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Anesthesia...Risky Business?

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    Posted: 27 Sep 2009 at 9:19pm
Anesthesia...Risky Business?

A 42-year-old woman dies shortly after undergoing five cosmetic procedures in a New York plastic surgeon’s office. A 53-year-old Tucson patient having liposuction and surgery to tighten her jaw line stops breathing. A 21-year-old man has a fatal reaction to anesthesia while undergoing minor genital surgery.

One thing these incidents have in common is that they were performed in doctors’ offices—a little regulated side of the fast-growing field of outpatient surgery, which eliminates the need for a hospital stay. Outpatient surgery is generally considered safe when performed at accredited hospital outpatient departments or ambulatory surgery centers. But an estimated 35,000 to 40,000 doctors’ offices also perform surgical procedures, representing about 17% of all outpatient procedures, and only a fraction of these offices are accredited.

Now, a growing number of states are regulating such procedures in doctors’ offices, or weighing measures to do so, including California, Indiana, Florida, Arizona and Nevada. This month, a law took effect in New York that for the first time requires the state’s approximately 3,000 doctors’ offices that perform surgery under moderate or deep sedation to have their facilities inspected and accredited by independent review agencies. Violators face penalties from the New York state medical board.

Outpatient surgery, from simple skin growth removals to knee replacements, accounts for more than 65% of all surgeries, up from about 20% two decades ago. Thanks to advances in anesthesia and minimally invasive surgical techniques, outpatient surgery offers lower costs, more convenient scheduling, and faster recovery and healing times than do hospital inpatient procedures. About 45% of such procedures take place in hospital outpatient departments, which are operated by highly regulated hospitals. An additional 38% of outpatient procedures are performed in more than 5,000 ambulatory surgery centers, which typically are certified by the federal Center for Medicare and Medicaid Services, are accredited by an independent agency, and may also have to be licensed by their state. To be accredited, facilities must meet strict standards for equipment, operating-room safety, personnel training and surgeon credentials.

Doctor’s offices in states with no regulation may perform surgery solely under the medical license of the physician with no formal licensing or accreditation requirements. Some doctors choose to be voluntarily accredited by one of three agencies that perform the inspections, but the process can cost several thousand dollars.

“People might think that most office-based practices have some level of oversight and accountability, but they often don’t,” says Fay Rozovsky, a health-care risk management consultant, who advises hospitals and medical institutions. “And without some kind of regulatory framework that is enforced by state authorities, it is possible that complications can result in catastrophic outcomes.”

Some facilities that call themselves surgery centers are really glorified doctor’s offices that aren’t accredited or certified by Medicare. To qualify as an ambulatory surgery center, for example, a facility can’t have any other business operations or shared waiting-room space for non-surgical patients. Consumers can check three Web sites to learn if a facility is accredited: The American Association for Accreditation of Ambulatory Surgery Facilities (; The Joint Commission (; and the Accreditation Association for Ambulatory Health Care (

Emergency Plans

Before undergoing surgery at a doctor’s office, Ms. Rozovsky advises patients to learn what plans are in place to transfer them to a hospital if that becomes necessary. Patients also should check what kind of training office staff have, such as advanced cardiac life support. Nurse anesthetists, who often work without the supervision of an anesthesiologist in doctors’ offices, are trained to administer and monitor anesthesia, but patients should ask how they will deal with an unexpected crisis.

Kay Cregan, who came from Ireland to New York for surgery in 2005, had five facial reconstruction procedures performed in a single day at a plastic surgeon’s office. The 42-year-old spent the night in a recovery room monitored by a nurse. Early in the morning, Ms. Cregan collapsed on her way to the bathroom and stopped breathing. According to court documents, the nurse said that she didn’t know how to insert a breathing tube into a patient’s airway. She said she called for an ambulance, but by the time it arrived, Ms. Cregan was in cardiac arrest with a suspected blood clot blocking her airway. After losing brain function, she died three days later.

Ms. Cregan’s husband, Liam, has brought a malpractice suit against Michael E. Sachs, the surgeon, and Madhavarao Subbaro, the anesthesiologist. The case is expected to go to trial this fall. Mr. Cregan’s attorney, Matthew Gaier, says the suit aims to prove that failure to post-operatively monitor the patient caused her death. Mark Aaronson, an attorney for Dr. Sachs, says that while his client feels terrible about the tragedy, it was an unfortunate event that was not his fault, adding that Ms. Cregan’s cardiac arrest had nothing to do with the surgery or the anesthesia. Sylvia Lee, an attorney for the anesthesiologist, says she can’t comment on matters in litigation.

