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July 2009 |
Vaccine
FDA approves vaccine for 2009-2010 seasonal influenza
The FDA has approved a vaccine for 2009-2010 seasonal influenza in the United States. The vaccine is directed against strains of influenza expected to be circulating during the 2009-2010 flu season. However, the vaccine will not provide protection against the 2009 H1N1 influenza virus. On June 11, 2009 the World Health Organization declared the 2009 Influenza virus a pandemic. The FDA continues to work with manufacturers, international partners and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus.
Learn more about the new seasonal influenza vaccine.
Recall
Propofol lots recalled after CDC, FDA investigation of fever following certain endoscopy procedures
The federal Centers for Disease Control and Prevention (CDC) has been investigating recent febrile reactions among patients undergoing endoscopy in the United States. This investigation has revealed that all affected patients received the anesthetic propofol from 100 ml vials manufactured by Teva Pharmaceutical Industries.
Testing conducted by the U.S. Food and Drug Administration (FDA) revealed that two lots of this product used in facilities reporting reactions were positive for elevated levels of endotoxin. The lots are 31305429B and 31305430B. Teva Pharmaceuticals is initiating a voluntary recall for these lots, and clinicians are advised to immediately stop using these lots of Teva Pharmaceuticals propofol. CDC, FDA, and Teva Pharmaceutical Industries are continuing to investigate this issue. To date, all case-patients have recovered.
Read the July 16 FDA MedWatch press release on the recall and stay tuned to aorn.org/News for updates to this story.
SAFETY
FDA ongoing safety review of arthroscopic shavers
The Food and Drug Administration (FDA) is working to gain more data on the safety of arthroscopic shavers, a device used in orthopedic surgical procedures.
The FDA in early July published information stating the department is aware of instances in which certain arthroscopic shavers are retaining pieces of tissue even after being cleaned according to manufacturers’ guidelines. Because of this the FDA said it is working with manufacturers to gather information and understand potential public impact. The administration is also encouraging facilities that use the devices to evaluate the adequacy of their cleaning procedures, to make sure personnel cleaning the devices are aware of the situation and complying with manufacturers’ guidelines, and to consider inspecting inside the devices after they’ve been cleaned.
Facilities that discover pieces of tissue retained within arthroscopic shavers may file a voluntary report with the FDA’s MedWatch Online Voluntary Reporting Form.
Read more about the FDA safety review of arthroscopic shavers.
STUDY
Study shows infection risk increase rises with torn gloves
The use of torn surgical gloves in procedures lasting more than two hours increases risk of patient infection more than six times over, according to a study published in the June issue of the Archives of Surgery.
HealthDay News reports the risk of infection rose from 8% to 50% because of perforated gloves. Data was gathered from 4,417 surgical procedures performed at University Hospital Basel in Basel, Switzerland between 2000 and 2001.
RECALL
FDA alerts patients to Medtronic pacemaker recall
The U.S. Food and Drug Administration (FDA) and Medtronic, Inc., recently notified healthcare professionals and patients of a Class I recall of Medtronic Kappa Series 600/700/900and Sigma Series 100/200/300 pacemakers due to a failure of the devices to pace the heart.
Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or death. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.
Most of the pacemakers affected by this recall have been implanted in patients for five years or longer. To determine if a pacemaker is part of this recall, contact Medtronic at 1-800-505-4636. Read the June 11 press release about this recall.
GREEN PRACTICES
WHO urges hospitals to join climate change battle
The health sector's use of electricity in the United States adds over $600 million per year in direct health costs and more than $500 million in indirect costs, according to findings from the World Health Organization (WHO) reported in Reuters.
While the push to make healthcare facilities more green is not new, these study findings indicate the need for hospitals to actively participate in the fight against climate change.
"The health sector can contribute a lot to reduce the carbon footprint because the health sector in many countries is the second most important user and energy consumption is very high," said Maria Neira, MD, director of the WHO's department of public health and environment, during a news briefing in May.
The WHO report includes recommendations to help healthcare facilities become more green, such as using alternative forms of energy like solar panels and wind turbines. Installing energy-efficient light bulbs, buying organic food from local suppliers and making ambulances more environmentally friendly can also make a difference, the WHO said.
Read about the WHO report.
EMPLOYMENT
Recession eases nursing shortage
While the United States continues to deal with hardships resulting from the nation's deep recession, there is at least one positive result to the economic downturn-it's knocking out the nursing shortage.
Nearly a quarter-million nurses entered the work force in 2007-2008, an 18% surge that was the largest two-year increase in at least three decades, according to a Wall Street Journal report on a new study authored by researchers from Vanderbilt University's school of nursing in Nashville, Tenn., the Congressional Budget Office in Washington and Dartmouth College in Hanover, N.H.
The study found that many nurses who had left the field have re-entered the work force to compensate for a spouse's lost income or health benefits and about half the increase in the nursing workforce in 2007-2008 came from nurses over the age of 50.
Study authors cautioned that long-term projections still indicate that the nursing shortage will widen over the next decade as the economy improves and the current, aging workforce retires.
Find the study abstract in the journal, Health Affairs.
COST SAVINGS
New toolkit to combat costs of antibiotic resistance
Because the spread of multi drug-resistant organisms in healthcare facilities continues to impact clinical, economic and patient safety concerns, Joint Commission Resources has released new guidance to healthcare organizations through a free tool kit, "What Every Health Care Executive Should Know: The Cost of Antibiotic Resistance."
The tool kit will be discussed during a session on how C-suite executives can implement a comprehensive program to reduce antibiotic resistance as part of Joint Commission Resources and The Joint Commission's 2009 Annual Infection Control Conference.
Hard copies of the toolkit will be distributed at the conference and can also be downloaded here.
Learn more about the conference.
CORRECTION
In the June 2009 cover story in AORN Connections titled "Dangerous savings," incorrect page numbers were cited for AORN's Recommended Practices for Prevention of Transmissible Infections in the Perioperative Practice Setting, in the Perioperative Standards and Recommended Practices, 2009 edition.
The correct page numbers for Recommended Practices for Prevention of Transmissible Infections in the Perioperative Practice Setting are pages 475-485, not pages 619-630 as misstated in the original article. This correction has been made to the online version of the news story, which can be found at aorn.org/News/June2009News/Savings.
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