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 Introduction to the Project

SAFRAD (SAFety in RADiological procedures) reporting system is a voluntary system where patients submitted to defined trigger levels or events in fluoroscopically-guided interventional procedures are included in an international database. There being rare, if any, operational national reporting system in place for such procedures in large part of the world, there is greater significance of SAFRAD. SAFRAD is an effort by an international organization to motivate the voluntary reporting of possible or confirmed patient injuries that result from X-ray exposure during these procedures. The primary objective of the system is educational in nature. It is believed that going through the process of SAFRAD itself results in safety. 

The root causes of radiation induced injuries in interventional procedures have been a) lack of training of staff and b) lack of monitoring radiation dose to the patient. Both these tend to get attended in the process of SAFRAD. SAFRAD makes the clinicians performing theses fluoroscopically-guided procedures aware of the potential for patient radiation injury, and provides them guidance regarding appropriate steps they can implement into their practice that will reduce the potential for injury where possible. Collecting information about patients in which defined trigger values are exceeded helps to extract information regarding factors that contribute to radiation injury or higher exposure than necessary.

Fluoroscopically-guided, therapeutic, interventional procedures are being performed with increasing frequency in most countries. In some situations, these procedures may be the mainstream treatment, or the treatment of choice, to address serious, life-threatening conditions. They can also often be performed on an out-patient basis and involve lower costs than open surgery. Many of these procedures also have the characteristic of requiring extended periods of fluoroscopic exposure compared to the exposure times typically associated with diagnostic procedures, or to require large numbers of high quality images.

High radiation doses occur in some interventional procedures owing to one or more of the following reasons:

  • In certain complex cases the procedures may require an hour or more of fluoroscopic guidance.
  • The patient’s body build may require higher doses to obtain images of sufficient quality
  • The need for high-quality, low-noise images.
  • Fluoroscopic equipment operators conducting these procedures may not have sufficient training in radiation protection.
  • The equipment is not optimized to provide acceptable image quality at the lowest possible dose.

Case reports describing deterministic effects (radiation-induced skin injury) have been reported in the literature and there is concern for long term stochastic effects in children (IAEA). It is reported that a case of radiation induced skin injury lands up in US courts almost every 6 weeks (Rehani and Ortiz-Lopez. Int J Cardiol. 2006 May 10;109(2):147-51)

The Food and Drug Administration has published a document to direct attention to skin injuries resulting from complex radiological interventions and means to minimize or prevent such injuries (FDA 1994). The IAEA has provided information on risks in interventional procedures at its website. The IAEA also provides training material with guidance for interventionalists at its website.

The numbers of radiation injuries is a small percentage of procedure volume, therefore it is essential to collect a sufficient number of entries into SAFRAD in order to increase the statistical power of the findings and to refine the dose estimates and relationships between skin dose and dose analogs such as fluoroscopy time, DAP/KAP, cumulative dose at interventional reference point, number of series, number of frames  as well as factors related to  interventionalist’s expertise and experience, age of equipment, level of staff training in radiation protection etc….

From preliminary data, it has been shown that less than 5% of the patients undergoing interventional procedures receive more than 2 Gy to the skin. These patients should be subject to reporting, in order to follow them up regarding any possible radiation-induced effects, and to sufficiently populate this international reporting system, which is intended to be educational rather than repressive. The reporting system is voluntary and is meant to provide an environment in which participants can share their experiences and information with others in the community.

SAFRAD reflects the concerns of IAEA to raise awareness of radiation protection concerns amongst the practicing communities and to help define evidence-based trigger levels for deterministic effects of radiation. The international nature of the system is very important, both to increase the statistical power of the findings with the assumption that the actual numbers in each country will most likely be very low, and to demonstrate potential differences between equipment configurations, levels of expertise, patient populations etc…

What are the potential benefits of SAFRAD?

  • A direct patient benefit because of early detection of deterministic effects that could be delayed for months if not investigated
  • Educational value- and confidence-building to participating individuals and institutions, and increasing radiation-safety awareness during the interventional procedures that promote follow-up of selected patients
  • An educational value to general practitioners and dermatologists who are first-line physicians to patients with possible skin injuries, help in detecting and recognizing radiation injuries, and improving their treatment or management
  • The contribution to world knowledge regarding the potential for such injuries that will promote refinement of dose and risks estimates
  • The identifying of fluoroscopic equipment and clinical practice factors that can lead to high patient doses
  • The optimization of radiation dose management practices, which will benefit both patients and staff

Who will benefit from SAFRAD?

  • The patients
  • The interventional physicians
  • The general practitioners and dermatologists
  • The radiographers and nurses
  • The medical physicists and the radiation safety personnel
  • The regulators and health administrators
  • The equipment vendors

What cases should be included in SAFRAD?

A case should be reported to SAFRAD if any one or more of the following conditions (trigger values or trigger events) are observed:

  1. Fluoroscopy time is greater than 40 minutes.
  2. Kerma-Air Product is greater than 200 Gy.cm2
  3. Cumulative Dose at interventional reference point is greater than 5 Gy
  4. Peak skin dose is greater than 2 Gy
  5. Number of cine acquisition series is greater than 20
  6. The wrong patient is treated
  7. An unprescribed or erroneously prescribed procedure is performed
  8. The patient is pregnant and the pregnancy is unknown at the time of the procedure
  9. Patient undergoes multiple procedures within a month time period

If any one of the above conditions is met, then the case is to be reported and the patient is to be followed up in order to detect any sign of deterministic effect.

How do we organize the follow-up of patients?

Patients that are entered in SAFRAD should be informed that they need to be observed for the possibility of injury resulting from the procedure(s) they underwent.

Patients need to be seen by a nurse or a doctor between 2 days and 37 days after the procedure(s). The follow-up can be done by telephone if the patient is able to see the exposed area or has a relative or care-giver who can answer the questions.

Any complaint from the patient should be recorded.

The clinical observation of injury to the patient will be categorized according to protocol as well as follow up.

What is required of the participants?

The voluntary participants in SAFRAD should register with the system, so that they can be entered in the reporting system. The confidentiality is maintained by ensuring that each user can only see the information pertaining to his/her facility.

Upon receiving notification of approval of registration, users are asked to give details about hospital, facility and equipment details as well as staffing details and annual workload per fluoroscopically-guided procedure.

A coordinator will be assigned by each facility. The coordinator will take responsibility for ensuring that:

  • all relevant personnel are informed of the project and what will be required, and to distribute the relevant documentation
  • all appropriate patient and dosimetric data is collected, stored securely, verified and submitted
  • the relevant personnel know that they must inform the patient as to the procedure to be followed if they notice any change in skin colour at the site and are given details of the contact person
  • patient contact is established by the relevant personnel at thirty days post procedure to confirm whether an adverse reaction is observed

An alternate staff member can serve as coordinator when needed.

 
Version 1.2, Copyright © 2009-2012 International Atomic Energy Agency, Vienna International Centre, PO Box 100, 1400 Vienna, Austria