June 7, 2022
Quality of medical equipment, whether simple or sophisticated, has a direct connection with quality of care. This especially applies to cases where a patient necessarily requires that he either uses some medical device on his own such as a hearing aid, or be placed on some machine such as a ventilator or a dialysis machine under expert supervision, or has some device installed internally such as a stent or a dental implant again in a procedure conducted by an expert.
This could also apply to equipment used in diagnostics and monitoring including in vitro diagnostics, or consumables such as a syringe or a needle that is used on him by a doctor. For best results, there is no doubt that the quality of the device would remain indispensable to over-all outcome. In fact, given the very nature of a medical device and its immense value to a patient, in somewhat metaphorical terms, quality and medical device must be inseparable from each other. Why is quality so important?
First of all, quality begins in the mind. For a manufacturer to produce quality product, his natural thought process should steer him into the direction of wanting to make quality medical devices. And so he must be able to envisage a long shelf life for his product prompting him to use quality inputs and components for the making of his product.
Second, from a patient’s point of view, the best available device at a given point in time would be the best bet for his health outcome. While the expert doctor’s proficiency and ability is important enough, the quality and the features of the ‘tool’ that he gets to use is equally crucial.
Third, quality has an innate linkage with patient safety. If the quality of a medical device is not above par, there is also a risk of endangering or even aggravating a patient’s health condition or in extreme cases, the patient can lose his life due to lack of sufficient safety features. There have been several instances reported in the media on how faulty devices have played havoc with the health and lives of Indians. Some years back, it was reported how the coronary stents of a top medical equipment maker were responsible for more that 50% of adverse event reports. In another instance, another leading healthcare and medical device manufacturer had to be hauled up before courts for supplying faulty hip transplants to patients and for which it had to pay compensation to the aggrieved patients. Some days back, it has been reported that nearly 100 heart patients who had got heart stent implants at a Delhi-government-run super specialty hospital had died in the last two years allegedly due to poor quality of heart stents. Then during the Covid fightback, there were reports of how poor quality ventilators were being churned out in the rush for ramping up the quantity of these lifesaving devices.
Fourth, from commercial point of view, turning out quality medical devices is also critical to India’s global business interests as well as to meet India’s cherished goal of becoming Atmanirbhar. Given the exceptionally demanding and rigorous quality benchmarks and standards set and expected by the Western regulatory authorities, only a quality Indian product would pass muster with them and be eligible and competitive for international markets. Especially in light of Chinese products being widely reputed to be of substandard quality and that often fail to live up to industry and consumers’ expectations, upgrading quality of Indian medical device products can also help Indian manufacturers take China’s place in the global market.
Fifth, quality of a finished and end-use medical device would be as good as the quality of its components. The pursuit of manufacturing quality product would by default necessitate sourcing and employing quality inputs and materials. This could lead to the setting up the base for a value chain of quality medical devices within the country. This would also entail incorporation of good manufacturing practices and putting in place credible and time-tested quality management systems accompanied with a quality manual, proper documentation and recording etc.
Sixth, making use of quality equipment also obviates the need for unnecessary and extra expenditure for patients. If a certain medical equipment is prone to malfunctioning or breaking down, besides posing risks to a patient’s health, it also adds to the patient and his family’s expenditure burden by way of repair or replacement costs. In government’s health facilities or those backed by the government, poor and malfunctioning equipment and machines would escalate the cost burden of the government.
Therefore, producing quality medical devices must become the overriding goal of the policymakers and manufacturers. While quantity production remains important for a huge country with an imposing health burden, quality cannot be glossed over. And the authorities have already taken several measures in that respect in recent years. From laying out a four-fold risk-based classification system to setting a separate regulatory framework for medical devices to making manufacturers and importers more accountable through registration to mandating the acquisition of ISO 13485 certification to reexamining and implementing Schedule MIII vis-à-vis quality management system for medical devices ((a draft guidance on good manufacturing practices and facility requirements), there has been clear intent on the part of the government to indeed make quality a priority.
Last year in June, the Quality Council of India (QCI) and the Association of Indian Manufacturers of Medical Devices (AiMeD) launched the Indian Certification of Medical Devices (ICMED) 13485 Plus scheme to undertake verification of the quality, safety and efficacy of medical devices.3 This demonstrates that we are on right track.
(The author is Ashok Patel, CEO, and Founder, Max Ventilator. Views expressed are personal and do not reflect the official position or policy of iCreate.)
