Florida Declares Ban on Office Surgery
Hoping to buy time to find ways to prevent office-surgery deaths, the Florida Board of Medicine declared a state-wide emergency moratorium on office-based, general-anesthesia (level-3) surgery on August 10. The day the ban went into effect, the state began sending certified letters to the estimated 600 physicians who could be impacted. In the letter, the board cited 20 adverse incidents reported to the state since April-just after new office-surgery rules went into effect-including five deaths related to office surgery, four of which involved cosmetic-surgery procedures.

Georges El-Bahri, MD, chair of the Florida Board of Medicine, said in an official statement that the "temporary halt" is due to "the alarming number of deaths in Florida primarily related to plastic or cosmetic surgery performed in offices" and that it will provide the board, the Florida Medical Association, and "other parties" time to work closely together to develop patient protections.

Meanwhile, surgeons in Florida-in both accredited and non-accredited facilities-have been variously scrambling to get operating space at hospitals and outpatient clinics, refunding surgery deposits, and closing down their offices. Despite Dr. El-Bahri's assertion that the moratorium "should not adversely affect a patient's access to elective surgical procedures," patients will face treatment delays and likely pay more for both the cosmetic and non-cosmetic procedures that will have to be rescheduled to hospitals and outpatient centers. Dental surgeries, surgeries that do not require general anesthesia, and surgeries performed in hospitals or licensed outpatient surgical centers are not affected.

Harlan Pollock, MD, a member of American Society for Aesthetic Plastic Surgery (ASAPS) and the director of American Society of Plastic Surgeons' Public Education Committee, says, "I don't think [the moratorium] is unreasonable. I think it's maybe too general, but it got a response. Non-surgeons---like some dermatologists-are out there performing, uncontrolled, and unless there is a catastrophe no one knows about it."

Daniel C. Morello, MD, president of ASAPS and immediate past president of the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF or "Quad-A") says that the focus for regulation should be on non-accredited facilities; he feels the ban unfairly targets doctors who are performing surgery safely in office facilities. Referring to a study for which he was a lead author in 1997, Dr. Morello says, "We looked at almost 250 Quad-A--accredited facilities, 400,000 operations, and found that there was no difference in safety between [these accredited office-based facilities and hospitals]." He says that he has received pleas for support from office-based surgeons who now find themselves in a state of economic peril. "I have four or five letters on my desk right now," he says. "One doctor has closed his office, laying off his entire operating-room staff. He is double board-certified, holds national Quad-A certification, and has performed [in his office practice] without incident for 15 years. It should be clear that facilities that don't have proper accreditation should not be allowed to continue to exist."

"This issue [of accreditation] has been on the table for years," states Dr. Morello, referring to the fact that the medical board in Florida has been grappling with how to curb office-surgery injuries and fatalities (related mostly to cosmetic surgery) for more than two years now, with the support of various surgery organizations. In February, the board approved rules that require accreditation of office operating rooms, restrict surgery time to eight hours or less, and limit the amount of fat that can be removed during liposuction. Those actions followed 1998 reports by Fort Lauderdale's Sun-Sentinel that at least 34 patients had died following cosmetic surgery in Florida since 1986; the newspaper has since confirmed 11 more deaths, nine involving cosmetic surgery performed in offices.

FDA Issues Final Guidance on Reprocessing SUDs
The FDA on August 2 issued final guidance on the practice of reprocessing and reusing single-use medical devices. The controversial measure and its requirements could have serious economic impact on the many hospitals that rely on reprocessing to keep costs down. For now, freestanding surgery centers not affiliated with hospitals will not be required to comply with the guidance; also, opened but unused single-use devices (SUDs) are not considered within the scope of the document.

According to Larry Spears, a director of the FDA's Center for Devices and Radiological Health, freestanding surgery centers will not have to comply "as of now," because, "We're doing this in a step-by-step fashion; the idea is to first move into hospitals, a very big step. We're hoping to learn the best way to approach [enforcement of the guidance] before we move into other areas." Freestanding surgery centers that are owned and operated by hospitals will be expected to comply if these facilities use the hospital for their sterile processing needs, which would include reprocessing.

