Scalpel Weekly News

Week of: January 18, 2016

IN THE NEWS


FDA Approves Diabetic Foot Ulcer Graft; Amputations May Be Avoided

The FDA has approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound. Omnigraft is manufactured by Integra LifeSciences Corporation of Plainsboro, New Jersey. Click title to continue reading...


 
MEDICAL ALERTS


Mislabeled Anti-Seizure Drug Recalled; Name and Barcode on Package Conflict

Hospira, Inc., a Pfizer company, has announced a voluntary recall of one lot of the anti-seizure drug, MAGNESIUM SULFATE IN WATER FOR INJECTION (0.325 mEq Mg**/mL) 40 mg/mL 2g total, 50 mL to the user level due to a confirmed customer report of an incorrect barcode on the primary bag labeling. The product has a barcode identifying the product contents on both the overwrap and on the primary container. The barcode on the overwrap is correct. However, there is potential for the primary container barcode to be mislabeled with the barcode for the blood thinner, HEPARIN SODIUM 2000 USP UNITS/1000 mL in 0.9%SODIUM CHLORIDE INJECTION. The product is labeled with the correct printed name on the primary container and overwrap. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Click title to continue reading...



Battery Power Supply May Cause Ventilators to Shut Down

Dräger is recalling the PS500 battery power supply for its ventilators because a software issue causes shorter than expected battery run times. The software issue with the power supply also prevents the appropriate alarm from sounding five minutes before the battery runs out of power and the device shuts down. If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death. Click title to continue reading...



Teens Use of E-Cigarettes Increases with Advertising

E-cigarette use among youth is rising as e-cigarette advertising grows. About seven in ten middle and high school students – more than 18 million young people – see e-cigarette advertising in stores, online, in newspapers and magazines, or on television and in movies, according to a new CDC report. About 2.4 million middle and high school students were current (past 30-day) users of electronic cigarettes, or e-cigarettes, in 2014. Click title to continue reading...


  CASE ALERTS


Adherence to Guidelines for Retinopathy of Prematurity Screening Not Negligence

A boy was born premature at 24 weeks gestation as the second of twins. As a premature infant, he was at very high risk for retinopathy of prematurity (ROP), a disease resulting from premature birth in which the blood vessels of the retina develop abnormally. Left untreated, ROP can lead to retinal traction folds, retinal detachments, and blindness. Click title to continue reading...



Dismissal Affirmed; Clerical Error in Pre-Complaint Certification; Anesthesia Negligence

A man suffered a burn on his right foot and was subsequently hospitalized. Three days later he underwent a skin graft to address the burn. This procedure employed the use of a Laryngeal Mask Airway to facilitate his breathing. During the operation, the attending anesthesiologist left the room. The man’s breathing, oxygenation, and ventilation were not documented for three minutes. Click title to continue reading...



Cancellation of Coverage for Private Duty Nursing Care Did Not Violate Michigan Law

A woman with quadriplegia had health insurance that covered private duty nursing care. The insurer discontinued coverage for private duty nursing care. The woman sued the insurer seeking a temporary restraining order and permanent injunction to prevent the insurer from discontinuing coverage for her private duty nursing care. The Gratiot Circuit Court granted the woman’s request for a temporary restraining order. Click title to continue reading...


FEATURE


Reply in Support of Motion to Exclude Plaintiffs’ Expert

As a special feature to our Premium subscribers we have included this feature containing an illustrative Reply in Support of Motion to Exclude Plaintiffs’ Expert in an action arising out of chemical exposure, which allegedly caused, worsened, and/or exacerbated the plaintiffs’ hypothyroidism and/or Hashimoto’s thyroiditis. Click title to continue reading...