1. Addressing decade long non-compliance of radiation safety in public health facilities of India
Er. Ajai Basil Consultant, Healthcare Technologies ( Collaborator, International Federation of Medical and Biological Engineering
WHO Collaborating Centre for Priority Medical Devices & health Technology Policy
National Health Systems Resource Centre
Ministry of Health & Family Welfare, Government of India
Er.Ajai Basil-Radiation Safety in India
20/05/2019

2. Medical use of x-rays for diagnosis and treatment has proven to be immensely beneficial to the society at large.
Unsafe use of x-ray radiation has health risks -proper care is exercised throughout the life cycle of the equipment i.e. from manufacture, supply, installation, use, maintenance, servicing and ultimately decommissioning
Er.Ajai Basil-Radiation Safety in India
20/05/2019

3. AERB-IAEA
Atomic Energy Act, 1962, Environmental (Protection) Act, Atomic Energy (Radiation Protection) Rules 2004.
Statutory requirement
eLORA – eLicensing of Radiation Application
Medical Diagnosis Facility having X-ray equipment Radiography, Fluoroscopy, CT, CathLab, C-arm, O-arm, Mammography, Dental, BMD etc.
Er.Ajai Basil-Radiation Safety in India
20/05/2019

4. Qualified/trained staff is available to carry out the procedure. PPE.
AERB Key Check Points
Equipment meets the quality requirements to acquire acceptable diagnostic image with optimum radiation dose to the patient. Periodic QA.
Qualified/trained staff is available to carry out the procedure. PPE.
Adequate shielding is provided to the X-ray room for radiation safety of People in the vicinity.
Adequate Warning
Er.Ajai Basil-Radiation Safety in India
20/05/2019

5. Survey Indicates Year: 2016
Biomedical equipment Inventory details in public health facility vs data of AERB.
5 States:
Tripura: 3.6 Million Population Facility (CHC,SDH,DH): 89
Non Compliance :100%
Er.Ajai Basil-Radiation Safety in India
20/05/2019

6. Survey Indicates
Nagaland: 2.2 Million Population Facility (CHC,SDH,DH): 20
Non Compliance :100%
Mizoram: 1.1 Million Population Facility (CHC,SDH,DH): 31
Non Compliance :81%
Er.Ajai Basil-Radiation Safety in India
20/05/2019

7. Survey Indicates
Pondicherry: 0.7 Million Population Facility (CHC,SDH,DH,GH,MH): 41
Non Compliance :93%
Maharashtra: 110 Million Population Facility (CHC,SDH,DH,GH,MH): 657
Non Compliance :99%
Er.Ajai Basil-Radiation Safety in India
20/05/2019

8. Regulatory Issues Medical devices are regulated in India as drugs.
Central Drugs Standard Control Organization- under Health Ministry-Regulates Notified medical devices.
Not aligned with global medical devices regulations.
Medical devices that are radiation based as not regulated by CDSCO.
Lack of knowledge among health professionals.
Er.Ajai Basil-Radiation Safety in India
20/05/2019

9. Resolution National Health Mission- Funding
National Health Systems Resource Center –Tech
Guideline and RFP
Estimated cost for compliance – Approx US $. Tendered in two approx US$.
Er.Ajai Basil-Radiation Safety in India
20/05/2019

10. Link for free download: http://nhsrcindia
Er.Ajai Basil-Radiation Safety in India
20/05/2019

11. Disclosure: No funding or grant received or any conflict of interest exist.
Er.Ajai Basil-Radiation Safety in India
20/05/2019