Module: Module: IMAGING AND IMAGING AND

REFERRALREFERRAL

IR(ME)RIR(ME)R

DR. GAIL REES-DR. GAIL REES-JONESJONES

M.Tech:Chiropractic (RSA)M.Tech:Chiropractic (RSA)

Ionising Radiation (Medical Ionising Radiation (Medical Exposure) Regulations Exposure) Regulations

[IR(ME)R][IR(ME)R]

WhyWhy is it so important?is it so important?

Need regulations to keep Need regulations to keep away the …away the …

The Ionising Radiation The Ionising Radiation (Medical Exposure) (Medical Exposure)

Regulations 2000 [IR(ME)R].Regulations 2000 [IR(ME)R].

Ionising radiation (medical exposure) regulations 2000

Purpose of DirectivePurpose of DirectiveDuty HoldersDuty Holders

•EmployerEmployer•PractitionerPractitioner•ReferrerReferrer•OperatorOperator

PrinciplesPrinciples•JustificationJustification•OptimizationOptimization•LimitationLimitation

IR(ME)RIR(ME)R

► In 1997 the Council of the European In 1997 the Council of the European Union (EU) issued a directive that Union (EU) issued a directive that came into force came into force

in the United Kingdom on 13 May in the United Kingdom on 13 May 2000 through the provisions of the 2000 through the provisions of the Ionising Ionising

Radiation (Medical Exposure) Radiation (Medical Exposure) Regulations 2000 [IR(ME)R]. Regulations 2000 [IR(ME)R].

Purpose of the Directive:Purpose of the Directive:

►Protection of individuals in relation to Protection of individuals in relation to radiographic exposure as part of their:radiographic exposure as part of their:

• Medical DiagnosisMedical Diagnosis• TreatmentTreatment• Occupational health surveillanceOccupational health surveillance• Health screeningHealth screening• ResearchResearch• Medico-legal proceduresMedico-legal procedures

Duty Holders – IR(ME)R 2000Employer

Referrer Practitioner Operator

Request Justify Do

Duty Holders – IR(ME)R 2000Employer

“CHIROPRACTIC HEALTH CLINIC”

Referrer Practitioner Operator

Employer (NHS Trust/Chiropractic Clinic)

► Identify and record duty holders ► RPA (Radiation Protection Advisor)► RPS (Radiation Protection Supervisor)► Ensure appropriate education, training and

supervision of staff► Establishing referral criteria and systems for

justifyingexaminations/procedures

► Written protocols for every standard examination of equipment (e.g. reference levels (DRL’s)

► Assessment of patient dose► Investigate incidents

Referrer

Responsible for providing clinical reasons for the

requested examination/s.

► 5.12.1. Decisions on who is entitled to act as a referrer should be taken at local level by agreement between the employer and the healthcare professionals involved in medical exposures.

► 5.12.2. The range of procedures that can be requested by a referrer should be agreed locally between the referrer and the employer of the radiological installation.

Practitioner

► 5.10.1. Decisions on who is entitled to act as a practitioner should be taken at local level by agreement between the employer and the healthcare professionals involved in medical exposures.

► 5.10.2. The primary responsibility of the practitioner is to JUSTIFY medical exposures. This requires the practitioner to have a full knowledge of the potential benefit and detriment associated with the procedure under consideration.

Operator

► 5.8.1. An operator is anyone who carries out a “practical aspect”.

► 5.9.1. The range of functions covered by this term is

extensive and includes the supporting functions prior to

the exposure taking place (e.g. the calibration of equipment that emits ionising radiation, the preparation of

radioactive medicinal products etc), as well as of performing the exposure itself.

Duty Holders

► Is there always a referrer?► Can individuals fulfill more than one role?

PrinciplesPrinciples

Justification Optimization Limitations

JustificationJustification

► 2.1. The Medical Exposures Directive requires that all medical exposures to ionising radiation must be justified prior to the exposure being made.

► Risk/Benefit: The benefit of the radiation exposure should be

greater than the risk of using it.

