Federal Regulation news
Patient Dismissal Is Last Resort for Vaccine Refusal
Written by Editor   
Monday, September 26, 2016 07:14 AM

The American Academy of Pediatrics (AAP) has changed its position and now says pediatricians can dismiss families for vaccine refusal, but only as a last resort. The new clinical report provides clinicians with multiple approaches for dealing with vaccine-hesitant families and stresses the role of pediatrician as educator in these situations.  However, if no approach works and pediatricians need to dismiss a family, they must do so in a thoughtful and professional manner. And they must ensure that the family has other options for medical care.

“The decision to dismiss a family who continues to refuse immunization is not one that should be made lightly, nor should it be made without considering and respecting the reasons for the parents’ point of view. Nevertheless, the individual pediatrician may consider dismissal of families who refuse vaccination as an acceptable option. In all practice settings, consistency, transparency, and openness regarding the practice's policy on vaccines is important."

FDA OKs Concussion Screening App
Written by Editor   
Monday, September 26, 2016 07:03 AM

The FDA has approved the ImPACT software and medical app, designed to help clinicians test cognitive skills after a head injury.

Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) has two versions. The first is designed for patients between 12 to 59 years old and runs on a laptop. The other, ImPACT Pediatric, is for kids younger than 12 years old and runs on an iPad. It's designed to perform a clinician-guided test of cognitive skills like word memory, reaction time and word recognition to aid in assessment of head injuries. Tests take about 25 minutes and results can be compared to an age-matched cohort from the company's large database of "normal" patients or to pre-injury baseline test taken by the patient. As the FDA points out in its press release, ImPACT is not designed to diagnose a concussion or recommend treatment.

FDA Yanks OTC Antibacterial Soaps
Written by Editor   
Thursday, September 15, 2016 12:00 AM

Over-the-counter antibacterial soaps containing any of 19 specific active ingredients can no longer be marketed, the FDA announced, including those with triclosan and triclocarban.

The rule does not affect antibacterial products used in healthcare settings, FDA said in a release, nor does it apply to OTC alcohol handrubs or wipes.

An FDA review of chemicals in OTC consumer antiseptic wash products did not find concrete evidence that the 19 banned chemicals prevent illness and infection better than plain soap and water, or are safe for long-term daily use.

CDC Puts Spotlight on Sepsis as 'Medical Emergency'
Written by Editor   
Wednesday, September 07, 2016 06:51 AM

Federal health officials are calling on healthcare providers to do more to prevent, recognize, and treat sepsis before it can cause life-threatening illness or death.

An infection that is getting worse and is not treated can lead to sepsis. We call on healthcare providers to take opportunities to prevent, identify, and rapidly treat patients with sepsis and to educate patients and family members about sepsis.

Each year, from 1 to 3 million people in the United States are diagnosed with sepsis. The mortality rate from sepsis is between 15% and 30%. Many who survive sepsis have a prolonged stay in a nursing home or other long-term care facility, Dr Frieden noted.

To describe characteristics of patients with sepsis and to inform sepsis initiatives, the CDC partnered with the New York State Department of Health and Emerging Infections Program on a retrospective chart review of 246 adult and 79 pediatric patients from four New York hospitals with administrative codes for severe sepsis or septic shock. The median age of adult patients was 69 years, and 52% were male. The pediatric group included 31 infants younger than 1 year and 48 children between 1 and 17 years of age.

Mirroring other studies, sepsis most commonly occurred among patients with one or more comorbid conditions. But about 80% of patients develop infections leading to sepsis outside a hospital.  The study also found that nearly a quarter of sepsis patients (72%) had seen a healthcare provider in the month preceding sepsis admission or had chronic diseases requiring frequent medical care.

FTC, not the FDA, Requires Peer Reviewed Data to Prove Claims
Written by Editor   
Wednesday, September 07, 2016 06:46 AM

The FTC has come down with a hammer on Lumosity — the online digital health company that promised consumers their games would help reduce neurocognitive deficits. The company has settled for $2 million, and is also being imposed a $50 million judgement by the FTC. The real story here is the wording the FTC used in their decision to put the digital health world on notice about creating apps that promise too much without having evidence and rigorous data to back it up their claims.

Notable in the FTC statement is:

In particular, I caution … companies about making representations that overstate the benefits of these products or misleadingly imply that improvements in the game setting transfer to real-world benefits. Section 5 of the FTC Act requires that advertisers have a reasonable basis to support their express and implied advertising claims before they are disseminated to ensure that such claims are truthful and non-deceptive. Advertisers must also have rigorous, scientific support to substantiate claims for products that purport to prevent or treat health or disease-related conditions.

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