![\"*\"](\"https://webarchive.library.unt.edu/eot2008/20090511174511/http://www.fda.gov/cdrh/images/ti-bullet.gif\")
Update Regarding the Availability of Rapid Influenza Tests and Viral Transport Media
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document.write("May 7, 2009 It has come to our attention that many customers are experiencing problems with the availability of rapid influenza tests and viral transport media. Some manufacturers are experiencing backorders; but others say they still have a supply. We have been informed that manufacturers are...
Class 1 Recall: Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide
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document.write("Medtronic and FDA notified healthcare professionals about a Class I recall of the Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide due to the possibility that the ventricular catheter may become detached from the snap base assembly after...
Class 1 Recall: Tri-State Hospital Supply Corporation - Centurion Trays and Kits
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document.write("Tri-State Hospital Supply Corporation initiated a recall on January 14, 2009 for a variety of Centurion Trays and Kits due to weak package sealing which may affect the sterility of the devices. The affected products were manufactured from November 17, 2008 through November 21, 2008 and distributed...
Class 1 Recall: Teleflex Medical, Arrow International Inc. 30, 40, and 50 cc Intra-Aortic Balloons
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document.write("Teleflex Medical and FDA notified healthcare professionals of the Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters, a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to...
Class 1 Recall: ZOLL Medical Corporation, ZOLL AED Plus Defibrillator
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document.write("ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to...
Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use
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document.write("The FDA notified healthcare providers and patients that insulin pens and insulin cartridges are never to be shared among patients. Sharing of insulin pens may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Insulin pens are not designed, and are not safe, for one...
Adverse Events in Hospitals: Overview of Key Issues
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document.write("A Report from the Department of Health and Human Services Office of Inspector General, December 2008 The Tax Relief and Health Care Act of 2006 (the Act) mandates that the Office of Inspector General (OIG) report to Congress regarding the incidence of ?never events? among Medicare beneficiaries,...
Data Snapshot: Iatrogenic Burn Injuries
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document.write("Pennsylvania Patient Safety Authority In 2007, the Pennsylvania Patient Safety Authority received 224 reports of burns, singes, or sparks occurring in the healthcare facility. These burns were reports of actual or proximal harm to the patient. More than half the submitted burns were reported to...
Safety in the MR Environment
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document.write("Pennsylvania Patient Safety Authority Electromagnetic and ferromagnetic materials in close proximity to a magnetic resonance imaging (MRI) scanner can be a hazardous safety risk to any individual near the scanner. To avoid injury from interference and attraction effects, individuals are screened...
Faucet and sink design contribute to splashing, ICU outbreak with resistant organism and 12 deaths
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document.write("SafetyShare Newsletter, Premier, Inc A multi-drug resistant organism (MDRO) causing an ICU outbreak and at least 12 deaths was associated with poor placement of handwashing sinks and environmental contamination. A recent study from the University of Toronto illustrates the importance of room...
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![\"LabNet](\"subnet-labnet.gif\")
Focuses on promoting awareness of medical devices in hospital laboratories and reporting identified problems to FDA?s Office of In Vitro Diagnostics. To see recently submitted MedSun Laboratory Device Reports, see Laboratory/In Vitro Diagnostic Devices.Update Regarding the Availability of Rapid Influenza Tests and Viral Transport Media
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document.write("See an important update regarding the availability of Rapid Influenza Tests and Viral Transport Media on this month's homepage. ...
MRSA Screening Used to Decrease SSIs
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document.write("American College of Surgeons Surgery News A recent study showed that universal preoperative surveillance for methicillin-resistant Staphylococcus aureus infection coupled with eradication before all elective procedures was not significantly better than screening of high-risk patients and...
![\"HomeNet](\"subnet-homenet.gif\")
Focuses on identifying, understanding, and solving problems with medical devices used in the home environment; also focuses on issues related to labeling, training, and servicing problematic devices.Bringing Medical Devices Home
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document.write("Medical Device and Diagnostic Industry Because of changes in healthcare, medical devices (both critical and noncritical) are used more often in the home and are used in different ways from in the hospital. This article discusses the challenges and experiences of those using medical products in the...
![\"KidNet](\"subnet-kidnet.gif\")
Focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric intensive care units. To see recently submitted MedSun Neonatal and Pediatric Device Reports, see Neonatal and Pediatric Devices.Ceftriaxone (marketed as Rocephin and generics)
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document.write("FDA notified healthcare professionals of an update to a previous alert on the interaction of ceftriaxone with calcium-containing products, based on previously reported fatal cases in neonates. Based on the results of new studies FDA now recommends that ceftriaxone and calcium-containing products...
FDA Approves Cardiac Adhesion Barrier for Pediatric Use
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document.write("The FDA announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery. Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the...
Highlighted Reports
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document.write("This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of...
Summary of MedSun Reports Describing Adverse Events With Surgical Mesh Products for Hernia Repair
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document.write("Surgical mesh is a polymeric, biologic or metallic screen intended for implant to reinforce soft tissue or bone where weakness exists. It is typically used in surgery for the repair, reconstruction, or substitution of tissue, commonly in hernia repair surgical procedures. Over the past 2 years,...