Device Rules 2020, ventilator manufacturers should adhere to quality management standards of ISO 13485.

Also, they should comply with general requirements for basic safety and essential performance of medical electrical equipment under IEC60601-1-12, and particular requirements for basic safety and essential performance of critical care ventilators under IEC60601-2-12, both global standards.

Related equipment such as catheters have been regulated before

Notably, similar medical devices have been regulated before. Under the Medical Devices Rules 2017, the government had listed out names, risk class and general uses for some catheters – a related device to ventilators – the quality and safety aspects of which are equally important for patients, although classified as B class, a notch below the more risky ventilators.

Some of these catheter devices were as follows.

Tracheal tube: that is used to obtain a closed circuit for ventilation;
Esophageal Obturator: thataids ventilation by blocking esophagus thereby permitting positive pressure ventilation through the trachea;
Tracheobronchia Suction Catheter: that clears the airways of mucus, pus, or aspirated materials to improve oxygenation and ventilation.

It is understandable that the government has allowed the manufacturing of critical lifesaving medical devices without licensing and with minimal specifications in response to the exigent nature of the times.

Only weeks ago, the government announced that it had delivered 36,433 ventilators to government hospitals in the country in less than a yearwith average cost ranging between ₹ 2-10 lakh.

This must be applauded. However, this increase in quantity must be followed up with regulations and standards for quality. Remember, there was uproar on domestic ventilators not being BiPAP-enabled forcing the government to clarify on the same.

A comprehensive blueprint on ventilator standards would obviate the need for such doubts and clarifications while establishing more clarity.

Also, given the criticality and the inherently risky nature of these medical devices, non-negotiable quality must go hand-in-hand with quantity. After all, it’s a question of patients’ safety and lives.

By Ashok Patel
Author is Founder & CEO, Max Ventilator

(DISCLAIMER: The views expressed are solely of the author and The Health Master does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person / organisation directly or indirectly.)

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