Quality & Patient Safety

1. Cypher stent linked to clots when not used properly 2. Minnesota nurse probed in five patient deaths 3. Rural hospitals might be less prepared for bioterrorism threat

Patient Safety Monitor Alert, August 1, 2003

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1. Cypher stent linked to clots when not used properly

A popular new kind of stent-coated with drugs to reduce the chance of arteries clogging again-has been linked to almost three dozen patients with blood clots. Five of those patients died, although it is not certain if the deaths were a direct result of the clots. Since the Food and Drug Administration (FDA) approved use of the Cypher stent in April, approximately 50,000 patients have received the device. The FDA reports 42 cases of blood clots developing at the time of insertion or a few days later.

The FDA urged doctors to use caution when choosing Cypher stents for patients. Cordis Corporation, the manufacturer of the stents, said clots can occur if a stent is too small for the patient's arteries or if patients don't receive the appropriate anti-clotting medication after physicians insert the device.

To reduce the chance of patients developing clots, physicians should only use Cypher stents on new patients, not with patients with a clogged stent. Patients must take anti-clogging medicine for three months after insertion, instead of the two weeks required for bare-metal stents. Physicians must choose Cypher stents that most closely match artery diameter, and the stent must be completely open and touching the artery wall.

2. Minnesota nurse probed in five patient deaths

North Memorial Medical Center in Minneapolis fired a nurse after a three month investigation for allegedly giving five terminally ill patients dangerous doses of morphine. No charges have been filed against the nurse-whose name has not been released-but state officials are investigating the incidents.

Medical staff had already removed all five patients from life support and all five had "do not resuscitate" orders. Each of the patients had been receiving two to five milligrams of morphine every few hours, when the nurse gave each patient an additional 10 milligram dose. One patient received two doses at this level within 18 minutes, according to a state Health Department report. Four of the patients died within 30 minutes of receiving the morphine; the fifth died a month later. No autopsies were performed.

According to the Health Department, the nurse said treating physicians authorized the doses. One physician denied ordering the high dosage and another could not remember authorizing so much morphine. The Health Department will turn over its report to the County attorney's office to see if further investigation is needed.

3. Rural hospitals might be less prepared for bioterrorism threat

A recent study from the Saint Louis University School of Public Health, published in the current issue of American Journal of Infection Control, concluded most health care workers believe the United States is at a relatively high risk for bioterrorism but few think their community is at risk. Researchers question how much preparation and training health care workers seek out if they feel their community is low risk.

Researchers interviewed more than 1,200 infection control practitioners, the majority of whom are nurses. Workers in the Midwest and more rural areas believe they were less at risk for a bioterrorism attack. When asked how they would obtain information in the event of a crisis, a majority said they would rely on the Internet or a telephone hotline. Those sources are not always adequate during emergencies, and researchers indicated a need for other reference material, such as CD-ROMS or pocket reference cards.



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