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First FRCR Examination in Clinical Radiology

Statutory Requirements and Non-Statutory Recommendations

(b) Ionising Radiation (Medical Exposure) Regulations 2000

John SaundersonRadiation Protection Adviser

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STATUTORY INSTRUMENTS

2000 No. 1059

HEALTH AND SAFETY

The Ionising Radiation (Medical Exposure) Regulations 2000

Made 13th April 2000

Laid before Parliament 14th April 2000

Coming into force

except for regulation 4(1) and4(2)

13th May 2000

regulation 4(1) and 4(2) 1st January 2001

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Basic Principles

• Justification

• Optimisation

• Roles & Responsibilities (employers, referrers, practitioners, operators, MP experts)

• Procedures & Protocols

• Adequate training & Audit .

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Function with associated duties

• employer

• referrer

• practitioner

• operator

• medical physics expert .

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Employer (1)

• Write procedures for all medical exposures .

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IRMER SCHEDULE 1Employer’s Procedures

• patient identification

• identification of competent staff for specific tasks

• medico-legal

• identifying pregnant patients

• QA programmes

• assessing patient dose.

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IRMER SCHEDULE 1Employer’s Procedures

• diagnostic reference levels

• dose constraints in research

• instructions to nuclear medicine patient on dose to others

• evaluating each medical exposure

• ensure chances of overdose are A.L.A.R.P.

patient identification ; identification of competent staff for specific tasks; medico-legal ; identifying pregnant patients ; QA programmes ; assessing patient dose

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Employer (2)

• Write procedures for all medical exposures

• Write protocols for every standard radiological practice for each equipment

• e.g. for X-ray room 29, PAchest: 120 kV, 2mAs. For preprogrammed units i.e. with a chest button, a record should be kept of what the programmed values are. For nuclear medicine, document amount administered for each routine examination and treatment .

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Employer (3)

• Establish • referal criteria and make available to referrers

• a QA programme

• diagnostic reference levels

• dose constraints fo medical research where no benefit to “exposee”

• Decide who is a practitioner or operator, and establish training records.

• For “sub-contractor operators” stipulate in contract adequate training .

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Employer (4)

• Ensure that they are undergoing continuing education & training

• Investigate all incidents and report all significant overdoses to DoH

• Review when diagnostic reference levels consistently exceeded and take appropriate action.

• Ensure a clinical evaluation of outcome of every exposure is carried out and recorded (including dose/activity) .

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Employer (5)

• Clinical audit in accordance with national procedures must be performed

• Ensure a medical physics expert in areas specified

• Keep an equipment inventory

• Limit the amount of equipment

---oooOOOooo--- .

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Referrer

• Must supply sufficient medical info’ to practisioner so that they can decide if justified

• (i.e. not “Give this guy a bone scan” but “Please give this guy a bone scan because . . . . . . . . ”

• Must be a “registered healthcare professional” .

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Practitioner

• Must comply with employers procedures.

• Responsible for justifying exposure - must be a net benefit (practical aspects can be delegated but not responsibility)

• Must be a “registered healthcare professional” - not necessarily a medic - could be a radiographer if specified in procedures

• Must cooperate with other specialists and staff involved in the exposure .

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Operator

• Responsible for the “practical aspects” they carry out.

• Must cooperate with other specialists and staff involved in the exposure

• Undergo continuing education & training

• In fluoroscopy, ensure AEC used unless other method justified .

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Medical Physics Expert

• Hold a science degree

• Be experienced in the application of physics to the diagnostic and therapeutic uses of ionising radiation

• Closely involved in radiotherapy

• Available in nuclear medicine

• Involved as appropriate in optimisation for other radiological practices .

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Justification

• No medical exposure can take place unless authorised by a practitioner - must be net benefit

• No medical or biomedical research unless approved by Local Research Ethics Committee.

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Optimisation (1)

• For diagnostic exposures (P & O)• A.L.A.R.P.

• For therapeutic exposures (P)• exposures to target volumes to be individually planned

• Doses to non-target volumes A.L.A.R.P.

• For medical or biomedical research (P)• volunteers only

• volunteer aware in advance of the risk

• if no medical benefit, adhere to dose constraints

• if medical benefit, plan individual target dose levels.

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Optimisation (2)

• For nuclear medicine (E)• instructions to patients to minimise risk to others (where

appropriate)

• or to other appropriate person

• Special attention to• A.L.A.R.P. for medico-legal exposures

• children

• screening programmes

• high dose procedures

• abdomen of the potentially pregnant

• breastfeeding females (NM).

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Notification Levels

Type of diagnostic examination Guideline multiplying factor

Barium enemas/meals, IVU, angiographyand any other such procedure involving fluoroscopy(including digital radiology) and CT

3

Nuclear medicine: intended E > 5 mSv,eg 201Tl (myocardial imaging)

3

Lumbar spine, abdomen,pelvis,mammography,and all other examinations not referred toelsewherein this table

10

Nuclear medicine: intended E ≤ 5 mSvbut > 0.5 mSv, eg 99mTc (MAA lung imaging)

10

Extremities, skull, chest, dental and other simpleexaminations such as elbow, knee, and shoulder

20

Nuclear medicine: intended E ≤ 0.5 mSv,eg 51Cr (EDTA) GFR measurement

20

Type of treatment Guideline multiplying factor

Beam therapy, brachytherapy 1.1 (whole course) or 1.2 (anyfraction)

Radionuclide therapy, eg 131I 1.2 (any administration)

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Latest proposed changes For doses “much greater than intended” not caused by equipment

• Diagnostic, inc. RT simulators– >10mSv more than intended, or x20 intended

• Treatment– Not if correctable (was 20% for a fraction, 10% whole

treatment)– Risk for severe normal tissue complications doubled,– Or wrong site irradiated.

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