The Danger of Buying Stolen Blood Glucose Monitoring Products

As the population ages, the incidence of diabetes is on the rise. More diabetics means greater demand for blood glucose monitoring products. It is in this vein that we report on the recent theft of a tractor-trailer shipment of Abbott Laboratories blood glucose monitoring products from a shipping carrier facility in Louisville, Kentucky. Stolen blood… Learn More »

Cardiac Stent Manufacturers Provide Majority of Funding to Society of Cardiac Angiography and Interventions

In the latest in a series of articles about disquieting financial ties between the medical community and the drug & medical device industry, ProPublica exposes that The Society for Cardiac Angiography and Interventions received the majority of its funding from medical device makers who produce cardiac stents, like Abbott Laboratories and Medtronic. What makes this… Learn More »

Medennium SMARTPlugs For Dry Eye May Pose Eye Infection Risk

Dry eye syndrome occurs when tears aren't able to provide adequate moisture for your eyes for any of a number or reasons. The eyes of individuals with this condition may sting or burn. One treatment for dry eyes has been the insertion of "plugs" that increase the patient’s own natural tears on the ocular surface. One popular plug,… Learn More »

TMJ Implant Manufacturers Directed by FDA to Perform Postmarket Surveillance Studies

We had previously blogged about the sorry state of regulatory oversight of manufacturers of temporomandibular joint (TMJ) implants. The good news is that the FDA announced last week that it had ordered three manufacturers of TMJ implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to… Learn More »

FDA Exercises Poor Oversight Over TMJ Device Manufacturers and Patients With TMJ Implants Suffer the Painful Consequences

More than 10 million Americans suffer from a condition known temporomandibular joint disorder, or TMJ, which causes varying levels of dysfunction and pain in and around the joint connecting the jaw to the head. Surgeons have sought to alleviate the condition by implanting artifical jaw joints in patients. But frequently these TMJ implants have broken down,… Learn More »

FDA Recalls Sigma Spectrum Infusion Pump Model 35700

FDA notified healthcare professionals of the class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700, which is used to deliver fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. The units may fail suddenly, causing inaccurate flow conditions during use,… Learn More »

Dental Handpieces May Cause Patient Burns

Late last month, the U.S. Food and Drug Administration issued an alert to healthcare professionals and dental organizations concerning patient burns from dental handpieces. These devices are AC-powered hand-held devices used to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. The patient burns from dental handpieces reported ranged from first degree burns to… Learn More »

Medtronic Recalls Kappa and Sigma Pacemakers With Wiring Problems

Notifies readers of the Class 1 recall of Medtronic pacemakers

Congress Considering Legislation to Eliminate Manufacturers’ Blanket Immunity From Lawsuits Over Faulty Medical Devices Preapproved by FDA

Provides status update on Medical Devices Safety Act of 2009 with link to article on pros and cons.