Society of Interventional Radiology
Safety and Health Committee Cataract Study Project
While serving as chair of the SIR Safety and Health Committee, Donald Miller, M.D., FSIR, became aware of the International Atomic Energy Association (IAEA) cataract studies, as discussed during a Multi-Specialty Occupational Health Group (MSOHG, a multispecialty group initiated by SIR) meeting. The Safety and Health Committee proposed doing a study at an Annual Scientific Meeting, with Norman Kleiman, PhD, who is currently the director, Eye Radiation and Environmental Research Laboratory (ERERL), Department of Environmental Health Sciences, Mailman School of Public Health at Columbia University, New York; and who was involved with the IAEA studies.
SIR Safety and Health Committee member Stephen Balter, PhD, notes that the results of this project will be important as currently 90 percent of the data on this subject comes from the cardiology community. Data culled from Kleiman's efforts will address an important member safety issue.
This Safety and Health Committee project's resulting publication is intended to be submitted to the Journal of Vascular and Interventional Radiology for the first right of refusal.
The type and severity of characteristic radiation-induced posterior lens changes, including potential for posterior subcapsular cataract, will be examined in an IR cohort attending the SIR annual meeting. The findings will then be compared to various medical and non-medical professional control groups, including non-interventional radiologists who are not normally exposed to X-rays.
Findings from this study may help in developing appropriate occupational guidelines for exposure to low levels of ionizing radiation and determining future risk of radiation cataract development.
- Where: Room TBD; San Diego Convention Center
- When: March 23-26 (during SIR 2014) a
- Times: 7:00 a.m. to 6:00 p.m., daily
Note: Steps 1 & 2 can be completed in the morning and step 3 in the afternoon/evening.
Lens changes will be observed using dilated slit lamp examination and contrast sensitivity measurements will be made using a computer generated pattern with a dedicated, computer based CS testing device.In addition to ocular examination, exposure history will be detailed using an occupational exposure questionnaire, medical history and, where available, hospital based dosimetry records. In this study, we seek to determine if there is a dose response relationship between X-ray exposure, the type and severity of posterior lens changes and/or decrements in contrast sensitivity.
Step 1: Completion of detailed questionnaire regarding workplace practice and occupational exposure in addition to relevant medical history.
Step 2: Completion of a non-invasive contrast sensitivity test by each subject (approximately 10 minutes)
Step 3: A dilated slit lamp examination to examine and document changes in the posterior lens region. (performed with a licensed ophthalmologist). Note: Mydriasis (dilation) is usually induced with one drop each of phenylephrine 2.5 percent and tropicamide 1 percent and may take up to 30 minutes for effect. Subjects may remain dilated for up to 4 hrs after exam so it is preferable to dilate subjects at the end of the day, after they have visited the exhibits and lectures.
Participants: please bring the card packed with your radiation badge with you.
An example of the Landauer card is shown in the figure to the left.
If you don't have a card, please bring your working radiation badge. Where possible, SIR will use this information to track down your dosimetry data. If available, please also bring your dosimetry records with you.
At the completion of the testing, findings will be made available to the participants and, if needed, participants will be advised on obtaining a follow-up ophthalmological exam once they return home.
For more information, contact Debbie Katsarelis, SIR's senior manager of guidelines and intersociety affairs, or call 703-460-5574.
The lens is one of the most radiosensitive tissues in the body. Exposure of the eye to ionizing radiation can result in a cataract, a loss of transparency in the lens. Over the course of a lifetime of work, interventional radiologists (IR) may be exposed to a relatively high cumulative level of X-ray exposure. Several preliminary pilot studies suggest that interventional radiologists and cardiologists (IC) may be at increased risk for radiation cataract due to their relatively high occupational exposures. These observations are supported by recent statements from the ICRP, which has suggested lowering the lens occupational dose limit from 150 mSv to 20 mSv/yr and which further suggests that acute, chronic or prolonged ionizing radiation exposure present the same long-term risks of cataract development. Historically, radiation cataract has been thought of as a deterministic phenomenon.Of particular interest to medical practice and occupational exposure however, recent findings in the Chernobyl Liquidator population, atomic bomb survivors, the astronaut pool, residents of radioactively contaminated buildings and those undergoing CAT scans or radiotherapy suggest a significantly lower or even zero threshold for radiation cataract development.
