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The November 2011 MedSun Newsletter is now available...



Title: The November 2011 MedSun Newsletter is now available...

MedSun in Action:

Pediatric Hospital Cribs: MedSun Small Sample Survey Summary
Learning about clinicians' experiences with pediatric hospital cribs with drop down side rails to gain a better understanding of the clinical perspective and the importance of this feature to the provision of hospital-based care for pediatric patients...

Harmonizing Emerging Risk Documents: MedSun Small Sample Survey Summary
Obtaining feedback on the format and design of two sample risk documents and learning about experiences with reviewing and sharing safety information in hospitals...

Radio Frequency Identification (RFID) and Real Time Locating Systems (RTLS): MedSun Small Sample Survey Summary
FDA is studying the nature of RFID and RTLS systems and working with manufacturers to learn how these systems co-exist in the hospital environment with a variety of medical devices and systems...

External Defibrillators: MedSun Small Sample Survey Summary
Learning about experiences with external defibrillators and gaining a better understanding of the clinical perspectives of these devices...

Highlighted Reports
A cross section of device-related events submitted by MedSun reporters during the period August 1 through August 31, 2011. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.

Recalls and Safety Alerts:

FDA Communication on Use of Jet Injectors with Influenza Vaccines
The FDA is clarifying its October 21, 2011 communication to inform the public that inactivated influenza vaccines labeled for IM injection are intended for administration using a sterile needle and syringe...

Carefusion Initiates Class I Recall Of EnVe Ventilators
A potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection upon transport...

Baby Products with SIDS Prevention Claims
The FDA has never cleared or approved a baby product to prevent or reduce the risk of SIDS...

CooperVision Avaira Toric Soft Contact Lenses: Class I Recall
The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses...

Preventing Surgical Fires - Collaborating to Reduce Preventable Harm
FDA and its partners are launching the “Preventing Surgical Fires” initiative to: increase awareness of factors that contribute to surgical fires, disseminate surgical fire prevention tools, and promote the adoption of risk reduction practices throughout the healthcare community...

H & P Industries Custom Dialysis Trays/Kits: Recall (Update)
Additional Lee Medical International Inc., Custom Dialysis Trays/Kits have been recalled...

Office of Pediatric Therapeutics
Its' primary mission is to assure access for children to innovative, safe and effective medical products...

Decorative Contact Lenses: Is Your Vision Worth It?
Tips from the FDA on how to safely buy decorative contact lenses...

Highlighted Articles:

Program Encourages Reporting Accidents Waiting To Happen
A new system that encourages every clinician to report situations that put patients at risk appears to be succeeding...

Charge Circuit Timeout: A Sequence of Events Leading to Failure of an Implantable Cardioverter-Defibrillator to Deliver Therapy
The importance of reporting medical device problems to FDA and the manufacturer...


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