NPR Segment Features Treatments for Low Back Pain

Last week, as part of their “Your Health” segment, NPR aired a piece about the effectiveness of various treatments for low back pain, with a focus on spinal manipulation. Lower back pain is a common complaint to physicians, and, as the article states, a common reason for the prescription of addictive narcotic painkillers. Other interventions can include:

  • Acupuncture
  • Physical therapy
  • Massage therapy
  • Nonsteroidal anti-inflammatory drugs (NSAIDS)
  • Chiropractic treatment
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Topics: Payers, Hospitals, Hayes Blog, Devices, Health Technology Assessments,

We’ve Got Your Back: Earn CE Credits with Our Vertebral Compression Fracture Webinar

Posted by Paula Goines, PhD, Medical Research Analyst on February 16, 2017

Meaning “porous bone,” osteoporosis occurs when the body loses or makes too little bone. The appearance of osteoporotic bone under a microscope does not reveal the traditional dense “honeycomb” pattern that gives the bone stability. Instead, the patterns are almost web-like, with large holes where smaller ones would normally be, causing the bone to be quite fragile. Depending on the severity of the condition, incidents as severe as a fall to as minor as a cough can cause bones to fracture, most commonly the vertebrae (spine). And unfortunately, chances are good you know or have known someone suffering from one of these fractures.

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Topics: Payers, Hayes Blog, Devices, Health Technology Assessments,

Neptune Waste Management System Back in Operating Suites

Posted by The Evidence Blog on January 3, 2017

The Neptune Waste Management Systems are used in operating room (OR) suites and surgical facilities to collect and dispose of surgical fluid waste. Some models also remove smoke generated at surgical sites by electrocautery or laser devices. In 2012, the manufacturer of these systems issued a voluntary class I recall. The Food and Drug Administration (FDA) defines class I recalls as those issued in situations in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.

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Topics: Health Technologies, Hospitals, Hayes Blog, Devices, recalls

510(k) vs PMA: Do you know the difference?

We’ve had recent questions regarding the Food and Drug Administration (FDA) approval process for new medical devices, so we felt it was time to revisit the topic. We realize that as both physicians and providers, the pressure can be great when both patients and clients come to you wanting information about the latest device reported on the news or Internet. The following is designed to give you an overview of the process to better inform those inevitable discussions.

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Topics: Hayes Blog, Devices

Peanut Allergy Drug Therapies Make National Headlines

WBUR’s “Here and Now” this week featured an article regarding the use of immunotherapies to decrease allergic reactions, specifically to peanuts.

Unless you’ve been living in a cave, you’re well aware of the significant health risks peanut allergies present to individuals. Symptoms run the spectrum from a runny nose and throat itchiness to full-blown anaphylaxis, which includes constriction of the airways, a severe drop in blood pressure (shock), and loss of consciousness. While the most common cause of a reaction is eating peanuts or food that contains them, they can also be triggered by skin contact, cross-contamination during food handling, and even inhalation of dusts or aerosols containing peanuts (Source: Mayoclinic.org). An allergic response to peanuts can occur in just minutes.

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Topics: Hayes Blog, Devices, Health Technology Assessments,, Consumers

CMS Weighs the Evidence for Leadless Pacemaker Coverage

This week, the Centers for Medicare & Medicaid Services (CMS) issued a proposed Decision Memorandum regarding coverage for leadless pacemakers. If approved, it will provide conditional coverage for leadless pacemakers only if they are used in an approved clinical study as determined by the Coverage with Evidence Development (CED) program.

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Topics: Health Technologies, Devices, Healthcare Evidence, Medicare, medical devices

IOM Report on 510(k) Process Criticized Before Publication

Posted by The Evidence Blog on August 11, 2011

By Susan Levine, MS, DVM, PhD, Senior Vice President of Health Technology Research and Consulting, Editor in Chief

Lots of buzz surrounds medical devices and how they are approved in the United States following the release of the Institute of Medicine’s (IOM) report on the 510(k) clearance process on July 29, 2011. The IOM committee was tasked with answering two questions:

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Topics: Hayes Blog, Devices