Scalpel Weekly News

Week of: January 05, 2015

IN THE NEWS


Cancer Drug Worldwide Recall; Subpotency and Elevated Impurity Levels

Hospira, Inc. of Lake Forest, IL, initiated a worldwide recall of ten lots of Mitoxantrone due to confirmed subpotency and elevated impurity levels. Risk factors associated with subpotency and elevated impurity levels may include the potential for decreased potency, which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention. Click title to continue reading...


 
MEDICAL ALERTS


Additional Surgical Convenience Kits Recalled; Sterility Problems

Customed, Inc., recalled additional lots of sterile convenience surgical kits (known as “convenience kits”) following the June 3, 2014, Class I recall of 233 sterile convenience surgical kits. The convenience kits have a potential package integrity defect that may compromise the sterility of the product, as well as serious deficiencies in manufacture and storage of the products that may significantly affect the risk of contamination and resultant infection. Customed recalled these products after becoming aware of potential defects through its Quality System. The FDA believes that it is unlikely that any infections that have occurred would be attributed to the convenience kits and consequently adverse events might be underreported. Click title to continue reading...



Heart Sync Electrodes Recalled; Do Not Use With Some Defibrillators

Philips made changes to the connector design of their FR3 and FRx Automated External Defibrillators (AEDs). Because of these changes, Heart Sync electrodes will no longer work with these AEDs. This is the third company who has recalled their electrodes in relation to their incompatibility with these Philips Automated External Defibrillators. These electrodes will work with other Philips AEDs that accept plug style connectors. Click title to continue reading...



Worldwide Study Shows Hazards of Smokeless Tobacco

The first-ever report on the global use and public health impact of smokeless tobacco found that more than 300 million people in at least 70 countries use these harmful products. The report, Smokeless Tobacco and Public Health: A Global Perspective, was released by the CDC and the National Cancer Institute at the National Conference on Smoking or Health in Mumbai, India on December 15, 2014. Thirty-two leading experts from around the world contributed to the report. Click title to continue reading...


  CASE ALERTS


Evidence of Physician's Collateral Misconduct Excluded; Traumatic Ruptured Aorta

A woman was involved in a car accident. Emergency personnel transported her to a local hospital where she underwent a head and neck CT scan. Because of concerns about potential internal bleeding, she was transported by air to a medical center. Click title to continue reading...



Discovery of County Health System’s After-Incident Reports Not Shielded; Surgical Fire

A woman went to a medical center for surgery to remove a possible basal cell carcinoma from her face. The surgery was performed by a plastic surgeon and total intravenous anesthesia was administered by an anesthesiologist. During the surgery, drapes were placed on the woman's face. The anesthesiologist along with nurse anesthetists, both county health system employees, administered supplemental oxygen to the woman through a face mask. The supplemental oxygen built up under the drapes on the woman's face. The oxygen and the drapes were ignited by an electrocautery device used by the plastic surgeon to stop bleeding. The resulting fire caused first and second degree burns and left the woman with permanent injuries and scars. Click title to continue reading...



Buy-Up Coverage Not Subject to Statutory Limits on Pre-Existing Condition Exclusions; Multiple Sclerosis

A woman worked for her employer for 12 years before she was diagnosed with multiple sclerosis (MS). She worked for her employer for another eight years. The employer provided a group disability insurance plan for its employees and the plan provided long-term disability (LTD) insurance coverage and benefits to eligible employees. In the group disability plan, the employer, as the plan administrator, ceded sole discretionary authority to the insurer to construe the terms of the plan and make eligibility determinations. Click title to continue reading...