FDA alerts hospitals, surgical centers to sterilizer product recall    07/05/2012
The Food and Drug Administration Tuesday announced the voluntary recall of a product used by hospitals and surgical centers to monitor the effectiveness of certain sterilization systems. An FDA review showed that the Sterrad Cyclesure 24 Biological Indicator, made by Advanced Sterilization Products, cannot effectively monitor the sterilization process throughout its stated 15-month shelf life. The agency recommends hospitals and other health care facilities determine the new expiration date by subtracting nine months from the expiration date printed on the product's packaging; manually re-label non-expired product cases with the new expiration date; return outdated product as instructed in the ASP recall notice; and use an appropriate alternative sterilizer if available.
CMS announces new deadline for Strong Start grant   07/05/2012
The Centers for Medicare & Medicaid Services has extended the grant application deadline for the Strong Start for Mothers and Newborns initiative to Aug. 9 and made the letter of intent optional, the agency announced Tuesday. In addition, CMS said the revised funding opportunity announcement shifts the responsibility for obtaining linked state vital statistics and Medicaid claims and utilization data from the applicant to CMS. "We believe these adjustments will promote a more diverse and robust applicant pool, and increase our likelihood of success in achieving the number of births required to test the models," CMS said. Announced in April, the Strong Start initiative will award up to $43.2 million in grants to hospitals and others to test new approaches to prenatal care for Medicaid enrollees at risk for pre-term births. In addition, the public-private initiative will work with the AHA and its Health Research & Educational Trust affiliate to reduce early-term, non-medically necessary deliveries at hospitals through CMS' Partnership for Patients campaign.
FDA approves test to help manage infection in organ transplant patients   07/05/2012
The Food and Drug Administration today approved the first DNA test to help health care professionals gauge the progress of anti-viral treatment for cytomegalovirus in organ transplant patients. Cytomegalovirus is a common virus that can cause severe diseases, such as pneumonia or colitis, in patients with weakened immune systems. For more information, see the FDA news release.