Published 11/1/2010

Second Look—Advocacy

If you missed these Headline News Now items the first time around, AAOS Now gives you a second chance to review them. Headline News Now—the AAOS thrice-weekly, online update of news of interest to orthopaedic surgeons—brings you the latest on clinical, socioeconomic, and political issues, as well as important announcements from AAOS.

Researchers fail to disclose conflicts
In the year after five orthopaedic device makers were required to post payments to orthopaedists, surgeons who published orthopaedic-related articles in medical journals often failed to disclose their financial ties with the companies, according to the Archives of Internal Medicine. The authors found 41 individuals who received at least $1 million during 2007; 32 had published orthopaedic-related articles between Jan. 1, 2008, and Jan. 15, 2009. First-, sole-, and senior-authored articles had a 54 percent disclosure rate. The accuracy of disclosures did not correspond to the strength of journals’ disclosure policies.

Ethics of placebo-controlled studies
Two articles in the New England Journal of Medicine (Sept. 30) examine the controversy surrounding placebo-controlled studies on osteoporosis. One set of authors argues that placebo-controlled studies that have fracture end points are often unethical and suggests that study sponsors, investigators, regulatory authorities, and medical journals must work to ensure that such trials are run in an ethical manner. The second group of authors says that ethical trials can be conducted when potential participants are provided with a high and clear standard of informed consent, and the trial includes active review by an institutional review board and an independent data and safety monitoring board.

Residents show up sick for work
According to data in the Journal of the American Medical Association (JAMA) (Sept. 15), three out of five residents surveyed came to work in the previous year while sick, potentially exposing coworkers and patients to communicable disease. The survey of 744 second- and third-year residents in 35 programs across 12 hospitals found that 60 percent of respondents reported working while sick at least once and 31 percent at least twice.

Infusion pumps recall
Hospira, Inc., has issued a recall of the 16026 Symbiq™ One-Channel Infuser and the 16027 Symbiq™ Two-Channel Infuser due to reports of unrestricted flow of fluid or medication if the administration set (cassette) is removed before the cassette carriage fully opens and the slide/roller clamp is not closed. Additionally, when unrestricted flow occurs, the “Check Flow Stop” alarm, which is designed to notify users of a free flow condition, may not function as intended and may not provide appropriate warning to users. Unrestricted flow of medication and/or other therapy has the potential to cause life-threatening effects and/or critical patient injury, especially in specific patient groups such as critically ill patients, patients with congestive heart failure, and/or neonates.

Physician self-referral disclosure protocol
The U.S. Centers for Medicare & Medicaid Services (CMS) has released the Medicare self-referral disclosure protocol (SRDP), which sets forth a process to enable providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral statute (Stark Law). Under this protocol, physicians who may have unintentionally violated the Stark Law may be able to work with CMS to lower their repayments to the government. The protocol was mandated under the Patient Protection and Affordable Care Act.

Liability premiums fall slightly
Medical Liability Monitor
reports that medical liability insurance premiums for internists, general surgeons, and obstetrician/gynecologists fell by an average of 0.5 percent in 2010—a reduction believed to be representative of cost changes across a wide range of specialties. The change marks the third year in a row such costs have decreased, but is less than reductions seen in 2009 (2.5 percent) and 2008 (4 percent). Of all rates in 2010, 67 percent did not change from 2009, while 19 percent decreased, and 14 percent increased—most by less than 10 percent.

Shorter resident duty hours
The Accreditation Council for Graduate Medical Education has approved new standards for resident duty. The new rules retain current duty hour limits of 80 hours per week, averaged over 4 weeks, but specify more detailed directives for first-year residents, reducing duty periods to no more than 16 hours a day and setting stricter requirements for duty hour exceptions. The system will go into effect July 1, 2011.

Texting while driving is deadly
According to a study in the American Journal of Public Health, texting while driving resulted in 16,141 road deaths between 2002 and 2007. Data from the Fatality Analysis Reporting System (FARS) indicate that, from 1999 to 2005, fatalities due to distracted driving declined, but have since risen from 4,572 in 2005 to 5,870 in 2008.

ATV injuries on the rise
According to a study in the Journal of Trauma, all-terrain vehicles (ATVs) are linked to a significant and increasing number of hospitalizations for children in the United States. Based on hospital discharge data from the Kid’s Inpatient Database of the Healthcare Cost and Utilization Project, from 1997 to 2006, hospitalizations for ATV injuries increased 150 percent among children younger than 18 years. Rates increased most in the South and Midwest and among teens aged 15 to 17 years. Males 15 to 17 years old had the highest overall rate of hospitalizations due to ATV use; the sharpest rise in hospitalizations was among females aged 15 to 17 years (250 percent).

Wright Medical settles consulting case
Wright Medical Technology, Inc., has entered into a Deferred Prosecution Agreement (DPA) with the U.S. Attorney’s Office (USAO) for the District of New Jersey. The agreement resolves the USAO investigation into the company’s consulting arrangements with orthopaedic surgeons relating to its hip and knee products. If the company satisfies its obligations under the terms of the DPA, which include federal monitoring of existing and new consulting agreements for the duration of the agreement, the USAO agrees not to prosecute the company in connection with the matter. Wright Medical also has entered into a Civil Settlement Agreement (CSA) with the Department of Justice and the U.S. Department of Health and Human Services, Office of Inspector General (OIG). Under terms of the CSA, the company will, with no admission of guilt, settle civil and administrative claims relating to the matter for a payment of $7,929,900 and enter into a 5-year Corporate Integrity Agreement with the OIG.

ED use of CT and MRI increasing
According to a study in JAMA (Oct. 6), the use of computed tomography (CT) and magnetic resonance imaging (MRI) scans in hospital emergency departments (EDs) increased significantly between 1998 and 2007—a shift that was not associated with a corresponding increase in life-threatening conditions. The retrospective cross-sectional analysis of data from the National Hospital Ambulatory Medical Care Survey (1998–2007) found that the prevalence of CT or MRI use during ED visits for injury-related conditions increased from 6 percent (257 of 5,237 visits) in 1998 to 15 percent (981 of 6,567 visits) in 2007. Over the same period, prevalence of life-threatening conditions increased from 1.7 percent (59 of 5,237 visits) to 2.0 percent (142 of 6,567 visits). No change was found in prevalence of visits that resulted in hospital admission.

FDA re-evaluates scaffold
The U.S. Food and Drug Administration (FDA) states that, following a re-evaluation of relevant scientific evidence, the Menaflex Collagen Scaffold, manufactured by ReGen Biologics, Inc., should not have been cleared for marketing in the United States. The agency plans to take action to rescind the product’s marketing clearance, after meeting with the product’s manufacturer to discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness.