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- Communication Improvement 4
- Education and Training 6
- Error Reporting and Analysis 5
- Human Factors Engineering 7
- Legal and Policy Approaches 1
- Quality Improvement Strategies 6
- Technologic Approaches 1
- Device-related Complications
- Diagnostic Errors 1
- Medical Complications 4
- Medication Errors/Preventable Adverse Drug Events 2
- MRI safety 2
- Nonsurgical Procedural Complications 1
- Surgical Complications 4
- Surgery 4
- Nursing 2
- Family Members and Caregivers 1
- Health Care Executives and Administrators 10
Health Care Providers
- Nurses 2
- Non-Health Care Professionals 5
- Patients 6
Search results for "Device-related Complications"
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.
FDA Safety Communication: caution when using robotically-assisted surgical devices in women's health including mastectomy and other cancer-related surgeries.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 28, 2019.
This announcement seeks to raise awareness of the potential risks associated with the use of robotic-assisted surgical devices in mastectomies or cancer-related care. Recommendations for patients who may seek to have robotically assisted surgery include asking about their surgeon's experience with these procedures and discussing benefits, risks, and alternatives regarding available treatment options with their health care provider. Suggestions for health care providers include completing specialized training on procedures they perform. A WebM&M commentary described the challenges and benefits associated with robotic surgery.
FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 14, 2018.
This safety announcement raises awareness of pump failures, dosing errors, and other potential safety issues associated with implanted pumps. Recommendations to enhance safety include review of medication labeling to select appropriate medicines and concentrations as well as open discussions with patients about risks associated with pump and medication options.
Bethesda, MD: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health. May 21, 2018. PA-18-790; PA-18-791.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; January 15, 2008.
This notification alerts providers to the potential danger of unretrieved device fragments (UDFs), types of adverse events that may occur, and prevention strategies.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; August 29, 2006.
This news release announces a seizure of infusion pumps that have a "key bounce" defect that could result in over-infusion of medication.
FDA preliminary public health notification: update of information about Ralstonia spp. associated with Vapotherm Respiratory Gas Administration device.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, Food and Drug Administration; December 20, 2005.
This safety alert for health care practitioners discusses bacterial contamination of gas devices and recommends alternatives be used until the source of the contamination is identified.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; October 27, 2005.
This announcement alerts patients and practitioners to a problem with glucose meters made by Abbott Diabetes Care. The meters have a measurement setting that, if inadvertently switched, could cause an inaccurate reading.
Implantable infusion pumps in the magnetic resonance (MR) environment: FDA safety communication—important safety precautions.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2017.
Hazards in the magnetic resonance imaging environment can result in patient harm. This announcement raises awareness of inaccuracies and disruptions that may affect the safety of patients with implantable infusion devices who undergo an MRI exam. The statement recommends that patients inform their care team and carry an implant card with information about the implanted device to prevent these problems.
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.
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.
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. Silver Spring, MD: US Food and Drug Administration; October 9, 2009.
This alert notifies health care providers of the potential for patient harm if a particular inhalation powder is reconstituted and incorrectly administered.
Information for healthcare professionals: risk of transmission of blood-borne pathogens from shared use of insulin pens.
FDA Alert [US Food and Drug Administration Web site]. March 19, 2009.
This announcement alerts clinicians and patients that insulin pens and insulin cartridges are never to be used on more than one patient.
10-State project to study methods to reduce central line-associated bloodstream infections in hospital ICUs.
Rockville, MD: Agency for Healthcare Research and Quality; February 19, 2009.
This announcement highlights a program in 10 states that will test methods of reducing central-line–associated blood stream infections in hospital intensive care units.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration. December 4, 2007.
This announcement includes safety instructions for avoiding entrapment and suffocation in a recalled model of a patient bed.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; April 18, 2007.
This announcement alerts health care providers and consumers to potential contamination of medical devices from one manufacturer.
FDA public health notification: MRI-caused injuries in patients with implanted neurological stimulators.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, Food and Drug Administration; May 10, 2005.
In response to reports of injuries in patients with implanted neurological stimulators who underwent magnetic resonance imaging procedures, the Food and Drug Administration suggests related precautions for radiology personnel and physicians.