• RPII Website
• RPII Code of Practice
• Statutory Instrument 303 of 2007
• GDP (UK) and RCSE Guidelines

MEDICAL EXPOSURES DIRECTIVE AND STATUTORY INSTRUMENT (SI) 478

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Existing legislation covering medical/dental ionising radiation is as follows:

• The Safety, Health and Welfare at Work Act, 1989, covers issues in relation to general principles of safe work practices, responsibilities of employers and employees etc.

• The Radiological Protection Act 1991 set up the Radiological Protection Institute of Ireland(R.P.I.I.)

• The E.U. directive 1996/ S.I. 125 of 2000 sets out basic safety standards for protection of the general public and workers, and the R.P.I.I. guidelines are based on this legislation.
• The E.U. Medical Devices Directive 1984/ S.I. 189 of 1988 sets out basic measures for radiation protection of patients undergoing medical examination and treatment.

The E.U. Medical devices directive 1984/S.I. 189 of 1988 has now been replaced by new legislation - E.U. Council Directive 1997/ S.I. 478 of 2002.

The old directive covered the following areas:

• Justification
• Optimisation
• Training
• Responsibilities ( there was v. little detail on responsibilities)

In addition to addressing these issues in much more detail, the new legislation also covers the following areas:

• Procedures
• Equipment
• Special Practices
• Special protection during pregnancy and breast-feeding
• Potential exposure and estimates of population dose
• Inspection

JUSTIFICATION: Issues addressed include guidelines for prescribers, responsibility on practitioners to obtain previous diagnostic information, research, medico-legal exposures, health screenings

OPTIMISATION: Issues addressed include quality assurance and dosimetry

TRAINING: Issues in relation to recognition of qualifications by the Medical/Dental Councils

RESPONSIBILITIES: The legislation gives considerable detail on the responsibilities of the following:

• C.E.O. of Health Board. Responsibilities include:
  1. Maintenance of a register of all X- Ray installations in his/her area, including those both in Health Board clinics/hospitals and those in private practice, and appointment of a person to conduct clinical audits in these locations.
  2. Appointment of a Radiation Safety Committee, and this committee may issue guidelines to practitioners. The committee must also produce an annual report of the total population dose of ionizing radiation for the Health Board area. The C.E.O. may also bring proceedings in relation to an offence under this legislation.
• Manager of the clinic/practice etc. Responsibilities include:
  1. The appointment of a practitioner as "practitioner in charge". This will usually be the P.D.S. in Health Board clinics.
  2. Ensuring that referral criteria are developed and advised to all practitioners
  3. Ensuring that clinical audits are carried out at least every 5 years
  4. Ensuring that appropriate quality assurance programmes are implemented for the clinic/practice.
  5. Assign a medical physicist to the clinic/practice to conduct periodic examinations of the equipment; including acceptance testing prior to first use and performance testing following major maintenance
  6. Take equipment out of service if it fails to comply with the criteria of acceptability on the advice of the physicist.
  7. Maintain a written inventory of all radiological equipment in the clinic/practice specifying inspection dates, new components and a replacement date
• Practitioner (i.e. person taking the x-ray). Responsibilities include:
  1. Ensuring that exposure is justified.
  2. Obtaining previous diagnostic information,
  3. Co-operation with clinical audit.
• Medical/Dental Councils. Responsibilities include:
  1. Development of written protocols for every type of standard radiological practice in respect of each type of equipment
  2. Adoption of criteria for clinical audit
  3. Preparation of procedures on the medical exposure of pregnant or breast-feeding female patients

PROCEDURES:

• Written protocols for every standard radiological practice to be established by the Medical/Dental Council
• Referral criteria to be developed in each Health Board Clinic/Practice.
• Medical/Dental Council to adopt criteria for clinical audit, and clinical auditor to be appointed by the C.E.O.
• Named physicist to be appointed to each clinic/practice.
• Radiation Safety Committee to advise the C.E.O. on radiation protection in the Health Board area

EQUIPMENT:

• Holder to keep written inventory of all x-ray equipment , including all service details and projected replacement date.
• Radiation Safety Committee to advise on continued use after that date, on the advice of the medical physicist
• Performance tests to be carried out after major maintenance.

SPECIAL PROTECTION DURING PREGNANCY AND BREAST FEEDING:

The new legislation states that all females of child-bearing age should be asked re. pregnancy and breast-feeding, and that their answers should be recorded in writing. This is under review for dentistry; at present in the SEHB we use the Guidelines of the Faculty of Radiography, which are incorporated into our local rules.

POTENTIAL EXPOSURE AND ESTIMATE POPULATION DOSE:

• Written protocols and quality assurance programmes to prevent accidental exposures to be developed by practitioners
• The Radiation Safety Committee to monitor the population dose for the Health board area.

INSPECTION:

C.E.O. can bring proceedings in relation to a breach of the legislation. Some issues need clarification. In particular, the issue in relation to D.S.As or hygienists who have a recognised radiography qualification needs to be clarified.