• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MedSun: Newsletter #1, February 2006

  • Print
  • Share
  • E-mail
-

Newsletter #1, February 2006

Articles

Five Years After To Err Is Human: What Have We Learned?

Print Item
E–mail Item

It has been five years since the Institute of Medicine reported that as many as 98,00 people die annually as the result of medical errors and called for a national effort to address this problem. In this Journal of the American Medical Association (May 18, 2005) article Drs. Lucian Leape and Donald Berwick assess the nation’s progress toward the goal of safer health care delivery. The authors summarize accomplishments, barriers to progress, and address the question of what steps need to be taken next.

Return to Top

Return to Medsun Home

New England Journal of Medicine publishes study: Diagnostic Performance of Digital versus Film Mammography for Breast-Cancer Screening

Print Item
E–mail Item

Film mammography has limitations in its sensitivity for detecting breast cancer in women with radiographically dense breasts. This study sought to determine whether digital mammography would eliminate some of these limitations. Results of the study indicate that the overall diagnostic accuracy of both the film and digital mammography are similar. However, digital mammography seemed to show higher accuracy in women younger than 50 years of age, women possessing radiographically dense breasts, and pre-menopausal/peri-menopausal women.

Additional Information:

Diagnostic Performance of Digital versus Film Mammography for Breast-Cancer Screening
http://content.nejm.org/cgi/content/full/353/17/1773

Return to Top

Return to Medsun Home

JCR Publishes “What Every Health Care Organization Should Know About Sentinel Events”

Print Item
E–mail Item

Joint Commission Resources (JCR) recently published, “What Every Health Care Organization Should Know About Sentinel Events.” This updated version discusses general sentinel events and tackles additional topics including ambulatory care, behavioral health, home care and long term care. In addition, there are special features such as a new chapter on disclosing medical errors, how to offer apologies to patients and families, and an explanation of sentinel event legal issues.

Return to Top

Return to Medsun Home

New England Journal of Medicine publishes study: Cost-Effectiveness of Implantable Cardioverter-Defibrillators

Print Item
E–mail Item

This study utilized the results of eight randomized trials to evaluate the cost-effectiveness of implantable cardioverter-defibrillators (ICD) used prophylactically to improve survival in patients who are at risk for sudden death as a result of a left ventricular systolic dysfunction, but have not had a life- threatening ventricular arrhythmia. In populations in which a significant device-related reduction in mortality was shown, prophylactic implantation of an ICD had a cost-effectiveness ratio below $100,000 per “quality-adjusted life-year (QALY).”

Additional Information:

Cost-Effectiveness of Implantable Cardioverter-Defibrillators
http://content.nejm.org/cgi/content/full/353/14/1471

Return to Top

Return to Medsun Home


DS-X Device Safety Exchange, a MedSun Program

DS-X Lessons Learned

Question of the Month with Comment

Print Item
E–mail Item

Question: Does MAUDE include reports about investigational devices?

Comment: MAUDE does not serve as the repository for reports about investigational devices involved in research protocols, however sometimes reports of this type are submitted by mistake. If the study is being conducted in the U.S. under the investigational device exemption (IDE), then the manufacturer sends adverse event reports to FDA as part of a supplement to the IDE. For more information about Investigational Device Exemptions (Code of Federal Regulations: 21CFR812.150), see Additional Information below.

Additional Information:

For more information about Investigational Device Exemptions (Code of Federal Regulations: 21CFR812.150) go to:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.150

Return to Top

Return to Medsun Home


Safety Tips

Safety Tip - Preventing PICC Fractures

Print Item
E–mail Item

By Roberta Sullivan, Nurse Consultant, CDRH, FDA

Device Description:
Peripherally-inserted central catheters provide access to the central venous system via a percutaneous access site, usually in the upper arm. PICC placement combines the benefits that a central line offers for complex medication and fluid administration along with the advantages of peripheral insertion.

Reported Incident:
A PICC catheter became clotted and was unable to be used for fluid administration or to draw blood. The catheter was sluggish to flush and one of the ports was totally occluded. The catheter was discontinued for use and a peripheral intravenous catheter was inserted.

In addition to adverse events involving catheter occlusion, the FDA receives reports involving PICCs associated with catheter tears, leaks, ruptures, and fractures. Potential patient complications from PICC fractures include migration, perforation, arrhythmia and embolization of catheter fragments. Health care practitioner awareness of PICC care guidelines to maintain catheter integrity will promote patient safety.

Recommended Actions:
•Follow the manufacturer’s device-specific instructions for catheter placement and insertion site maintenance. Certain chemicals, solutions, or antibiotic ointments should be avoided near catheters made of materials susceptible to damage.

•Position in-line clamps near the center of the distal connector hubs. If the clamps are placed too close to the connector ends, excessive or repeated clamping may lead to tubing fatigue and stress fractures. However, failure to use the clamps may increase the risk of air embolism or blood loss.

•Secure the catheter to prevent occlusion, stress or kinking. Observe and monitor the length of the catheter from the placement site. Catheter migration from the intended placement in the superior vena cava can lead to serious complications such as perforation, erosion, and cardiac tamponade. Pediatric patients with PICCs pose special challenges for securing the catheter. Tubular elastic netting applied over the child’s arm may help prevent dislodgement and the need to repeat line placements in this high risk population.

•Always use at least a 10 cc syringe for flushes and medication administration. Flush the catheter with a brisk push/pause technique. To prevent damage to blood vessels or catheters, infusion pressure should not exceed 25 psi (pressure per square inch). The same force applied to a 3 cc syringe can result in a psi up to 55, compared to only 15 psi if using a 10 cc syringe. When using small gauge (< 4Fr) catheters in pediatric patients, a 10 cc syringe should still be used for medication and flushes, with the appropriate volume.

•Do not flush against resistance. Partial or complete catheter occlusions may be caused by thrombosis, drug precipitates or mechanical factors. Prevention of occlusion includes the use of heparin, positive pressure, and adequate flushing techniques between medications, blood draws, and TPN (total parenteral nutrition). Follow your institution’s protocol for appropriate interventions.

References:
Gorski L. and Czaplewski L. (June 2005). Managing complications of midlines and PICCs. Nursing 2005. 35(6):68-9.

Infusion Nurses Society. (November/December 2000). Infusion nursing standards of practice. Journal of Intravenous Nursing. 23(65).

Ray C. (2001). Central Venous Access. Lippincott, Williams & Wilkins: Philadelphia, PA.

Return to Top

Return to Medsun Home

Updated February 1, 2006

Return to MedSun: Medical Product Safety Network

-
-