Radiation-induced lens opacities typically have an initial clinical presentation and morphology distinct from that of classical age-related lens opacification. Most commonly, such opacities appear in the posterior subcapsular region of the lens. Dilated slit-lamp examination is the preferred method for detecting and staging posterior subscapsular cataract formation (psc). Of note, only this type of cataract is strongly associated with decrements in contrast sensitivity, an important second measure of visual function and relevant to IR practice.
- Radiation-associated Lens Opacities in Catheterization Personnel: Results of a Survey and Direct Assessments. JVIR, Feb. 2013.
- Occupational Health Hazards in the Interventional Laboratory: Progress Report of the Multispecialty Occupational Health Group (there is a section on cataracts), by Miller et. al., JVIR, 2010.
(Retrospective Evaluation of Lens Injuries and Dose), studies among
staff working in cardiac catheterization laboratories (IAEA)
Protection of Patients (RPOP) Radiation and Cataracts (IAEA)
For More Information
Contact Debbie Katsarelis, SIR's senior manager of guidelines and intersociety affairs, or call 703-460-5574.
Position Statement on Radiation Safety
Society of Interventional Radiology Position Statement on Radiation Safety (Journal of Vascular and Interventional Radiology, 2003)
Interventional Fluoroscopy: Reducing Radiation Risks for Patients and Staff
Interventional Fluoroscopy: Reducing Radiation Risks for Patients and Staff (Commentary, Journal of Vascular and Interventional Radiology, 2009)
Interventional Fluoroscopy: Reducing Radiation Risks for Patients and Staff (SIR and the National Cancer Institute)
Guidelines for Patient Radiation Dose Management (Journal of Vascular and Interventional Radiology, 2009)
Occupational Health Hazards in the Interventional Laboratory: Time for a Safer Environment (Journal of Vascular and Interventional Radiology, 2009)
X-rays and Radiation Safety (SIR Patient Information Brochure, 2007)
Radiation Doses in Interventional Radiology Procedures: The RAD-IR Study/Part III: Dosimetric Performance of the Interventional Fluoroscopy Units (Journal of Vascular and Interventional Radiology, 2004)
Quality Improvement Guidelines for Recording Patient Radiation Dose in the Medical Record (Journal of Vascular and Interventional Radiology, 2004)
Radiation Doses in Interventional Radiology Procedures: The RAD-IR Study/Part II: Skin Dose (Journal of Vascular and Interventional Radiology, 2003)
The Radiation Dose in Interventional Radiology Study: Knowledge Brings Responsibility (Commentary, Journal of Vascular and Interventional Radiology, 2003)
Radiation Doses in Interventional Radiology Procedures: The RAD-IR Study/Part I: Overall Measures of Dose (Journal of Vascular and Interventional Radiology, 2003)
Society of Interventional Radiology Position Statement on Radiation Safety (Journal of Vascular and Interventional Radiology, 2003)
Image Gently, Step Lightly: Increasing Radiation Dose Awareness in Pediatric Interventions Through an International Social Marketing Campaign
Image Gently, Step Lightly: Increasing Radiation Dose Awareness in Pediatric Interventions Through an International Social Marketing Campaign (Special Communication, Journal of Vascular and Interventional Radiology, 2009)
Image Gently Campaign: Using Lowest Dose Necessary to Perform Interventional Radiology Procedures on Children; SIR Partners With Alliance for Radiation Safety in Pediatric Imaging
The Image Gently campaign has developed easily accessible online teaching materials and checklists to help interventional radiology providers use the lowest dose necessary to perform interventional procedures on children. Interventional physicians, medical physicists and radiologic technologists are encouraged to visit the Image Gently Web site to review these important materials and factor the information into their clinical decision making.
