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March 2009 |
SAFETY WARNING
STERIS, FDA continue discussions on STERIS SYSTEM 1® sterile processing system
The U.S. Food and Drug Administration (FDA) issued a warning to STERIS in May 2008 about its SYSTEM 1 and S-20 Sterilant because of changes and modifications made to the system.
STERIS and FDA met to discuss the warning letter. Although the parties continue to disagree, STERIS agreed to submit a new premarket notification for an updated SYSTEM 1 processor that includes the changes listed in the warning letter and other technology updates. In conjunction with the submission to FDA, STERIS voluntarily distributed a customer notice regarding SYSTEM 1 on Jan. 20 that was not the result of any health or safety issues. The letter explained that there is no change required to the hospital’s clinical practice and that the company will continue servicing and supporting existing SYSTEM 1 units for at least 2 years. STERIS also agreed to discontinue selling SYSTEM 1 processors in the United States, except for sales related to product replacement.
STERIS says it will work with customers on a timetable to transition to an updated SYSTEM 1 once it is cleared for market use by FDA. STERIS says the issue is a regulatory one, and not the result of product performance or adverse events. More than 23,000 SYSTEM 1 units have been sold to more than 5,000 facilities in the United States since 1988.
HEALTHCARE IT
Economic stimulus also brings health care IT job
A new National Coordinator of Health Care Information Technology (IT) position that comes as part of the American Recovery and Reinvestment Act has already begun to draw some criticism.
While the economic package allocates billions of dollars toward the development of electronic health records, former New York lieutenant governor Betsy McCaughey has publicly warned that a national health care IT coordinator could put too much government influence on patient care. Other lawmakers, however, see the potential candidate as being one who ushers in a new era of technology in terms of patient records.
An editorial in The Washington Post describes the situation and highlights the fact that a national health care IT coordinator was provisioned for in 2004 under then President George W. Bush.
Learn more.INNOVATION
New type of surgery may help amputees
A new technique that reconnects amputated nerve fibers to chest muscles may give amputees improved control over artificial limbs.
Using electrical impulses sent from the reconnected nerves to operate a special motorized arm, amputees could gain a range of motion and control of artificial limbs previously thought to be lost completely.
A team of researchers reported their findings in the Journal of the American Medical Association. Read a news story about the study.
COMMUNICATION
HHS uses micro-blog Twitter to keep public informed on recalls and health news
The Department of Health and Human Services (HHS) recently began warning the public about food recalls and health news 140 characters at time.
Using popular micro-blogging service Twitter, which allows users to communicate online via short messages, HHS has warned of salmonella outbreaks and has shared emergency preparedness information. HHS has also highlighted research published on its Web sites.
See how the government is using social media to reach a wider audience at twitter.com/FDARecalls (Food and Drug Administration recalls), twitter.com/NIHforHealth (National Institutes for Health), twitter.com/AIDSGov (Aids.gov) and twitter.com/CDCEmergency (Centers for Disease Control and Prevention).
NURSING SHORTAGE
Idaho nurse shortage could become surplus
In what could be a growing trend nationwide, Idaho hospitals are beginning to see the shortage of registered nurses (RNs) turn into a surplus.
The Idaho Statesman reports that Idaho’s current community of 11,200 RNs is growing rapidly and that the state’s nursing schools are nearing capacity. The state’s 22-member nursing council expects Idaho’s nursing demand will be met within three years. The council says that, despite these projections, aspiring nurses shouldn’t necessarily begin looking for different careers. Because the economy is hard to predict, and the nation’s baby boomers are starting to retire, demand for nurses could come back in a matter of time.
Read more.CORRECTION
An incorrect URL was cited in the February issue of AORN Connections in a news brief titled FDA okays quick test for drug-resistant staph infections. The correct URL is www.fda.gov/consumer/updates/mrsa011008.html.
Read more news in AORN Connections.