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The FDA as a Public Health Agency
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document.write("New England Journal of Medicine A public health approach recognizes that the potential good of a new medical product or policy must be balanced against the potential harm. The FDA has always been a work in progress and updating this work means modernizing scientific and legal regulatory approaches...
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![\"LabNet](\"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/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.Roche Diagnostics notifies customers of the potential for ACCU-CHEK Softclix 10 and/or 17 count lancets to be uncapped which may lead to an accidental needle stick
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document.write("FDA Recall Notice Roche Diagnostics announced that it is notifying its customers and healthcare professionals about a potential issue with a small number of ACCU-CHEK Softclix 10 and/or 17 count lancets that have missing caps that were distributed as samples or in meter kits....
Detection of Novel Influenza A (H1N1) Virus by Laboratory Testing
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document.write("FDA - Office of In Vitro Diagnostics (OIVD) website On April 30, 2009, CDC issued interim guidance on specimen collection and processing [http://www.cdc.gov/h1n1flu/specimencollection.htm], and on May 1, 2009, CDC issued interim guidance on testing for the novel influenza A (H1N1) virus in regions...
False Positive Results with a Commercially Available West Nile Virus Immunoglobulin M Assay
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document.write("CDC MMWR In September 2008, CDC, the Food and Drug Administration (FDA), and state health departments began a nationwide investigation into an increase in false-positive test results obtained with a commercially available West Nile virus (WNV) immunoglobulin M (IgM) capture enzyme-linked...
![\"HeartNet](\"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/subnet-heartnet.gif\")
Focuses on identifying, understanding, and solving problems with medical devices used in electrophysiology laboratories. To see recently submitted MedSun Cardiovascular and EP Device Reports, see Cardiovascular including EP Devices. For more details about heart devices visit Heart Health.Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers
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document.write("FDA Recall Notice Medtronic and FDA notified healthcare professionals and patients of a Class I recall of Medtronic Kappa Series 600/700/900 and Sigma Series 100/200/300 pacemakers due to a failure of the devices to pace the heart. Patients with malfunctioning pacemakers may experience a return of...
![\"HomeNet](\"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/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.How You Can Get the Best Results with Home Use Tests
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document.write("FDA - Office of In Vitro Diagnostics (OIVD) website Last month, the MedSun Newsletter featured general information on Home-Use Tests. July's Newsletter provides recommendations as to how you may use home use-tests to get the best results....
![\"KidNet](\"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/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.Use Infant Heel Warmers with Care
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document.write("By: Diane Dwyer, RN, BSN FDA Medical Device Safety Website (Article reprinted from April Nursing2009, Volume 39, Issue 4) The article provides recommendations so as to avoid patient and caregiver complications associated with the use of infant heel warmers....
![\"SightNet](\"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/subnet-eyenet.gif\")
Focuses on adverse events observed with ophthalmic medical devices used in providing all levels of eye care. To see recently submitted MedSun Opthalamic Device Reports, see Ophthalmic Devices.
FDA Letter to Eye Care Professionals
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document.write("FDA website FDA has received information, comments, and complaints from interested persons regarding the promotion and advertising of LASIK procedures and the FDA-approved lasers used in LASIK procedures. The FDA believes that eliminating deceptive or misleading health-related advertising claims...
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 Vascular Hemostasis Devices
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document.write("Vascular hemostasis devices are used to stop bleeding from a blood vessel, usually after a medical procedure has opened an artery. During cardiac catheterization, balloon angioplasty or catheter-based procedures, the physician often will obtain access for the procedure through the femoral artery in...
Summary of MedSun Reports Describing Adverse Events With Electrosurgical Cutting and Coagulation Devices: Fire Associated Reports
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document.write("An electrosurgical cutting and coagulation device (and its accessories) is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.[1] Over the past 2 years, MedSun has received 13 reports where fire is association with the use of electrosurgical cutting...
Summary of MedSun Reports Describing Adverse Events With Electrosurgical Cutting and Coagulation Devices: Patient Burns
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document.write("An electrosurgical cutting and coagulation device (and its accessories) are devices intended to remove tissue and control bleeding by use of high-frequency electrical current. [1] Over the past 2 years, MedSun has received 36 reports where patients receive a burn in association with the use of...