Highlighted articles include:
What Happens to an Adverse Event Report Submitted to FDA?
Please see the adverse event flowchart to see what happens when adverse event reports are submitted to the FDA through the MedWatch program...
Infusion Pump Improvement Initiative - Public Workshop presentations are available
Presentation slides and transcripts from the workshop are now available online...
Class I Recall and Safety Investigation of Counterfeit Polypropylene Surgical Mesh - Update
This update contains additional information about the recall and FDA's recommendations...
Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED - Recall
When the AED is used with an affected battery pack, the AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy...
Chondrolysis Linked to Intra-articular Infusions
FDA has received reports of chondrolysis in patients who received continuous intra-articular infusions of local anesthetics with elastomeric infusion devices for postoperative pain management...
Tubing Misconnections: Making the Connection to Patient Safety
Methods for reducing the likelihood of tubing misconnections include equipment design solutions and administrative policies and work practices...
Safeguarding the Storage of Drug Products
Events reported to the Pennsylvania Patient Safety Authority describe how breakdowns in the storage of medications have contributed to drug product mix-ups...
OR Fire Prevention Video Available
Free video offered by the Anesthesia Patient Safety Foundation promotes best practices on OR fire prevention...
FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests
FDA will hold a public meeting July 19-20, 2010 to obtain input on implementing a reasonable, risk-based, and effective regulatory framework for laboratory-developed tests and in vitro diagnostics that are manufactured by, and offered in the same laboratory...
The Path to Personalized Medicine
FDA's goal is an efficient review process that produces diagnostic–therapeutic approaches that clinicians can rely on and allows companies that invest in establishing the validity and usefulness of tests to make specific, FDA-backed claims about benefits...
Heart Failure Associated with Pacemaker-Induced Dyssynchrony
Recent research has shown that permanent right ventricular pacing is causally linked to heart failure...
Featured HeartNet Report of Interest
HeartNet has received a report related to Medtronic's May 2010 physician letter on a rare device software issue in some ICD and CRT-D devices, a software update will be available to correct this issue...
Medical Device Home Use Initiative: Public Workshop presentations now available
Presentation slides are now available online and address the premarket review process, postmarket surveillance, risks in the home environment, user characteristics, training issues and wireless technologies...
Human Factors Can Cause Pediatric Medical Device Adverse Events
KidNet had received adverse event reports involving cracked luer hubs of peripherally inserted central venous catheters, FDA follow-up resulted in design and material improvements to the luer hub, which resists cracking...
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