NEWS

February 2010

STERILIZATION
FDA extends time period for transitioning from Steris Modified System 1 processor
The U.S. Food and Drug Administration (FDA) is extending to 18 months from the date of Feb. 2, the total recommended time period for transitioning from Steris Corporation’s modified System 1 processor to legally-marketed alternative devices.

The FDA issued a notice on Dec. 3 to health care facility administrators and infection control practitioners conveying agency concerns about the STERIS System 1 Processor (SS1). FDA has not approved or cleared the currently-marketed SS1 and the agency has not determined whether it is safe or effective for its labeled claims, including claims that it sterilizes medical devices.

FDA recommended health care facilities transition to an acceptable alternative to the SS1 to meet sterilization and disinfection needs within a three to six month period. However, the FDA states that a three to six month transition period may present significant difficulties for some healthcare facilities, which could, in turn, adversely affect patient care. Learn more.

PATIENT SAFETY
Joint Commission alert: Preventing deaths during, after pregnancy
Preventing maternal deaths is the subject of a Jan. 26 Sentinel Event Alert issued by The Joint Commission. Common preventable causes that lead to maternal deaths include hemorrhage following a Cesarean section, failure to pay attention to vital signs after a Cesarean section, uncontrolled high blood pressure, and undiagnosed fluid build-up in the lungs of women with pre-eclampsia. Pre-existing medical conditions such as high blood pressure also put women at greater risk for death during or shortly after pregnancy.

The most current statistics from the Centers for Disease Control and Prevention (CDC) show that there are 13.3 maternal deaths per 100,000 live births, well over the target of 3.3 maternal deaths per 100,000 live births set as part of the U.S. government’s Healthy People 2010 initiative. Common preventable causes that lead to maternal deaths include uncontrolled high blood pressure, undiagnosed fluid build-up in the lungs of women with pre-eclampsia, failure to pay attention to vital signs after a Cesarean section, and hemorrhage following a Cesarean section.

To prevent pregnancy-related deaths and severe illness, The Joint Commission’s Sentinel Event Alert suggests that hospitals take a series of six specific steps, including:

Educate physicians and other caregivers about underlying conditions such as high blood pressure, diabetes or morbid obesity that may put women at risk if they become pregnant.
Use specific protocols to treat pregnant women who have, for example, experienced a change in vital signs, hemorrhage or pre-eclampsia.
Train emergency room staff to consider whether female patients may be pregnant or recently pregnant. Pregnancy can affect the diagnostic process or change a woman’s response to treatment.

Read the full Sentinel Event Alert.

ACCREDITATION
CMS designates The Joint Commission for advanced diagnostic imaging accreditation
The Joint Commission is now a designated accreditor of advanced diagnostic imaging centers by the Centers for Medicare and Medicaid Services (CMS), according to a CMS designation announcement that appears in the Jan, 26, 2010 Federal Register.

Medicare suppliers furnishing the technical component of advanced diagnostic imaging services must become accredited by a CMS-designated accrediting organization, such as The Joint Commission, by Jan. 1, 2012 in order to qualify for Medicare reimbursement payments. This new rule affects providers of MRI, CT, PET and nuclear medicine imaging services for Medicare beneficiaries on an outpatient basis.

The requirement is expected to impact more than 7,000 health care organizations that use advanced diagnostic imaging services. Find more information here.

LEGISLATION
Report documents health and financial benefits to chemical reforms
The American Nurses Association joins the Safer Chemicals, Healthy Families coalition in touting the release of new analysis on the need for toxic chemical legislation reform. “The Health Case for Reforming the Toxic Substances Control Act” provides evidence to support that rising rates of diseases and health care costs could be reduced by overhauling federal chemical policy.

The report summarizes a number of peer-reviewed studies that estimate the disease burden attributable to chemical exposure. Conservatively assuming that chemical policy reform were to reduce the contribution of toxic chemical exposures to chronic diseases by 0.1 percent, the resulting reduction in annual health care costs would amount to an estimated $5 billion. The Safer Chemicals, Healthy Families coalition has estimated health care cost savings on a state-by-state basis, using census figures projected for 2020. Read more at www.nursingworld.org.

RESEARCH
Lighter sedation for elderly during surgery may reduce risk of confusion, disorientation after
New findings from a Johns Hopkins study in hip fracture patients suggest a 50 % drop in risk of postoperative delirium--a common complication following surgery in elderly patients—when limiting the depth of sedation during procedures.

In a double-blind randomized study of 114 patients undergoing hip fracture repair at Johns Hopkins Bayview Medical Center, patients first received spinal block anesthesia and were then either lightly sedated with propofol or more deeply sedated with the same medication. The prevalence of postoperative delirium was significantly lower in the group that was lightly sedated. The findings, which appear in the January issue of Mayo Clinic Proceedings, suggest that one incident of delirium could be prevented for every 4.7 patients treated with light sedation. The average age of the patients in the study was 81.

Frederick E. Sieber, MD, an associate professor of anesthesia at the Johns Hopkins University School of Medicine and director of anesthesiology at Johns Hopkins Bayview Medical Center says propofol and similar anesthetics may not behave as the clear “on/off phenomena” they were long thought to be, with effects disappearing as soon as the drugs are withdrawn. “What our study indicates,” he says, “is that there may be lingering effects of anesthesia that heretofore may not have been appreciated, especially in the elderly.”

To find the report, visit www.hopkinsmedicine.org/Press_releases/2010/01_20_10.html.