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Non Recognition Biomedical Engineers in public health facilities of India

Trained biomedical engineers are vital for designing, regulating, and managing medical devices in healthcare systems. Despite their importance, recognition and engagement in public health facilities in India remain suboptimal. This article explores the role of biomedical engineers in radiation safety, assessment, and regulation of medical devices in India, highlighting the need for their active participation in health technology assessment and policy development.

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Non Recognition Biomedical Engineers in public health facilities of India

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  1. Non Recognition Biomedical Engineers in public health facilities of India Er. Ajai BasilConsultant, Healthcare Technologies (Medical devices)E-mail: ajaibasil@gmail.com Er.Ajai Basil-Radiation Safety in India

  2. Trained and qualified biomedical engineering professionals are required to design, evaluate, regulate, maintain and manage medical devices, and train on their safe use in health systems around the world. • ‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease, …………………..investigation, replacement, modification, or support of the anatomy or of a physiological process, ………………………. and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. Er.Ajai Basil-Radiation Safety in India

  3. Role of Biomedical Engineers in Management of Medical devices • Health Technology Assessment – Limited • Procurement- 16/36 Medical devices service corporation • Health Risk management- No • Health Technology management- Desirable as per IPHS for every districts Approx.100-150/722 Medical colleges- Not required as per MCI minimum staff requirement. • User Training- In districts with BME. • Ethics committee -No Er.Ajai Basil-Radiation Safety in India

  4. Role of Biomedical Engineers in Assessment of Medical devices • Innovation selection –MoHFW • Health Technology AssessmentDepartment of Health Research – MTABOnly few partner institute house biomedical experts. --/No. of centers for HTA. • Need for Biomedical engineers (working in Medical college) to engage in active participation on HTA. Er.Ajai Basil-Radiation Safety in India

  5. Role of Biomedical Engineers in Regulation of Medical devices • Medical devices standard Preparation-BIS-NIL • Quality management systems and manufacturing operation- limited in public facility • Clinical Research / R&D- limited • Pre market approval- CDSCO-Limited • Post Market analysis - Limited • Lack of Medical device Policy at National and State level mandating Academic research, R&D, Manufacturing, Import substitutions etc… Er.Ajai Basil-Radiation Safety in India

  6. Availability of Biomedical Engineers in India • All India Council of Technical Education, MHRD, GoI.- Grant University/college for initiating Engineering programs. • 2017, Number of Engineering Univ/college: 90 • Per year Biomedical engineering- Bachelors Degree(BE/B.Tech)- Approx. 3800 Masters Degree (ME/MTech)- Approx.400In last 10 year~ 30,000-50,000 BME for 1.3 Billion. • Out of BME, mostly in Sales & Service, remaining in Public/Private health facilities. Er.Ajai Basil-Radiation Safety in India

  7. International standard classification of Occupation ISCO 08 Vol 1.Engineering professional -2149Also considered as integral part of health workforce sub major group 22.And Biomedical researcher as unit group 2131(Non clincal) Er.Ajai Basil-Radiation Safety in India

  8. Disclosure: No funding or grant received or any conflict of interest exist. Er.Ajai Basil-Radiation Safety in India

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