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Addressing decade long non-compliance of radiation safety in public health facilities of India

This article discusses the non-compliance of radiation safety in public health facilities in India and proposes resolutions to address the issue. It highlights the risks of unsafe radiation use and the regulatory challenges faced in the country.

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Addressing decade long non-compliance of radiation safety in public health facilities of India

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  1. Addressing decade long non-compliance of radiation safety in public health facilities of India Er. Ajai BasilConsultant, Healthcare Technologies (E-mail: ajaibasil@gmail.com)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

  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

  3. AERB-IAEA • Atomic Energy Act, 1962,Environmental (Protection) Act, 1986-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

  4. 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

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

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

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

  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

  9. Resolution • National Health Mission- Funding • National Health Systems Resource Center –Tech Guideline and RFP • Estimated cost for compliance – Approx. 3000-4000 US$. Tendered in two states @ approx. 2000 US$. Er.Ajai Basil-Radiation Safety in India

  10. Link for free download:http://nhsrcindia.org/sites/default/files/practice_file/AERB%20Compliance%20-%20Web%20Optimized%20PDF%20Version%20-%2017%2010%2017.pdf Er.Ajai Basil-Radiation Safety in India

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

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