Scalpel Weekly News

Week of: August 29, 2016

IN THE NEWS


Expanded Use of Transcatheter Heart Valves Approved

The FDA approved on August 18, 2016, an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery. Sapien XT and Sapien 3 are manufactured by Edwards Lifesciences, LLC, based in Irvine, California. Click title continue reading...


 
MEDICAL ALERTS


Antidote for Acetaminophen Overdose Recalled; Risk of Sub-Therapeutic Dosing

On August 18, 2016, Arbor Pharmaceuticals announced a voluntary recall of three lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity, which can start the effervescent process. This results in enlarged and swelled tablets that could also completely dissolve within the blister pack. Click title to continue reading...



Antibiotic Recall; Iron Oxide Particulates; Vial with Possible Rust

Sagent Pharmaceuticals, Inc. announced on August 19, 2016 the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g, (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent initiated this recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide. Click title to continue reading...



Improper Care of Contact Lenses Can Cause Serious Eye Infections

Nearly one in five contact lens-related eye infections reported to a federal database involved a patient who experienced eye damage, according to a CDC report published on August 18, 2016. Keratitis (inflammation of the cornea) can result from contact lens wear or other causes. Keratitis from all causes, including contact lens wear, results in approximately one million clinic and emergency department visits annually, with an estimated cost of $175 million in direct health care expenditures in 2010. In 2014, over 99% of contact lens wearers surveyed reported at least one behavior that puts them at risk for a contact lens-related eye infection. Click title to continue reading...


  CASE ALERTS


No Causal Link between 19-Day Delay in Finding Tumor and Terminal Cancer Prognosis

A man underwent an abdominal CT Scan. The radiologist who reviewed the scan found nothing abnormal. Nineteen days later the man underwent another abdominal CT scan. Two different radiologists reviewed the second CT scan and detected a mass in the man’s abdomen and reported that they could not exclude a carcinoid tumor, meaning there may or may not be cancer. A surgeon evaluated the mass, determined it was probably benign, and ordered a follow up CT in three to four months. No biopsy or surgery was performed. Click title to continue reading...



Expert on How Antibiotics Would Prevent Injury Post C-Section

A woman underwent a C-section. The OB/GYN’s operative notes stated that there was an “extremely foul odor upon opening of the uterus,” and that her membranes were “very yellow.” She had a fever, tachycardia, and leukocytosis. She was discharged with no treatment for postpartum infection. Click title to continue reading...



Adverse External Review Did Not Bar Challenge to Medical Necessity Determination; Anorexia

A woman suffered from anorexia. She was enrolled in her employer’s employee benefits plan that included health insurance. She was admitted to an eating disorder treatment facility for partial hospitalization level of care to treat her depression and anorexia. Click title to continue reading...


FEATURE


Summary Judgment: Stroke

As a special feature for our Premium subscribers we have included this feature containing an illustrative Defendants’ Motion for Summary Judgment in a medical malpractice action in which the teenage patient suffered respiratory failure and stroke after surgery, which included the administration of anesthesia by a resident. Click title to continue reading...