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ACIP recommends meningococcal B vaccine during college outbreaks
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices unanimously recommended serogroup B meningococcal (MenB) vaccination for several groups at increased risk for serogroup B disease, including students during outbreaks at college campuses, but is not addressing broader use of these vaccines in adolescents and college students until June 2015.
At a meeting of the Advisory Committee on Immunization Practices (ACIP) on Feb. 26, the panel voted 15-0 to recommend vaccination for the following groups of people over age 10 years at increased risk of serogroup B meningococcal disease: those with persistent complement deficiencies; anatomic or functional asplenia, including people with sickle cell; microbiologists routinely exposed to Neisseria meningitidis isolates; and individuals, such as college students, at increased risk during an outbreak of serogroup B meningococcal disease.
First-year college students living in residence halls were not discussed at this meeting. The ACIP work group on meningococcal vaccines also has been reviewing the available data and evidence for broader use of MenB vaccines in adolescents and college students separately, Jessica MacNeil of the CDC’s National Center for Immunization and Respiratory Diseases said at the meeting. Recommendations for more universal use of MenB vaccination in adolescents and college students will be discussed and voted on at the next ACIP meeting in June 2015.
Two vaccines are now licensed by the Food and Drug Administration for preventing meningococcal disease caused by N. meningitidis serogroup B in people aged 10-25 years in the United States: Trumenba (Pfizer), licensed in October 2014, and Bexsero (Novartis Vaccines and Diagnostics), in January 2015. Bexsero is already licensed in more than 30 countries for people aged 2 months and older. The currently recommended meningococcal vaccines cover four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease (A, C, W, and Y): they are the meningococcal polysaccharide vaccine (Menomune) and the meningococcal conjugate vaccine (Menactra and Menveo).
Based on the available data and evidence reviewed, Ms. MacNeil said that the work group supported routine vaccination of people at increased risk of meningococcal disease, based on the risk of disease in those groups and because they are included in the current recommendation for the meningitis A, C, W, Y conjugate vaccines. In addition, “there is demonstrated immune response to MenB in the general adolescent population … and there are no theoretical safety concerns for persons over 25 years of age, from vaccination, as compared to persons 10-25 years of age.”
Ms. MacNeil referred to the serogroup B clusters and outbreaks during the past several years on U.S. college campuses, noting that, in two of the recent outbreaks, “students were estimated to be at 200- to 1,400-fold increased risk for meningococcal disease during the outbreak period.”
In the first two months of 2015, there have already been two outbreaks of serogroup B meningococcal disease at U.S. college campuses: two cases at Providence College in Rhode Island, where students are being vaccinated with Trumenba; and four cases at the University of Oregon, including one death, where a mass vaccination campaign is being planned – the first doses are scheduled to be administered on March 2.
The threshold for vaccination during serogroup B outbreaks in institutional settings has been two cases in a population of under 5,000 people and three cases in a population of 5,000 or more people. Providence has 4,500 students and the University of Oregon has 25,000 students, Ms. MacNeil said. About 98% of the target population at Providence College has received one dose so far, she added.
During the public comments segment of the meeting, consumer advocates and parents of children who had died of meningitis B questioned why the discussion for routine use in college students and adolescents was being delayed, when the two vaccines had been approved.
“We think it would benefit even more if students came to campus protected,” said one of the public speakers, Dr. Mary Ferris, director of student health at the University of California, Santa Barbara, which had an outbreak of serogroup B disease in 2013. In November 2013, four cases at UCSB were diagnosed within 10 days, including a freshman athlete who survived but had two limbs amputated, she added.
Even one case in a college setting has a major impact on the community, Dr. Ferris said.
In response to the outbreak, more than 17,000 students at UCSB received the vaccine, which was not yet approved but was made available through an FDA investigational new drug application.
ACIP is composed of medical and public health experts who develop recommendations on how to use vaccines to control diseases in the United States. One of the members said that he received research funding from MedImmune; the other members had no disclosures.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices unanimously recommended serogroup B meningococcal (MenB) vaccination for several groups at increased risk for serogroup B disease, including students during outbreaks at college campuses, but is not addressing broader use of these vaccines in adolescents and college students until June 2015.
