Radiation Exposure and the Need for Better Protection

Diagnostic and interventional imaging has revolutionized modern image-guided medicine. Driven by its benefits, the number of X-rays has exploded to 180 million and the number of CT scans to 60 million annually in the United States.1,2

Improvement in techniques and increased technical and anatomical complexity of the procedures will continue to fuel this rise. As a result, there is a heightened concern of occupational exposure to the harmful effects of ionizing radiation. Experts estimate that 29,000 additional cancers could arise from excessive radiation exposure per year.3

Recent literature points to potential causal links between excessive radiation exposure and malignancies.4 There is consensus that reducing radiation exposure to “as low as reasonably achievable,” or ALARA, is prudent in decreasing long-term consequences of chronic low dose exposure.5

The majority of occupational radiation exposure is derived from radiation scatter.6

This type of radiation emanates from the patient and from the X-ray source. Despite best practices, there is always the chance that the operator might insert parts of their anatomies into the primary beam. Historically, clinicians have used heavy, fatigue-inducing lead or “light-lead” aprons, which pose risks to clinicians in the form of spine injuries and debilitating back pain from their extended use.

With 50 percent of interventional clinicians suffering from spine injuries and 33% reporting occupational injury claims for back pain, effective lightweight radiation protection is crucial.7

In terms of hand protection, clinicians routinely forgo the use of radiation-attenuating gloves because of their diminished tactile feel, and thus are subject to radiation exposure to their hands. Studies show that clinicians’ hands receive among the highest scatter radiation doses.8,9 Signs of radiation overexposure include peeling skin, halted hair growth, and discoloration of the nail beds. It is recognized that “long-term, low doses of ionizing radiation can lead to significant somatic DNA damage in professionally exposed physicians.”10

A means to effectively cut radiation to unprotected hands without reducing tactile feel would be an important advance in radiation safety for the clinician.

XPF® and ULTRABLOX® Redefine Radiation Protection
BLOXR® XPF® Technology supplies radiation protection apparel with a novel bi-layered construction that uses a non-heavy metal combination of barium sulfate in one layer and bismuth oxide in the other layer. This design is optimized for the reduction of scatter radiation. The energy (keV) of scattered radiation is significantly less than that of the incident energy, due to Compton scattering.11

The K absorption edge of lead (69 keV) is higher than the energy of much of the scatter radiation energy present in medical imaging. The first layer of barium sulfate in XPF garments, with K edge of ~ 37 keV, has a higher mass attenuation coefficient than lead and thus can effectively reduce dose at lighter weight.

In reducing dose, barium sulfate itself generates fluorescent energy peaks at ~ 37 keV. These sub-40 keV peaks are known to be biologically more harmful. The second layer of bismuth oxide removes these fluorescence peaks. This barium sulfate upstream/bismuth oxide downstream bi-layer configuration is particularly effective in eliminating the more harmful sub-40 keV radiation spectrum, rendering XPF® Technology safer than other lead-free alternatives. Studies show that XPF offers the highest attenuation per unit weight, enabling lighter, more comfortable protective garments.

Because the XPF bilayers contain no heavy metals, there are no special disposal requirements. The XPF layers have also been demonstrated to be more flexible, strong and tear-resistant than conventional materials, withstanding over 1 million cycles of bending without cracking.12

XPF Radiation Protection Apparel is optimized to be safer, more comfortable and greener than traditional toxic, heavy metal-based radiation shielding. ULTRABLOX® Cream utilizes bismuth oxide as a radiocontrast agent to provide attenuation protection from harmful scatter radiation exposure in the diagnostic imaging range of up to 130 kVp. The cream is sterile and biocompatible. It contains no lead, lead by-products or other toxic metals.

Independent Clinical Evidence

Independently-conducted, randomized, prospectively controlled clinical studies show that XPF thyroid collars transmit 18 percent lower dose than 0.5mm Pb equivalent collars.13

Not only does XPF Technology provide greater overall dose reduction, but it also eliminates the more harmful sub-40 keV spectrum and is more comfortable and crack-resistant than other alternatives. Numerous other studies have also validated the performance benefits of XPF Technology in reducing scatter in actual clinical practice.14,15,16

In addition, XPF Radiation Protective Apparel is cleared by the FDA as 0.5mm Pb lead equivalent product (K110900).

ULTRABLOX Cream is the world’s first attenuating cream for protecting hands from scatter radiation without loss of tactile feel. Clinical studies have shown that ULTRABLOX Cream provides up to 85 percent dose reduction, twice that of sterile attenuating surgeon’s gloves.17,18

Clinicians can protect their hands without loss of tactile feel or dexterity. The ULTRABLOX X-Ray Attenuating Cream is cleared by the FDA (K123422, K133684).

