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Published 8/1/2015

Second Look—Advocacy

FDA Class I recall
The U.S. Food and Drug Administration has announced a Class I recall of Zimmer M/L Taper with Kinectiv Technology Prostheses manufactured and distributed between March 31, 2015, and April 20, 2015. The agency states that a process monitoring failure led to higher-than-expected amounts of manufacturing residues left on the femoral stems and necks. FDA states that the residues can cause serious adverse health issues including allergic reactions, pain, infections, or death, and that use of the affected products may require revision surgery to replace the implant.

Increase quality, decrease liability
Data in the American Journal of Medical Quality (May/June) suggest that increased quality improvement measures may be associated with a decrease in frequency of medical liability claims. In a comparison of two groups of hospitals (Texas and Louisiana) within the same multihospital organization, researchers found that tort reform in Texas was linked to a significant reduction in the number of medical liability claims. In Louisiana, they noted a significant correlation between increase in mean U.S. Centers for Medicare & Medicaid Services performance scores and decrease in claim frequency.

OIG increasing staff
Modern Healthcare
reports that the U.S. Department of Health and Human Services Office of Inspector General (OIG) plans to hire additional legal staff to increase scrutiny of physician payment arrangements. An OIG fraud alert warns physicians to carefully consider terms and conditions of medical directorships and other compensation arrangements that could violate the anti-kickback statute.

Hand washing practices
A report from nonprofit The Leapfrog Group finds that as many as 23 percent of hospitals surveyed may fall short in encouraging proper hand hygiene, although the percentage of hospitals that met all 10 of Leapfrog’s hand-hygiene practices increased from 69 percent in 2013 to 77 percent in 2014. However, in six states, only 60 percent or less of reporting hospitals met all practices.

Wisconsin physicians not meeting CME rules
An audit of licensed physicians in Wisconsin found that 8.3 percent of those selected were not in compliance with continuing medical education (CME) requirements. According to the Wisconsin State Journal, the audit conducted by the state Safety and Professional Services Department found that 94 of 1,135 medical doctors and 7 of 81 osteopathic doctors could not prove that they had completed their CME.

Copy-and-paste in EHRs
HealthLeaders Media note that so-called cloning of text may adversely affect patient care and may raise ethical issues if the pasted text misrepresents the work performed. Some Medicare Administrative Contractors have issued policies regarding the use of cloned documentation, noting that cloned documentation does not meet the medical necessity requirements and may lead to a denial of payment and/or recoupment of overpayments.

Coaches and concussions
According to survey information presented at the annual meeting of the National Athletic Trainers’ Association, many high school coaches have a good understanding of the signs and symptoms of concussion, but may often fail to follow recommended management guidelines. The online survey of 104 public high school coaches found that most coaches correctly identified symptoms such as confusion, headache, dizziness, blurred vision, loss of consciousness, nausea, and amnesia as indicators of concussion. However, although more than 90 percent of coaches knew appropriate management strategies in typical concussion scenarios, when faced with atypical scenarios, only 57 percent would appropriately remove an athlete from play.

Publications requiring data sharing
has announced a new policy to require upon-request data sharing of all clinical trials submitted to it for publication. According to an editorial The BMJ will extend its requirements for data sharing to apply to all submitted clinical trials, not just those that test drugs or devices, beginning July 1. A report released by the U.S. Institute of Medicine (IOM) in January 2015 called for “responsible data sharing to become pervasive, sustained, and rooted as a professional norm.”

Errors involving warfarin at nursing homes
A report released jointly by ProPublica and The Washington Post found that, from 2011 to 2014, at least 165 nursing home residents were hospitalized or died after errors involving warfarin. In addition, a 2007 study published in The American Journal of Medicine estimated that nursing home residents suffer 34,000 fatal, life-threatening, or serious events related to warfarin each year, and a 2011 report published in The New England Journal of Medicine found that the drug accounted for some 33,000 emergency hospitalizations among the elderly from 2007 to 2009—more than twice as many as the next highest drug, insulin.

These items originally appeared in AAOS Headline News Now, a thrice-weekly enewsletter that keeps AAOS members up to date on clinical, socioeconomic, and political issues, with links to more detailed information. Subscribe at www.aaos.org/news/news.asp (member login required)