This Just In

Fire Safety
Fires Prompt Warning Letter, Ultane Label Change
Abbott Laboratories sent more than 50,000 anesthetists a letter last month that warned of possible fires or extreme heat in the respiratory circuits of anesthesia machines when Ultane (sevoflurane) is used along with a desiccated carbon dioxide absorbent.

After receiving reports of fires in the United States, Abbott began working with the FDA several months ago to change the dosing and administration passages in Ultane's package insert, says Ann Fahey-Widman, Abbott's senior manager of public affairs for pharmaceuticals.

Four fires occurred between 1995 - the year the product was launched - and 2003, says Ms. Fahey-Widman. In the past two months, the FDA's Division of Anesthetic, Critical Care and Addiction Drug Products says it discovered at least four additional cases, including one that landed a patient in the ICU with severe airway inflammation. Each of the domestic reports indicates Ultane was used with Baralyme CO2 absorbent.

"Features seen in more than one case included failed inhalation induction or inadequate anesthesia with Ultane, a lower than expected monitored sevoflurane concentration, clinical signs of airway irritation (such as coughing), elevated carboxyhemoglobin levels, and first anesthesia case of the day," says an FDA spokesperson. "In some of the cases, the event occurred without a patient connected to the breathing circuit."

The reason this can happen, says Alan Marco, MD, MMM, an associate professor of anesthesiology at the Medical College of Ohio in Toledo, is that when anesthesia machines are left running for long periods of time, the dry gas running through the machine will desiccate the absorbent in the canister. In addition, he says, letting the CO2 absorbent dry out can affect the color indicator that signals you when it's time to replace the absorbent.

"The color indicator usually changes pink or purple, depending on the product," says Dr. Marco. "But when the agent is dried out, you don't get that color change, so you won't know to replace it. If it's dried out, it could, in theory, produce the situation they described in the letter."

In the letter, Abbott advises taking these precautions:

• If the CO2 absorbent has not been used for an extended period of time, replace it.
• Shut the machine off completely at the end of clinical use or when you expect the machine to be idle for an unusually long time.
• Turn off all vaporizers when not in use.
• Verify the integrity of the packaging of new CO2 absorbents prior to use.
• Periodically monitor the temperature of the CO2 absorbent canisters.
• Monitor the correlation between the sevoflurane vaporizer setting and the inspired sevoflurane concentration. Be wary of unusually delayed concentration rises or unexpected drops, which may be signs of excessive heating.

The new package inserts, sent out along with the letters, are posted on www.abbotthosp.com/prod/anes/ultanepi.pdf. The dear healthcare professional letter is available at www.fda.gov/medwatch/safety/2003/ultane_deardoc.pdf.

- Stephanie Wasek

Inside The Numbers

• 21% - Percentage of safety sharps disposed without staff's having activated the safety mechanism, according to a sharps audit at one facility.
• 23% - Percentage of safety-sharps accidents that occur when staff have not activated the safety mechanism.
• 38% - Percentage of safety-sharps accidents that occur when staff attempt to activate the safety mechanism but do so incorrectly.
• 46% - Percentage of IV safety-catheter accidents that occur during use.
• 38% - Percentage of IV safety-catheter accidents that occur after use but before disposal.
• 15% - Percentage of IV safety-catheter accidents that occur during or after disposal.
• 89% - Percentage of respondents to a survey of 247 hospital-based administrators and executives who say their facility has established a patient-safety committee.
• 81% - Percentage of respondents who called medication safety their No. 1 patient-safety indicator.

Office Surgery Safety
Office Surgery Regulatory Crackdown May Loom
In the wake of the controversial September Archives of Surgery study indicting office-based surgery safety, some have called for closer scrutiny of office practices. Others raise concerns that hastily constructed rules could unfairly penalize office surgeons who run safe surgical practices.

Hector Vila, Jr., MD, lead author of the Archives study and anesthesiologist at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, says his study implicates a combination of factors that should be addressed through policy change. "Poor-quality anesthesia services, unqualified surgeons, lack of accreditation, absence of peer review, no emergency transfer agreement and unqualified nurses. ' At least one of these factors contributed to adverse incidents or death in every case," says Dr. Vila. He believes this study is verification for stronger regulatory oversight of office surgery practices - like licensure, certification and accreditation. "This study says: 'Yes, those regulations and policies that drive everyone crazy do pay off.' They are necessary," says Dr. Vila.

Dissenters, such as Rajesh Balkrishnan, PhD, an associate professor with the University of Texas Health Sciences Center and lead author of a recent review of office surgery-safety studies published in Dermatological Surgery, say that sweeping policy changes may only penalize the majority of surgeons who already practice safe office surgery. "Before we rush into policies that put a stranglehold on office surgery, we need to reign in the evidence carefully and look at the quality of the data," he says.

Presently, 13 state boards of medicine or state legislatures regulate office surgery practices. Alabama, Louisiana, Tennessee and Washington also are considering action.

- Dianne Taylor