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Search results for "Press Release/Announcement"
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.
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 Draft guidance for industry and Food and Drug Administration staff.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.
Move toward full use of metric dosing: eliminate dosage cups that measure liquids in fluid drams. Use cups that measure mL.
National Alert Network. Horsham, PA: Institute for Safe Medication Practices; Bethesda, MD: American Society of Health-System Pharmacists. June 30, 2015.
Standard use of metric oral dosage instructions has been advocated as a medication safety strategy. Raising concerns around dosing cups that include drams and ounces as scales—measures no longer in clinical use—which are available from major vendors and may be found in health care facilities, this announcement recommends use of oral syringes that only measure in milliliters for oral liquid medications to prevent errors.
Potentially dangerous confusion between Bloxiverz (neostigmine) injection and Vazculep (phenylephrine) injection.
National Alert Network. Horsham, PA: Institute for Safe Medication Practices; Bethesda, MD: American Society of Health-System Pharmacists. March 23, 2015.
Misunderstanding prescription drug labels is a recognized source of errors in ambulatory care. This announcement raises awareness of new packaging for existing medications that may cause confusion due to similarities in color and layout. Recommendations are outlined to prevent mistakes associated with use of these medications.
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.
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.
MedWatch Safety Alert. Rockville, MD: US Food and Drug Administration; February 17, 2010.
This announcement alerts consumers and health care professionals to dangers associated with name confusion on a widely used over-the-counter medicine.
Information Exchange System Alert. Geneva, Switzerland: World Health Organization; July 18, 2007.
This international announcement provides guidance on the safe administration of the chemotherapeutic agent vincristine.