1. Non Recognition Biomedical Engineers in public health facilities of India
Er. Ajai Basil Consultant, Healthcare Technologies (Medical devices)
Er.Ajai Basil-Radiation Safety in India
29/04/2019

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
29/04/2019

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 /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
29/04/2019

4. Role of Biomedical Engineers in Assessment of Medical devices
Innovation selection –MoHFW
Health Technology Assessment Department of Health Research – MTAB Only 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
29/04/2019

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
29/04/2019

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 Masters Degree (ME/MTech)- Approx.400 In 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
29/04/2019

7. International standard classification of Occupation ISCO 08 Vol 1
International standard classification of Occupation ISCO 08 Vol 1. Engineering professional Also 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
29/04/2019

8. Disclosure: No funding or grant received or any conflict of interest exist.
Er.Ajai Basil-Radiation Safety in India
29/04/2019