The February 2010 MedSun Newsletter

Highlighted articles include:
please, see here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=45#1

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
The plastic centrifuge rotor may crack, break apart and be forcefully ejected through the plastic centrifuge housing at a high rate of speed...

Edwards Lifesciences Aquarius Hemodialysis System: Recall
Reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm...

Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall
Recall due to 'coring', the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted...

Nipro GlucoPro Insulin Syringes: Recall
Needles may detach from the syringe...

ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall
Device may crack near the radiopaque marker band, possibly resulting in serious patient injury...


Rapamune (sirolimus): Drug Monitoring Recommendations
Changes in the performance of an immunoassay used for therapeutic drug monitoring (TDM) of Rapamune...


Interpretive Comments on Test Results: How Far Should Labs Go?
In order to help clinicians understand test results, some labs have started including interpretive comments on their lab reports...

Human factors and ergonomics in home care: Current concerns and future considerations for health information technology
Health information technologies are being promoted as possible solutions to human factors and ergonomic concerns for the home care nurse and patient, but these same technologies also bring a new set of concerns...

Children are Commonly Harmed by Adverse Events in Intensive Care Units
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...