Scalpel Weekly News

Week of: April 30, 2018

IN THE NEWS


Implantable Cardiac Device Battery Performance; Cybersecurity

On April 11, 2018, the FDA approved a firmware update for certain Abbott implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). This firmware update included mitigations to addresses two separate issues: (1) a device-based Battery Performance Alert to detect rapid battery depletion, and (2) updates to address cybersecurity vulnerabilities across Abbott’s radio frequency (RF) enabled ICDs and CRT-Ds. Click title to continue reading...


 
MEDICAL ALERTS


First Test for Yeast Causing Severe Illness in Hospitalized Patients

On April 20, 2018, the FDA granted Bruker Daltonik GmbH authorization to market the first test to identify the emerging pathogen Candida auris (C. auris), a yeast which can cause serious infections in hospitalized patients and does not respond to common antifungal drugs. Specifically, the FDA permitted marketing for a new use of the Bruker MALDI Biotyper CA system for the identification of C. auris, adding to the system’s already cleared uses for the identification of 333 species or species groups, covering 424 clinically relevant bacteria and yeast species. Click title to continue reading...



Cross-Contamination; Multi-Patient Use Endoscope Connectors

On April 18, 2018, the FDA alerted health care providers and facilities about the risk of cross-contamination with certain connectors that are used in gastrointestinal endoscopy. Endoscope connectors that are labeled for use with multiple patients over the course of 24 hours without reprocessing are known as 24-hour multi-patient use endoscope connectors. The FDA has not received acceptable testing to demonstrate the safe use of these products. Click title to continue reading...



Most Adults with Active Epilepsy Uncontrolled by Medication

On April 20, 2018, the CDC published a report that found that 56 percent of adults with active epilepsy who took epilepsy medication had a seizure in the past year. Click title to continue reading... 


  CASE ALERTS


Vaginal Delivery of Breech Baby Ends in Hypoxic Brain Injury

A woman who was more than 40 weeks pregnant was admitted to the hospital after the woman’s water broke. The woman’s obstetrician noted that the fetus was in the vertex position, head down ready for a vaginal birth. Before leaving the hospital, the obstetrician wrote an order that Pitocin (oxytocin), a hormone which can cause or strengthen labor contractions during childbirth, should be administered to induce contractions if the woman did no go into labor by a certain time. The order included a note that the baby was vertex and an instruction that vaginal examinations should not be performed prior to administering the Piton. Click title to continue reading...



Prescribing Antibiotic with Steroid Contrary to Black Box Warning

A 76-year-old woman was admitted to the hospital with a fever, altered mental status, and weakness. The admission notes recorded that the woman was taking prednisone, a corticosteroid, on a daily basis. Urine and blood cultures were performed. Due to a suspected infection and sepsis, the physician ordered 500 mg of IV Levaquin (levofloxacin), an antibiotic. Click title to continue reading...



Class Action Challenging Uninsured Patients’ Hospital Bills

Before receiving treatment for an emergency procedure at a hospital, an uninsured man signed the hospital’s consent form. The form stated: “I understand that I am financially responsible for, guarantee and agree to pay in full, in accordance with the regular rates and terms of [the hospital] at the time of patient’s treatment, for charges for all services provided to me by” the hospital. After the man was discharged, the hospital billed the man $14,578.14 for services rendered and materials provided during the man’s stay at the hospital. When the bill went uncollected, the hospital sued the man and the man’s wife. Click title to continue reading...


FEATURE


Checklist - Expert Deposition: Retained Surgical Item Injury

As a special feature for our Premium subscribers, we have included this feature containing a checklist to be used in preparing to depose the plaintiff’s expert witness in a case involving a retained surgical item injury. In this illustrative situation, a woman underwent surgery, suffered post-surgical pain and infection, and underwent an additional surgery to remove a piece of a surgical instrument that had broken off inside the plaintiff during the original surgery. The woman sued the surgeon and the hospital for medical malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...