January 19, 2018
Today’s Top Story

FDA announces recall of one lot of AuroMedics Levofloxacin in 5% Dextrose Injection

The U.S. Food and Drug Administration reports that AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, with an expiration date of May 2018. The product is packaged in a carton containing 24 bags and can be identified as a single-use, ready-to-use flexible plastic infusion bag in a foil laminate overwrap. The product has been found to contain visible particulate matter tentatively identified as mold.

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Other News

HHS opens new Conscience and Religious Freedom Division

The U.S. Department of Health & Human Services (HHS) has announced the formation of a Conscience and Religious Freedom Division within the existing HHS Office for Civil Rights. According to HHS, the division will help the agency enforce existing laws protecting the rights of conscience and religious freedom of healthcare providers. However, some observers have voiced concerns that the move may have the effect of legitimizing certain forms of discrimination.

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Read the HHS announcement…

Read the HHS proposed rule…

CMS updates Open Payments database

The U.S. Centers for Medicare & Medicaid Services (CMS) has updated the Open Payments database to reflect changes that have taken place since the last publication on June 30, 2017. The update includes changes to non-disputed records made on or before Nov. 15, 2017; dispute resolutions completed on or before Dec. 31, 2017; and records with active disputes that remained unresolved as of Dec. 31, 2017, which are displayed as disputed.

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Visit the CMS Open Payments site…

Study: Next-generation sequencing may help identify cause of PJI

Findings published in the Jan. 17 issue of The Journal of Bone & Joint Surgery suggest that next-generation DNA sequencing may be used to help identify causative organisms associated with periprosthetic joint infection (PJI). The authors collected samples from 65 revision arthroplasties (39 knees and 26 hips) and 17 primary arthroplasties (eight knees and nine hips). They found that among 28 revisions considered to be infected, cultures were positive in 17 cases and next-generation sequencing was positive in 25 cases, with concordance across both methods in 15 cases. The authors note that next-generation sequencing identified microbes in nine of 36 aseptic revisions with negative cultures and in six of 17 primary total joint arthroplasties.

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Study: Preoperative PT intervention linked to reduced PT time for certain arthroplasty patients

According to a study published in the January issue of the journal Clinical Orthopaedics and Related Research, a one-on-one preoperative physical therapy (PT) education session along with web-based information may help reduce time to PT discharge for patients undergoing unilateral total hip arthroplasty (THA) or total knee arthroplasty (TKA). Members of the research team conducted a prospective study of 126 typical arthroplasty patients, 63 of whom received a one-time, one-on-one session with a physical therapist and given access to a lateralized, joint-specific microsite with detailed information on exercises, transfers, ambulation, and activities of daily living, and 63 of whom received no additional information. Compared to patients in the control cohort, patients in the intervention cohort had fewer postoperative inpatient PT visits and achieved readiness to discharge from PT more quickly. However, the researchers note that there was no significant difference in length of stay or Western Ontario and McMaster Universities Osteoarthritis Index scores at 6-week follow-up.

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Study: “Weekend effect” may affect risk of mortality for surgical patients

A study published in the February issue of the journal Medical Care suggests that the so-called “weekend effect” may impact risk of postoperative mortality for both elective and urgent/emergent surgery. The researchers conducted a systematic review and meta-analysis of 10 elective surgery studies covering more than 6,685,970 patients and 19 urgent/emergent surgery studies covering at least 1,424,316 patients. They found that the pooled odds of mortality following elective surgery rose in a graded manner as the day of the week of surgery approached the weekend. In addition, they found that mortality was higher among patients who underwent urgent/emergent surgery after admission on the weekend, compared to patients admitted on a weekday.

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Your AAOS

Call for volunteers: Orthoinfo—trauma section editor

Jan. 31, 2017, is the last day to submit an application for the position of Orthoinfo—trauma section editor. OrthoInfo.org provides AAOS members, patients, and the general public with authoritative information on a wide range of musculoskeletal issues and treatments. The section editor must be an active or emeritus fellow, and will be engaged by the Academy as an independent contractor on an annual basis. Applicants for this position must submit the following: an online AAOS CAP application, a current curriculum vitae, a cover letter detailing one’s interest and qualifications, and three references, to Laura Giblin, at:

giblin@aaos.org

Learn more and submit your application…  (member login required)

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