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U.S. Department of Health and Human Services

MedSun: Newsletter #4, May 2006

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Newsletter #4, May 2006

Articles

Pennsylvania State Authority Advises on Patient Safety

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The Pennsylvania State Patient Safety Authority, an independent State agency, presents evidence in its recently issued Annual Report for 2005 that mandatory reporting of adverse events and subsequent clinical guidance on avoiding such events in the future make significant contributions to promoting and improving patient safety. The first full year of statewide mandatory reporting yielded close to 175,000 reports, most of them not qualifying as serious events. Based on these reports, the Authority published more than 60 scholarly articles in its quarterly Patient Safety Advisory, a journal that provides guidance to facilities about promoting patient safety and reducing the potential for medical error.

Some of the changes that have been instituted in hospitals and ambulatory surgical facilities as a result of Advisory articles include the following:

•Reducing the number of color-coded patient wristbands in use in facilities;
•Minimizing the risk of alcohol-based fires by using towels to catch alcohol runoff in operating rooms;
•Educating surgeons about the importance of “time out” before surgery, in which the patient’s identity and other critical elements of the planned procedure are reviewed;
•Adding to providers’ list of prohibited abbreviations, based on potentially confusing abbreviations identified in the Advisory; and
•Educating staff on how to minimize the risk of anesthesia awareness.

Additional Information:

Pennsylvania’s Patient Safety Authority
http://www.psa.state.pa.us

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Commonwealth Fund Addresses Patient Safety

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In Committed to Safety: Ten Case Studies on Reducing Harm to Patients, a new report from The Commonwealth Fund, Douglas McCarthy, president of Issues Research, Inc., and David Blumenthal, M.D., director of the Institute for Health Policy at Harvard Medical School, describe 10 organizations—ranging from large, recognized health systems to small community hospitals—that made changes to improve patient care and prevent unnecessary harm. The five areas that are shown to hold great promise for improving patient safety include promoting an organizational culture of safety, improving teamwork and communication, enhancing rapid response to prevent heart attacks and other crises, preventing health care-associated infections in the intensive care unit, and preventing adverse drug events.

Additional Information:

The complete report is available at The Fund’s Web site:
http://www.cmwf.org

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Convictions in Unapproved Sterilization Device Scheme

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Two executives of a Mundelein, IL, company were convicted April 13, 2006, of fraudulently selling uncleared surgical sterilizing devices that led to eye damage in 18 patients, causing them to lose sight in one eye.

Ross Caputo was president and chief executive officer of AbTox and Robert Riley was vice president of regulatory affairs of AbTox when the company received permission to market a small gas plasma sterilizer only for use in sterilizing flat stainless-steel surgical instruments without lumens (tubes) or hinges. The defendants instead marketed a larger, unauthorized version of the sterilizer and promoted its use for a wide array of nonstainless-steel instruments.

Hospitals that purchased the larger unauthorized units were shown by AbTox the clearance letter for the smaller, authorized unit. These larger units were used in an unauthorized manner—because AbTox marketed them that way—to sterilize complex instruments, including cataract instruments that have small tubes used to put solution into the patient’s eye. One unauthorized use was to sterilize ophthalmic instruments that had brass joints, which reacted to the sterilizing agent creating a toxic residue. AbTox knew of the reaction but did not advise users or seek proper corrective action. The blindness was caused by a harmful copper acetate residue that remained in the tube of the instrument after sterilization by this machine.

The company sold 168 of the unauthorized units to hospitals nationwide, including U.S. Department of Veterans Affairs hospitals and other government agencies, totaling over $18 million in sales. Hospitals in Chicago, IL, Columbia, MO, and St. Louis, MO, reported to AbTox that their sterilizers were suspected of causing injuries to several patients. The company failed to notify the FDA about these reports as required.

“These convictions are evidence of the [Food and Drug Administration’s (FDA)] resolve to ensure the safety and efficacy of human medical devices. Our criminal investigators aggressively pursue those that endanger the public health by manufacturing and selling unsafe products,” said Margaret O’K. Glavin, the FDA Associate Commissioner for Regulatory Affairs.

The conviction of these two men is the result of an investigation conducted by the FDA Office of Criminal Investigations. The defendants were convicted of three counts of wire fraud, four counts of mail fraud, seven counts of selling an adulterated (unapproved) or misbranded (mislabeled) human medical device, and conspiracy to defraud the FDA. Mr. Riley was also convicted of one count of making a false statement for lying to the FDA.

The defendants face significant penalties, including incarceration, fines, and restitution. Sentencing will be at a later date. Two other defendants, Mark E. Schmitt, former AbTox director of marketing, and Marilyn M. Lynch, former AbTox director of clinical services, previously pleaded guilty in this case.

The defendants were found guilty after a 9-week trial in the Northern District of Illinois as the result of a successful prosecution under the direction of Patrick J. Fitzgerald, United States Attorney for the Northern District of Illinois, in conjunction with the U.S. Department of Veterans Affairs Office of Inspector General, Office of Investigations; the U.S. Naval Criminal Investigative Service; and the U.S. Air Force Office of Special Investigations; along with the FDA.

Additional Information:

For this FDA press release go to:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108648.htm

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DS-X Device Safety Exchange, a MedSun Program

DS-X Lessons Learned

Question of the Month with Comment

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Question:
We are using electrosurgical units (ESUs) with infants in radiant warmers and are concerned that the patient temperature probe used with the radiant warmer might provide an alternate path for the ESU’s radio frequency energy and lead to a burn at the site of the temperature probe. Are there recommendations from ESU or radiant warmer manufacturers about this, or any standard of practice that would provide a reference on the subject?

Comment:
One of the standards of practice for ESU use is provided by the Association of Perioperative Registered Nurses (AORN). The organization’s “Recommended Practices for Electrosurgery” appears in its AORN Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc., 2005). While there is no reference to the use of ESUs with radiant warmers, the guidelines state that “Patient monitoring electrodes (e.g., electrocardiogram, oximetry, fetal) should be placed as far away from the surgical site as possible. Alternate pathway burns have been reported at electrocardiogram electrode sites and temperature probe entry sites with ground-referenced electrosurgery units.” While modern ESUs are not ground-referenced, some older models may be. One should additionally be on the lookout for the radio frequency from the ESU interfering with the temperature regulation of the radiant warmer; in other words, the temperature display may fluctuate when the ESU is activated.

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Updated May 1, 2006

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