Innovation in Radiation Protection
BLOXR® XPF® Radiation Protection Apparel and ULTRABLOX® X-Ray Attenuating Cream provide increased clinician safety through effective radiation dose reduction. These products can benefit clinicians who perform an estimated 1.25 million coronary interventions, 750,000 peripheral vascular interventions, 5 million angiograms, and more than 5 million orthopedic and spine procedures annually in the US.19

These clinicians are exposed to ionizing radiation on a daily basis and are subject to the chronic, cumulative effects of such exposure. BLOXR XPF Apparel features a comfortable, lightweight material that can be bent and folded without cracking, while providing 0.5mm lead equivalent protection — and is machine washable. ULTRABLOX X-Ray Attenuating Cream is the first and only X-ray attenuation cream. It is proven to reduce radiation exposure to a clinician’s hands by up to 85% without affecting dexterity or tactile feel.17,18

BLOXR® can be your new radiology supply leader. Contact Legacy Scientific today to learn how we can help service your professional medical supply needs.

REFERENCES: 1 Brenner, D. J. et al. “Computed Tomography – An Increasing Source of Radiation Exposure.” New England Jrnl of Med. Nov. 27, 2007. 357; 22, pp2277-2284. 2 “U.S. Markets for Computer-Aided Diagnostic Imaging Products.” MedTech Insight. Dec. 2009 3 Redberg, R. “Cancer Risks and Radiation Exposure from Computed Tomographic Scans.” Arch Intern Med. Vol 169 (No. 22), 2049, Dec 14/28, 2009. 4 Roguin, A., et al. “Brain and Neck Tumors Among Physicians Performing Interventional Procedures.” Amer. Jrnl of Cardiology.2013. 5 Balter, S. “Radiation Safety in the Cardiac Catheterization Laboratory: Operational Radiation Safety.” CCVI. 47:347–353 (1999). 6 Schueler, B. et al. “An Investigation of Operator Exposure in Interventional Radiology”. Mayo Clinic – Dept of Radiology. RadioGraphics 2006. RSNA. Vol. 26, No. 5, p. 1533-1540. 7 Goldstein, J.A. et al. “Occupational Hazards of Intervntnl Cardiologists: Prevalence of Orthopedic Health Problems in Contemporary Practice.” CCVI. 63:407–411 (2004). 8 Balter, S. “Radiation Safety in the Cardiac Catheterization Laboratory: Operational Radiation Safety.” CCVI. 47:347–353 (1999). 9 Whitby, M. et al. “Study of the Distribution of Dose Across the Hands of Interventional Radiologists and Cardiologists.” The British Jrnl of Radiology. Health Physics, Dept. of Clinical Physics and Bio-eng., Gartnaval Royal Hosp., Glasgow, UK. 2005 pgs. 219 – 229. 10 Uthoff, H. et al. ”Lightweight Bilayer Barium Sulfate–Bismuth Oxide Composite Thyroid Collars for Superior Radiation Protection in Fluoroscopy-guided Interventions: A Prospective Randomized Controlled Trial.” Radiology, doi: 10.1148/radiol.13122834, Oct. 2013. 11 McCaffrey, F. et al. “Radiation Shielding Materials and Radiation Scatter for IR Physicians.” Med. Phys. 39 (7), 4537, July 2012. 12 Internal testing 13 Uthoff, H. et al. Op. cit. 14 Mayekar, E et al. ”Radiation Exposure To The Orthopaedic Surgeon and Efficacy of a Novel Radiation Attenuation Product.” Southern Orthopaedic Soc. June, 2014. 15 Reeves, R. et al. “Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures.” SCAI Annual Mtg, May 2014. 16 Weisz, G. et al. ”X-ray Radiation Protection With a Disposable XPF Cervical Collar – Comparison To a Lead-Based Collar.” ICI Mtg, Tel Aviv, Dec. 2013. 17 Shah, S. et al. “Radiation Protection to Surgeons Hands with a Novel Radiation Attenuating Lotion” Amer. Acad. of Orthopaedic Surgeons. Scientific exhibit abstract 12 SE- 2596- AAOS. May, 2011. 18 Dougherty, E. et al. “Fluoroscopic Radiation to the Orthopedic Traumatologist’s Hand & Efficacy of a Novel Radiation Attenuation Product.” AAOS Annual Mtng, Chicago, Mar. 2013. 19 “U.S. Surgical Procedure Volumes.” MedTech Insight. Mar. 2009.