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    <recommendedItem id="20100101_19_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.009"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265772529345"
                     
      &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_169"
                     title="Hospitals Post Gains in Evidence-Based Care"
                     score="-0.004"
                     href="http://www.medpagetoday.com/HospitalBasedMedicine/Hospitalists/tb/17989?impressionId=1265772529345"
                     
      &lt;p&gt;WASHINGTON  --  The latest report from the nation&apos;s official hospital oversight agency, the Joint Commission, found more good than bad  --  overall, hospitals are following evidence-based standards for treatment of myocardial infarction, heart failure, and pneumonia.&lt;/p&gt;
&lt;p&gt;The annual report, &quot;Improving America&apos;s Hospitals: The Joint Commission&apos;s Annual Report on Quality and Safety,&quot; found that hospitals provided evidence-based heart attack treatments  --  including giving patients aspirin when they admitted  --  nearly 97% of the time in 2008, up 10% from the rate in 2002.&lt;/p&gt;
&lt;p&gt;Adherence was even better for treating heart failure. Back in 2002, hospitals treating heart failure patients were only following about 60% of evidence-based recommendations, but in 2008 hospitals were providing evidence-based treatment, including offering smoking cessation counseling and testing left ventricular systolic function, about 92% of the time.&lt;/p&gt;
&lt;p&gt;But mixed in with the glowing words there was a handful of cautions about areas where hospitals still fall short of the mark.&lt;/p&gt;
&lt;p&gt;Hospitals are still often doing too little, too late when it comes to the use of fibrinolytic therapy for MI  --  door-to-needle time only makes the 30-minute threshold about half of the time. A single but important pneumonia measure, initiation of antibiotics within 24 hours of admittance, was also disappointing, with just 60% of hospitals adhering to that measure.&lt;/p&gt;
&lt;p&gt;The Joint Commission&apos;s report tracks hospital use of 31 evidence-based measures.&lt;/p&gt;
&lt;p&gt;On the plus side, hospitals did improve overall adherence to care measures for pneumonia patients, following evidence-based treatment recommendations 93% of the time in 2008, versus 73% in 2002.&lt;/p&gt;
&lt;p&gt;Current guidelines recommend that smokers who are admitted for treatment of acute coronary syndromes, heart failure, or pneumonia should receive smoking cessation counseling, a recommendation that had often been ignored.&lt;/p&gt;
&lt;p&gt;In 2002 hospitals reported providing smoking cessation counseling to about 67% of heart attack patients, 42% of heart failure patients, and 37% of pneumonia patients  --  in 2008 the counseling rate for each of those three admitting diagnoses had climbed to 96% to 99%.&lt;/p&gt;
&lt;p&gt;In the report Mark R. Chassin, MD, Joint Commission president, wrote that improved adherence to evidence-based guidelines should not only improve outcomes, but also save money by reducing both complications and readmissions.&lt;/p&gt;
&lt;p&gt;The report also found that hospitals adhered to quality measures relating to inpatient treatment of childhood asthma  --  which includes giving relievers and systematic corticosteroids for asthmatic kids  --  in nearly 100% of eligible cases. &lt;ul&gt; &lt;/ul&gt;&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_19_3110"
                     title="Study Shows Surgical Masks Equal Respirators for Healthcare Workers (CME/CE)"
                     score="-0.005"
                     href="http://www.medpagetoday.com/HospitalBasedMedicine/InfectionControl/tb/16248?impressionId=1265772529345"
                     