At a meeting of the Advisory Committee on Immunization Practices (ACIP) on Feb. 26, the panel voted 15-0 to recommend vaccination for the following groups of people over age 10 years at increased risk of serogroup B meningococcal disease: those with persistent complement deficiencies; anatomic or functional asplenia, including people with sickle cell; microbiologists routinely exposed to Neisseria meningitidis isolates; and individuals, such as college students, at increased risk during an outbreak of serogroup B meningococcal disease.
First-year college students living in residence halls were not discussed at this meeting. The ACIP work group on meningococcal vaccines also has been reviewing the available data and evidence for broader use of MenB vaccines in adolescents and college students separately, Jessica MacNeil of the CDC’s National Center for Immunization and Respiratory Diseases said at the meeting. Recommendations for more universal use of MenB vaccination in adolescents and college students will be discussed and voted on at the next ACIP meeting in June 2015.
Two vaccines are now licensed by the Food and Drug Administration for preventing meningococcal disease caused by N. meningitidis serogroup B in people aged 10-25 years in the United States: Trumenba (Pfizer), licensed in October 2014, and Bexsero (Novartis Vaccines and Diagnostics), in January 2015. Bexsero is already licensed in more than 30 countries for people aged 2 months and older. The currently recommended meningococcal vaccines cover four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease (A, C, W, and Y): they are the meningococcal polysaccharide vaccine (Menomune) and the meningococcal conjugate vaccine (Menactra and Menveo).
Based on the available data and evidence reviewed, Ms. MacNeil said that the work group supported routine vaccination of people at increased risk of meningococcal disease, based on the risk of disease in those groups and because they are included in the current recommendation for the meningitis A, C, W, Y conjugate vaccines. In addition, “there is demonstrated immune response to MenB in the general adolescent population … and there are no theoretical safety concerns for persons over 25 years of age, from vaccination, as compared to persons 10-25 years of age.”
Ms. MacNeil referred to the serogroup B clusters and outbreaks during the past several years on U.S. college campuses, noting that, in two of the recent outbreaks, “students were estimated to be at 200- to 1,400-fold increased risk for meningococcal disease during the outbreak period.”
In the first two months of 2015, there have already been two outbreaks of serogroup B meningococcal disease at U.S. college campuses: two cases at Providence College in Rhode Island, where students are being vaccinated with Trumenba; and four cases at the University of Oregon, including one death, where a mass vaccination campaign is being planned – the first doses are scheduled to be administered on March 2.
The threshold for vaccination during serogroup B outbreaks in institutional settings has been two cases in a population of under 5,000 people and three cases in a population of 5,000 or more people. Providence has 4,500 students and the University of Oregon has 25,000 students, Ms. MacNeil said. About 98% of the target population at Providence College has received one dose so far, she added.
During the public comments segment of the meeting, consumer advocates and parents of children who had died of meningitis B questioned why the discussion for routine use in college students and adolescents was being delayed, when the two vaccines had been approved.
“We think it would benefit even more if students came to campus protected,” said one of the public speakers, Dr. Mary Ferris, director of student health at the University of California, Santa Barbara, which had an outbreak of serogroup B disease in 2013. In November 2013, four cases at UCSB were diagnosed within 10 days, including a freshman athlete who survived but had two limbs amputated, she added.
Even one case in a college setting has a major impact on the community, Dr. Ferris said.
In response to the outbreak, more than 17,000 students at UCSB received the vaccine, which was not yet approved but was made available through an FDA investigational new drug application.
ACIP is composed of medical and public health experts who develop recommendations on how to use vaccines to control diseases in the United States. One of the members said that he received research funding from MedImmune; the other members had no disclosures.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices unanimously recommended serogroup B meningococcal (MenB) vaccination for several groups at increased risk for serogroup B disease, including students during outbreaks at college campuses, but is not addressing broader use of these vaccines in adolescents and college students until June 2015.
At a meeting of the Advisory Committee on Immunization Practices (ACIP) on Feb. 26, the panel voted 15-0 to recommend vaccination for the following groups of people over age 10 years at increased risk of serogroup B meningococcal disease: those with persistent complement deficiencies; anatomic or functional asplenia, including people with sickle cell; microbiologists routinely exposed to Neisseria meningitidis isolates; and individuals, such as college students, at increased risk during an outbreak of serogroup B meningococcal disease.
