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    <recommendedItem id="20100101_19_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.008"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265747719789"
                     
      &lt;p&gt;WASHINGTON  --  U.S. Marshals have seized 77 unapproved ozone generators, valued at almost $76,000 from a California device manufacturer, the FDA announced.&lt;/p&gt;
&lt;p&gt;The devices were advertised as treatments for various conditions, including cancer, AIDS, hepatitis, herpes, and other diseases, but lacked approval or efficacy data to support the claims made on their behalf, an FDA release said.&lt;/p&gt;
&lt;p&gt;The raid came after the company, Applied Ozone Systems (AOS) of Auburn, Calif., failed to respond to a voluntary recall request last December, the agency said.&lt;/p&gt;
&lt;p&gt;The FDA raised concerns that patients using AOS-IM and AOS-IMD devices will consider it an appropriate treatment for an affliction and delay or stop FDA-approved and proven medical treatments. Patients using the devices may risk infection from contamination of the applicator or catheter, the release said.&lt;/p&gt;
&lt;p&gt;The FDA recommended that healthcare professionals and consumers cease use of the devices.&lt;/p&gt;
&lt;p&gt;The agency said it obtained an inspection warrant for the company&apos;s manufacturing facilities after the owner refused to admit FDA inspectors. It said the inspection revealed several breaches of the FDA&apos;s good manufacturing practice requirements for medical devices, which had never been approved in the first place.&lt;/p&gt;
&lt;p&gt;Ozone is an unstable allotrope of oxygen with three atoms, instead of the normal two. Ozone generators produce ozone from oxygen and have consumer and industrial applications, but ozone itself is harmful to the respiratory system, even at relatively low concentrations.&lt;/p&gt;
&lt;p&gt;Instructions with the Applied Ozone Systems devices suggest blowing ozoned air into the rectal and vaginal areas.&lt;/p&gt;
&lt;p&gt;Friday&apos;s seizure was part of a joint effort of the FDA and the California Department of Public Health to remove or prevent unapproved or unsafe medical devices from entering the market.&lt;/p&gt;
&lt;p&gt;A statement on the company&apos;s Web site said the two ozone generator models, which sold for $750 and $1,200 respectively, were no longer available by order of the FDA and California authorities.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_168"
                     title="Concussion Label Can be Confusing (CME/CE)"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Neurology/HeadTrauma/tb/18000?impressionId=1265747719789"
                     
      Whether a clinician calls a mild traumatic brain injury a concussion or not appears to influence how serious the injury is considered to be, researchers found.&lt;br&gt;
&lt;br&gt;Among children admitted for a traumatic brain injury, those who were told they had a concussion were discharged significantly earlier (OR 1.49, 95% CI 1.15 to 1.94) and returned to school sooner (OR 2.42, 95% CI 1.56 to 3.73) than those who were not given the label, Carol DeMatteo, MSc, of McMaster University in Hamilton, Ontario, and colleagues reported in the February issue of &lt;em&gt;Pediatrics&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;The trends remained significant even after adjusting for the severity of the head injury and the presence of other injuries.&lt;/p&gt;
&lt;p&gt;&quot;We suggest that the [concussion] label itself conveys a message and also directs outcomes,&quot; the researchers wrote. &quot;If we want to encourage full reporting with subsequent adequate management and convalescence, perhaps we should use the term &apos;mild traumatic brain injury.&apos;&quot;


