Recalls and Safety Alerts:
FDA Continues to Study BPA
The Food and Drug Administration’s assessment is that the scientific evidence at this time does not suggest that the very low levels of human exposure to BPA through the diet are unsafe. FDA is continuing its research and monitoring of studies to address uncertainties raised about BPA...
Acclarent Inspira AIR Balloon Dilation System - Class 1 Recall
Acclarent received four reports of incidents, one resulting in patient injury, in which the device has apparently malfunctioned. In each of these cases, difficulty deflating the balloon occurred after the surgeon pulled against resistance in response to the balloon moving distally during dilation. The force applied to the catheter stretched and narrowed the catheter shaft, causing the balloon to be difficult or impossible to deflate...
Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs) - Class I Recall
FDA notified healthcare professionals and medical care organizations of the Class 1 recall of certain AEDs which contain a component that may fail unexpectedly due to a defect. The unit's self test may not detect the failure or impending failure of the component...
Safety Tips for Intense Pulsed Light Therapy
Although IPL is safe and effective when clinicians follow the manufacturer's instructions for using and properly maintaining the equipment, complications have been reported when these measures weren't taken...
MedSun's KidNet Update: Continuing as a Model for Patient Safety
KidNet focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric patient populations, with an emphasis on those occurring in neonatal and pediatric intensive care units (NICUs and PICUs)...
MedSun in Action:
Burn Wound Management: MedSun Small Sample Survey Summary
This survey effort addresses the use of current and new products, technologies and advancements in burn care and their effect on clinical outcomes...
Ferromagnetic Detector Utility and Magnetic Resonance (MR) Safety: MedSun Small Sample Survey Summary
Overall, respondents indicate that FD systems – archway, pole-style and handheld – are effective in preventing harm, yet want to emphasize they are only as good as the staff who use them...
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