Today’s Top Story
FDA announces recall of one lot of Hospira Vancomycin Hydrochloride for Injection.
The U.S. Food and Drug Administration (FDA) states that Hospira is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level, due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial. In the event the particulate is administered to a patient, it may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma. The agency states that no adverse events have been reported as of Aug. 31. However, anyone with an existing inventory of the recalled lot should stop use and distribution, and immediately quarantine it. Read more…

Other News

FDA letter recommends use of thermoregulating devices during surgery, notes no consistent link to SSI.
The FDA Center for Devices and Radiological Health issued a letter to healthcare providers, stating that use of thermoregulating devices during surgery—including forced air thermoregulating systems—has been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients. The agency notes that some clinicians have elected not to use such systems during surgical procedures, including joint arthroplasty, due to concerns of increased risk of surgical site infection (SSI). “After a thorough review of available data,” the letter states, “the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and [SSI]. Therefore, the FDA continues to recommend the use of thermoregulating devices, including forced air thermal regulating systems, for surgical procedures when clinically warranted.” Read more…

Study: Distal femoral angle linked to loss of quadriceps strength after TKA.
Data from a study published in the September issue of The Journal of Arthroplasty suggest that distal femoral angle (DFA) may be linked to reductions in quadriceps strength following total knee arthroplasty (TKA). The research team reviewed information on 73 patients (mean age 62 years; mean body mass index 29.7 kg/m2) who had undergone primary, unilateral TKA at a single institution. At 1- and 6-month follow-up, the researchers found that DFA was significantly associated with changes in quadriceps strength. They state that no other measures of lower extremity alignment (mechanical axis, proximal tibial angle, and patellofemoral angle) were found to contribute to quadriceps strength in the sample cohort. Read the complete study…

CDC announces sepsis education initiative.
The U.S. Centers for Disease Control and Prevention (CDC) launched an educational initiative emphasizing the importance of early recognition and timely treatment of sepsis, as well as the importance of preventing infections that could lead to sepsis. Among other things, the Get Ahead of Sepsis initiative calls on healthcare professionals to educate patients, prevent infections, suspect and identify sepsis early, and quickly initiate sepsis treatment. In addition, the program urges patients and their families to prevent infections, be alert to the symptoms of sepsis, and seek immediate medical care if sepsis is suspected or for an infection that is not improving or is getting worse. Read more…
View the Get Ahead of Sepsis home page…

Starting in 2020, newly insured Medicare beneficiaries will be required to pay Part B deductibles themselves.
The U.S. Centers for Medicare & Medicaid Services released a notice to remind providers of a section of the Medicare Access and CHIP Reauthorization Act (MACRA) that will affect Medicare supplemental insurance (Medigap) policies starting in 2020. Starting Jan. 1, 2020, the relevant section will prohibit sale of Medigap plans with first-dollar coverage to newly eligible Medicare beneficiaries. The agency states that such newly eligible Medicare beneficiaries will be required to pay out-of-pocket for the Medicare Part B deductible. The Part B deductible for 2016 was $166 and for 2017 it is $183. Read the notice…

New Jersey.
The Associated Press reports that the governor of New Jersey introduced a proposed regulation that, if implemented, would cap payments from pharmaceutical companies to prescribers at $10,000 per year. In addition, the proposal would prohibit prescribers from accepting certain gifts but would permit meals under $15 and compensation received for speaking at continuing education events. Supporters of the rule argue that it would help reduce conflicts of interest and improve patient care. A public hearing on the proposal is scheduled for Oct. 19, 2017. Read more…

Last call: AMA nominee to the ACGME Review Committee for Orthopaedic Surgery.
AAOS seeks to nominate members to the Accreditation Council for Graduate Medical Education (ACGME) Review Committee for Orthopaedic Surgery. The nomination is for the American Medical Association (AMA) member candidate nominated by the AMA Board of Trustees. Applicants for this position must be AAOS active fellows, AMA members, and have expertise or fellowship training in oncology or spine. In addition, all applicants must provide the following: an online AAOS CAP application, an electronic application for AMA Nomination for External Leadership Position, a current abbreviated curriculum vitae (not to exceed three pages), a current full-curriculum vitae, and a brief biosketch. The AMA nomination application, curriculum vitae, and biosketch. Submit materials to Kyle Trivedi by Sept. 4, 2017, at 11:59 p.m. CT, at: trivedi@aaos.org.
Learn more and submit your application…(member login required)
Learn more and obtain the AMA nomination form…

The AAOS offices will be closed and AAOS Headline News Now will not be published on Labor Day, Monday, Sept. 4. Publication will resume on Sept. 6.