UK Regulation and Nuclear Cardiology

1. UK Regulation and Nuclear Cardiology Dr. Craig Moore Medical Physicist & Radiation Protection Adviser Radiation Physics Service CHH Oncology

2. Do we need radiation protection in nuclear medicine? Why?

3. What can radiation do? Death Cancer Skin Burns Cataract Infertility Genetic effects

4. What’s the Point in Legislating? • Ionising radiation such as X-rays can cause the following effects: • Tissue effects such as skin burns and loss of hair • Stochastic effects (per 1 mSv) • 1 in 20,000 risk of fatal cancer • 1 in 100,000 risk of non fatal cancer • 1 in 77,000 risk of hereditary effects • Roughly, patient would receive approx 1 mSv radiation dose from a permanent pacemaker repositioning at this Trust • From abdo x-ray • Thyroid imaging with Tc99m • Staff receive radiation doses from X-rays that scatter from the patient and radiation emanating from patient • Ionising radiation is invisible so you can’t see or smell it, hence it can cause damage without you knowing about it (at first!!!)

5. What can radiationdo? Deterministic effects death, skin burns, cataract, infertility Stochastic effects cancer, genetic effects

6. Deterministic effects cataract infertility erythema epilation Cancer Genetic Prob  dose 500 mSv cataract 150 mSv for sterility (temporary-males) 2500 mSv for ovarian EFFECT Stochastic effects DOSE

7. OBJECTIVES OF RADIATION PROTECTION • PREVENTION of deterministic effect • LIMITING the probability of stochastic effect

8. The need for protection applies to all dose levels • It is generally assumed that even very small doses of ionizing radiation can potentially be harmful (linear no threshold hypothesis) • Therefore, persons must be protected from ionizing radiation at all dose levels

9. Who should be protected in nuclear medicine? • Patient • Members of his/her family • Worker • General public

10. How should the people be protected? • Optimize protection • Justify the exposure • Dose limitations

11. This is the system of radiological protection as defined by the ICRP (International Commission on Radiological Protection)

12. What is the ICRP? A non-governmental professional organization established in 1928 by the International Congress of Radiology

13. ICRP The International Commission of Radiological Protection (ICRP) makes recommendations relating to radiation protection

14. Recommendations of the ICRP • Prepared typically by a task group which includes other experts • Approved by the full commission • Published in the journal “Annals of the ICRP” • Have no legal status themselves - however, are typically the foundation onto which national legislation is built

15. The Ionising Radiations Regulations 1999 (IRR99) • Protection of • Staff • Public from ionising radiation

16. Authorisation • Enforced by the Health and Safety Executive

17. Structure of IRR99 • 7 ‘Parts’ • 41 Regulations • 9 Schedules • Approved Code of Practice - Statutory Guidance (HSE approved) • Non-statutory guidance (i.e. guidance notes)

18. So what’s included in IRR99 • General Principles and Procedures • Risk assessment • Dose restriction • Dose limitation • Arrangements for the Management of Radiation Protection • Radiation Protection Adviser • Radiation Protection Supervisor • Local Rules • Designated Areas • Controlled Areas • Classification and Monitoring of Persons • Dose badges • Control of Radioactive Substances • Duties of Employees • All of us have duties under these regulations

19. Structure of IRR99 • Legislation • Approved code of Practice & HSE Guidance (approx 170 pages) • Medical & Dental Guidance Notes (approx 230 pages)

20. Reg 7: Prior Risk Assessment • Must be undertaken before work commences with ionising radiations • Identify hazards • Decide who might be harmed and how • Evaluate risks and decide whether existing precautions are adequate or not • Record findings of risk assessment • Review and revise it • By Law has to be done (or approved) by a certified Radiation Protection Adviser

22. Reg 8: Restriction of Exposure • Doses must be optimised • As Low As Reasonably Practicable (ALARP) • Hierarchy of protection measures: • Containment and local shielding • Ease of cleaning of floors, work tops etc • Sufficient space • Systems of work such as local rules • PPE such as lead aprons • Dose constraints (planning) • 1 mSv to foetus during declared term • Formal Investigation levels of staff dose