      Surgical masks may be just as good as N95 respirators for protecting healthcare workers against the flu, according to a randomized clinical trial whose findings conflict with the only previous study.&lt;br&gt;
&lt;br&gt;Nurses who wore surgical masks while caring for patients with flu-like symptoms were no more likely to catch seasonal flu than those who wore the higher filtration devices (23.6% versus 22.9%, &lt;em&gt;P&lt;/em&gt;=0.86), Mark Loeb, MD, MSc, of McMaster University in Hamilton, Ontario, and colleagues reported online in the &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;These findings do not apply to settings where there is a high risk that the virus will become aerosolized, such as intubation or bronchoscopy, the researchers cautioned.&lt;br&gt;
&lt;br&gt;But for &quot;routine healthcare settings, particularly where the availability of N95 respirators is limited,&quot; the results are reassuring, they wrote.&lt;br&gt;
&lt;br&gt;However, the new findings contradict those of another randomized, controlled trial comparing efficacy of the N95 respirators and standard surgical masks, a trial reported just two weeks ago at the &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/ICAAC/16006&quot; mce_href=&quot;http://www.medpagetoday.com/MeetingCoverage/ICAAC/16006&quot; target=&quot;_blank&quot;&gt;Interscience Conference on Antimicrobial Agents and Chemotherapy&lt;/a&gt;.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;That study indicated that when used consistently, N95 respirator masks prevented 75% of respiratory infections for high-risk healthcare workers in China. But consistent surgical mask use was no better than low use for prevention of clinical respiratory illness (6.7% versus 9.2%, &lt;em&gt;P&lt;/em&gt;=0.159) or of influenza-like illness (0.6% versus 1.3%, &lt;em&gt;P&lt;/em&gt;=0.336).&lt;/p&gt;
&lt;p&gt;Given the discrepancies, &quot;a single study will not end the debate over influenza respiratory protection for healthcare professionals,&quot; noted CDC&apos;s Arjun Srinivasan, MD, and Trish M. Perl, MD, MSc, of Johns Hopkins, in an editorial accompanying today&apos;s online &lt;em&gt;JAMA&lt;/em&gt; article.&lt;/p&gt;
&lt;p&gt;With the current H1N1 pandemic (swine) flu, the issue has gained urgency, but there is little consensus, they wrote.&lt;/p&gt;
&lt;p&gt;Some groups, including the World Health Organization and Society for Healthcare Epidemiology of America (SHEA), say surgical masks are sufficient for most patient care activities. SHEA cited &quot;serious cost, compliance, and supply concerns&quot; in a statement opposing mandatory N95 respirator use.&lt;/p&gt;
&lt;p&gt;While the CDC recommends surgical masks as part of the arsenal deployed against seasonal flu, it recommended only N95 respirators for protection against H1N1  --  in part, because of animal studies indicating airborne transmission via small particles.&lt;/p&gt;
&lt;p&gt;Surgical masks were designed to prevent transmission via relatively large particles, such as sputum droplets, whereas N95 respirators are made of material certified to block 95% of particles 0.3 &amp;#956;m or larger in diameter. Unlike surgical masks, they also seal tight to block inflow around the nose and mouth.&lt;/p&gt;
&lt;p&gt;Last month, after hearing interim results of the Chinese trial, the Institute of Medicine sided with the CDC in &lt;a href=&quot;http://www.medpagetoday.com/HospitalBasedMedicine/WorkForce/15518&quot; mce_href=&quot;http://www.medpagetoday.com/HospitalBasedMedicine/WorkForce/15518&quot; target=&quot;_blank&quot;&gt;recommending N95 respirators&lt;/a&gt; to protect healthcare workers from the pandemic flu.&lt;/p&gt;
&lt;p&gt;That study included nearly 2,000 emergency and respiratory ward nurses and physicians. They were cluster-randomized to wear surgical masks, fit-tested N95 respirators, or non-fit tested N95 respirators during all work hours for four consecutive weeks during the cold and flu season.&lt;/p&gt;
&lt;p&gt;Loeb&apos;s study included 478 nurses who worked in emergency departments, medical units, and pediatric units in eight Ontario tertiary care hospitals. They were randomized to open-label use of a fit-tested N95 respirator or a surgical mask when providing care to patients with febrile respiratory illness during the 2008-2009 influenza season.&lt;/p&gt;
&lt;p&gt;Participants were to maintain randomization even during aerosol-generating procedures such as intubation. The groups had similar rates of flu vaccination and exposure to a sick spouse, roommate, or child.&lt;/p&gt;
&lt;p&gt;Unlike the findings of the Chinese study, though, laboratory-confirmed influenza on nasal swabs met noninferiority criteria for surgical masks compared with N95 respirators (absolute risk difference -0.73%, 95% confidence interval -8.8% to 7.3%).&lt;/p&gt;
&lt;p&gt;The results, if anything, tended to be better for surgical masks in confirmed H1N1 rates (8.0% versus 11.9%, &lt;em&gt;P&lt;/em&gt;=0.18), though again meeting noninferiority criteria.&lt;/p&gt;
&lt;p&gt;Clinical influenza-like illness, though, tended to be less likely with use of the N95 respirators (1.0% versus 4.2%, &lt;em&gt;P&lt;/em&gt;=0.06), which the researchers called an unexpected finding based on similarity of the serology results.&lt;/p&gt;
&lt;p&gt;Srinivasan speculated that the difference could have been accounted for by bias if nurses felt more protected with the N95 respirators and were less likely to report symptoms.&lt;/p&gt;
&lt;p&gt;Adherence to randomization was 100% in the surgical mask group and 85.7% with the respirators, high rates likely driven by &quot;the fact that all hospitals in the study were in Ontario, which was affected by the SARS outbreak and where use of personal protective equipment is mandated and audited by the Ontario Ministry of Labour,&quot; Loeb&apos;s group said.&lt;/p&gt;
&lt;p&gt;The CDC will consider these results as an important part, but only one piece, of the evidence in ongoing revision of its guidelines for healthcare worker respiratory protection to replace the interim recommendations made in the spring, Srinivasan said.&lt;/p&gt;
&lt;p&gt;&quot;We&apos;ve learned a lot since then,&quot; he declared.&lt;/p&gt;
&lt;p&gt;The revised guidelines are expected to be released by the end of next week , according to a CDC spokesperson.&lt;/p&gt;
&lt;p&gt;The JAMA editorialists also stressed the need for multiple measures to prevent spread of influenza and other respiratory diseases.&lt;/p&gt;
&lt;p&gt;&quot;Unfortunately, this intense discussion over respiratory protection has distracted attention from the critical importance of implementing other strategies known to prevent the transmission of influenza in healthcare settings,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;&quot;Indeed, the use of personal protective equipment such as masks and respirators should be considered the &apos;last line of defense&apos; in a hierarchy of infection control measures.&quot;&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 supported by the Public Health Agency of Canada.The researchers reported no conflicts of interest.&lt;/p&gt;&lt;p&gt;The editorialists reported no conflicts of interest, though Perl reported being a member of the IOM committee that set recommendations for respiratory protection of healthcare workers against H1N1 influenza.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_1_276"
                     title="SPECIAL REPORT 2005: Who&apos;s Afraid Of Avian Flu?"
                     score="-0.005"
                     href="