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Search results for "Food and Drug Administration (FDA)"
- Food and Drug Administration (FDA)
- Human Factors Engineering
Rockville, MD: Center for Drug Evaluation and Research, US Food and Drug Administration; April 2016.
US Food and Drug Administration. March 8, 2019.
Errors of commission during complex procedures can contribute to patient harm. Drawing from an analysis of medical device reports submitted to the Food and Drug Administration, this announcement seeks to raise awareness of common adverse events associated with surgical staplers and implantable staples. User-related problems include opening of the staple line, misapplied staples, and staple gun difficulties. Recommendations include ensuring availability of various staple sizes and avoiding use of staples on large blood vessels.
Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Silver Spring, MD: US Food and Drug Administration; September 29, 2018.
FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2018.
FDA Drug Safety Communication: FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; July 30, 2015.
Look-alike and sound-alike drug names can contribute to confusion and result in medication errors. To raise awareness of potential wrong-patient errors due to similarity between two proprietary names, this announcement describes near misses with the drugs at the prescribing and dispensing stage and suggests clinicians use the generic names for the medications to reduce risk of patient harm.
Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff.
Federal Register. Washington, DC: US Department of Health and Human Services. Baltimore, MD: Food and Drug Administration. July 9, 2015;80:39440-39441.
FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam).
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; May 20, 2015.
Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; February 23, 2015.
Design limitations and production pressure may contribute to insufficient sterilization of complicated medical devices between uses. This announcement raises awareness of risks associated with inadequate cleaning of duodenoscopes that surfaced after a cluster of nosocomial infections at Ronald Reagan UCLA Medical Center.
Legislation/Regulation > Government Resource
Safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; February 11, 2015.
Journal Article > Commentary
The Food and Drug Administration's initiative for safe design and effective use of home medical equipment.
Weick-Brady M, Singh S. Home Healthc Nurse. 2014;32:343-348.
Medical devices are increasingly being used outside clinical facilities, and this can present unique safety challenges for both untrained and skilled personnel. This commentary describes FDA efforts intended to enhance safety of medical equipment use at home, including a guidance which focuses on factors relating to the user, environment, and labeling along with a campaign to increase public awareness of the risks associated with inappropriate device use.
Legislation/Regulation > Government Resource
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Draft Guidance.
Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; April 24, 2013.
This draft guidance seeks to outline design elements that reduce errors associated with medication labels. The process for submitting public comments is now closed.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; December 6, 2012.
Web Resource > Multi-use Website
Medical Product Safety Network. Silver Spring, MD; US Food and Drug Administration.
This Web site provides information about tubing misconnections and how to prevent them.
MedWatch Safety Alert, FDA Drug Safety Communication. Silver Spring, MD: US Food and Drug Administration; June 13, 2011.
This notice raises awareness of a two look-alike/sound-alike drugs, one an antipsychotic medication and the other a dopamine agonist.
Tools/Toolkit > Fact Sheet/FAQs
Silver Spring, MD: US Food and Drug Administration; May 2011.
This flyer provides tips to help prevent consumer medication errors.
Hydrocodone bitartrate and acetaminophen tablets, phenobarbital tablets by Qualitest: recall—incorrect package labeling.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 7, 2011.
This announcement reports the recall of two products that may have been mislabeled.
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL): medication use error—reports of accidental overdose.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 10, 2011.
This announcement reveals a labeling change to reduce the potential for misadministration of a pain medication.
Rockville, MD: US Food and Drug Administration; November 9, 2010.
This notice analyzes findings from a government initiative on CT scan injuries and provides recommendations to enhance safety and prevent such incidents.
MedWatch Safety Alert, FDA Drug Safety Communication. Silver Spring, MD: US Food and Drug Administration; August 2, 2010.
This announcement reports on numerous errors in which an oral medication, nimodipine, was administered intravenously and describes how such errors occur.
US Food and Drug Administration. June 24–25, 2010; Marriott Residence Inn, Bethesda, MD.
This session kicks off an FDA initiative to redesign drug labeling in an effort to prevent medication errors and develop policies to support the changes. The opportunity to submit comments based on materials discussed at the session has passed.