There is no doubt that interventional radiology procedures improve and save lives. However, children are more sensitive to radiation received from imaging scans than adults, and cumulative radiation exposure to their smaller, developing bodies could, over time, have adverse effects. When interventional procedures are the correct treatment for disease or injury, providers are, where appropriate, urged to
- Take time out: stop and child size the technique
- Step lightly on the fluoroscopy pedal
- Consider ultrasound or, when applicable, MRI guidance
"Interventional or image-guided, minimally invasive surgeries are increasingly replacing more invasive techniques. This latest extension of the Image Gently campaign can give interventional providers real world, practical guidance regarding how they can help ensure that the radiation dose administered to the patients is as low as possible given the particular circumstances of each case," said Marilyn Goske, M.D., chair of the Alliance for Radiation Safety in Pediatric Imaging, past board chair of the Society for Pediatric Radiology and Silverman chair for radiology education, Cincinnati Children's Hospital Medical Center.
New on the Image Gently Web site are
- Downloadable slide presentation for use by providers to teach their staff methods to reduce dose and maintain quality. Radiologists are encouraged to give this talk locally
- Downloadable checklist of dose reduction steps the team can review for each patient
- Downloadable outline of dose reduction and quality maintenance steps to take in the department
- Patient brochure including answers for parents about IR procedures. Providers can use this as a guide to communicate concerns and benefits of interventional procedures to patients.
"Interventional techniques are increasingly being used to treat many different types of disease and injury. The fantastic results that these approaches provide, as with all medical techniques, also come with their own potential questions and concerns. We health care providers want to ensure that these lifesaving procedures are performed with the utmost care and safety in children. In addition, the materials housed on the Image Gently site can help interventionalists clearly explain the benefits and considerations associated with these techniques," said Manrita Sidhu, M.D., pediatric and interventional radiologist, seattle radiologists, and clinical assistant professor, department of radiology, Seattle Children's Hospital, who is leading the interventional radiology component of the Image Gently campaign.
The Image Gently site also contains the latest research and educational materials to aid interventional radiologists, radiologic technologists, medical physicists and other imaging stakeholders in determining the appropriate techniques to be used in the imaging of children and how the radiation received from these exams may affect pediatric patients over time.
SIR joined the Alliance in fall 2008 and is an active partner in promoting the Image Gently message. The September issue of JVIR includes an article, advertisement and sticker announcing the campaign launch, as well as a sticker bearing the Image Gently logo. The sticker is meant to be placed at the point of use on the fluoroscopy pedal or monitor as a quick visual reminder to reduce dose when possible.
A Commitment to Radiation Safety by the Society of Interventional Radiology
The Society of Interventional Radiology (SIR) has a long-term commitment to radiation safety and has taken a leading role in measuring and assessing radiation dosage; developing educational programs on radiation safety, radiation protection and reduction of skin dosage; and promoting the safety of patients and health care professionals. The following timeline summarizes SIR activity since the early 1990s.
1992: SIR began educational workshops on radiation safety and exposure during its Annual Scientific Meeting. SIR members M. Victoria Marx, MD, and John Cardella, MD, participated as presenters during an ACR/FDA-sponsored workshop on fluoroscopic safety: ACR/FDA Fluoroscopy Workshop, Washington D.C., October 15-17, 1992.
1993: SIR members John Cardella, MD, and Stephen Balter, PhD, began serving on the International Electrotechnical Commission (IEC) Working Group 24. The Working Group's charge was to develop specific safety standards for interventional equipment. This project was completed and published in 2000.
