NEW MEDICAL PRACTICES: A CHALLENGE FOR REGULATORY BODIES
Ana M. Rojo, Nancy Puerta, Sebastián Gossio
Autoridad Regulatoria Nuclear
The Regulatory Bodies should face the regulation for new medical practices to assess the Abstract:
radiation protection of workers and patients, the safety of the installation and reduce subjectivity in their regulatory decisions. In many cases this could result in adapting or preparing new regulations, developing new licensing requirements and adjusting their regulatory processes.
It is known the nuclear regulators difficulty regarding the radiation exposure to patients for medical purposes. So that, in this paper, those topics that could contribute positively for optimizing the radiation exposure to patients, like cooperation with professional societies in general and the medical profession in particular, are analyzed with the aim of proposing new strategies to deal with. Finally, the case of workers is analyzed considering the increase of new medical practice involving radiopharmaceuticals and a proposal for a revision of occupational exposure surveillance to assure their radiological protection is presented.
Medical exposures are the most important contribution to the human exposition from artificial ionizing radiations. Since statistics indicate an increasing number of practices and facilities, it is relevant to assure the radiation protection of workers and patients and the safety of the installation and Regulatory Bodies plays a significant role in promoting a high level of radiation protection.
It is of interest to focus on how to improve the regulatory process to face new medical practices since a balance should be achieved between: too many or not enough. The challenge for the regulator is to establish a regulatory structure that helps to minimize unintended risks, while avoiding undue interference in medical judgments.
Too many regulations can result in medical or technological needless delay while too few regulations can lead to an increase in misadministrations and the likelihood for patients, medical staff, and the public to receive unjustified exposures.
A careful balance must be attained in establishing an appropriate regulatory regime. Regulation should provide the appropriate vehicle for reducing radiation risks, avoiding unnecessary doses and maximizing the beneficial uses of medicine.
2. A proposal for facing this Regulatory Body challenge
Based on the experience in some countries, the cooperation between radiation users and Regulatory Bodies seems to be the best approach for optimizing the radiation patients
exposures, and for reducing workers exposures. The next topics of this point addressed
possible ways for achieving this aim:
2.1 Regulatory Bodies guides
The need for producing and revising the Regulatory Bodies guides could come through
changes of regulation or arise from the issues identified during regulatory control activities.
Radiation users meet inspectors from Regulatory Bodies regularly on the installation visits,
but it seems not enough. Other positive interaction should be the promotion and the developed
of specific guides in collaboration between them.
2.2 Regulatory Bodies Research and Development (R&D) Projects
The R&D Projects could be the bases for supporting new regulations or new licensing
The Regulatory Bodies could constitute multidisciplinary expertise teams specialized in
performing measurements of radiological parameters of interest for occupational control of
workers exposure. It means, teams with the capability to design and implement integral
monitoring including area monitoring (activity air measurements, dose rates, sweep test) and
individual monitoring (internal and external) for assessing the effective dose of workers in
routine operations in order to verify the radiological safety conditions.
The outcomes of these R&D projects could be of help to identify the need to update
Regulatory Bodies requirements for new medical practices.
2.3 Regulatory Bodies in education and training
The Regulatory Bodies should actively promote the organization of workshops for radiation
users. Some of them have professional associations that organize their periodic meetings, but
radiation protection issues are not traditionally included in the program of such meetings or
particular radiation protection problems are not addressed to the extent necessary.
The promotion and participation in these activities could be made possible to promote
discussions and will play a major role in creating common strategies for education and
training in radiation protection. The Regulatory Bodies could illustrate actual situations
showing the outcomes of R&D projects and giving advice on possible radiation protection
actions aimed at improving the current situation.
2.4 Regulatory Bodies in users procedures
The Regulatory Bodies jointly to radiation users associations should establish workgroups for
preparing procedures to minimize radiation exposure during normal operation and to prevent
the occurrence of potential exposures.
Valuable information could be exchange for deciding the best modality for future training in
the implementation of procedures. The role of the Regulatory Bodies would be mainly as
coordinator and contributor through the participation of their experts.
2.5 Regulatory Bodies and the continuously improving
The information reported by the inspectors could be useful as a baseline for new cooperative training and for the optimization of new medical practices. All the abnormal incidents or situations occurred or suspected should be reported in an annual report on radiation protection. The discussion in an annual openly meeting should be promoted so that lessons should be learned and some weaknesses could be foreseen.
These activities should be an opportunity for Regulatory Bodies to disseminate relevant concepts published by the IAEA, , , and recommendations from ICRP on this field , , , . Particularly, ICRP Committee 3 is concerned with protection in medicine and in recent years has produced many publications with detailed advices on different aspects of the radiological protection of patients. The most recent, Publication 105: “Radiological Protection in Medicine” , was written as a foundation document for the Commission’s 2007 Recommendations.
This paper proposed that the challenge for Regulatory Bodies since the increasing of the new medical practices may be better face through the collaboration with radiation users, particularly the development of Regulatory Guides, the implementation of Regulatory R&D Projects and the involvement in education and training activities.
The advantage of the cooperation between Regulatory Bodies and radiation users could be to maximize the special knowledge with minimal resources.
The competence of the authority could be strengthened with the practical knowledge from radiation users and the radiation protection will be consolidated by applying the approaches summarized above.
 IAEA, 1996. International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources. Safety Series 115. STI/PUB/996. International Atomic Energy Agency, Vienna, Austria.
 IAEA, 1999. Occupational radiation protection. Safety Guide RS-G-1.1. International Atomic Energy Agency, Vienna, Austria.
 ICRP, 1996a. Radiological protection in medicine. ICRP Publication 73. Ann. ICRP 26 (2).
 ICRP, 1997a. General principles for the radiation protection of workers. ICRP Publication 75. Ann. ICRP 27 (1). ICRP, 1997b
 ICRP, 2000c. Prevention of accidental exposures to patients undergoing radiation herapy. ICRP Publication 86. Ann. ICRP 30 (3).
 ICRP, 2001b. Radiation and your patient: A guide for medical practitioners. ICRP Supporting Guidance 2. Ann. ICRP 31 (4).
 ICRP, 2007b. Radiological protection in medicine. ICRP Publication 105. Ann. ICRP 37 (5).