Scalpel Weekly News

Week of: March 02, 2015

IN THE NEWS


Over 100 Patient Infections Reported; Proper Endoscope Cleaning Affected by Design

The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it. Click title to continue reading...


 
MEDICAL ALERTS


New Permanent Adhesive Treatment for Varicose Veins

The FDA approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent. This system is the first to use adhesive to cut off blood supply. The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, North Carolina. Click title to continue reading...



FDA Approves At-Home Genetic Test for Bloom Syndrome; Clears Path For Similar Tests

The FDA authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder. Along with this authorization, the FDA is also classifying carrier screening tests as class II. In addition, the FDA intends to exempt these devices from FDA premarket review. The agency plans to issue a notice that announces the intent to exempt these tests and that provides a 30-day period for public comment. This action creates the least burdensome regulatory path for autosomal recessive carrier screening tests with similar uses to enter the market. Click title to continue reading...



Hypothermia Deaths Increase; Risk Factors: Older, Male, Intoxicated, Homeless, Mental Illness

Hypothermia is a preventable cause of death that begins when core body temperature decreases to <95°F (<35°C). Initial symptoms include shivering and cool extremities. As hypothermia worsens, symptoms progress to confusion, loss of fine motor skills, and amnesia. Continued heat loss without adequate rewarming can result in hypotension, impaired respiration, cardiac arrhythmias, and death. Key risk factors include drug intoxication, mental illness, and social isolation. Exposure to cold is a leading cause of weather-related mortality and is responsible for approximately twice the number of deaths annually as exposure to heat in the United States. Hypothermia continues to be an important cause of weather-related death. State and local health agencies need to focus outreach on vulnerable populations and target interventions for groups at highest risk for death. Click title to continue reading...


  CASE ALERTS


North Carolina Governed Breast Implant Claim; Michigan Venue for Manufacturer’s Bankruptcy Did Not

A Virginia resident had her breasts augmented with silicone implants in a surgical procedure in North Carolina. The silicone-based filling in the implants was produced by a manufacturer, whose corporate headquarters was in Michigan. After the surgery, the woman began to suffer from a number of health problems: vomiting, tinnitus, balance problems, swelling of her uterus and gallbladder, edema, skin rashes, the appearance of painful knots on her body, and chronic pain. Over the years she was apparently diagnosed with lupus, atypical connective tissue disease (which is similar to lupus), and Reynaud's disease. Her doctors eventually diagnosed her with silicone-induced autoimmune dysfunction. It was not clear when that diagnosis was first made. Click title to continue reading...



DIB ‘Totally Disabled’ Same as ‘Unemployable,’ Even If No Diagnostic Evidence of Pain

An aviation mechanic for the U.S. military was discharged due to pain from an ankle injury. The Department of Veterans Affairs (VA) determined that he was 70 percent disabled and “unemployable” in “a substantially gainful occupation” and, therefore, was totally disabled. Nine years later he applied for social security disability insurance benefits (DIB) on the ground that pain from his ankle injury, together with back and knee pain and other ailments, had steadily worsened and by that time had rendered him totally disabled under the standards of the Social Security Act. Click title to continue reading...



Transport Not Included in PIP Medical Service Expense

A woman was insured under a motor vehicle insurance policy. As statutorily required, the woman’s insurance policy included personal injury protection coverage, which is Oregon’s version of no-fault motor vehicle insurance. Under the personal injury protection statutory scheme, when an insured is injured in a motor vehicle accident, regardless of fault, the insurer is required to pay certain expenses. These expenses include “expenses of medical … services.” ORS 742.524(l)(a). Click title to continue reading...