23. Regs 9: Personal Protective Equipment • Should be provided where necessary • Should comply with PPE regulations • Should be properly maintained

24. Reg 10: Engineering Controls • All safety features of an installation must be maintained and tested at suitable intervals • Contamination monitoring can be used to check the continuing suitability of easy clean surfaces/floors • Visual inspections of lead windows etc • QA manual should spell out who does what (user, engineer, physics etc)

25. Reg 11: Staff and public dose limits

26. BUT FIRST…..

27. RADIATION TISSUE Radiation Dose • Absorbed Dose (Jkg-1) • Amount of energy deposited per kilogram • Dose to an organ or tissue • Unit is the Gray (Gy) • DOSE TO A CERTAIN PLACE IN THE BODY • Effective Dose (Jkg-1) • This is the average dose to whole body • Unit is the Sievert (Sv) • This gives us the risk of contracting cancer of the exposure • THIS IS THE OVERALL DOSE TO THE WHOLE BODY

28. External and Internal dose • Dose from external sources • X-ray • Radiation emanating from patient (Nuclear Medicine and Brachytherapy) • Contamination of work surfaces etc • Dose from internal sources: • Ingestion • Inhalation • Absorption • Committed effective dose • Dose delivered due to deposition of radionuclide in the body

29. Reg 11: Dose Limits for non-classified staff & public (mSv) per calendar year Possibly changing to 15 mSv/yr in a couple of years

30. Dose Monitoring • Most employees who work with radiation in a Hospital Trust have radiation monitoring badges. • These monitor the exposure to radiation of an employee • Doses received are assessed by the RPA to ensure they are being kept ALARP • BUT, it is also an RPS duty to monitor results • Please ensure your staff wear and return it promptly • There have been recent prosecutions for not doing so under these regulations

31. Typical Dose Monitoring Results across the Trust • Radiotherapy: • Typically less than 0.1 mSv/month • This equates to less than 1 mSv/yr • Much lower than legal limit of 6 mSv/yr • Nuclear Medicine: • Typically less than 0.3 mSv/month • This equates to less than 4 mSv/yr • Lower than legal limit of 6 mSv/yr • Radiology: • Typically less than 0.3 mSv/month • This equates to less than 4 mSv/yr • Lower than legal limit of 6 mSv/yr • Dental: • Typically less than 0.1 mSv/month • This equates to less than 1 mSv/yr • Much lower than legal limit of 6 mSv/yr • Under reg 8 we have to set dose investigation levels

32. Dose Investigation Levels • Radiotherapy: • 0.1 mSv/month • Nuclear Medicine: • Technologist: • Whole body = 0.35 mSv/month (averaged over three months) • Finger = 5 mSv/month • Others: • Whole body = 0.2 mSv/month • Fingers = 3 mSv/month • Radiology: • 0.35 mSv/month • Dental: • 0.1 mSv/month • Breast Screening: • 0.1 mSv/month

33. Women of reproductive capacity • Refers to ‘women at work’ • 1 mSv to foetus • This is roughly 1.3 mSv to abdomen during declared term

34. Female Staff of Child Bearing Age • Staff working with radiation are naturally concerned to minimise the risk to a foetus should they become pregnant • IRR99 places the onus on the employer to provide adequate information and on the employee to inform that they are pregnant • The employer must: • ensure that the dose to the foetus does not exceed 1 mSv • Notify female employees working with radiation the risk to the foetus, and the importance of informing the employer in writing as soon as they are pregnant

35. Doses and Risk to the Foetus • Current legal limit to foetus is 1 mSv • For NM, this corresponds to around 1.3 mSv to the abdomen • Assuming 8 months of declared pregnancy, dose to abdomen must be kept below 0.16 mSv per month • Individual risk assessment MUST be carried out • Possible areas that work may need to cease are: • Dealing with spills • Using aerosols • Imaging very ill patients • Preparing radionuclide therapy doses • PET?

