Today’s Top Story
FDA announces recall of certain Hospira products due to possible contamination.
The U.S. Food and Drug Administration (FDA) reports that Hospira, Inc. is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials due to microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. However, FDA states that the possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately. Read more and view the affected lots…

Other News

AAHKS and ACR release guideline on management of antirheumatic medication for certain joint arthroplasty patients.
The American Association of Hip and Knee Surgeons (AAHKS) and the American College of Rheumatology (ACR) have jointly published a guideline on the perioperative management of antirheumatic medication for patients with rheumatic diseases who undergo elective total hip arthroplasty (THA) or total knee arthroplasty (TKA). Primary recommendations include:

  • Nonbiologic disease-modifying antirheumatic drugs (DMARDs) may be continued throughout the perioperative period in patients with rheumatoid arthritis, spondyloarthritis, juvenile idiopathic arthritis, and lupus undergoing elective THA or TKA.
  • Biologic medications should be withheld as close to one dosing cycle as scheduling permits prior to elective THA or TKA, and restarted after evidence of wound healing, typically 14 days, for all patients with rheumatic diseases.

The guideline is based on a multi-step systematic literature review conducted by 31 specialists from more than 20 hospitals and professional organizations. Read the complete guideline…

Study: ACL reconstructions are on the rise among adolescent females.
A research letter published online in the journal JAMA Pediatrics notes a strong increase in the rate of anterior cruciate ligament (ACL) reconstruction among adolescent females. The researchers reviewed data on 283,810 ACL reconstructions performed in the United States from 2002 through 2014. They found that ACL reconstruction rates per 100,000 person-years rose 22 percent overall, from 61.4 in 2002 to 74.6 in 2014. Overall, males were more likely than females to undergo ACL reconstruction. However, the rate of ACL reconstruction for females grew 34 percent over the study period, compared to 13 percent for males. In addition, females and males aged 13 to 17 years saw the highest absolute increases in ACL reconstruction rates. The researchers write that the rise in rates among adolescent female patients was so steep that, “by the end of the study period in 2014, they had a higher rate of ACL reconstruction than any other age-sex strata.” Read more…
Read the abstract…

Study: Racial disparities in surgical mortality may be narrowing over time.
Data from a study published in the June issue of the journal Health Affairs suggest a reduction in racial disparities for surgical mortality. The authors reviewed Medicare inpatient claims data from 2005 through 2014 for five high-risk and three low-risk procedures, including hip arthroplasty and knee arthroplasty. Based on 30-day mortality rates, they found that national mortality trends improved by 0.10 percent per year for black patients and by 0.07 percent per year for white patients, which significantly narrowed the black-white difference. Read the abstract…

Study: Interns and residents may not come forward when they observe unprofessional behavior.
A study published online in the journal The BMJ suggests that interns and residents may be unlikely to speak up when presented with unprofessional behavior, even when they perceive a high potential for patient harm. The research team queried 837 medical and surgical interns and residents from six academic medical centers in the United States regarding professional behavior vignettes. They found that 75 percent perceived unprofessional behavior, and of those, 46 percent said they would speak up regarding that behavior. In addition, 49 percent perceived traditional safety threats, and of those 71 percent said they would speak up in response. Overall, respondents were less likely to speak up to an attending physician in the professionalism vignette than the traditional safety vignette, even when they perceived a high potential for patient harm. Read more…
Read the abstract…

FDA seeks to develop new certification channel for certain low-risk products.
An article in Healthcare IT News reports on comments from FDA commissioner Scott Gottlieb, MD, regarding implementation of a third-party certification program that would allow low-risk products to be marketed without premarket review. The agency is investigating the development of a third-party certification program to oversee medical technologies such as software and certain digital devices. The agency intends to provide guidance for products with multiple software functions and other products with “low enough risks that the FDA does not intend to subject them to certain pre-market regulatory requirements,” Dr. Gottlieb said. “Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA’s compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher-risk priorities.” Read more…

Call for volunteers: Communications Cabinet.
June 30 is the last day to submit your application for chair of the Communications Cabinet. The Communications Cabinet directs and evaluates AAOS communication vehicles, undertakes special communications projects, and provides public and media relations expertise to various AAOS governance units. Applicants for this position must be active fellows with strong knowledge, experience, and interest in communications, and experience in writing and editing nonclinical documents. Learn more and submit your application…(member login required)