MAY/JUNE 2009
FDA Warns About Risk of Wearing
Medicated Patches During MRIs
Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. According to the U.S. Food and Drug Administration, the patches, if worn while undergoing magnetic resonance imaging scans, can cause skin burns. The patches of concern include both brand-name and generic products and patches purchased over the counter without a prescription.
The FDA issued a public health advisory on transdermal drug patches after learning that a warning was missing on some patches that contain aluminum or other metals in their non-adhesive backing. The backing is the portion of the patch not in direct contact with the skin. While not attracted to the magnetic field of the MRI, the metal can conduct electricity, generating heat that can cause burns. Users of the patches reported receiving skin burns at their patch site when wearing the patch during an MRI scan.
“The risk of using a metallic patch during an MRI has been well-established, but the FDA recently discovered that not all manufacturers include a safety warning with their patches,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Because the metal in these patches may not be visible and the product labeling may not disclose the presence of metal, patients should tell both their health care professional and their MRI facility that they wear a medicated adhesive patch.”
Risk Management Recommendation:
Before performing MRIs, questions should be asked regarding medicated adhesive patches and patches should be removed if clinically advisable. Please see this article for more advice relating to MRI safety.
CDC Report Reveals Increase in GBS Disease
The overall rate of early-onset group B streptococcus disease increased from 2003 to 2006, according to a Feb. 13, 2009, Centers for Disease Control and Prevention article in the Morbidity and Mortality Weekly Report. Although rates of late-onset GBS disease remained stable over the observed time frame, the CDC explains that continued monitoring of early-onset GBS disease is needed, especially among African American infants, to determine whether additional interventions are warranted. According to the report, the CDC will work with the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and other partners to update the guidelines on preventing perinatal GBS disease within the coming year. The planned update will focus on both the laboratory and clinical components of the guidelines and will be based on data accumulated by the CDC since 2002. The CDC currently recommends universal prenatal screening for GBS.
Risk Management Recommendation:
GBS can colonize the female genitourinary tract and can be transmitted from mother to baby during pregnancy, labor or delivery. It is a leading cause of neonatal sepsis and meningitis. Because GBS infection can inflict severe injury or death, professional liability cases involving GBS disease can result in high jury verdicts and settlements. Risk managers should keep current on published standards and guidelines and review hospital policies to ensure that they are consistent with current standards.
The Joint Commission Publishes
Monograph on Hand Hygiene Adherence
The Joint Commission has released a monograph, Measuring Hand Hygiene Adherence: Overcoming the Challenges, to assist health care organizations in measuring hand hygiene performance. A lack of standardized approaches to measuring hand hygiene performance makes it difficult for health care organizations to determine whether overall performance is improving as they introduce new interventions. These variations in approaches to measurement also make rates of adherence to hand hygiene guidelines difficult to compare. The monograph includes a framework to help health care workers make necessary decisions about when and why to perform hand hygiene and how to measure compliance with hand hygiene requirements, systematically reviews the strengths and weaknesses of commonly used approaches, and provides examples of measurement methods and tools submitted by organizations through the Consensus Measurement in Hand Hygiene project.
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Inside This Issue
FDA Warns About Risk of Wearing Medicated Patches During MRIs
CDC Report Reveals Increase in GBS Disease
The Joint Commission Publishes Monograph on Hand Hygiene Adherence
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THIE Board
John L. Simms
Chair
President/Chief Executive Officer
Trinity Medical Center, Brenham
Thomas Kennedy
Vice Chair
Chief Executive Officer Consultant
Rolling Plains Memorial Hospital, Sweetwater
Dan Stultz, M.D., FACP, FACHE
Secretary
President/Chief Executive Officer
Texas Hospital Association, Austin
Lance Gatlin
Administrator
Parmer County Community Hospital, Friona
Steve Hartgraves
Chief Executive Officer
Graham Regional Medical Center
Jim Smith
Director Emeritus
Goodall-Witcher Healthcare Foundation, Clifton
Kenneth Poteete
President Emeritus
Georgetown Healthcare System Foundation
Evan Moore, FACHE
Chief Executive Officer
D.M. Cogdell Memorial Hospital, Snyder
Sandra Gayle Wright, Ed.D., RN
Chief Executive Officer
Tyler County Hospital, Woodville
Russell Tippin
Administrator/Chief Executive Officer
Pecos County Memorial Hospital, Fort Stockton
James Vanek
Chief Executive Officer
Lavaca Medical Center, Hallettsville
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