Recalls and Safety Alerts:
Silicone Gel-Filled Breast Implants: Updated Safety Information
FDA has released a report that includes preliminary safety data from follow-up studies conducted on the long-term performance and safety of silicone gel-filled breast implants...
Boston Scientific Innova Self-Expanding Stent System: Recall - Failure to Deploy
Complaints of no deployment and partial deployment have been received...
American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates
This voluntary recall was initiated because some of the vials of this lot contain visible particulates...
Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall - Catheter Tip Can Break Inside of the Patient
The catheter tip can break inside of the patient and embolize causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery...
Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall - Fragments of Adhesive and Plastic in the Cannula Tip May Embolize
Foreign fragments of adhesive and plastic in the cannula tip may embolize causing arterial injury, hemorrhaging or other serious events...
Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall - Shuts Off Without Warning
Defective fan in the power supply may cause overheating and shut down the device without visible or audible alarms...
American Regent Initiates Nationwide Voluntary Recall of Methyldopate HCL Injection, USP 5 mL Single Dose Vial Due to Glass Particulates
Voluntary recall was initiated because some of the vials of this lot contained translucent visible particles consistent with glass delamination...
Churchill Medical Systems, a Vygon Company, Skin-Prep Wipes Used in Convenience Kits and Trays
The skin-prep wipes were recalled by the manufacturer due to the potential for bacterial contamination...
Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication
FDA notified consumers, women who participate in breast cancer screening and healthcare professionals that thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer...
Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient
Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient...
Highlighted articles:
Guide to Infection Prevention in Outpatient Settings: Minimum Expectations for Safe Care
The following document is a summary guide of infection prevention recommendations for outpatient (ambulatory care) settings...
Reducing Alarm Hazards: Selection and Implementation of Alarm Notification Systems
In December 2010, ECRI Institute listed "Alarm Hazards" as the second highest technology hazard of 2011...
A Novel Approach to Increase Residents' Involvement in Reporting Adverse Events
In 2008-2009, the authors measured participation in adverse-event reporting by residents at Oregon Health & Science University before and after implementing a quality improvement initiative, which consisted of a financial incentive and multifaceted educational campaign...
The 2011 Joint Commission National Patient Safety Goals: Why Laboratories Need to Pay Close Attention
Although no new goals were added in 2011 that directly relate to laboratories, significant revisions in the 2010 NPSGs that do affect laboratories were kept in place...
Privacy in the Era of EHRs
As labs connect to Electronic Health Records (EHRs) within hospitals or with physician practices, they will need to lean heavily on their chief compliance officers, IT support, and other colleagues to make wise decisions about where and how lab results are delivered...
Putting the 'patient' in patient safety: a qualitative study of consumer experiences
Perceptual measures of patient safety and quality may help to identify areas where there are higher risks of preventable adverse events...
Drugs of Abuse Tests
The information on this webpage may be helpful to anyone who performs drugs of abuse testing, i.e. parents or other consumers, as well as trained medical professionals...
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