MedSun: Subnetworks
Subnetworks
These subnetworks are designed to collect and share information about actual and potential adverse events from specific clinical areas of MedSun facilities using high-risk products.
For related information, see the latest device approvals that may be relevant to your specific clinical area.
The following represent the latest content from each subnetwork: HeartNet, HomeNet, KidNet, LabNet, SightNet, and TissueNet. For a complete listing of all content for a particular subnetwork, select it from the navigation menu or use these links.
HeartNet
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.
Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers |
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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 symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.
Additional Information:
Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers. FDA Recall Notice. May 18, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm166344.htm
FDA Alerts Patients to Medtronic Pacemaker Recall. FDA Press Release. June 11, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165853.htm
Patients Alerted to Pacemaker Recall. FDA Consumer Information. June 11, 2009.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm165619.htm
HomeNet
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.
Buying Medical Devices and Diagnostic Tests Online - FDA |
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FDA
Buying online has advantages, but it also can produce pitfalls for some consumers. The Internet offers many quality medical devices from legitimate sites. It also offers medical devices that don't work and some that may even harm you or your family. Some Web sites sell medical devices for unapproved uses, or they sell medical devices that have not been cleared or approved by FDA. This article provides tips on how to safely purchase devices on the internet.
Additional Information:
Buying Medical Devices and Diagnostic Tests Online. FDA website. June 26, 2009.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/BuyingMedicalDevicesandDiagnosticTestsOnline/default.htm
KidNet
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.
Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) |
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FDA MedWatch Safety Alert
Smiths Medical and FDA notified healthcare professionals about a nationwide voluntary recall of Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm). A small number of tubes were manufactured with internal diameters slightly smaller than indicated on the labeling, which may create the potential for the clinician to experience difficulty passing through or withdrawing the suction catheter.
Additional Information:
FDA MedWatch Safety Alert. Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm). Updated September 21, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182084.htm
LabNet
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.
Sodium Azide Safety Tip (OIVD) |
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FDA MedWatch Safety Alert
FDA has received an increasing number of reports of explosions involving solutions containing sodium azide used in clinical facilities. This communication is to remind laboratories and hospitals about the danger posed by long-term accumulation of sodium azide solutions, and to recommend steps to prevent such incidents. This safety tip provides recommendations on proper handling, storage, and disposal of sodium azide.
Additional Information:
FDA Office of In-Vitro Diagnostics (OIVD) website. Sodium Azide Solutions: Potential for Explosions from Improper Handling and Disposal. October 9, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm186147.htm
Higher Standards on the Way for Glucose Meters? |
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AACC Clinical Laboratory News
The FDA will consider tightening standards for strip-based blood glucose meters, echoing the concerns of many in the clinical lab field who have warned for a decade that the meters are not reliable. FDA also acknowledged an issue that has been a growing concern among laboratorians—that poor outcomes in recent tight glucose control (TGC) trials might be, in part, due to the use of error-prone meters instead of more accurate point-of-care instruments.
Additional Information:
Higher Standards on the Way for Glucose Meters? AACC Clinical Laboratory News. September 2009.
http://www.aacc.org/publications/cln/2009/september/Pages/inside0909.aspx
Lab Safety: Evaluating Training |
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Lab Manager Magazine
With a research facility's typical mix of research laboratories, instrument rooms, chemical storage, waste handling and busy receiving/loading docks, a wide array of hazards is always present. Every day, employees must deal with these hazards while hopefully avoiding accidents and injuries. The article lists ways to evaluate lab training programs and tips on preventing accidents and injuries.
Additional Information:
Lab Safety: Evaluating Training. Lab Manager Magazine. September 3, 2009.
http://www.labmanager.com/articles.asp?ID=341
SightNet
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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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 is an important part of protecting the public health. The FDA LASIK website can also be used as a resource for eye care professionals.
Additional Information:
FDA Letter to Eye Care Professionals. FDA LASIK website. May 22, 2009.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm154882.htm
Latest on FDA's LASIK Program. FDA LASIK website. May 22, 2009.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm061421.htm
Updated November 23, 2009