Quality of medical equipment, whether simple or sophisticated, has a direct impact on the quality of care. This especially applies to cases where a patient uses the medical device by themselves, such as a hearing aid, or they are placed on a ventilator under expert supervision, or have a some device installed internally such as a stent 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 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.
Quality is a function of intent and thought First of all, quality begins in the mind. For a manufacturer to produce quality product, their natural thought process should steer towards wanting to make quality medical devices. For this, they must envisage a long shelf life for the product, prompting the use of quality inputs and components.
Best for patient’s health outcome
Second, from a patient’s perspective, the best available device at a given point in time would be ideal for their health outcome. While the expert doctor’s proficiency and ability is important enough, the quality and features of the tool that they use is equally critical.
Quality innately linked with patient safety
Third, quality has an innate linkage to patient safety. If the quality of a medical device is not above par, there is a risk of endangering or even aggravating a patient’s health condition, or, in extreme cases, endangering the patient’s life. 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 ago, the coronary stents of a top medical equipment maker were found to be responsible for more that 50 per cent of adverse events. In another instance, a leading healthcare and medical device manufacturer had to be hauled up before courts for supplying faulty hip transplants to patients, resulting in compensation being paid to the aggrieved patients. Recently, it has been reported that nearly 100 heart patients, who had got heart stent implants at a Delhi-government-run super specialty hospital died in the last two years allegedly due to poor quality of the stents. During the COVID fight back, there were reports of how poor quality ventilators were being churned out in the rush for ramping up the quantity of these lifesaving devices.
Quality critical to India’s commercial interests
Fourth, from a commercial pointof-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(self-reliant). Given the exceptionally demanding and rigorous quality benchmarks and standards set by Western regulatory authorities, only a high-quality products would pass muster with them and compete in international markets. Moreover, with Chinese products being widely reported to be of substandard quality, and failing to live up to industry and consumer expectations, upgrading quality of Indian medical device products can also help Indian manufacturers take China’s place in the global market.
Quality of a product equivalent to the quality of components
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 necessitate sourcing quality inputs and materials. This could lead to setting up the base for a value chain of quality medical devices within the country. It would also entail incorporation of good manufacturing practices and putting in place credible and time-tested quality management systems backed by a quality manual, proper documentation and recording etc.
Quality rules out unnecessary and recurrent expenditure
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 adds to the patient and their family’s monetary burden by way of repair or replacement costs. Similarly, in government-run, or government-backed health facilities, 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 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, aking manufacturers and importers more accountable through registration, 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 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. This demonstrates that we are on right track.