First-year college students living in residence halls were not discussed at this meeting. The ACIP work group on meningococcal vaccines also has been reviewing the available data and evidence for broader use of MenB vaccines in adolescents and college students separately, Jessica MacNeil of the CDC’s National Center for Immunization and Respiratory Diseases said at the meeting. Recommendations for more universal use of MenB vaccination in adolescents and college students will be discussed and voted on at the next ACIP meeting in June 2015.
Two vaccines are now licensed by the Food and Drug Administration for preventing meningococcal disease caused by N. meningitidis serogroup B in people aged 10-25 years in the United States: Trumenba (Pfizer), licensed in October 2014, and Bexsero (Novartis Vaccines and Diagnostics), in January 2015. Bexsero is already licensed in more than 30 countries for people aged 2 months and older. The currently recommended meningococcal vaccines cover four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease (A, C, W, and Y): they are the meningococcal polysaccharide vaccine (Menomune) and the meningococcal conjugate vaccine (Menactra and Menveo).
Based on the available data and evidence reviewed, Ms. MacNeil said that the work group supported routine vaccination of people at increased risk of meningococcal disease, based on the risk of disease in those groups and because they are included in the current recommendation for the meningitis A, C, W, Y conjugate vaccines. In addition, “there is demonstrated immune response to MenB in the general adolescent population … and there are no theoretical safety concerns for persons over 25 years of age, from vaccination, as compared to persons 10-25 years of age.”
Ms. MacNeil referred to the serogroup B clusters and outbreaks during the past several years on U.S. college campuses, noting that, in two of the recent outbreaks, “students were estimated to be at 200- to 1,400-fold increased risk for meningococcal disease during the outbreak period.”
In the first two months of 2015, there have already been two outbreaks of serogroup B meningococcal disease at U.S. college campuses: two cases at Providence College in Rhode Island, where students are being vaccinated with Trumenba; and four cases at the University of Oregon, including one death, where a mass vaccination campaign is being planned – the first doses are scheduled to be administered on March 2.
The threshold for vaccination during serogroup B outbreaks in institutional settings has been two cases in a population of under 5,000 people and three cases in a population of 5,000 or more people. Providence has 4,500 students and the University of Oregon has 25,000 students, Ms. MacNeil said. About 98% of the target population at Providence College has received one dose so far, she added.
During the public comments segment of the meeting, consumer advocates and parents of children who had died of meningitis B questioned why the discussion for routine use in college students and adolescents was being delayed, when the two vaccines had been approved.
“We think it would benefit even more if students came to campus protected,” said one of the public speakers, Dr. Mary Ferris, director of student health at the University of California, Santa Barbara, which had an outbreak of serogroup B disease in 2013. In November 2013, four cases at UCSB were diagnosed within 10 days, including a freshman athlete who survived but had two limbs amputated, she added.
Even one case in a college setting has a major impact on the community, Dr. Ferris said.
In response to the outbreak, more than 17,000 students at UCSB received the vaccine, which was not yet approved but was made available through an FDA investigational new drug application.
ACIP is composed of medical and public health experts who develop recommendations on how to use vaccines to control diseases in the United States. One of the members said that he received research funding from MedImmune; the other members had no disclosures.
FROM AN ACIP MEETING
FDA approves antibacterial combo drug Avycaz
The Food and Drug Administration has approved the antibacterial drug ceftazidime-avibactam (Avycaz) on Feb. 25 for complicated intra-abdominal infections in combination with metronidazole, and for complicated urinary tract infections including pyelonephritis in adults.
“It is important that the use of Avycaz be reserved for situations where there are limited or no alternative antibacterial drugs for treating a patient’s infection,” Dr. Edward Cox, director of the FDA’s Office of Antimicrobial Products in the Center for Drug Evaluation and Research, said in a statement.
Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin with in vitro activity against certain gram-negative and gram-positive bacteria, and avibactam, a beta-lactamase inhibitor.
The addition of avibactam to ceftazidime protects ceftazidime from breakdown by extended spectrum beta-lactamases, Klebsiella pneumoniae carbapenemase (KPC), and AmpC-producing pathogens, according to David Nicholson, Ph.D., executive vice president of branded research and development at Actavis, which is jointly developing the drug with AstraZeneca.
