December 2009 MedSun Newsletter

Highlighted articles include:

.Stryker Operating Room System II Surgical Navigation System - Recall
potential for the navigation PC SPC-1 component to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all...

.Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators - Initial Communication
Affected devices may not deliver electric shocks and the devices' self-test may not detect the problem...

.Preventing Cross-Contamination in Endoscope Reprocessing - Safety Communication from FDA, CDC, and the VA
Healthcare facilities are cautioned about the risks to patients if flexible endoscopes and their accessories are not processed properly, and recommends steps to reduce these risks...

.Cardiovascular Systems ViperSheath Sheath Introducer - Recall
Nationwide recall of all lots of due to reports about stretching or fracture of the sheath during use...

.Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification
Patients should be monitored frequently and practitioners should be vigilant for potentially life-threatening complications, such as bleeding...

.Synthes USA, Ti Synex II Vertebral Body Replacement - Recall
Surgeons and hospitals in possession of affected devices must stop implanting them immediately...

.External Biphasic Defibrillators Energy Levels - Initial Communication
FDA has received reports in which 200 J biphasic defibrillators were ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion...

.Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Recall
The balloon catheters may spontaneously rupture during surgery...

.Cybersecurity for Networked Medical Devices is a Shared Responsibility - Reminder from FDA
FDA is aware of misinterpretation of the regulations for the cybersecurity of medical devices that are connected to computer networks...

.Centurion Medical Products - Premie Pack and Meconium Pack - Recall
Pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient...

.Cordis CROSSOVER Sheath Introducer - Recall
Recall of all lots of the device due to stretching or fracture of the sheath during use...

.Accusure Insulin Syringes (Qualitest Pharmaceuticals) - Recall
Syringes in these lots may have needles which detach from the syringe...

.Pointe Scientific Liquid Glucose Hexokinase Reagent - Recall
Testing laboratories should consider all test results obtained with the lot numbers listed above to be questionable...

.The Pursuit of Traceability: Lab Groups Push for Greater Harmonization
The lab community hopes to resolve inconsistencies by engaging the concepts of a science known as metrology...

.A New Online Guide to Hearing Aids
FDA has launched a new website that will benefit current and potential users of hearing aids...

.LASIK: Quality of Life Project, Warning Letters to Facilities
The launch of a collaborative study to examine the potential impact on individuals' quality of life from LASIK surgery and the issuance of warning letters to 17 LASIK ambulatory surgical centers...

.Keep An Eye Out For Contact Lens Problems
Ophthalmologists and other eye care professionals believe reported problems are caused by contact lens wearers’ poor hygiene and failure to follow directions when using and caring for these types of lenses...
Announcement: Vision Health Initiative Website

CDC has created a new website with information regarding vision and eye health, projects with diverse stakeholders, journal publications and reports, and vision health--related resources for professionals and consumers...

abrir aquí para acceder a los documentos listados:
MedSun: Newsletter #43, December 2009