By 6 February 2018, all Member States of EU should have implemented radiation dose management provisions defined by the European Atomic Energy Community (Euratom), called 2013/59/Euratom.

 

What is the 2013/59/Euratom?

 

It is a Council Directive that sets safety standards for protection against the risk that comes from exposure to ionizing radiation.

This directive significantly influences radiology departments across Europe and replaces previous directives – the Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom, and 2003/122/Euratom.

The Directive was adopted by the Council of the European Union (EU) on 5 December 2013 after four years of work by various European scientific and technical committees.

This Directive reflects a system of radiation protection based on the three principles: justification, optimization, and dose limitation for all exposure situations. The standards defined in the Council Directive 2013/59/Euratom are based on recommendations from ICRP (The International Commission on Radiological Protection).

Most importantly, the Member States of the European Union had 4 years to transpose this Directive into national legislation. As mentioned before, by 6 February 2018, the Council Directive 2013/59/Euratom should have been fully implemented.

 

What has changed?

The most important changes for radiology imaging, that the new Directive 2013/59/Euratom brings, regard:

  1. A new set of definitions within radiology
  2. Lower X-ray dose limit for the lens of the eye
  3. You have to consider the justification and optimization principles for occupational doses.
  4. Regulation of radiological procedures in asymptomatic individuals
  5. Use and regular review of diagnostic reference levels – they are specified in more detail
  6. Reporting of patient dose, education, and training has increased in importance
  7. The Directive have defined roles and responsibilities for radiation safety more clearly
  8. They have defined roles of medical physics experts in diagnostic and interventional procedures more clearly
  9. New requirements for equipment in use – mainly regarding radiation doses
  10. There must be written procedures for the optimization processes, clinical protocols, and clinical audits
  11. A new set of requirements for registry and analysis of accidental or unintended exposures
  12. They replaced the “medico-legal” exposures with the “non-medical imaging exposures”. The Directive adopts a different approach for procedures using medical radiological equipment in examinations where the primary intention of the exposure is not health benefits.

What do these changes mean for the Member States of EU, radiology communities, the industry, and your institution? To be in compliance with the 2013/59/Euratom, the Member States, radiology communities, the industry, and your institution are required to adopt regulations, practices, and equipment for a high standard of radiation safety.

 

Implications for Imaging Equipment

One of the main goals of the directive is to ensure that imaging systems have a method for automatic control of dose rate. Furthermore, the imaging equipment must have a device that informs the operator and those conducting the exam about the amount of radiation produced by the equipment during the procedure.

CT scanners and equipment used for interventional procedures must have a function for providing relevant parameters for assessing patient dose. Moreover, it must have the ability to transfer the dose information to the reporting system (i.e. PACS) for inclusion in the patient record.

Luckily, due to the XR29 regulation is the US market, and the general race between the OEMs for the lowest dose, most OEMs have already implemented lower dose acquisition in their devices. Furthermore, many systems can be upgraded to reduce the radiation dose.

 

How will this change the market of pre-owned medical imaging equipment – Our insights:

We are certain that from the changes mentioned above, the radiation dose management is the one that will have have the biggest impact on the market for medical equipment.

The systems available on the EU market will be more effective in terms of dose management. And there is a possibility that some CTs and X-rays older than 10 years will leave the EU market completely, as they might not comply with the new regulation.

However, we do not expect to see these changes immediately. Current machines will most likely stay and newer models will come when these need to be changed.

Remember that the radiation dose regulation has an effect only within the European Union. But it is comparable to the US NEMA XR-29 Smart Dose Standard. However, the rest of the market for medical equipment still has a long way to go before setting such a regulation for dose level. Therefore, this change is not going to influence your business in other countries than those in EU.

In conclusion, the rules in the Council Directive 2013/59/Euratom seek to increase patient safety. You can do this by optimizing examinations and treatments involving radiation to achieve the best possible treatment quality with the lowest possible risk.

It is not something brand new, but rather the newest addition to a series of stricter requirements that aim to achieve such an optimization.

At LBN Medical, we keep an eye on new technologies and new regulations on the market. Furthermore, we make sure that we adapt our business to them.

If you would like to learn more about 2013/59/Euratom, use one of the sources provided for further information.

 

Sources and further information:

https://link.springer.com/article/10.1007/s13244-015-0410-4

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32013L0059

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32013L0059&from=EN

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4519811/

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