“The FDA approval of Avycaz is an important step forward in enhancing our ability to respond to serious pathogens caused by difficult-to-treat gram-negative pathogens,” he said in a statement.
The recent rise in the incidence of multidrug-resistant gram-negative pathogens poses a significant threat to patients and places a tremendous strain on the U.S. health care system, Dr. Jose Vazquez, chief of infectious disease at Georgia Regents University in Augusta, Ga., commented in the same statement.
“The increasing prevalence of KPC-producing Enterobacteriaceae in particular, has become a major therapeutic challenge for physicians managing these infections. Unfortunately, there are currently a limited number of safe and effective antimicrobials to treat these serious infections,” he said.
Avycaz was granted priority review and named a Qualified Infectious Disease Product (QIDP), a designation given to antibacterial products to treat serious or life-threatening infections.
Its efficacy was supported in part by findings of the efficacy and safety of ceftazidime for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). The contribution of avibactam to Avycaz was based on data from in vitro studies and animal models of infection. Avycaz was also studied in two phase II trials, one each in cIAI and cUTI.
The most common side effects are vomiting, nausea, constipation, and anxiety. The FDA advises health care professionals to inform patients of these risks and that decreased efficacy, seizures, and other neurologic events were seen in patients with renal impairment. Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.
The recommended dosage for patients with normal renal function is 2.5 g administered every 8 hours by intravenous infusion over 2 hours in adults aged 18 years and older. For patients with changing or impaired renal function (creatinine clearance < 50 mL/min), CrCL should be monitored at least daily and the dosage adjusted accordingly.
In a phase III trial of intra-abdominal infections, clinical cure rates were lower in the subgroup of patients with CrCL of 30-50 mL/min, compared with those with CrCL greater than 50 mL/min, according to the company. The reduction in cure rates was more marked in patients treated with Avycaz plus metronidazole vs. meropenem-treated patients.
Avycaz will be available in the second quarter of 2015, according to the company. Phase III studies evaluating Avycaz for the treatment of cIAI and cUTI are ongoing and targeted for completion in late 2015.
The Food and Drug Administration has approved the antibacterial drug ceftazidime-avibactam (Avycaz) on Feb. 25 for complicated intra-abdominal infections in combination with metronidazole, and for complicated urinary tract infections including pyelonephritis in adults.
“It is important that the use of Avycaz be reserved for situations where there are limited or no alternative antibacterial drugs for treating a patient’s infection,” Dr. Edward Cox, director of the FDA’s Office of Antimicrobial Products in the Center for Drug Evaluation and Research, said in a statement.
Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin with in vitro activity against certain gram-negative and gram-positive bacteria, and avibactam, a beta-lactamase inhibitor.
The addition of avibactam to ceftazidime protects ceftazidime from breakdown by extended spectrum beta-lactamases, Klebsiella pneumoniae carbapenemase (KPC), and AmpC-producing pathogens, according to David Nicholson, Ph.D., executive vice president of branded research and development at Actavis, which is jointly developing the drug with AstraZeneca.
“The FDA approval of Avycaz is an important step forward in enhancing our ability to respond to serious pathogens caused by difficult-to-treat gram-negative pathogens,” he said in a statement.
The recent rise in the incidence of multidrug-resistant gram-negative pathogens poses a significant threat to patients and places a tremendous strain on the U.S. health care system, Dr. Jose Vazquez, chief of infectious disease at Georgia Regents University in Augusta, Ga., commented in the same statement.
“The increasing prevalence of KPC-producing Enterobacteriaceae in particular, has become a major therapeutic challenge for physicians managing these infections. Unfortunately, there are currently a limited number of safe and effective antimicrobials to treat these serious infections,” he said.
Avycaz was granted priority review and named a Qualified Infectious Disease Product (QIDP), a designation given to antibacterial products to treat serious or life-threatening infections.
Its efficacy was supported in part by findings of the efficacy and safety of ceftazidime for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). The contribution of avibactam to Avycaz was based on data from in vitro studies and animal models of infection. Avycaz was also studied in two phase II trials, one each in cIAI and cUTI.
The most common side effects are vomiting, nausea, constipation, and anxiety. The FDA advises health care professionals to inform patients of these risks and that decreased efficacy, seizures, and other neurologic events were seen in patients with renal impairment. Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.
