900,000 Office Cases, 16 Deaths
Study: Cosmetic Surgery in Accredited Facilities is Safe
Office-based surgical suites, long portrayed as unsafe venues where a disproportionately high number of patients are injured or killed, can point with pride to a study that found only 16 of nearly 900,000 patients operated on in AAAASF-accredited facilities during a four-year period died, a safety record rivaling that of hospitals.
The study detailed the American Association for Accreditation of Ambulatory Surgery Facilities' ongoing Internet-based peer-review program, which has analyzed 872,115 procedures between 2001 and 2004. Patient deaths occurred in 16 of those procedures, says Geoffrey R. Keyes, MD, a Los Angeles-based plastic and reconstructive surgeon and AAAASF board member. Dr. Keyes presented the study results at last month's American Society of Plastic Surgeons meeting in Chicago.
Dr. Keyes notes that 10 of the 16 deaths were the result of pulmonary emboli. "Pulmonary emboli occur in inpatient as well as outpatient settings," notes Dr. Keyes. "It's a problem in all of surgery and we will be conducting studies to lessen its occurrence."
To this point, the most publicized study of office-based surgery was a damning one, the seminal Archives of Surgery study in which researchers found the risk of adverse incidents and death in Florida surgical offices was 10 times that of the state's ASCs.
Surgeons operating in the country's 1,250 AAAASF-accredited office surgery facilities must be board certified in the specialty for which they operate and must be credentialed to perform the same procedure in a hospital. They're required to report all unanticipated sequelae into the Internet program, and to enter random case reviews twice a year, says Dr. Keyes, who notes that unanticipated sequelae occurred in one of 299 cases studied. Last year, AAAASF required its accredited facilities that administer propofol to upgrade to Class C (general anesthesia facilities).
- Daniel Cook
Doctor Disciplined for Cell Phone Photo in OR
A Pierre, S.D., hospital has taken corrective action against an orthopedic surgeon for using his cellular phone's camera in the OR to snap a photo that included an unconscious patient.
Gonzalo H. Sanchez, MD, explained that he'd taken the photo to lampoon a fellow doctor's attempts to hold a patient's leg while turning her over during foot surgery, according to the Argus Leader in Sioux Falls, S.D. The patient was not unclothed and not identifiable in the photo, he says, and he deleted the photo shortly afterward. Dr. Sanchez declined comment.
A spokeswoman for St. Mary's Healthcare Center says the details of the discipline issued to Dr. Sanchez are confidential and that Dr. Sanchez's qualifications, surgical skills and credentials as a qualified physician have never been in question. The hospital prohibits cellular phones in surgery suites as well as surgical photographs taken without a patient's prior consent.
Jose C. Rostro, a former surgical tech at Edward Hospital in Naperville, Ill., faces up to a year in jail after pleading guilty to photographing with his cellular phone an undressed, unconscious female patient on an OR table. The patient was prepped for a dilation and curettage procedure and her legs were in stirrups, says Ed Fox, the patient's Chicago-based lawyer.
- David Bernard and Daniel Cook
Court: Generic Sevoflurane Doesn't Infringe Patent
A generic version of the inhalational anesthetic sevoflurane produced by Baxter International does not infringe on Abbott Laboratories' patented version, a federal court in Chicago has ruled.
The ruling lets Baxter market the first generic sevoflurane in the United States after Dec. 10, a date set by an arbitration panel at a previous date. Abbott had petitioned the arbitrators to block Baxter from selling the product before the patent's license had expired.
"We are obviously pleased with the ruling, and are looking ahead to the marketing after the Dec. 10 date," says Baxter spokeswoman Deborah Spak.
The Abbott Park, Ill., pharmaceutical manufacturer says it will appeal the court's ruling. "We believe our intellectual property rights have been violated, and that Abbott has a strong basis for appeal," says spokesman Jonathan Hamilton.
Deerfield, Ill.-based Baxter created sevoflurane in the 1970s. Since its manufacturing focus at that time was anesthesia devices and not drugs, says Ms. Spak, it licensed the patent to another manufacturer in the 1980s, which in turn licensed the patent to Abbott.
After Baxter acquired Ohmeda Pharmaceuticals in the late 1990s, the company submitted Ohmeda's differently manufactured version of sevoflurane for FDA approval. The agency approved the anesthetic in 2002, after which Abbott filed its infringement lawsuit and arbitration action.
- David Bernard
Researchers Develop Antibiotic-Implant Bond
Researchers have discovered a method by which antibiotics may be permanently joined to implant materials in order to kill bacteria and help fight infection at the site.
In a study published in the journal Chemistry and Biology, researchers from Jefferson Medical College at Thomas Jefferson University in Philadelphia report their development of a chemical bond between the antibiotic vancomycin and titanium powder that retains the antibiotic's power.
