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 |
Print Item E–mail Item |
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.
How You Can Get the Best Results with Home Use Tests |
Print Item E–mail Item |
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.
Additional Information:
How You Can Get the Best Results with Home Use Tests. FDA OIVD website.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm125664.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.
Use Infant Heel Warmers with Care |
Print Item E–mail Item |
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.
Additional Information:
Use Infant Heel Warmers with Care. Diane Dwyer, RN, BSN. FDA Medical Device Safety Website. April 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm129270.htm
FDA Patient Safety News (video). Avoiding Infant Burns from Heel Warmers. July 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=88#6
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.
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 |
Print Item E–mail Item |
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.
Additional Information:
FDA Recall Notice. May 18, 2009.
http://www.fda.gov/Safety/Recalls/ucm164092.htm
Detection of Novel Influenza A (H1N1) Virus by Laboratory Testing |
Print Item E–mail Item |
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 with few or no reported cases [http://www.cdc.gov/h1n1flu/screening.htm].
These documents provide interim guidance to health care providers and clinical laboratories on specimen collection and testing specimens from patients suspected of being infected with novel influenza A (H1N1) virus. Clinicians and laboratories should refer to these interim guidances frequently for updated information.
Additional information for laboratories:
At this time the novel influenza A (H1N1) virus is not known to differ in the nucleoprotein antigen that is conserved across all influenza A subtypes. The majority of tests that are currently cleared for detection or differentiation of Influenza A virus in human specimens may be able detect the Type A marker in all influenza A viruses including the novel H1N1 strain. None of the cleared tests, however, are able to distinguish the novel influenza A (H1N1) virus from other influenza A viruses (i.e., to specifically identify novel influenza A (H1N1) virus). The majority of the currently cleared tests have unknown sensitivity and specificity to detect human infection with influenza A (H1N1) virus in clinical specimens.
Most importantly, no influenza tests are sufficiently sensitive to rule out an influenza infection, and clinicians must consider clinical and epidemiological criteria along with laboratory testing results. Clinicians who suspect novel influenza A (H1N1) virus infections in humans should obtain nasopharyngeal swabs, nasal swabs, throat swabs, dual NPS/TS swab specimens and/or nasal aspirates, store the specimen following the testing laboratory’s recommendation (usually under refrigeration), and then contact their state or local health department to facilitate transport and timely diagnosis at public health and other qualified laboratories.
Laboratorians should also maintain awareness of unusual findings and report inaccurate testing results or other problems to the device manufacturer and/or FDA. Health care professionals and consumers may report serious adverse events, such as inaccurate results, or product quality problems with the use of influenza detection assays to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
•Online: http://www.fda.gov/MedWatch/report.htm
•Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
•Fax: (800) FDA-0178
•Phone: (800) FDA-1088
Additional Information:
Detection of Novel Influenza A (H1N1) Virus by Laboratory Testing. FDA OIVD website. April 30, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm161623.htm
False Positive Results with a Commercially Available West Nile Virus Immunoglobulin M Assay |
Print Item E–mail Item |
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 immunosorbent assay (ELISA). The investigation revealed that, in the United States, one lot of the commercially available test kits was the source of the false-positive results. That lot was recalled, and a second lot distributed outside the United States also was recalled.
Additional Information:
False Positive Results with a Commercially Available West Nile Virus Immunoglobulin M Assay. CDC MMWR. May 8, 2009.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5817a2.htm?s_cid=mm5817a2_e
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 |
Print Item E–mail Item |
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 July 3, 2009