The recommended dosage for patients with normal renal function is 2.5 g administered every 8 hours by intravenous infusion over 2 hours in adults aged 18 years and older. For patients with changing or impaired renal function (creatinine clearance < 50 mL/min), CrCL should be monitored at least daily and the dosage adjusted accordingly.
In a phase III trial of intra-abdominal infections, clinical cure rates were lower in the subgroup of patients with CrCL of 30-50 mL/min, compared with those with CrCL greater than 50 mL/min, according to the company. The reduction in cure rates was more marked in patients treated with Avycaz plus metronidazole vs. meropenem-treated patients.
Avycaz will be available in the second quarter of 2015, according to the company. Phase III studies evaluating Avycaz for the treatment of cIAI and cUTI are ongoing and targeted for completion in late 2015.
The Food and Drug Administration has approved the antibacterial drug ceftazidime-avibactam (Avycaz) on Feb. 25 for complicated intra-abdominal infections in combination with metronidazole, and for complicated urinary tract infections including pyelonephritis in adults.
“It is important that the use of Avycaz be reserved for situations where there are limited or no alternative antibacterial drugs for treating a patient’s infection,” Dr. Edward Cox, director of the FDA’s Office of Antimicrobial Products in the Center for Drug Evaluation and Research, said in a statement.
Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin with in vitro activity against certain gram-negative and gram-positive bacteria, and avibactam, a beta-lactamase inhibitor.
The addition of avibactam to ceftazidime protects ceftazidime from breakdown by extended spectrum beta-lactamases, Klebsiella pneumoniae carbapenemase (KPC), and AmpC-producing pathogens, according to David Nicholson, Ph.D., executive vice president of branded research and development at Actavis, which is jointly developing the drug with AstraZeneca.
“The FDA approval of Avycaz is an important step forward in enhancing our ability to respond to serious pathogens caused by difficult-to-treat gram-negative pathogens,” he said in a statement.
The recent rise in the incidence of multidrug-resistant gram-negative pathogens poses a significant threat to patients and places a tremendous strain on the U.S. health care system, Dr. Jose Vazquez, chief of infectious disease at Georgia Regents University in Augusta, Ga., commented in the same statement.
“The increasing prevalence of KPC-producing Enterobacteriaceae in particular, has become a major therapeutic challenge for physicians managing these infections. Unfortunately, there are currently a limited number of safe and effective antimicrobials to treat these serious infections,” he said.
Avycaz was granted priority review and named a Qualified Infectious Disease Product (QIDP), a designation given to antibacterial products to treat serious or life-threatening infections.
Its efficacy was supported in part by findings of the efficacy and safety of ceftazidime for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). The contribution of avibactam to Avycaz was based on data from in vitro studies and animal models of infection. Avycaz was also studied in two phase II trials, one each in cIAI and cUTI.
The most common side effects are vomiting, nausea, constipation, and anxiety. The FDA advises health care professionals to inform patients of these risks and that decreased efficacy, seizures, and other neurologic events were seen in patients with renal impairment. Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.
The recommended dosage for patients with normal renal function is 2.5 g administered every 8 hours by intravenous infusion over 2 hours in adults aged 18 years and older. For patients with changing or impaired renal function (creatinine clearance < 50 mL/min), CrCL should be monitored at least daily and the dosage adjusted accordingly.
In a phase III trial of intra-abdominal infections, clinical cure rates were lower in the subgroup of patients with CrCL of 30-50 mL/min, compared with those with CrCL greater than 50 mL/min, according to the company. The reduction in cure rates was more marked in patients treated with Avycaz plus metronidazole vs. meropenem-treated patients.
Avycaz will be available in the second quarter of 2015, according to the company. Phase III studies evaluating Avycaz for the treatment of cIAI and cUTI are ongoing and targeted for completion in late 2015.
C. difficile burden in U.S. documented in 2011 estimates of infections, deaths
The estimated 453,000 infections and 29,300 deaths caused by Clostridium difficile in the United States in 2011 underline the importance of appropriate use of antibiotics and rigorous infection control measures in health care settings, Dr. Michael Bell, an official at the Centers for Disease Control and Prevention, said during a CDC telebriefing.
