As per the World Health Organisation's (WHO) sustainable developmental goals (SDG 3), by 2030, countries should substantially increase health care spending to recruit, train, and retain skilled health care professionals (HCPs) to substantially reduce the epidemic of non-communicable diseases (NCDs).
From the accessibility of thousands of innovative medical devices to increasing skill sets of HCPs, patient safety is now recognised as an indispensable arm of a healthcare setting. At a time when innovations are promising solutions to hitherto unmet medical needs, the call is now, more than ever to have professionals who can drive this change.
This is where biomedical engineers (BMEs) become an indispensable part of the health sector. Let’s understand why. Working alongside the HCPs are BMEs, responsible for the overall inspection, management, and regulation of existing and future medical devices. Often, unsung heroes, a BME is the brain behind managing crisis during an entire treatment procedure.
While a doctor diagnoses and treats a patient, a BME ensures the medical devices function as per the requirement and is usually the first respondent to any emergency caused by technical malware. From the concept to market reach and clinical trials, BMEs are part of the health care ecosystem contributing to meeting the SDGs, especially universal health coverage.
As India witnesses a surge in the influx of innovative medical devices (<75 percent overall imports), there arises a greater need to recruit more skilled BMEs to evaluate the quality, efficacy, and safety of emerging technologies which will ultimately trickle down to benefit patients. Contrastingly, for every 10,000 patients, there are 0.31 BMEs.
The Union Budget 2019-20 focused on upgrading district hospitals, state government medical colleges and setting up state institutions of paramedical sciences. However, it did not include anything specific for the BME. Yet the good news is that the Ministry of Health and Family Welfare in Patient Safety Implementation Framework 2018-25 standards notified to ensure BMEs are available at health care facilities.
By 2020, every empaneled hospital is also directed to have a Hospital Infection Control Committee with BME as a member. Similarly, Indian Public Health Standards (IPHS) is revised with a provision for deploying at least one BME in each of the district hospitals. To achieve this, Central Drugs Standard Control Organisation (CDSCO) has announced to recruit BMEs in various fields—754 regulatory officers, additional 1,195 new posts including 64 experts, and 4,300 personnel for new laboratories, mobile drug testing labs, e-governance, and training. While the move is laudable, there is still a lot more that needs to be done.
Firstly, while recruiting BMEs, the medical industry has to shift focus from pharmacists and science graduates to specialists in biomedical engineering i.e., BMEs. Since a BME possesses a deep understanding of human physiology as well as a medical device, it is imperative that the right professional serves the required purpose.
Secondly, one of the major gaps acting as a barrier in the delivery of quality care in the country today is that medical devices are considered the same as drugs in the policies. This confusion often weakens their significance as health care providers. If we are to achieve the SDGs by 2030, we must value the crucial role of BMEs in the capacity building of an overall health care ecosystem.
An all-encompassing role of BME
While a BME possesses the skills to be a decisive authority in the design and evaluation of medical devices, their role goes beyond the expected responsibilities. For instance, they can serve immensely in the regulatory aspect of emerging medical devices. How? They evaluate information based on scientific parameters for the purpose of obtaining marketing authorisation provided by the industry to regulatory authorities.
Another area, where BMEs can offer their expertise, is health technology assessment (HTA) i.e., decision-making authority in health care responsible for allocating limited funds to health interventions and technologies. The HTA agencies can consider including a BME professional in their multidisciplinary teams for better policy decision-making, especially involving medical technologies. As more expertise finds a space in a healthcare setting, the innovation of medical technologies will be strengthened and the contribution of HTA to sustainable health systems will be enhanced.
Furthermore, a biomedical engineer can also aid in managing multiple subsets of health care. From supporting and promoting patient safety by applying engineering, economic, communication and managerial skills to health technologies, a BME professional becomes an imminent part of the entire health care setup. As patient safety becomes increasingly dependent on more sophisticated technologies, biomedical engineers act as a bridge between modern medicine and equally modern engineering.
From analysing and recording the event to offering a diagnostic solution, a BME operates within a health-care facility. Possessing a vast pool of information on core issues such as wrong maintenance, design deficiencies, human-machine interaction deficiencies, inappropriate use, they can rectify the clinical errors. Because of their expertise in systems analysis, communication systems coupled with the integration of IT, market research, and organisational processes, a BME plays a vital role in ensuring the safe and effective integration as well as interoperability of medical devices.
(The writer is president, Biomedical Engineering Society of India and advisor-health care technology, NHSRC)
Updated Date: Jul 16, 2019 17:35:58 IST