The discovery of the chemical bond provides conditions that could increase an implant's likelihood of success while suggesting its use with other antibiotics and device materials. "Orthopedic infections are very difficult to treat," says Noreen Hickok, PhD, an associate professor of orthopedic surgery at Jefferson and one of the study's authors.
In the case of implant site infections, she says, bacteria form a biofilm over the implant that may outlast large doses of antibiotics and that may remain after loose bacteria have been eliminated.
"This was our answer to it," says Dr. Hickok. "If you can prevent the biofilm from forming on the surface, it's easier to treat the infection in the other places. We're putting a blockade up."
The antibiotic-and-titanium bond has yet to be applied to an actual implant, and the researchers are still testing how durable the combination is, but Dr. Hickok says her team is confident that their discovery has a multitude of uses. "If we can do this with vancomycin and titanium powder, we can do this with other antibiotics and materials," she says.
In other infection prevention news, University of Florida researchers have led the development of a new type of wound dressing that could keep antibiotic-resistant bacteria from spreading in hospitals. This microbicidal coating - which can be chemically bonded to gauze bandages, socks and even hospital bedding and gowns - kills the two most common and harmful types of antibiotic-resistant bacteria that cause infections in hospitals, the researchers said.
A patent is pending on the researchers' method of chemically bonding the substance to fabrics and other materials. This method lets the substance be efficiently mass-produced and permanently adhered to wound dressings or ready-to-wear clothing to make antifungal and microbicidal socks and underwear. Clinical trials of the coating in gauze will be conducted at UF later this year.
- David Bernard
Insurer, Hospitals Pilot Price Disclosure Plan
Two Wisconsin healthcare systems are taking a small but revolutionary step toward price transparency by accepting an insurer's flat rate for select procedures and by disclosing that price for those procedures to potential patients.
ProHealth Care, which runs two hospitals in the Milwaukee area, and Columbia St. Mary's, which runs three, have agreed to plan proposed by HealthCare Direct LLC, a Waukesha-based preferred provider organization with about 2,000 employee households in its network.
The plan, which includes 26 of the most common inpatient procedures performed at the hospitals, aims to provide healthcare consumers with the tools to compare prices for their surgical needs. The plan does not include outpatient procedures at the two systems.
"Unless the price is public, how can you expect consumers or purchasers to behave wisely?" says Jack Meler, president of HealthCare Direct.
Comparative shopping and wiser consumers may lead facilities to become more efficient and health care costs to slow their rise, he says. A recent Government Accountability Office report shows that Wisconsin is home to eight of the 10 U.S. metropolitan areas with the highest physician fees.
- David Bernard
Headlines on Deadline
Utah ASC Denied HIV-Positive Man Surgery. An HIV-positive man has filed suit against two doctors and HealthSouth Provo Surgical Center, after he was refused surgery on an ulcerated toe due to his HIV status. The denial of surgery violates the Americans with Disabilities Act, according to the lawsuit, filed Aug. 26. The surgery center allegedly told the patient's primary care physician that it had a policy of not operating on HIV-positive patients, says Marlin G. Criddle, the defendant's lawyer. The surgery was performed at another surgery center a week later. "HIV is never a reason to not perform surgery," says Judene Bartley, MS, MPH, CIC, a clinical consultant for the Premier Safety Institute. The only time elective surgery should not be performed is if an HIV-positive patient has an active ancillary infection, she says. In that case, it "should be treated with antibiotics for about two weeks, and then the surgery should be performed."
Lawsuit Seeks to End Surgical Ban. Three medical associations, a surgical center and two physicians have taken Pennsylvania's Department of Health to court in hopes of reversing its ban on laparoscopic cholecystectomy procedures at ASCs. Their lawsuit argues that there are no differences between lap choles and the laparoscopic procedures the state permits at ASCs; that ASCs have access to the same resources as hospitals that perform lap choles; and that the ban reinterprets state regulations in effect for more than 15 years. The department banned laparoscopic procedures from ASCs in December 2004, citing safety concerns. In March, it agreed to allow some procedures to return to ASCs, with prior approval, but has continued to deny lap choles.
GlaxoSmithKline Pays $150M on Alleged Antiemetic Fraud. GlaxoSmithKline has paid more than $150 million to resolve allegations it violated the False Claims Act through fraudulent pricing and marketing of the 5HT-3 antiemetics Zofran and Kytril, says the U.S. Department of Justice.
Tenn. Hospital Association Seeks to Block Major Office-based Surgery. Citing safety and regulatory concerns, the Tennessee Hospital Association is suing the state's board of medical examiners to block a rule the association says would bring to doctors' offices such major surgery as mastectomy, hysterectomy and orthopedic cases.