Scalpel Weekly News

Week of: July 18, 2016

IN THE NEWS


Precision Medicine Initiative Advances; Next Generation Genomic Sequencing Guidance

On July 6, 2016, in support of the President’s Precision Medicine Initiative, the FDA issued two draft guidance that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup. Click title to continue reading...


 
MEDICAL ALERTS


Nationwide Recall of HeartWare Ventricular Assist Device Due to Multiple Defects

On June 29, 2016, the FDA classified the HeartWare Ventricular Assist Device (HVAD) recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death. Click title to continue reading...



FDA Approves HPV Test for Use With SurePath Preservative Fluid

On July 7, 2016, the FDA approved the Roche cobas HPV Test as the first test for Human Papilloma Virus (HPV) that can be used with cervical cells obtained for a Pap test, a test to detect cancer of the cervix or uterus, using a specimen of cellular material from the neck of the uterus spread on a microscope slide, also known as a Pap smear, and collected in SurePath Preservative Fluid. Click title to continue reading...



Vehicle Crash Fatalities Could Drop by Half with Proven Strategies; Country Comparisons

On July 6, 2016, the CDC reported that, about 90 people die each day from motor vehicle crashes in the United States, resulting in the highest death rate among 19 high-income comparison countries. The U.S. has made progress in road safety, reducing crash deaths by 31 percent from 2000 to 2013. But other high-income countries reduced crash deaths even further—by an average of 56 percent during the same period, according to the latest report by the CDC. Click title to continue reading...


  CASE ALERTS


Failure to Biopsy Lesion Leads to Undiagnosed Malignant Melanoma; Malpractice

A man saw his primary care doctor to have a lesion on his back examined. The primary care doctor diagnosed the lesion as a benign seborrheic keratosis and removed it using liquid nitrogen. Click title to continue reading...



Journal Evidence on Pressure Ulcers; Jury Verdict for Hospital

A man was involved in an automobile accident. After being stabilized at one hospital, he was transferred the following day to a medical center. Having sustained severe injuries in the wreck, the man required multiple surgeries and was hospitalized at the medical center for several weeks. During his stay at the medical center, the man developed a deep tissue injury (also called a pressure ulcer) on his sacrum, a type of injury caused by sustained pressure on the affected body part. Click title to continue reading...



Michigan No-Fault Act Requires Social Security with Survivors' Loss Benefits

A man died as a result of injuries he suffered in a car accident. At the time he died, the man was entitled to a gross sum of $1,611.90 per month in old-age social security benefits. Click title to continue reading...


FEATURE


Complaint: Multiple Sclerosis Discrimination

As a special feature for our Premium subscribers we have included this feature containing an illustrative Complaint for discrimination involving an employee’s diagnosis of multiple sclerosis. The complaint includes counts for violations of the state law against discrimination, the state Constitution, and state public policy; breach of the employment agreement; breach of the covenant of good faith and fair dealing; emotional distress; and for a hostile work environment. Click title to continue reading...