The U.S. Food and Drug Administration has instructed about 20 hip implant manufacturers to conduct post-market studies on metal-on-metal hips amid concerns about their failure rates and potential adverse effects.

The FDA's unusual action - an official told the New York Times it was the agency's broadest invocation to date of its authority to order studies of approved devices - stems from reports that the metal implants have a relatively high rate of early failure and that they may shed metallic debris into surrounding tissue and the bloodstream.

Johnson & Johnson, Zimmer, Stryker, Biomet and other companies have all been ordered to develop their own plans for studying the long-term success rates and health effects of metal-on-metal hips. "Our concern is the product, not about a [particular] manufacturer," William H. Maisel, MD, of the FDA's Center for Devices and Radiological Health told the Times. He says it's the largest group of studies asked of any approved class of devices.

The American Academy of Orthopaedic Surgeons responded to the issue earlier this year after the FDA first issued a public health comment warning of the potential adverse effects associated with metal-on-metal hip implants as they wear over time. Specifically, the agency is concerned that if the devices shed significant levels of metallic particles into the bloodstream, they could harm the heart, nervous system and thyroid.

The implant manufacturers have 30 days to file proposals for their post-market device studies with the FDA. Dr. Maisel says the companies are expected to gather data on patients who have already received metal-on-metal implants, including how much metallic ion is in their blood, as well as the failure rates of the devices.

Irene Tsikitas

An open-access colonoscopy program, in which patients are scheduled for routine exams after primary care physicians' referrals and nurses' reviews, are as safe and effective as programs in which patients first consult with gastroenterologists, say researchers.

Researchers at Henry Ford Hospital in Detroit found that open-access patients, whose electronic medical records are reviewed beforehand, showed no more incidents of post-colonoscopy bleeding, perforations or deaths than patients undergoing traditional pre-colonoscopy consultations.

According to their study, presented at Digestive Diseases Week in Chicago last week, open-access patients also had fewer post-procedure emergency room visits and hospital admissions.

"The results of this study, using such a large cohort of patients (15,901), suggest that open-access programs can be utilized cost-effectively to make this important screening procedure more easily accessible to patients," says study co-author Gregory Olds, MD, chief of interventional gastroenterology and director of endoscopy at the hospital.

Kent Steinriede

Deep surgical site infection risks following joint replacement surgeries decrease when all members of the patient care team work in concert to promote aseptic practices, according to a study conducted at Penn Presbyterian Medical Center in Philadelphia.

In an effort to standardize the perioperative care of joint replacement patients, the researchers developed a multi-disciplinary working group made up of orthopedic surgeons, perioperative nurses and nurse managers, anesthesia providers, central sterile staff and infection prevention experts.

After reviewing the medical center's perioperative processes and analyzing its SSI data, the team implemented initiatives aimed at reducing infection rates. They retrained the OR staff on the basics of aseptic technique, including maintaining sterility around the surgical site; they standardized the prepping of the patient's skin using a chlorhexidine gluconate prepping agent; they instructed patients to shower with CHG prior to surgery; and they administered the antibiotic vancomycin to joint replacement patients along with a renewed focus on optimizing the timing of pre-op delivery.

A year after implementing the initiatives, the researchers observed a 66% and 80% reduction in deep SSIs following hip arthroplasties and knee surgeries, respectively. The improvements continued for 6 months following the conclusion of the study, say the researchers, who presented their findings last April at the 2011 annual meeting of the Society for Healthcare Epidemiology of America.

Lead researcher Judith O'Donnell, MD, chief of infectious diseases and hospital epidemiologist at Penn Presbyterian, says everyone involved in patient care has to be on board with changes made to infection control protocols in order for those changes to be effective. She thinks reviewing best practices "is something any institution should do on a routine basis, especially if they have a high turnover of staff."

Steven Gordon, chair of the department of infectious disease at the Cleveland Clinic in Ohio, is encouraged by the study's results, even though he says the findings do not reflect what role, if any, surgical skill played in reducing SSI rates. Nevertheless, he believes a system approach to infection control is gaining momentum in facilities across the country. "It's not just what happens in the operating room," he says. "You want to be sure that the team is educated up and down, from the preoperative team, the perioperative team, to the postoperative (team)."

Daniel Cook

Do you have to sidestep equipment and tiptoe over cords to maneuver through your ORs? If so, your ORs might be cluttered. Tell us about it in this week's InstaPoll. Check back here next week for the results.

Office romances are apparently not much of a problem in today's surgical facilties, according to the results of last week's poll. Only 13% of 84 facility managers say they have a policy against dating in the workplace.

Dan O'Connor