“To reduce the majority of C. difficile infections, we will need to improve how antibiotics are being prescribed in hospitals and throughout health care,” said Dr. Bell, deputy director of the division of health care quality promotion, at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases. Early diagnosis is also critical to prevent spread of C. difficile. Many infections are community acquired, and “it is essential that patients and their clinicians be aware that they need to take any diarrhea following antibiotic use very seriously,” he added.
The briefing was held to discuss the results and implications of the study published in the New England Journal of Medicine, which was supported by the CDC and the Emerging Infections Program (EIP) Cooperative Agreement between the 10 EIP sites and the CDC. In the study of 10 geographic regions in the United States in 2011, 15,461 cases were confirmed, with the estimated incidence of the infection being 453,000 (95% confidence interval, 397,100-508,500) after predictors of incidence were adjusted for, the investigators found. The estimated number of deaths from C. difficile was 29,300 (95% CI, 16,500-42,100).
Estimates for disease incidence were higher among women, whites, and patients 65 years of age or older, wrote Dr. Fernanda Lessa of the CDC, and her associates. Future efforts should focus on antibiotic use, the proper management of which may be effective in decreasing infection rates, the authors said in the report.
“Antibiotics clearly are driving this whole epidemic,” one of the study authors, Dr. Clifford McDonald of the CDC, said during the briefing. The epidemic strain in the United States, which emerged in 2000 in Pittsburgh and Montreal, is now spread globally, and accounted for about 30% of cases in this study, he added. It is transmitted more easily than other strains and causes more severe disease.
Dr. Bell said that to reduce the rate of these infections, antibiotics should be used only when needed and for as long as necessary, “and to ensure rigorous infection control in all health care settings.” The CDC’s National Strategy to Combat Antibiotic Resistant Bacteria has the potential to reduce C. difficile infections by 50%, he added.
“There’s no room for error” when infection control is considered, he added, pointing out that hand sanitizers do not kill C. difficile spores, which spread easily and are durable, “so that any breach in correct glove use, hand hygiene, or cleaning protocol can allow the spores to spread.”
The study also estimated that more than 150,000 infections were community acquired, with no documentation of inpatient exposure in the hospital. “Nonetheless, as we showed in another recent CDC study, 80% of patients with community-associated C. difficile infections did, in fact, have contact with a health care setting like a doctor’s office or a dental clinic,” generally during the 3-month period before being diagnosed, and most of the patients had also been treated with antibiotics, Dr. Bell said.
Future efforts should focus on antibiotic use, which may be effective in decreasing infection rates, Dr. Fernanda C. Lessa and her coauthors at the Centers for Disease Control and Prevention reported in The New England Journal of Medicine.
In a study of 10 geographic regions in the United States in 2011, 15,461 cases were confirmed, with the estimated incidence of the infection being 453,000 (95% confidence interval, 397,100-508,500) after predictors of incidence were adjusted for, the investigators found. The estimated number of deaths from C. difficile was 29,300 (95% CI, 16,500-42,100). Estimates for disease incidence were higher among women, whites, and patients 65 years of age or older, wrote Dr. Lessa and associates.
National efforts to address the increase in C. difficile infections include the requirement since 2013 that hospitals participating in the Centers for Medicare & Medicaid Services’ Hospital Inpatient Quality Reporting Program data on C. difficile infections to the CDC’s National Healthcare Safety Network, which has shown at least a 10% drop since 2013, Dr Bell said. Targets for reducing C. difficile infections in the United States by 2020 are being established in the National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination.
Madhu Rajaraman contributed to this report.
The estimated 453,000 infections and 29,300 deaths caused by Clostridium difficile in the United States in 2011 underline the importance of appropriate use of antibiotics and rigorous infection control measures in health care settings, Dr. Michael Bell, an official at the Centers for Disease Control and Prevention, said during a CDC telebriefing.
“To reduce the majority of C. difficile infections, we will need to improve how antibiotics are being prescribed in hospitals and throughout health care,” said Dr. Bell, deputy director of the division of health care quality promotion, at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases. Early diagnosis is also critical to prevent spread of C. difficile. Many infections are community acquired, and “it is essential that patients and their clinicians be aware that they need to take any diarrhea following antibiotic use very seriously,” he added.