1994: SIR was actively involved in helping FDA draft its September 1994 advisory, Avoidance of Serious X-ray-induced Skin Injuries to Patients During Fluoroscopically-Guided Procedures. SIR also developed and issued a statement, "Interventional Radiology Perspective on the Food and Drug Administration Warning on Fluoroscopy." This statement included a table detailing fluoroscopically-guided procedures and typical fluoroscopy times. The table identified procedures that rarely, if ever, required exposure times that would result in skin injury when performed by trained professionals using appropriate equipment. SIR was closely involved in the development of the FDA's September 1995 advisory Recording Information in the Patient's Medical Record That Identifies the Potential for Serious X-ray-induced Skin Injuries. SIR's Annual Scientific Meeting included a plenary session focused on radiation safety and exposure.
1995: The Society created the SIR Radiation Safety and Exposure Task Force under the FDA Committee.
1996: SIR began the complex task of discussing how to measure radiation exposure for interventional procedures. Methods considered were direct measurement and a computer modeling plan. Advances in equipment facilitated the ability to directly measure radiation dose by the time the study was initiated in 1998.
1997: SIR's Standards Division began work on an adverse events reporting system, which evolved into a classification system that defines and rates the severity of complications, including radiation exposure and complications considered to be medical errors.
1998: John Cardella, MD, and M. Victoria Marx, MD, began three-year terms on the FDA Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). A major prospective study was initiated by the SIR Radiation Safety and Exposure Task Force aimed at measuring and reducing radiation dosage during image-guided procedures: "Determination of Skin Entrance Radiation Dose for Certain Interventional Radiology Procedures" (the RAD-IR study).
1999: Data collection started for SIR's multicenter RAD-IR study, led by SIR member Donald Miller, MD. Data on more than 2,100 cases were collected before the study was completed in 2002. The project was funded by the Cardiovascular and Interventional Radiology Research and Education Foundation (CIRREF). The results were published in the Journal of Vascular and Interventional Radiology (JVIR) in three parts in 2003 and 2004. SIR also created the Medical Errors Task Force.
2000: SIR initiated multisociety comments (SIR/ASITN/ASNR) on the International Commission on Radiological Protection (ICRP) Draft Report Avoidance of Radiation Injuries From Interventional Procedures. In response to FDA's request for an early look at the SIR data from the RAD-IR study, the Society provided FDA with a confidential report. The IEC Working Group 24 Guidelines were published by the IEC as a worldwide standard (IEC 60601-2-43). FDA moved forward to harmonize U.S. equipment regulations with the world standard. SIR was actively involved in both efforts. SIR initiated multisociety comments (SIR/ASITN/ASNR) on FDA's Assessment of the Impact of the Proposed Amendments to the Diagnostic X-ray Equipment Performance Standard Addressing Fluoroscopic X-ray Systems.
2001: SIR developed a Radiation Safety Position Statement, which was published in JVIR. SIR reviewed the FDA's proposed statement regarding Joint Commission standards and privileges to use fluoroscopic X-ray equipment. SIR informed FDA that the Society agrees in principle with the concept of a national fluoroscopy license. SIR believes it is important for professional societies whose members are significant users of fluoroscopic equipment to support this concept. The SIR Standards of Practice Committee began developing clinical practice guidelines on radiation safety.
2002: SIR conducted a plenary session and workshop on radiation safety and radiation protection at the Annual Scientific Meeting; topics included reducing skin dose.
2003: SIR members began serving on IEC Maintenance Team 38. The Maintenance Team's charge was to develop safety standards for radiography and fluoroscopy equipment. SIR members Stephen Balter, PhD, and Donald Miller, MD, began work as members of an International Atomic Energy Agency (IAEA) Coordinated Research Project entitled Exploring the Possibility of Establishing Reference Levels for Interventional Radiology. The results were published in Medical Physics in 2008 and as IAEA Safety Report Series No. 59 in 2009.
2004: SIR's Standards of Practice Committee developed a document entitled "Quality Improvement Guidelines for Recording Patient Radiation Dose in the Medical Record," which was published in JVIR. SIR member Donald Miller, MD, proposed development of a common user interface for interventional fluoroscopic equipment to the National Electrical Manufacturer's Association (NEMA). With advice and input from SIR and its members, this guidance for this interface was published in 2008 as NEMA Standard XR 24. The Society established the Safety and Health Committee, which is responsible for radiation safety matters. The SIR Annual Scientific Meeting included courses on patient radiation safety.