In a FDA Talk Paper, the agency assures third-party reprocessors, health care facilities, and the general public alike that the guidance is "designed to protect the public health by assuring that the practice of reusing single-use medical devices is based on good science," as well as ensure that the requirements "are equitable to all parties." The parties on both sides of this issue may disagree.

Health care facilities that reprocess SUDs are in a battle to continue the cost-saving tactic without potentially prohibitive FDA restrictions. Hospital administrators argue that the FDA's experience is in regulating manufacturers, and that a host of other agencies are already charged with overseeing their activities. Some point to the lack of evidence of a threat to patient safety with the use of SUDs.

SUD manufacturers counter by arguing that at least nine reports of patient injuries have implicated reprocessed SUDs. They point out that assigning responsibility to reprocessors for adverse events is often difficult, because facilities that reprocess frequently fail to relabel items once they have been reprocessed. SUD manufacturers say that the lack of data on the effects of multiple sterilizations on functionality and material toxicity of SUDs is reason in itself to be skeptical about safety.

The FDA will henceforth regulate reprocessing firms (third-party reprocessors) and hospitals that engage in the reprocessing of SUDs in the same way that it now regulates equipment manufacturers. The regulations include: pre-market notification and approval requirements; registration and listing of reprocessing firms; manufacturing requirements; labeling requirements; submission of adverse event reports; medical device tracking; and correction or removal of unsafe medical devices from the market. The FDA intends to begin enforcing the pre-market submission requirements for third-party and hospital reprocessors in six months from the issuing date of the guidance for class III (high risk) devices, in 12 months for class II (moderate risk) devices, and in 18 months for class I (low risk) devices.

Some class I and class II devices are currently exempt from the ruling; the FDA intends to examine "on a case-by-case basis the need to revoke [their] exemptions from pre-market requirements," if new use risks are found, according to the Talk Paper.

The FDA will continue to enforce non-pre-market requirements for third-party reprocessors as it has previously; the enforcement of such for hospitals will be phased in within a year. The document is available at www.fda.gov/cdrh/comp/guidance/1168.pdf.

Plastic Surgeries Increase 175 percent in Seven Years
The 1999 numbers are in, and liposuction was once again the most commonly performed cosmetic procedure in the United States, up 34 percent since 1998 with 230,865 procedures, almost five times its showing of 1992. Liposuction was followed by breast augmentation, up 26 percent from 1998, and eyelid surgery was third, up 18 percent. The statistics are the result of the latest survey conducted by the American Society of Plastic and Reconstructive Surgeons (ASPS) National Clearinghouse of Plastic Surgery Statistics, which has been tracking procedures performed by its approximately 5,000 board-certified surgeons since 1992.
- A closing of the gender gap: "I think the statistics identify that there is increasing interest in growing old gracefully, that people are more body-conscious, and that men are becoming more aware of opportunities available to them," Dr. Greco says. He says that these days, he and his colleagues treat more men than ever---between 10 and 15 percent of patients, whereas "it used to be more like 2 percent."
- Affordability: Overall, Dr. Greco explains, cosmetic surgery is "more affordable...the average middle-class person might be able to afford [a cosmetic procedure] more than a vacation. Plus, there is financing available."
- Greater safety and patient comfort: Dr. Greco points out that "breast-implant safety has been proven and recovery time has become shorter as minimally invasive techniques have developed and a quicker anesthesia-recovery time [has evolved]." Enhanced post-op care has resulted in satisfied patients who spread the word. "Plastic surgeons have learned to use massage, and the use of herb supplements has helped post-operative pain and swelling," he offers. "Think of where we were with inguinal hernias a few years ago--people used to be hospitalized for days. We're seeing the same revolution in cosmetic surgery."