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.
The use of technology at home: what patient manuals say and sell vs. what patients face and fear |
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PubMed Abstract
Over the past 15 years, the use of specialised medical equipment by patients at home has increased in most industrialised countries. Adopting a conceptual framework that brings together two research perspectives, i.e. the sociology of technology and the sociology of illness, this paper empirically examines why and how patients use health technology at home and in the broader social world. Our study compares and contrasts the use of four interventions: antibiotic intravenous therapy, parenteral nutrition, peritoneal dialysis and oxygen therapy. We conducted interviews with patients (n = 16) and caregivers (n = 6), and made direct observations of home visits by nurses (n = 16). The content and structure of patient manuals distributed by major manufacturers and hospitals were analysed (n = 26). The aim of our study was to determine how technology was supposed to be used versus how it was actually used. This study shows that patients are deeply ambivalent about the benefits and drawbacks of technology, and that these advantages and disadvantages are shaped by the various places in which the technology is used. While technology can be pivotal in making patients autonomous and able to participate in the social world, it also imposes heavy restrictions that are intimately interwoven with the nature of the particular disease and with the patient's personal life trajectory.
Additional Information:
PubMed Abstract. The use of technology at home: what patient manuals say and sell vs. what patients face and fear. July 2004.
http://www.ncbi.nlm.nih.gov/pubmed/15283780
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.
Children are commonly harmed by adverse events in intensive care units. |
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AHRQ
When adverse events (AEs) occur in pediatric intensive care units (ICUs), one-third of such incidents result in physical injury to children, while two-thirds harm children in other ways, according to a new study. Johns Hopkins researchers analyzed data collected over a 2-year period describing safety incidents taking place in pediatric ICUs around the country. Providers were able to report such incidents and near misses through a Web-based incident reporting system called the Intensive Care Unit Safety Reporting System. During the 2-year study period, 23 pediatric ICUs reported 464 incidents. Patient contributing factors were the strongest predictor of harm, and training and education factors also played a role. To improve safety in pediatric ICUs, the researchers recommend developing protocols for high-risk procedures involving lines and tubes; improved monitoring; and staffing, training, and communication initiatives.
Additional Information:
AHRQ. Children are commonly harmed by adverse events in intensive care units. 2009.
http://www.ahrq.gov/research/nov09/1109RA3.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.
Lyme Disease: Finding the Balance of Diagnostic Testing and Clinical Disease Features |
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AACC Clinical Laboratory News
Recent legal and public inquiries brought about as a result of a highly publicized lawsuit between the Infectious Disease Society of America (IDSA) and the state of Connecticut has thrust Lyme disease into the forefront for clinicians and clinical laboratories. The disease's etiology and clinical manifestations are described in this paper, as well as the proper use and interpretations of tests for Lyme disease.
Additional Information:
AACC Clinical Laboratory News. Lyme Disease: Finding the Balance of Diagnostic Testing and Clinical Disease Features. January 2010.
http://www.aacc.org/publications/cln/2010/January/Pages/SeriesJan10.aspx
Lab Medicine Outlook: What Will the Coming Decade Bring? |
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AACC Clinical Laboratory News
The first decade of the 21st Century by any measure has been transformative for lab medicine. Pharmacogenetics (PGx), point-of-care testing (POCT), lab automation, and LEAN went beyond buzzwords to become mainstream realities. Evidence mounted about certain biomarkers and pushed them into the limelight, while others fell out of favor. Still others that showed great promise have yet to make their mark on clinical practice. The field of lab medicine also sharpened its focus on standardizing and improving the analytical performance of assays, and on the methods used to report lab-related research.
Additional Information:
AACC Clinical Laboratory News. Lab Medicine Outlook: What Will the Coming Decade Bring? January 2010.
http://www.aacc.org/publications/cln/2010/January/Pages/CoverStory1Jan10.aspx
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.
Corneal Abrasion Injuries |
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Pennsylvania Patient Safety Authority
Corneal abrasion is the most common ocular injury occurring in the perioperative period. Most of the Pennsylvania Patient Safety Authority reports (81%) were recognized in the perioperative setting. However, 19% of the reports occurred in diverse care areas such as the medical intensive care unit, the emergency department, on telemetry floors, in radiation oncology, and in labor and delivery wards, leading to the conclusion that all staff should be able to quickly identify, report, and treat corneal abrasions. The lack of information about corneal abrasions prevents the Pennsylvania Patient Safety Authority from making new insights about this problem. Reports that are more detailed might be helpful in determining how and why these injuries occur.
Additional Information:
Pennsylvania Patient Safety Authority. Corneal Abrasion Injuries. December 2009.
http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Dec6(4)/Pages/144.aspx
Updated March 22, 2010