1. Regulation of Work with Ionising Radiations in the Medical Sector in Great Britain
Sharan Packer
Specialist Inspector (Radiation)
Health & Safety Executive

2. Health Services Legislation
Health and Safety Executive
[HSE]
Department of Health
[DoH]
Environment Agency
[EA]
Department for Transport
[DfT]

3. Legislation enforced by HSE
Health and Safety at Work etc Act 1974 [HSWA]
Management of Health and Safety at Work Regulations 1999 [MHSWR99]
Ionising Radiations Regulations 1999 [IRR99]
Radiation Emergencies Preparedness and Public Information Regulations 2001 [REPPIR]
Transport of Dangerous Goods (Safety Adviser) Regulations 1998 [TDGSA98]

4. Legislation enforced by DoH
Ionising Radiations (Medical Exposures) Regulations 2000 [IRMER]
Medicines Act 1968
Medicines (Administration of Radioactive Substances) Regulations1978
Medical Devices Regulations 1994

5. Legislation enforced by EA and DfT
Radioactive Substances Act 1993
Special Waste Regulations 1996
DfT
Radioactive Materials (Road Transport) Regulations 2001

6. HSE contacts with medical sector from January 2000 to date
64 entries on database
41 inspections
18 hospitals
5 dentists
4 chiropractors
2 blood authorities
18 patient exposures much greater than intended
5 over exposures
17 improvement notices served

7. IRR99: Restriction of exposure to ionising radiations: employees
Risk assessment
Maintenance & examination of engineering controls
Monitoring of designated areas
Information, training, instruction
Supervision, Local rules
Dose restriction
Over exposures

8. IRR99: Restriction of exposure to ionising radiations: employees
Risk Assessments
Majority not suitable or sufficient
Many not carried out at all
Few include radiation accidents
5 improvement notices under IRR99 and MHSWR99

9. IRR99: Restriction of exposure to ionising radiations: employees
Maintenance and examination of engineering controls
Insufficient frequency of testing
Very few written maintenance and testing schedules
Inadequate records kept
1 improvement notice

10. IRR99: Restriction of exposure to ionising radiations: employees
Monitoring of designated areas
Generally inadequate
Radiation levels checked for new installations, little follow up monitoring
Contamination levels – very variable, not always recorded
Lack of monitoring has been a contributory factor in employees receiving skin/internal doses

11. IRR99: Restriction of exposure to ionising radiations: employees
Information, instruction and training
Variable
Well trained – radiographers, radiologists, physicists
Variable – nurses, laboratory staff, supervisors
Poorly trained – consultants, porters, support staff
3 improvement notices

12. IRR99: Restriction of exposure to ionising radiations: employees
Supervision and local rules
Work not adequately supervised
Too few supervisors for the number of people working in a department
Supervisors not trained
Local rules not revised following introduction of IRR99
2 improvement notices

13. IRR99: Restriction of exposure to ionising radiations: employees
Dose restriction
Not keeping exposures as low as reasonably practicable because of
Poor risk assessments
Inadequate training, information and instruction
Poor supervision
Insufficient maintenance and testing of equipment
2 improvement notices

14. IRR99: Over exposures reported to HSE
Interventional X-ray nurse failed to wear lead apron [70 mSv whole body (wb)]
Dental nurse mSv wb
Interventional radiologist mSv extremity dose
Student 25 mSv wb
Member of public [patient] 7.5 mSv wb

15. IRR99: Restriction of exposure to ionising radiations: patients
Equipment used for medical exposures
Designed, constructed, installed, maintained etc to restrict patient exposures so far as reasonably practicable (while still achieving the clinical objective)
X-ray equipment (tables, cassettes, films etc)
Nuclear Medicine equipment (gamma cameras, dose calibrators, etc)
Radiotherapy equipment (including planning computers & simulators)

16. IRR99: Restriction of exposure to ionising radiations: patients
Provision of quality assurance programme
To include testing at
installation
periodic tests
tests following maintenance & repair
Patient dose assessment programmes
Special attention when equipment used for:
Children, screening programme, or involves high patient doses e.g. CT, radiotherapy

17. IRR99: Restriction of exposure to ionising radiations: patients
Investigation & notification of exposures much greater than intended (MGTI)
MGTI depends on type of exposure, eg x20 (extremity X-rays), x3 (fluoroscopy)
Investigation & report
Notify HSE under IRR99

18. IRR99: Restriction of exposure to ionising radiations: patients
Inspection findings
Variable standards of compliance with requirement for QA programmes
Lack of resources to implement programmes
Poor record keeping

19. IRR99: Patient exposures much greater than intended reported to HSE
Diagnostic x-ray – 16
Failure to terminate exposure
Cardiac brachytherapy – 1
Failure of source train to retract
Not specified – 1
4 improvement notices relating to QA programmes

20. Use of ionising radiation in the medical sector: future HSE action
Audit of 30 hospital trusts for compliance with IRR99 by April 2003
Publication of revised guidance on equipment used for medical exposures
Continued liaison with DoH, EA, DfT
Continued liaison with professional organisations

21. HSE ionising radiation website