Are you ready for
Euratom compliance?

6 February, 2018 is fast approaching. On that date, radiation dose management provisions defined by the European Atomic Energy Community (Euratom) must be fully implemented by member states of the European Union.

In 2013, Euratom issued Council Directive 2013/59/Euratom, which lays down basic safety standards for protection against the dangers arising from exposure to ionizing radiation. This new directive supersedes previous directives and significantly impacts radiology departments across Europe.

The standards defined in Council Directive 2013/59/Euratom are based on recommendations from ICRP and are comparable to the IAEA (International) basic safety standards for radiation safety. To be in compliance, your institution must be ready to meet these new standards by 6 February, 2018.

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What has changed?

The new directive brings into sharper focus several areas of radiation dose management with exam justification, dose optimization, clinical responsibility, and dose reporting being the most significant.

You and your staff can take control of patient and staff radiation exposure by managing the effects of:

Diagnostic reference levels

Diagnostic reference levels and the role of medical physics experts are specified in more detail

Dose limits for eye lens

X-ray dose limit to the eye lens have been lowered – guided by the ICRP

Role of the medical physics expert

Roles and responsibilities for radiation safety have been more clearly defined

Reporting of patient dose

Reporting, education, and training are emphasized

Highlights of the important elements?

Following is a high-level summary of those areas that require attention from radiology departments.

Diagnostic reference levels: The directive strengthens and expands (for interventional radiology) the previous requirements regarding diagnostic reference levels (DRLs). Diagnostic reference levels are not limits to radiation exposure that a patient can receive, they are simply guidelines to benchmark yourself against peers, and the ICRP has published suggested DRLs for use by care providers. If/when diagnostic reference levels are consistently exceeded, review and corrective action must be conducted without delay.
Dose limits for eye lens: The directive modifies the occupational dose limit for the eye lens from 150 mSv/year down to 20 mSv/year, or 100 mSv in any 5 consecutive years. This is based on new scientific information on the long term effects of eye tissue to radiation exposure.
Role of the medical physics expert: The directive states that a medical physics expert must be involved in any radiological procedures that involve high radiation doses such as interventional radiology and computed tomography. The medical physics expert will give appropriate advice related to radiation physics for implementation of established exam protocols and will take responsibility for dosimetry, including physical measurements for evaluation of the dose delivered to the patient and staff.
Recording, reporting, and registration of patient dose: The directive states that imaging systems must have the capability to record the patient dose for each exam and that that information be transferred to an in-house reporting system which associates the exposure data to the individual patient record. Any accidental or unintended exposures must be documented, the patient informed, and corrective actions undertaken.
Exam justification: The directive requires that medical patient radiation exposure must be justified and optimized prior to an X-ray exam so that the net benefit of the procedure to the patient outweighs the risk of the radiation exposure. In addition, medical radiological procedures performed on asymptomatic individuals (i.e. for early disease detection) also require specific documented justification and the need to inform the exam subject. Protection of radiology staff in all working conditions must be based on the ALARA principle of radiation exposure, ensuring that staff exposure is kept as low as reasonably and economically possible.
Procedures and protocols: The directive requires the establishment of written protocols for every type of standard medical radiological procedure on every piece of imaging equipment. It requires that information relating to patient exposure be included as part of every procedure and that clinical audits to ensure proper compliance be carried out ‘in accordance with national procedures.’
Responsibilities and cooperation between physicians: The directive states that the referring physician and the imaging practitioner are both to be involved in exam justification. The referring physician or imaging practitioner must provide the patient with adequate information relating to the benefits and risks associated with radiation dose from the imaging procedure.
Equipment safety: The directive places responsibility to ensure imaging systems have a method for the automatic control of the dose rate, on member states. Imaging equipment must also have a device that informs the operator and those carrying out the exam the quantity of radiation produced by the equipment during the procedure.

CTs and equipment used for interventional procedures must have a feature for providing relevant parameters for assessing patient dose and must have the ability to transfer dose information to the reporting system (i.e. PACS) for inclusion in the patient record.
Education and training: The directive states that member states will ensure that anyone involved in radiological procedures have adequate education, information, and training. In addition, continuing education is required in the use of new imaging techniques and the associated radiation protection requirements.

Enable dose management across your organization

DoseWise Portal is a vendor-agnostic, web-based solution that collects, measures, analyzes, and reports patient & staff radiation exposure, assisting you to take control of quality of care, efficiency, and patient/staff safety.

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Your course of action

These changes will require Member States, the radiology community and the industry to adapt regulations, practices and equipment for a high standard of radiation safety. By 6 February 2018, the Directive has to be transposed into the national legislation of the Member States of the European Union.”¹

- European Society of Radiation (ESR)

Every EU member state will implement the directive in its own way. Your individual institution may have already begin the path to compliance. If this is not true, and you are unsure of the status of the process, please contact your local regulatory/legislative authorities.

For specific questions regarding radiation safety compliance in the Netherlands, please contact our Dutch Radiation Protection Expert:

Sandra van den Eeden at Sandra.van.den.eeden@philips.com

References

¹European Society of Radiation (ESR), Summary of the European Directive 2013/59/Euratom: essentials for health professionals in radiology, Insights Imaging (2015) 6:411–417

Are you ready for Euratom compliance?