 &lt;p&gt;Disagreeing was Kenneth Perrine, PhD, a neuropsychologist at Hackensack University Medical Center in New Jersey.
    &lt;p&gt;&quot;Granted, concussion is by definition a mild brain injury, but it&apos;s so transient that I think it would be a disservice both to the public and for research to continue to confuse mild traumatic brain injury with concussion,&quot; said Perrine, who was not involved in the study.
    &lt;p&gt;He said a true concussion is characterized by feeling like one is in a fog, fatigue, sensitivity to light and sound, headache, blurred vision or other visual disturbances, and feeling off balance.
    &lt;p&gt;A mild traumatic brain injury, on the other hand, has longer-lasting effects and is not usually accompanied by concussion symptoms. Retrograde amnesia, post-traumatic amnesia, and more severe memory loss would occur, he said.
    &lt;p&gt;&quot;They are two distinct entities both from what we call it and from a prognostic standpoint,&quot; said Perrine, who is also consulting neuropsychologist for the New York Jets.
    &lt;p&gt;But, although the term concussion is used widely in clinical records and has garnered much attention in recent years because of head injuries to athletes at all levels of sports, an accepted definition does not exist, according to DeMatteo and her colleagues.&lt;/p&gt;



&lt;p&gt;&quot;Clinicians may use the concussion label because it is less alarming to parents than the term &quot;mild brain injury,&quot; with the intent of implying that the injury is transient with no signi&amp;#64257;cant long-term health consequences,&quot; they said.&lt;/p&gt;

&lt;p&gt;Commenting on the study, Wendy Wright, MD, a neurologist at Emory University in Atlanta, said in an e-mail, &quot;This study puts a spotlight on the issue that concussion is not always taken as seriously as it should be, partly because concussion encompasses a spectrum of disease.&quot;&lt;/p&gt;
&lt;p&gt;She said parents, coaches, teammates, and the individual with the concussion may not believe the injury is serious because symptoms are transient.&lt;/p&gt;
&lt;p&gt;That perception appears to be held by both clinicians and parents alike. DeMatteo and colleagues noted in the journal that during recruitment of the current study, both groups were heard saying, &quot;He doesn&apos;t have a head injury, he has a concussion.&quot;&lt;/p&gt;
&lt;p&gt;However, Wright said, &quot;it must be noted that concussion means brain injury.&quot;&lt;/p&gt;


&lt;p&gt;To explore how the term is used clinically, DeMatteo and colleagues analyzed the records of 434 children admitted to McMaster Children&apos;s Hospital with a diagnosis of acquired brain injury.&lt;/p&gt;
&lt;p&gt;Of those determined to have a traumatic brain injury, 72.7% had a mild injury according to the Glasgow Coma Scale. Nearly one-third (32.4%) were said to have a concussion.&lt;/p&gt;
&lt;p&gt;The concussion label was more likely to be given to children with a mild injury (&lt;em&gt;P&lt;/em&gt;=0.03), but the association was weak, according to the researchers, and nearly one-quarter (24%) of children with moderate or severe scores were also said to have a concussion.&lt;/p&gt;
&lt;p&gt;&quot;This leads one to question the use of the term as being reflective of mild injury and again supports the existence of confusion about what a concussion really is and how the term should best be used in the care of children,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;Our findings, both in the return-to-school data and the phenomenon we experienced during recruitment, suggest that if a child is given a diagnosis of concussion, then the family is less likely to consider it as a brain injury,&quot; the researchers said.&lt;/p&gt;
&lt;p&gt;They acknowledged some limitations of the study, including the fact that data from medical charts may have had missing information and a lack of control over the validity of measurements and that their use of only a single center might influence the results.&lt;/p&gt;
&lt;p&gt;Further, they wrote, some measures, such as CT frequency, might be inflated because only children who were admitted to the hospital were included in the study. &lt;ul&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was funded by a research grant from the Ontario Neurotrauma Foundation. The &lt;em&gt;CanChild&lt;/em&gt;&lt;em&gt;&lt;/em&gt; Center for Childhood Disability Research is supported by the Ontario Ministry of Health and Long-Term Care.&lt;/p&gt;&lt;p&gt;The authors reported that they had no relevant financial disclosures to make.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_19_2206"
                     title="Falls, Not Scalds, Pose Biggest Bathtime Danger for Kids"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/tb/15059?impressionId=1265747719789"
                     
