Scalpel Weekly News

Week of: June 30, 2014

IN THE NEWS


International Recall of Vascular Guidewire; Vessel Occlusion

Nitinol Devices & Components, Inc. (NDC) recalled its HydroFinity Hydrophilic Guidewires. The HydroFinity Guidewire was developed and manufactured by NDC and distributed by Covidien. It is a nitinol-core, polymer-jacketed guidewire with a hydrophilic coating intended for use in catheter placement and other procedures to treat vascular diseases. Click title to continue reading...


 
MEDICAL ALERTS


FDA Adds Warning to Testosterone Products; Blood Clots

The FDA is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Click title to continue reading...



Alcohol in Cancer Drug Causes Signs of Intoxication

The FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. The FDA is revising the labels of all docetaxel drug products to warn about this risk. Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications. Click title to continue reading...



Unsafe Injection Practices Addressed by Legal Action

A public health analyst at the CDC’s Public Health Law Program compiled legal sources and described principles that impact responses to unsafe injection practices that result in infection and injury. In particular, the article aimed to inform healthcare providers and healthcare facility leaders about the statutory, administrative, criminal, and tort law implications related to preventable harms from unsafe injection practices. Click title to continue reading...


  CASE ALERTS


MCO Not Liable Under Apparent Agency for Negligent Specialist

A woman was enrolled in a Managed Care Organization (MCO), an entity that contracted with physicians, hospitals, pharmacies, and other providers to provide health care services to individuals and families enrolled in Maryland’s Medicaid program. She began to experience foot pain as a result of a bunion on her right foot. Her primary care provider referred her to a podiatrist, who was a specialist who participated in the woman’s MCO as an independent contractor. The podiatrist was not an employee or agent of the MCO. All of the woman’s visits to the podiatrist were at his private clinic, not an MCO clinic. Click title to continue reading...



Expert Affidavit Required for Failure to Obtain Informed Consent

A plastic surgeon performed liposuction and an abdominoplasty (or skin recision) on a woman. The woman suffered an improper placement of the incision, a wound edge discrepancy, infection, excess drainage, an infected hematoma, scarring, abdominal numbness, and a weakened abdominal wall. Click title to continue reading...



Insurer Must Cover Residential Treatment for Eating Disorders

In 1999, the California legislature enacted the California Mental Health Parity Act (Health & Saf. Code, § 1374.72) (Parity Act) to address the imbalance between medical coverage for physical illnesses and mental illnesses. The Parity Act mandated that every health care service plan contract “provide coverage for the diagnosis and medically necessary treatment of severe mental illnesses ... under the same terms and conditions applied to other medical conditions.” (§ 1374.72(a).) The statute specifically stated that anorexia nervosa and bulimia must be covered. (§ 1374.72(d)(7), (8).)  Click title to continue reading...