February 2001 Bulletin


FDA concerned about use of PMMA cement in spine

The U.S. Food and Drug Administration (FDA) has expressed concern about potential serious patient care issues involved with the use of polymethlymethacrylate (PMMA) bone cement in the spine. A physician might insert the PMMA bone cement into vertebrae by various procedures, including vertebroplasty and kyphoplasty. Orthopaedic surgeons should be alert to possible complications. PMMA bone cement is considered a device for FDA purposes. In October 1999, the FDA reclassified PMMA bone cement as a Class II device for its intended use "in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone." The use of a device for other than its FDA-cleared indication is an off-label use. Physicians may use a device off-label if they believe, in their best medical judgment, that its use is appropriate for a particular patient (e.g., tumors). The use of PMMA bone cement in the spine is described in Academy educational courses, videotapes and publications for educational purposes only. As is the Academy’s policy regarding all of its educational offerings, the fact that the use of PMMA bone cement in the spine is discussed does not constitute an Academy endorsement of this use.

Workplace injuries report fails to settle controversy

A report by the National Academy of Sciences on workplace injuries, commissioned by Congress more than two years ago, failed to settle the controversy over the new OSHA ergonomics regulations. Unions said the new report proves the need for the regulations; business groups say it shows the OSHA regulations are too broad. The report says musculoskeletal disorders of the lower back and upper extremities can be attributed to particular jobs and working conditions, including heavy lifting, repetitive motion and forceful motions, and stressful work environments. Each year these disorders affect about 1 million workers and cost the nation between $45 billion and $54 billion in compensation expenditures, lost wages and decreased productivity. "Scientifically based prevention efforts can be effective in the workplace, substantially reducing the risk of job-related musculoskeletal disorders," according to the report.

Managed care didn’t shrink office visit time

It may seem like physicians have less time for patients since managed care entered the scene, but a study in the Jan. 18, 2001 of The New England Journal of Medicine says that’s not true. The average duration of office visits in 1989 was 16.3 minutes according to the National Ambulatory Medical Care Survey and 20.4 minutes based on an AMA survey. According to both sets of data, the average duration of visits increased by between one and two minutes between 1989 and 1998. There was an increase in length of visits for both primary and specialty care for new and established patients. The researchers suggested that there have been some changes in recent years that have placed more demands on their time. Doctors are treating more complex cases during office visits instead of in hospitals, they must evaluate an ever-broader range of treatments and do more preventative care, and with the expansion of the Internet and drug advertising, patients are asking more questions. Jerome Kassirer, MD, former journal editor, says the study carries a few potential sources of error. For example, the length of visit was not objectively measured, but was reported by doctors and staff.

FDA proposes rule to put gene therapy safety data on web

The FDA published in the Jan. 18, 2001 Federal Register a rule that would make publicly available information on all new or ongoing clinical trials involving either gene therapy or xenotransplantation. Researchers would have to post on the FDA’s web site most of the safety information about an experiment when it begins. Consumer advocates praised the rule, but the biotechnology industry opposed it, arguing that the information could confuse the public about whether a study was truly safe.

Orthopaedic surgeons can volunteer for new programs in Nepal

Orthopaedics Overseas has initiated two new programs in Nepal, a small country in the Himalayas sandwiched between China and India. Adequate medical care is unavailable to the majority of the population of 23 million, in part due to mountainous geography and a lack of trained manpower and resources. The major orthopaedic problems in the country include: infection, trauma (usually delayed presentation), tuberculosis, degenerative joint disease, and polio (on the decline). The programs sites are at the Tribhuvan University Institute of Medicine in Kathmandu, the capital city, and at the Hospital and Rehabilitation Centre for Disabled Children (HRDC) in Banepa, approximately 45 minutes by car from Kathmandu. These are independent programs and volunteers will be assigned to one or the other facility depending on their expertise. The HRDC site will only accept pediatric orthopaedic surgeons. Assignments are generally for one month, although two-week placements will be considered. For more information, call the Orthopaedics Overseas office at (202) 296-0928 or visit the web site www.hvousa.org.

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