      LITTLE FALLS, N.J., July 13 -- Slips, trips, and falls account for the vast majority of injuries that befall children in bathtubs and showers, a retrospective study showed. 
              &lt;br&gt;&lt;br&gt;Of the estimated 43,600 bathtub- and shower-related injuries among children treated in emergency departments each year, 81% were caused by slips, trips, and falls, according to Gary Smith, MD, DrPH, of Ohio State University and Nationwide Children&apos;s Hospital in Columbus, Ohio, and colleagues. 
              &lt;br&gt;&lt;br&gt;Although the dangers of bathtime have long been recognized, most research has focused on more severe injuries like scalding or near drowning, the researchers reported online in &lt;em&gt;Pediatrics&lt;/em&gt;. 
              &lt;br&gt;&lt;br&gt;&quot;This study, for the first time, has really emphasized slips and falls,&quot; Dr. Smith said. 
              &lt;br&gt;&lt;br&gt;He noted that parental supervision often is not enough to avoid these types of injuries. 
              &lt;p&gt;&quot;They happen so quickly that a parent simply can&apos;t react quickly enough to prevent them,&quot; he said. &quot;Therefore, it is important to prevent them from happening by using a slip resistant mat inside and outside the bath and shower.&quot; 
              &lt;p&gt;Other recommendations included installing support bars for children to grab on to while getting in and out of the tub, removing sharp edges, and using shatterproof enclosures to prevent lacerations. 
              &lt;p&gt;Dr. Smith and his colleagues looked at nationally representative data from the U.S. Consumer Product Safety Commission&apos;s National Electronic Injury Surveillance System, which collects data from a representative sample of 100 emergency departments in the U.S. 
              &lt;p&gt;From 1990 to 2007, EDs treated an estimated 791,200 injuries related to bathing in children and teens younger than 19. That works out to about 5.9 injuries per 10,000 children per year. 
              &lt;p&gt;Overall, 81% of the injuries were related to slips, trips, or falls, 9.3% to impact, 4% to burns, 1.6% to submersions, and 4.1% to other causes. 
              &lt;p&gt;The greatest number of injuries occurred in 2-year-olds, and more than half (54.3%) occurred in children younger than 5. 
              &lt;p&gt;About two-thirds of the injuries in this age group affected the face, a consequence of young children&apos;s high center of gravity and inability to protect themselves because of limited arm strength and coordination, according to the researchers. 
              &lt;p&gt;The most common diagnoses in the overall cohort were laceration (59.5%) and soft-tissue injury (21.6%). 
              &lt;p&gt;Only 2.8% of the cases were admitted, transferred to another hospital, or held for observation; the rest were treated and released or left against medical advice. 
              &lt;p&gt;Over the study period, the number of injuries remained relatively constant, which the researchers said argues &quot;for the need to increase prevention efforts with a focus on the prevention of slips, trips, and falls in the bathtub and shower, especially among young children.&quot; 
              &lt;p&gt;In addition to the changes parents can make in the bathroom, the coefficient of friction for bathtub and shower surfaces, a measure of the likelihood of slipping, should be reexamined, according to Dr. Smith. 
              &lt;p&gt;They noted that the current voluntary standard for coefficient of friction was determined by an &quot;arbitrary and clearly flawed method,&quot; and bathtubs were never tested for the likelihood of slips and falls. 
              &lt;p&gt;&quot;Furthermore,&quot; they said, &quot;the value is 12 times lower than the widely accepted static COF for safe walking.&quot; 
              &lt;p&gt;Requiring higher coefficients of friction might reduce injuries, he said. 
              &lt;p&gt;The authors said the results might underestimate the actual rate of bathtub- and shower-related injuries because the data only reflected those treated in emergency departments. 
              &lt;p&gt;In addition, they said, the database does not capture fatalities well, is subject to missing or inaccurate data, and fails to distinguish between intentional and unintentional injuries.  
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt; The authors did not make any financial disclosures.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
    </recommendedItem>
    <recommendedItem id="20090101_1_200"
                     title="SCCM: Safety Devices Saving Kids&apos; Lives"
                     score="-0.006"
                     href="