January 23, 2015

Today’s Top Story
1. FDA announces recall of one lot of Hospira 0.9 Percent Sodium Chloride Injection, USP, 250 mL.
The U.S. Food and Drug Administration (FDA) has announced that Hospira, Inc. has initiated a voluntary nationwide recall of one lot of 0.9 percent Sodium Chloride Injection, USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016) to the user level due to one confirmed customer report of particulate in a single unit. The company has identified the particulate as a human hair, sealed in the bag at the additive port area. The affected lot was distributed nationwide from September 2014 through November 2014. FDA states that anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Hospira has not received reports of any adverse events associated with this issue for this lot.  Read more…Back to top
Other News
2. FDA: Bone graft substitutes containing recombinant proteins or synthetic peptides should not be first-line treatment for younger patients.
FDA has issued a safety communication regarding the use of bone graft substitutes containing recombinant proteins or synthetic peptides in patients younger than 18 years. The agency states that these products should not be the first treatment considered for patients younger than age 18 with significant bone defects or rare bone disorders, because their bones may still be growing and using such products may cause serious injuries. FDA considers bone graft substitutes containing recombinant proteins or synthetic peptides high-risk (Class III) medical devices. Read more…
An article in the December 2014 issue of AAOS Now looks at alternatives to the use of recombinant human bone morphogenetic protein. Read more…

3. House committee begins discussion on long-term SGR fix.
HealthLeaders Media reports that the U.S. House of Representatives Committee on Energy and Commerce health panel held a 2-day meeting this week to discuss a permanent solution to the Medicare Sustainable Growth Rate (SGR) formula, which currently calls for an estimated 21 percent cut to physician reimbursement to take effect April 1, 2015. The publication reports that lawmakers supported reaching a long-term agreement to replace the SGR, with many voicing support for a previous bipartisan proposal that, if enacted, would provide for a 5-year period with a 0.5 percent annual pay rate hike for physicians, along with a series of reforms designed to transition Medicare physician reimbursement toward value-based models. However, representatives remain divided on how to fund the proposal. Read more…
View information from the committee meeting…

4. Study: Rotator cuff tear type linked to risk of pain development.
Findings from a study published in the Jan. 21 issue of The Journal of Bone & Joint Surgery (JBJS) examine the progressive nature of degenerative rotator cuff disease. The researchers conducted a prospective study of patients with an asymptomatic rotator cuff tear who were seen for evaluation of shoulder pain secondary to rotator cuff disease in the contralateral shoulder. At median 5.1-year follow-up of 224 participants (118 initial full-thickness tears, 56 initial partial-thickness tears, 50 controls), researchers found tear enlargement in 49 percent of shoulders, with a median time to enlargement of 2.8 years. Overall, 100 patients (46 percent) reported new pain. Final tear type was associated with a greater risk of pain development, with new pain developing in 28 percent of controls, 46 percent of the shoulders with a partial-thickness tear, and 50 percent of shoulders with a full-thickness tear. Progressive degenerative changes of the supraspinatus muscle were associated with tear enlargement, with an increase of supraspinatus muscle degeneration in 4 percent of shoulders with a stable tear, compared with 30 percent of shoulders with tear enlargement.
Read the abstract…

5. Study: Fracture ratio may help identify nonaccidental trauma in pediatric patients.
According to a study published in the Jan. 21 issue of JBJS, fracture ratio may be helpful to determine fracture morphology for children with suspected nonaccidental trauma. The authors reviewed data on 95 patients aged 3 years or younger who were seen with a closed, isolated femoral shaft fracture at an urban, pediatric, level-I trauma center. Of those, 51 had either a Child Protective Services or a Child Assessment Program consultation because of suspected nonaccidental trauma, and of those, 13 were found to have nonaccidental trauma as determined by Child Protective Services or the Child Assessment Program team, and 7 had indeterminate Child Protective Services or Child Assessment Program investigations. A fellowship-trained pediatric orthopaedic surgeon blinded to the patient’s clinical history found that patients who had nonaccidental trauma had significantly decreased mean anteroposterior fracture ratios, compared with those who had confirmed accidental trauma.
Read the abstract…

6. CDC: Many women of reproductive age have been prescribed opioids.
A report released by the U.S. Centers for Disease Control and Prevention projects that 39 percent of reproductive-aged women enrolled in Medicaid and 28 percent of those with private insurance filled a prescription for an opioid pain medication each year during the period 2008 through 2012. The research team analyzed data from two large health insurance claims datasets: one of women aged 15-44 years with private insurance, and another of women in the same age group enrolled in Medicaid. They note that previous studies have associated opioid use in pregnancy with increased risk of neural tube defects, congenital heart defects, gastroschisis, and neonatal abstinence syndrome.  Read more…
Read the CDC press release…
Read the complete report…

7. Open payments data complicated by company errors and use of multiple drug names.
Information from The New York Times suggests a variety of errors in information released by drug and medical device manufacturers to the Open Payments (Sunshine Act) database. The paper states that its researchers encountered widespread problems with companies’ submissions as they attempted to tally payments associated with individual drugs and devices. For example, companies routinely recorded payments associated with a single drug under multiple names. Taken in aggregate, payments made for drugs with multiple names ranked much higher on the spending scale. In addition, about 8.5 percent of the 4.3 million general payments companies reported to the government were not connected to specific products, and more than 140 companies did not list products at all in their payment records. The paper states that there was no indication that companies were being deliberately evasive, “but the complexity shows how difficult it would be for the general public to get a true sense of payments from the publicly released data sets.”  Read more…

8. Call for volunteers: Commission on Motion Lab Accreditation board of directors.
AAOS seeks to nominate two members to serve on the Commission on Motion Lab Accreditation (CMLA) board of directors. CMLA is a nonprofit organization established and operated to enhance the clinical care of persons with disorders of human movement by evaluating and accrediting clinical motion laboratories by a set of evaluative criteria. The board is composed of professionals from several disciplines with expertise in clinical motion analysis, and includes two directors from each of four member societies: AAOS, the American Academy of Physical Medicine and Rehabilitation, the American Physical Therapy Association, and the Gait and Clinical Movement Analysis Society. Applicants for this position must be active fellows, candidate members, candidate members osteopathic, candidate member applicants for fellowship, or candidate member applicants for fellowship osteopathic. In addition, all applicants must provide the following: an online AAOS CAP application, current curriculum vitae, a 100-word biosketch, and a letter of interest highlighting his or her expertise in the subject area and a statement that he or she is able to participate in full capacity. All supporting materials must be submitted by Feb. 15, 2015, at 11:59 p.m. CT, to Kyle Shah at shah@aaos.org.
Learn more and submit your application…(member login required)