Today’s Top Story
FDA guidance clarifies use of data from foreign clinical studies of medical devices.
The U.S. Food and Drug Administration (FDA) has released draft guidance to clarify agency policies regarding the use of scientifically valid clinical data obtained from foreign clinical studies in support of premarket submissions for devices. The guidance notes challenges in using data derived from studies of devices from sites from outside the United States in support of an FDA marketing decision, such as differences in clinical conditions, regulatory requirements (including human subject protections), and the size of study population. This guidance focuses on considerations that sponsors of device submissions should take into account when initiating, or relying on previously collected data from, a clinical study conducted outside the United States in support of an Investigational Device Exemption, 510(k) Premarket Notification, De Novo Petition, Humanitarian Device Exemption, or Premarket Approval Application. FDA states that the guidance is not intended to announce new policy, but to describe the agency’s existing approach to this topic. Read more…
Other News
Study: Introduction of abuse-deterrent opioids linked to reductions in dispensing of and overdoses due to prescription opioids.
A study published online in the journal JAMA Internal Medicine finds that opioid dispensing and prescription opioid overdoses decreased substantially after the 2010 introduction of abuse-deterrent, extended-release oxycodone hydrochloride and the withdrawal of propoxyphene from the U.S. market. The researchers analyzed claims from 31.3 million commercially insured members from a large, national health insurance database. They found that, 2 years after the changes in the opioid market, total opioid dispensing had decreased by 19 percent from the expected rate. In addition, at 2 years, the estimated overdose rate attributed to prescription opioids had decreased by 20 percent, but heroin overdose had increased by 23 percent. Read more…
Read the abstract…
Study: Osteoporosis treatment may affect life expectancy.
Data from a Danish study published online in The Journal of Bone and Mineral Research suggest that patients—especially men—who are treated for osteoporosis may be at reduced life expectancy compared to the general population. The authors used Danish national registries to conduct an observational study of 58,637 osteoporosis patients and 225,084 age- and gender-matched control participants. They found that 1-year mortality was 16.0 percent in treated men and 6.6 percent in treated women, compared to 3.0 percent and 4.6 percent respectively in the control population. At 5 years, mortality was 48.2 percent among treated men, compared to 24.6 percent among controls, and 28.3 percent among treated women, compared to 31.9 percent among controls. Read more…
Read the complete study (PDF)…
Study: Weekend admission linked to increased likelihood of HACs.
According to a study published online in the journal The BMJ, weekend admission to hospital may be associated with an increased likelihood of hospital-acquired condition (HAC). The research team reviewed data on 351 million patients from the U.S. Nationwide Inpatient Sample discharge database and found that the likelihood of an HAC was 5.7 percent among weekend admissions, compared to 3.7 percent among weekday admissions. After adjustment, they found that the risk of HAC was more than 20 percent higher in weekend admissions compared with weekday admissions. Read more…
Read the complete study…
Would increased transparency improve care in the military medical environment?
An article in The New York Times looks at the issue of health care in the U.S. military, arguing that a lack of transparency and accountability may affect patient care. The writer states that patients in the military medical system are often unable to seek care elsewhere if they have concerns about their care, and have few legal rights to challenge their care through the medical liability system. In addition, the publication alleges that “military hospitals often fail to conduct safety investigations that the Defense Department mandates when patients suffer serious harm or die. Many medical workers report reprisals for speaking out about problems with care. And system-wide efforts to limit errors and bolster quality have often foundered in a convoluted bureaucracy.” Read more…
Report: Physicians see modest gains in income.
According to information released in the Medscape Annual Physician Compensation Report, physicians have seen modest increases in compensation over the last year, yet overall satisfaction levels have remained similar. The report, which surveyed more than 19,500 physicians, finds orthopaedists to be the top earners, at an average compensation of $421,000 per year. In addition, orthopaedic surgeons earn the most from non-patient care activities. Compared to the previous year, only rheumatologists and urologists experienced decreases in income, while all other physician specialties reported an increase. Read more…
View the report overview…
Kansas, Tennessee.
Kaiser Health News reports that Kansas and Tennessee have joined Florida and Texas as states that have been warned by the U.S. Centers for Medicare & Medicaid Services (CMS) that their failure to expand Medicaid under the Affordable Care Act could risk the funding of “uncompensated care pools,” which help pay the cost of care for the uninsured. In a recent letter to Florida officials, CMS stated that increased Medicaid coverage is “the best way to secure affordable access to health care for low-income individuals,” and that “uncompensated care pool funding should not pay for costs that would be covered in a Medicaid expansion.” The governor of Florida recently threatened to sue the federal government over the issue—a move that, according to The Hill, has received support from the governor of Texas. Read more in Kaiser Health News…
Read more in The Hill…
Read the CMS letter to Florida officials (PDF)…
Last call: Foot & Ankle Program Committee.
April 24 is the last day to submit your application for chair of the Foot & Ankle Program Committee. Members of Program Committees grade symposia in May and abstracts in June and July, and potentially serve as moderators of paper sessions during the AAOS Annual Meeting. The committee chair is responsible for developing the paper sessions in the appropriate classification, including slotting accepted abstracts into sub-classification specific sessions. Applicants for this position must be active fellows with a practice emphasis in foot and ankle. Learn more and submit your application…(member login required)
