Scalpel Weekly News

Week of: March 16, 2015

IN THE NEWS


Risk of Heart Attack from Testosterone Use for Loss Due to Aging

The FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. The FDA is requiring the manufacturers of all approved prescription testosterone products to change their labeling to clarify the approved uses of these medications. The FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attack and stroke in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Click title to continue reading...


 
MEDICAL ALERTS


New CPR Devices; May Increase Survival After Cardiac Arrest

The FDA approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on people whose hearts stop beating (cardiac arrest). The devices may improve the patient’s chances of surviving cardiac arrest. The CDC estimates that approximately 300,000 Americans experience an out-of-hospital cardiac arrest each year. CPR is an emergency procedure that can be life-saving for people in cardiac arrest. Click title to continue reading...



Mislabeled Magnesium Sulfate Has Heparin Barcode; Serious Birthing Injury Risk

Hospira, Inc., of Lake Forest, IL, has recalled one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/mL (NDC: 0409-6727-23, Lot 42-120-JT, Expiry 1DEC2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the overwrap is correct. However, there is potential for the primary container barcode to be mislabeled with the barcode for Heparin Sodium 2000 USP units/1000 mL in 0.9% Sodium Chloride Inj. The product is labeled with the correct printed name on the primary container and overwrap. Click title to continue reading...



Shortage of IV Normal Saline Leads to Use of Unsterile Product; Injuries Reported

On December 23, 2014, the New York State Department of Health (NYSDOH) was notified of adverse health events in two patients who had been inadvertently administered non-sterile, simulation 0.9% sodium chloride intravenous (IV) fluids at an urgent care facility. Simulation saline is a non-sterile product not meant for human or animal use. It is intended for use by medical trainees practicing IV administration of saline on mannequins or other training devices. Both patients experienced a febrile illness during product administration and were hospitalized; one patient developed sepsis and disseminated intravascular coagulation. Neither patient died. Staff members at the clinic reported having ordered the product through their normal medical supply distributor and not recognizing during administration that it was not intended for human use. Click title to continue reading... 


  CASE ALERTS


Hospital Possible Vicarious Liability for Nurse’s Excessive Force during C-Section

A woman gave birth via cesarean section to a son at a medical center. The mother’s obstetrician performed the surgical procedure. During the procedure the obstetrician was initially unable to remove the child because his head was deep in the birth canal. An unidentified nurse inserted a hand vaginally to push the child’s head up the canal so the obstetrician could remove the child through the surgical incision. Although not noted immediately, the child developed difficulties within a day and was discovered to have suffered a fractured skull and other asserted serious injuries. Click title to continue reading...



Physical Therapist Is “Physician”; Can Conduct IME for PIP Benefits

A man was injured in an automobile accident while riding in a car that was insured. Following the accident, the man notified the insurer that he sought personal injury protection (PIP) benefits available under the insurance policy to pay for medical expenses that resulted from the accident. The insurer engaged a medical services provider to arrange an independent medical examination (IME) of the man. The medical services provider notified the man and his lawyer in writing that the man was scheduled to undergo a “Physical Therapy Medical Evaluation” to be conducted by an examiner with the credentials “DPT, OCS,” after his name, whom the notification characterized as the “Examining Physician.” The examiner was a licensed physical therapist, not a licensed medical doctor. The man attended the examination conducted by the physical therapist. The physical therapist prepared a report of the IME that indicated that he took the man’s history, physically examined him, and reviewed his medical records. The physical therapist’s report included his opinion of the extent of the man’s injuries. Click title to continue reading...



State Health Plan “Health Insurance Coverage” Required Diabetes Education Coverage

A public school district employee was insured under the state health plan. The state health plan was offered through the Budget and Control Board Employee Insurance Program Appeals Committee (EIP). The employee’s daughter was diagnosed with type I diabetes at the age of two years old. The daughter’s doctor prescribed an insulin pump to regulate the daughter’s insulin levels. Two weeks prior to attaching the pump to her body, her family and to school nurses attended a two-hour training session at the hospital, during which a diabetic educator taught the caregivers how to operate the insulin pump. The man submitted a $560 claim for the educational training session. Click title to continue reading...