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| Execs Convicted for Illegal Equipment Sales
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The chief executives of a medical equipment manufacturer have been convicted in federal court for fraudulent business practices and the unauthorized sale of a surgical sterilizing device which resulted in eyesight loss for 18 patients.
Ross Caputo, president and CEO of AbTox, Inc., of Mundelein, Ill., and Robert Riley, vice president of regulatory affairs for the company, face the possibility of incarceration, fines and restitution payments when they are sentenced at a later date.
According to the U.S. Food and Drug Administration, AbTox had been cleared in the 1990s to market a small gas plasma sterilizer designed only for the processing of stainless steel instruments without lumens or hinges.
The company, however, also marketed the Plazlyte Sterilization System, a larger sterilizing unit which it said could be used to process a wider range of instruments. AbTox promoted the unit with its earlier clearance letter.
About 168 of the Plazlyte units were sold nationwide. Hospitals in Chicago, St. Louis and Columbia, Mo., reported that ophthalmic instruments made with brass, copper, zinc or soldered joints had a toxic reaction to the sterilizing agent, creating copper acetate residue that blinded patients.
Mr. Caputo and Mr. Riley were each convicted in the April trial of multiple counts of selling an adulterated or misbranded human medical device, conspiracy to defraud the FDA, mail fraud and wire fraud. Mr. Riley was also convicted of false statements for lying to the agency.
Two other AbTox executives, director of marketing Mark Schmitt and director of clinical services Marilyn Lynch, pleaded guilty before the trial.
"These convictions are evidence of FDA's resolve to ensure the safety and efficacy of human medical devices," says Margaret Glavin, the agency's associate commissioner for regulatory affairs, in a statement.
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| Teamwork Study Ranks CRNAs High, Surgeons Low |
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How well does your surgical staff work together? If a new survey of employee attitudes in the healthcare workplace is any guide, it's likely that your CRNAs and nurses are seen as dedicated team players. As for your surgeons, well ... read on.
The survey, led by Martin A. Makary, MD, MPH, an assistant professor of surgery at Johns Hopkins University's School of Medicine, found that 85 percent of OR personnel perceived CRNAs as having a "high" or "very high" level of teamwork. General surgical nurses had similarly high ratings at 83.5 percent and anesthesiologists scored 79 percent.
However, only 65 percent of OR staffers felt that surgeons earned "high" or "very high" teamwork ratings according to the survey, which appears in the May issues of the Annals of Surgery and the Journal of the American College of Surgeons.
The aim and value of a study of OR teamwork, says Dr. Makary, is patient safety. The survey his team used was adapted from one created to assess accidents in the airline industry. Sixty-five questions gauge employees' views on teamwork, safety, job satisfaction, management, working conditions and stress response at their facilities.
"No one knows how to stop these (patient safety) mistakes. There's no real science to it," he says. "This is a way to scientifically measure how good a safety program is, according to your frontline providers."
The survey questionnaire was administered to 222 surgeons, 1,058 OR nurses, 564 surgical technicians, 170 anesthesiologists and 121 CRNAs in a 60-hospital, 16-state health care system during the summer of 2004.
Other significant findings included
- One in five respondents said they would not feel comfortable undergoing surgery in their own ORs.
- Few surgical staffers said they would feel comfortable speaking up if they had a patient safety concern.
- Many respondents said they often don't know the names of all the people they're working with on a procedure.
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| Repeating Doctors' Orders Reduces Errors |
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In a study that suggests wider applications for patient safety, researchers found that medication errors during rounds in a pediatric hospital were eliminated if a doctor's orders were read back to him as they were entered a computer system.
Michael T. Vossmeyer, MD, of the Cincinnati Children's Hospital Medical Center presented his findings at the Pediatric Academic Societies' annual meeting last month. Researchers observed a team on rounds as it took 70 consecutive orders, then examined the orders taken. About nine percent of the orders contained minor errors, the researchers found, and in two cases, an intern recording the orders entered an incorrect drug.
Dr. Vossmeyer and his colleagues then introduced a new process in which the person recording the orders verbally repeats them back to the attending physician or chief resident for verification. Observing the team through another 75 orders, researchers found no errors. The improvement added only a few seconds and cost nothing.
"Although this was a small study, these results are encouraging," says Dr. Vossmeyer in a statement. "We're doing a follow-up study to determine if the results are sustainable and the process is reliable, but they appear to be very generalizable."
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| News and Notes
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In a study that suggests wider applications for patient safety, researchers found that medication errors during rounds in a pediatric hospital were eliminated if a doctor's orders were read back to him as they were entered a computer system.
Michael T. Vossmeyer, MD, of the Cincinnati Children's Hospital Medical Center presented his findings at the Pediatric Academic Societies' annual meeting last month. Researchers observed a team on rounds as it took 70 consecutive orders, then examined the orders taken. About nine percent of the orders contained minor errors, the researchers found, and in two cases, an intern recording the orders entered an incorrect drug.
Dr. Vossmeyer and his colleagues then introduced a new process in which the person recording the orders verbally repeats them back to the attending physician or chief resident for verification. Observing the team through another 75 orders, researchers found no errors. The improvement added only a few seconds and cost nothing.
"Although this was a small study, these results are encouraging," says Dr. Vossmeyer in a statement. "We're doing a follow-up study to determine if the results are sustainable and the process is reliable, but they appear to be very generalizable."
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