Highlighted articles include:
Infant Phototherapy Light - Medical Device Safety Tips
Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks...
Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification (Update)
An update of activities to date involving NPWT, including additional recommendations and a summary of additional adverse event reports received by the FDA since November 2009...
Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class I Recall
Pocket fills (the unintended injection of drugs or fluids into the patient's subcutaneous tissue at the pump pocket site instead of the pump) may result in patient harm due to drug overdose or underdose...
Triad Sterile Lubricating Jelly: Recall - Product May Not Be Sterile
These products may not be sterile, immediately contact your kit, pack or tray suppliers to determine whether you have affected products...
Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results
When affected strips are exposed to warm weather or prolonged storage they may be more likely to provide a false result...
FDA orders postmarket surveillance of certain TMJ implants
Postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to pain or other reasons...
FDA Launches Medical Device Innovation Initiative
The new proposed Innovation Pathway program is part of a broader effort underway designed to encourage cutting-edge technologies among medical device manufacturers...
Information about Metal-on-Metal Hip Implants
Information on how metal-on-metal implants differ from other hip implants and recommendations for patients and physicians about the benefits and risks of these products...
Arstasis One Access System: Class I Recall
Affected components may fracture and/or separate during use...
Merit Prelude Short Sheath Catheter Introducer: Class I Recall
Introducer tip may detach during use, causing arterial injury, hemorrhaging, or other serious events, while introducer tip material may enter into the bloodstream, causing blood clots (thrombosis)...
American Regent Injectable Products: Recall
Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination....
B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall
Infusion systems upgraded with the Motorola compact flash hardware and supporting software, when used in certain networks may potentially induce a memory leak that can cause the management processor to become non-responsive...
CDC Injection Safety
Despite safe injection recommendations, outbreaks and patient notifications resulting from healthcare personnel failing to adhere to Standard Precautions and basic infection control practices continue to be reported...
Q&A with FDA's Alberto Gutierrez
How FDA is grappling with challenges related to new technologies, shifts in clinical practice, and a move toward greater transparency in the agency...
Barcode Scanning Errors, a Threat to Patient Safety
Despite improved efficiency and accuracy of barcode-based identification, a recent report demonstrates that linear barcode identification methods are not fail-safe...
Reference Intervals and Patient Safety
Inaccurate reference intervals can lead physicians astray and are a likely contributor to suboptimal diagnosis, suboptimal treatment, and unnecessary follow-up testing...
Lab QC by Risk Management
The draft CLSI guidelines will assist labs in choosing control processes for test hazards...
Non-evidence-based ICD implantations in the United States
Among patients with ICD implants in this registry, 22.5% did not meet evidence-based criteria for implantation...
MedSun In Action - Negative Pressure Wound Therapy (NPWT): Special Study Summary
Please see this month's MedSun in Action section for a summary describing what FDA learned about device issues faced by caregivers who use NPWT in the home setting or in other non-hospital environments...
Information about Luer Misconnections
Patient injuries and deaths have occurred when different device delivery systems are mistakenly connected to each other...
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