Arizona last year put rules in place governing surgery that takes place in a physician’s office. Doctors are required to have equipment necessary to safely perform procedures, administer and monitor sedation, and rescue a patient who enters a deeper state of sedation than intended.

High-Profile Cases

The new regulations followed several high-profile cases in the state. One of them was the death in 2007 of Kimberly Taylor, a 53-year-old Tucson attorney who stopped breathing while undergoing two procedures at a plastic surgeon’s office under anesthesia. The surgeon and nurse were unable to rescue her. By the time emergency medical technicians arrived she had suffered severe brain damage from oxygen deprivation and died a few days later.

The American Association for Accreditation of Ambulatory Surgery Facilities, the leading accrediting group, studied data at accredited outpatient centers from January 2001 through June 2006 and found 23 deaths among 1.1 million procedures. The most common procedure associated with the deaths was abdominoplasty, or tummy tuck, followed by face-lift surgery. Risks increased when multiple procedures were performed during the same visit. The leading cause of death was a pulmonary embolism, in which a blood clot forms and travels to the lung. Other causes of death included heart attacks following surgery, heart and breathing problems related to anesthesia, and abuse of pain medications given after surgery.

Patients also had complications including hematoma, or internal bleeding, following breast-enlargement surgery, infection, the development of dead tissue known as necrosis, cardiac arrests, breathing problems, pulmonary embolism and other blood clots, and allergic reactions. “Complications occur even in the best of hands under the best of circumstances,” says Los Angeles plastic surgeon Geoffrey Keyes, who led the study. “But outpatient surgery is very safe for healthy patients in accredited facilities run by competent professionals.”

New Medicare rules will begin requiring ambulatory surgery centers to report information on quality and safety measures, as hospitals now do. The Ambulatory Surgery Center Association, a trade group, has begun gathering data from its members on six such measures in anticipation of the new Medicare guidelines. S. David Shapiro, co-chairman of the quality reporting project, says 1,100 surgery centers are voluntarily submitting data.

David Hidalgo, a plastic surgeon in New York City who has had his office voluntarily accredited for more than a decade, urges patients to take a tour of the surgical facility at which they are considering undergoing treatment. “If it looks like a converted exam room without much equipment and dim light, that’s a place to run away from,” he says. Patients should also ask if a surgeon is board-certified in his or her specialty. Also check if that specialty provides training in the procedure the patient plans to undergo. For example, dermatologists often perform liposuction despite the fact that their training doesn’t include a surgical residency.

Anesthesiologist Henry Rosenberg, director of medical education at St. Barnabas Medical Center in Livingston, N.J., and president of the Malignant Hyperthermia Association of the United States, conducts research on a rare risk of anesthesia that can lead to temperature spikes, cardiac arrest and death for patients with a certain gene mutation.

In a recent case he reviewed, a 21-year-old man was undergoing outpatient surgery in New York for a minor procedure on his genitals when he stopped breathing. After his death it was discovered he had the mutation associated with that disorder.

“There needs to be an effective transfer arrangement between the outpatient facility and the hospital” should signs of malignant hyperthermia emerge, says Dr. Rosenberg, who is working on a protocol to be used in such cases.
Risky Conditions

For patients with certain high-risk conditions such as sleep apnea, a common disorder involving pauses in breathing during sleep, experts say it is generally better to have surgery in a hospital or a facility that is adjacent to one. But even then, things can go wrong, particularly if there isn’t adequate information about a patient’s medical condition.

Ruthell Howard, a newspaper copy editor, stopped breathing during minor surgery in 2005 under sedation with the drug propofol, sustained severe brain damage and died in a nursing home at age 50 two years later. She suffered from both sleep apnea and a condition that caused inflammation in her lungs. Her sister-in-law, Myrna Howard, says Ruthell was a conscientious and careful patient, but she may not have been aware of the extent of the risks.

One lesson for patients, Ms. Howard says, is to fully disclose any conditions that might put them at risk during surgery and to make sure their medical records have been reviewed prior to any procedure.

But she also says doctors and nurses have a duty to elicit information, especially if there are language barriers or a patient’s medical knowledge is limited. “There are too many patients going into surgery who might not fully appreciate the dangers,” she says.

- Wall Street Journal


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