2005: In cooperation with the National Cancer Institute (NCI), SIR developed a brochure for physicians entitled "Interventional Fluoroscopy: Reducing Radiation Risks for Patients and Staff." This was published by NCI in 2005 as NIH Publication No. 05-5286. SIR was a founding member of the Multispecialty Occupational Health Group (MSOHG), composed of interventional radiology, interventional neuroradiology, interventional cardiology, cardiac electrophysiology and medical physics societies that represent the vast majority of the interventionalists in the United States.
2006: SIR members began serving on International Electrotechnical Commission (IEC) Maintenance Team 41. The Maintenance Team's charge was to review and revise IEC 60601-2-43, the IEC safety standard for safety of interventional fluoroscopy equipment. The revised document will be published in 2010. SIR became a collaborating organization with the National Council on Radiation Protection & Measurements (NCRP). Two SIR members are already members of council of NCRP.
2007: The SIR Annual Scientific Meeting included a maintenance of certification course on radiation risk. SIR's journal, JVIR, instituted a new section, IR Safety Rounds. A third SIR member was elected a member of the council of NCRP. SIR member Bob Dixon, MD, led a group of SIR members who began development of a curriculum in radiation management and radiation safety to be included in interventional radiology fellowship training. SIR members began work as chair and vice-chair of an NCRP committee drafting a new NCRP report to be entitled "Radiation Dose Management for Fluoroscopically Guided Interventional Procedures." SIR collaborated with the American College of Radiology (ACR) in the revision of four interventional radiology-related ACR practice guidelines (abscess drainage, needle biopsy, venography and radioembolization).
2008: The SIR representative at the American Board of Radiology Summit on Radiation Safety led a session on developing practice quality improvement (PQI) projects for angiography and fluoroscopy. SIR member Craig Glaiberman MD, began developing PQI projects on radiation management for SIR. These were completed, approved by the American Board of Radiology, and made available in 2009. The SIR Annual Scientific Meeting included a workshop on radiation safety. SIR collaborated with ACR in the revision of four interventional radiology-related ACR practice guidelines (clinical practice, reporting and archiving, vertebroplasty, and diagnosis and treatment of renal artery stenosis).
In addition, SIR joined the Alliance for Radiation Safety in Pediatric Imaging in August 2008. SIR is working with the Alliance to ensure safe, high quality pediatric imaging nationwide through the Image Gently Campaign.
2009: The SIR Annual Scientific Meeting included a workshop on radiation safety and a separate session on patient safety in interventional radiology. SIR member Michael Stecker, MD, and other members of the SIR Safety and Health Committee, in cooperation with the Standards of Practice Committee of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), developed a document entitled Guidelines for Patient Radiation Dose Management, which was endorsed by both societies and published in 2009 in JVIR. Also in 2009, the MSOHG published Occupational Health Hazards in the Interventional Laboratory: Time for a Safer Environment. This document was published simultaneously in JVIR, Radiology, Heart Rhythm and Catheterization and Cardiovascular Interventions. SIR collaborated with ACR in the revision of four interventional radiology-related ACR practice guidelines (cerebrovascular MRA, cervicocerebral angiography, sedation and IVC filters).
2010: The SIR Annual Scientific Meeting program includes a workshop on radiation safety and a presentation on radiation management when interventional procedures must be performed on pregnant patients. SIR member Donald Miller, MD, in cooperation with the Standards of Practice Committee of CIRSE and other members of the SIR Safety and Health Committee, developed a document entitled Occupational Radiation Protection in Interventional Radiology, which will be published in 2010 in Cardiovascular and Interventional Radiology (CVIR) and JVIR. SIR is collaborating with ACR in the revision of four additional interventional radiology-related ACR practice guidelines.