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- Food and Drug Administration (FDA)
- Infusion Pumps
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.
Web Resource > Government Resource
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration. April 12, 2016.
This website alerts clinicians and patients to risks for patient harm associated with implanted electronic medical devices, such as insulin infusion pump and pacemakers, when x-rays are used during CT examinations.
Journal Article > Study
Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events.
Cope JU, Morrison AE, Samuels-Reid J. Pediatrics. 2008;121:e1133-e1138.
This study examined more than 1600 medical device adverse event reports and categorized the frequency and cause of each event. The authors conclude that the adolescent population warrants special consideration when using device technology and a greater understanding of the safety problems that face this patient group.