36. Exclusions to Dose Limits • Comforter and Carer • These knowingly and willingly incur an exposure having been fully advised of the risks • Not as part of their job • What about the other? • Persons undergoing medical exposure

37. Reg 12: Contingency plans • Contingency plan required for ‘reasonably foreseeable’ accident • Radiotherapy: • Emergency stop buttons • In Brachytherapy if the source fails to retract during treatment: • Take out applicators and place in lead pot • Wire cutters may be needed in some instances! • Radiology: • Emergency stop buttons • Nuclear Medicine: • Spills and contamination • Plan must be documented in Local Rules • Must be rehearsed at appropriate intervals dependent on: • Potential severity • Likely doses • Complexity of plan • Number of people involved • Involvement of emergency services

38. What is Contingency Plan for a Major Spill? • Major Spill = • 1 MBq I-131 • 400 MBq Tc99m • 500 MBq Tl201 • Prevent other persons from walking over spill • Contact RPS • Check whether anyone has become contaminated • Wear appropriate clothing • Gloves • Overshoes • Lab coat • Plastic apron or gown may also be worn • Use paper towels or moistened tissues and work inwards from the outside • Monitor to ensure radioactive material has been removed • If this is unsuccessful use detergent but avoid vigorous scrubbing • Put waste in a yellow bag and label with trefoil • Report incident • Rehearsal????????

39. Part 3 Arrangements for the Management of Radiation Protection

40. Reg 13: Radiation Protection Adviser • RPA must be suitably qualified • Must be certified by HSE approved body • Employer must consult RPA on the following matters: • Implementation of Controlled and Supervised Areas (eg signage) • Prior examination of plans for installations and the acceptance into service of new or modified sources of radiation in relation to safety and warning features • Regular calibration of equipment provided for monitoring levels of ionising radiation • Regular checking of systems of work provided to restrict exposure to ionising radiation • In addition, employer should consult RPA on: • Risk assessment • Designation of controlled areas • Conduct of investigations • Drawing up of contingency plans • QA programmes • In this Trust: • Dr. Craig Moore • Mr. John Saunderson

41. Reg 14: Information, Instruction and Training • Employees must receive adequate training • Risks from ionising radiations • Precautions to reduce risk • Importance of complying with regs • Also need training under the IRMER regulations (much more physics!!!!!)

42. Reg 15: Cooperation between employers • If staff work in controlled areas of other employers (private hospitals for example) • Must be able to demonstrate that total dose is less than 6 mSv/yr • Improvement notice has been issued at another Trust recently • Also needs to be clear which procedures staff members have to follow • HEY Trust or other employer

43. Part 5 Designated Areas

44. Reg 16: Designation of Controlled and Supervised Areas • Based on risk assessment • Controlled • ……..if it is necessary to follow special procedures to restrict significant exposure to ionising radiation in that area or prevent or limit the probability and magnitude of radiation accidents of their effects, • or any person working in that area likely to receive effective dose greater than 6 mSv or 3/10 of any other dose limit (eye, hands etc)

45. Reg 16: Controlled Areas • External Beam Radiotherapy: • LINAC treatment room including the maze when the unit is switched on • Brachytherapy: • Whole of treatment room whilst the treatment unit is capable of sending source out • Radiology & BSU: • Whole room when the unit is switched on • Nuclear Medicine: • Radiopharmacy • Dispensing room • Waste Store • Therapy Room • Dental: • 1.5m or 2 m from the patient (depending on workload)

48. Reg 17: Local Rules & Radiation Protection Supervisors • Local rules must be provided for controlled areas • RPS’s must be appointed if an area is subject to local rules

49. Local Rules • Local Rules must be written and adhered to for every radiation controlled area • Essential contents of local rules include: • Dose investigation level • Contingency arrangements • Name of radiation protection supervisor • Identification of area covered • Working instructions • Protective clothing • Wear Monitoring badge • No eating, drinking or smoking • All manipulations must be carried out over drip trays and behind lead window

50. Reg 17: Radiation Protection Supervisor • There to ensure local rules are being followed • Knowledge of regulations and Local Rules • Ability to command respect • Understanding of precautions required and extent to which these will restrict exposures • Who are NM RPSs? • Kat • Alison • Sallyann RPS must be adequately trained