► When applied directly to the exposure of patients; each particular medical practice in a department

must be justified twofold:1. As a general procedure (IRR 99)2. As regards the individual patient (IR(ME)R 2000

BENEFITS VS RISKS:BENEFITS VS RISKS:

Justification & Pregnancy

► “28 day rule” for routine radiographic examinations

► “10 day rule” for high-dose procedures, such as barium enemas, abdominal or pelvic CT, and Nuclear Medicine

► Special case where individual justification is needed

►28 Day Rule:28 Day Rule: Menstrual cycle varies, generally 28 days. If patient Menstrual cycle varies, generally 28 days. If patient

is to be exposed to ionising radiation for diagnostic is to be exposed to ionising radiation for diagnostic purposes and the patient is of child-bearing age, purposes and the patient is of child-bearing age, postpone exposure for 28 days from first day of postpone exposure for 28 days from first day of menstrual cycle to next to rule out pregnancy. menstrual cycle to next to rule out pregnancy.

►10 Day Rule:10 Day Rule: If patient is to be exposed to ionising radiation for If patient is to be exposed to ionising radiation for

diagnostic purposes If patient is to be exposed to diagnostic purposes If patient is to be exposed to ionising radiation for diagnostic purposes and the ionising radiation for diagnostic purposes and the patient is of child-bearing age, she should be patient is of child-bearing age, she should be booked in the first 10 days of the menstrual cycle, booked in the first 10 days of the menstrual cycle, when conception is unlikely to have occurred.when conception is unlikely to have occurred.

Advice from National Radiological Advice from National Radiological Protection Board:Protection Board:

Radiation doses resulting from most diagnostic procedures in an individual pregnancy present no substantial risk ofcausing fetal death or malformation or impairment of mental development.

Procedures giving the greatest foetal exposure are: ►Barium Enemas►Pelvic and Abdominal CT scans►Nuclear Medicine

[Most sensitive time period for CNS teratogenesis is between 10-17weeks.]

Special Cases:Special Cases: A patient at 19 weeks of gestation presented with A patient at 19 weeks of gestation presented with

flank pain and microscopic hematuria. She was flank pain and microscopic hematuria. She was diagnosed with pyelonephritis and treated with diagnosed with pyelonephritis and treated with parenteral antibiotics. Her flank pain progressed parenteral antibiotics. Her flank pain progressed despite antibiotic treatment, necessitating a renal despite antibiotic treatment, necessitating a renal ultrasound examination, which was inconclusive. An ultrasound examination, which was inconclusive. An intravenous pyelogram (IVP) was ordered, but the intravenous pyelogram (IVP) was ordered, but the radiologist refused to perform the study because of radiologist refused to perform the study because of concern about radiation exposure to the fetus. concern about radiation exposure to the fetus. Despite further discussion, the study was denied Despite further discussion, the study was denied until a perinatologist verified the appropriateness until a perinatologist verified the appropriateness and relative safety of the study. and relative safety of the study.

The IVP revealed two stones, and the patient The IVP revealed two stones, and the patient eventually required ureteral stent placement. eventually required ureteral stent placement. Despite treatment, she had progressive renal Despite treatment, she had progressive renal disease with obstruction, requiring induction of disease with obstruction, requiring induction of labor at 35 weeks of gestation. At birth, her infant labor at 35 weeks of gestation. At birth, her infant was healthy and weighed an age-appropriate 2,500 was healthy and weighed an age-appropriate 2,500 g (5 lb, 8 oz). g (5 lb, 8 oz).

JustificationJustification

►When might an individual exposure be unjustified?

► What do you do if an individual falls outside the anticipated selection procedure?

► What do you do if the patient has been examined radiologically at another hospital recently for the same condition?

JustificationJustification

►Chief causes of wasteful use of radiology:Chief causes of wasteful use of radiology:► Repeating investigations which have already been done► Investigation when results are unlikely to affect patient

management► Investigating too often► Doing the wrong investigation► Failing to provide appropriate clinical information and questions

that the imaging investigation should answer.► Over-investigating.

RADIATION PROTECTION 118 “Referral guidelines for imaging”

OptimizationOptimization

► 9.1. Regulation 7 provides for the optimisation process which involves ensuring that doses arising from

exposures are kept as low as reasonably practicable.

• ALARP• Reducing number of images taken of a patient• Dose-reducing equipment• Good technique• Quality Assurance Program• Adequate training

LimitationLimitation

► Legal dose limits for workers and members of the public

• ensuring that no deterministic effects are produced and

probability of stochastic effects is reasonably low.• diagnostic reference levels for each standard radiological investigation

• Staff: 20mSv per year whole body dose. Not to exceed 100mSv over 5 year period• Trainees/Students: 6mSv per year whole body dose• Members of the public/foetus: 1mSv per year

Individual Responsibilities