Technology | August 02, 2013

FDA Clears X-Ray Attenuating Cream to Protect Physicians' Hands Under X-Ray

Cream offers some degree of protection from radiation exposure

August 2, 2013 — The U.S. Food and Drug Administration (FDA) recently granted market clearance for a hand lotion designed to offer radiation protection from X-rays. Physicians such as interventional cardiologists who work with live angiographic fluoroscopic X-ray systems often have their hands in the radiation field during imaging. The cream, developed BloXR Corp., is applied prior to donning gloves, or over a glove with another glove on top, to serve as a lightweight radiation shield.

BloXR’s X-ray Attenuating Cream is intended to be used during medical procedures where hands are necessarily exposed to radiation, to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures. X-ray Attenuating Cream is not intended to be used in or adjacent to the primary X-ray beam or the transmitted beam, and should not be used in lieu of a radiographic procedure glove, which is used in radiography for those studies requiring the physician’s hand or forearm be in the direct path of the primary X-ray beam.

The FDA has identified the risks of cream for X-ray attenuation as adverse tissue reaction from direct contact to the skin and infection risk to the patient as a result of patient contact with contaminated/compromised cream due to glove failure. Glove failure could occur due to incompatibility with the cream formulation, weakening the mechanical characteristics of the surgical gloves.

The FDA also said in its approval letter that the cream could pose a radiation exposure risk to healthcare professionals due to lack of radiation attenuation, which can occur due to inadequate or inconsistent cream formulation. The radiation attenuating agent in the cream may not be present in high enough concentration or is not appropriate to provide the amount of protection needed. Lack of continuous protection during actual use can also result from poor cream composition such that the cream will absorb, crack or flake off during use in a clinical setting. For these reasons, the FDA will require a black box warning on the cream.

For more information:

Related Content

Mirion Technologies Introduces Instadose Radiation Dosimeter
Technology | Radiation Dose Management | February 08, 2018
The Instadose + dosimeter, the latest by Mirion Technologies, transforms...
FDA Releases New Guidance on Children's X-ray Exams
Feature | Pediatric Imaging | January 26, 2018
Most people have had an X-ray taken at some time during their lives — perhaps checking for a possible broken bone or...
Philips Introduces Technology Maximizer Program for Imaging Equipment Upgrades
Technology | Imaging | January 17, 2018
January 17, 2018 — Philips recently announced the launch of Technology Maximizer, a cross-modality program designed t
Videos | RSNA 2017 | December 20, 2017
ITN and DAIC Editor Dave Fornell takes a tour of some of the most interesting new medical imaging technologies on the
Sectra Offers Gadolinium Tracking Functionality in DoseTrack Software
Technology | Contrast Media | December 11, 2017
December 11, 2017 — Sectra recently announced the global introduction of gadolinium tracking in its dose monitoring s
Philips Azurion Platform Improves Clinical Workflow and Staff Experience Benefits
News | Angiography | December 04, 2017
Philips recently announced the results of a comprehensive, independent, two-year study demonstrating the clinical...
Philips Azurion Image-Guided Therapy Platform Improves Clinical Workflow for Interventional Procedures
News | Angiography | November 15, 2017
Philips announced the results of a comprehensive, independent, two-year study demonstrating the clinical workflow...
Siemens Healthineers Introduces Share360 Tailored Service Portfolio
News | Imaging | November 10, 2017
November 10, 2017 — To address the specific needs of...
GE Healthcare and Medis Collaborate to Expand Availability of Quantitative Flow Ratio Software
News | Angiography | November 10, 2017
GE Healthcare and Dutch-based cardiovascular imaging software provider Medis announced at the 2017 Transcatheter...
UnityPoint Health Installs Infinix-i 4-D CT System for Interventional Procedures
News | Interventional Radiology | November 08, 2017
November 8, 2017 — Physicians at UnityPoint Health Methodist, Peoria, Ill., are now offering fast, safe and accurate
Overlay Init