The health-care landscape in India is getting transformed at a blistering pace. Minimally invasive surgeries, improved patient outcomes, advanced techniques and smarter machinery are among a wave of innovations being led by the ever-evolving medical device industry. Aiding all this are industry experts who are bringing them to us. A significant contribution is being made by biomedical engineers, who are at the core of all patient safety measures.
India, which was the host of the Fourth edition of the ‘WHO (World Health Organisation) Global Forum on Medical Devices’ at Visakhapatnam, December 13-15, is also witnessing a tirade against the quality of health-care equipment, with a special focus on the lack of adverse-event reporting.
It is the time to understand the importance of biomedical engineers, who play a significant role in bringing transparency to medical device adverse-event reporting and yet are under-represented and underrated.
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The Global Health Observatory data repository notes that the density of biomedical engineers and technicians in India per thousand of population decreased from 0.32 (2014) to 0.31 (2015) to 0.23 ( 2017). This is an alarming trend, especially when WHO estimates that less than half of all medical equipment in developing countries is usable. The numbers highlight the need for more such engineers, who affirm the safety of a medical device by ensuring that they are safe, have quality and effective for the intended purpose.
Why India needs more
It is important to understand the profile of a biomedical engineer in the medical industry. A rare combination of medicine and engineering, biomedical engineers collaborate with doctors and researchers to develop innovative technological solutions, evolve health systems, and ensure the correct deployment of medical equipment or devices. Using engineering principles, they create solutions for health care and are involved in the development and design of a medical product and its safety.
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In case of an adverse event, it is important to determine whether the root cause is surgical procedure-led, medical device-led or infrastructure-led. As a patient ultimately gets a surgical procedure and not a medical device alone, a biomedical engineer can effectively help distinguish the nature of the issue that led to an adverse event. For example, if a biomedical engineer works on the development of a device that enables a person with a disability to walk again, he helps the hospital to ensure that the device is working perfectly, and the patient eventually benefits from it. Biomedical engineering professionals are also key to developing and advancing the use of devices and clinical services.
Biomedical engineers can help integrate vertical domain knowledge of various sectors in a comprehensive manner, according to the needs of the population. The role of biomedical engineers ranges from national policy, regulations, technical standards and specifications, research and development, design, prototyping, clinical research, assessments, contracting, supply chain, deployment, integration with IT and business systems, monitoring, re-engineering, maintenance, adverse event management, inventory management and more. It goes without saying that their role is imperative in any modern health-care innovator, manufacturer, planner, care provider or government agency.
The future
The Government of India, through its programme called the Biomedical Equipment Management and Maintenance Programme, aims to improve the functionality of medical equipment in public health facilities. However, the dearth of biomedical engineers is still a major challenge, which is what the WHO global forum attempted to address.
The forum also demonstrated India’s commitment towards improved access to safe, effective, innovative, quality medical devices and diagnostics — a contribution to Universal Health Coverage and Sustainable Health Goals. The event also talked about the need for medical equipment maintenance strategies, methodology for the design of health technologies and regulations of medical devices.
As we walk into the future of medical innovations, and bring them to India, we must also invest in our medical professionals like biomedical engineers, who are at the core of all patient safety.
Mohammad Ameel is Senior Consultant, Healthcare Technologies (Medical Devices), Ministry of Health and Family Welfare