The briefing was held to discuss the results and implications of the study published in the New England Journal of Medicine, which was supported by the CDC and the Emerging Infections Program (EIP) Cooperative Agreement between the 10 EIP sites and the CDC. In the study of 10 geographic regions in the United States in 2011, 15,461 cases were confirmed, with the estimated incidence of the infection being 453,000 (95% confidence interval, 397,100-508,500) after predictors of incidence were adjusted for, the investigators found. The estimated number of deaths from C. difficile was 29,300 (95% CI, 16,500-42,100).
Estimates for disease incidence were higher among women, whites, and patients 65 years of age or older, wrote Dr. Fernanda Lessa of the CDC, and her associates. Future efforts should focus on antibiotic use, the proper management of which may be effective in decreasing infection rates, the authors said in the report.
“Antibiotics clearly are driving this whole epidemic,” one of the study authors, Dr. Clifford McDonald of the CDC, said during the briefing. The epidemic strain in the United States, which emerged in 2000 in Pittsburgh and Montreal, is now spread globally, and accounted for about 30% of cases in this study, he added. It is transmitted more easily than other strains and causes more severe disease.
Dr. Bell said that to reduce the rate of these infections, antibiotics should be used only when needed and for as long as necessary, “and to ensure rigorous infection control in all health care settings.” The CDC’s National Strategy to Combat Antibiotic Resistant Bacteria has the potential to reduce C. difficile infections by 50%, he added.
“There’s no room for error” when infection control is considered, he added, pointing out that hand sanitizers do not kill C. difficile spores, which spread easily and are durable, “so that any breach in correct glove use, hand hygiene, or cleaning protocol can allow the spores to spread.”
The study also estimated that more than 150,000 infections were community acquired, with no documentation of inpatient exposure in the hospital. “Nonetheless, as we showed in another recent CDC study, 80% of patients with community-associated C. difficile infections did, in fact, have contact with a health care setting like a doctor’s office or a dental clinic,” generally during the 3-month period before being diagnosed, and most of the patients had also been treated with antibiotics, Dr. Bell said.
Future efforts should focus on antibiotic use, which may be effective in decreasing infection rates, Dr. Fernanda C. Lessa and her coauthors at the Centers for Disease Control and Prevention reported in The New England Journal of Medicine.
In a study of 10 geographic regions in the United States in 2011, 15,461 cases were confirmed, with the estimated incidence of the infection being 453,000 (95% confidence interval, 397,100-508,500) after predictors of incidence were adjusted for, the investigators found. The estimated number of deaths from C. difficile was 29,300 (95% CI, 16,500-42,100). Estimates for disease incidence were higher among women, whites, and patients 65 years of age or older, wrote Dr. Lessa and associates.
National efforts to address the increase in C. difficile infections include the requirement since 2013 that hospitals participating in the Centers for Medicare & Medicaid Services’ Hospital Inpatient Quality Reporting Program data on C. difficile infections to the CDC’s National Healthcare Safety Network, which has shown at least a 10% drop since 2013, Dr Bell said. Targets for reducing C. difficile infections in the United States by 2020 are being established in the National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination.
Madhu Rajaraman contributed to this report.
The estimated 453,000 infections and 29,300 deaths caused by Clostridium difficile in the United States in 2011 underline the importance of appropriate use of antibiotics and rigorous infection control measures in health care settings, Dr. Michael Bell, an official at the Centers for Disease Control and Prevention, said during a CDC telebriefing.
“To reduce the majority of C. difficile infections, we will need to improve how antibiotics are being prescribed in hospitals and throughout health care,” said Dr. Bell, deputy director of the division of health care quality promotion, at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases. Early diagnosis is also critical to prevent spread of C. difficile. Many infections are community acquired, and “it is essential that patients and their clinicians be aware that they need to take any diarrhea following antibiotic use very seriously,” he added.
The briefing was held to discuss the results and implications of the study published in the New England Journal of Medicine, which was supported by the CDC and the Emerging Infections Program (EIP) Cooperative Agreement between the 10 EIP sites and the CDC. In the study of 10 geographic regions in the United States in 2011, 15,461 cases were confirmed, with the estimated incidence of the infection being 453,000 (95% confidence interval, 397,100-508,500) after predictors of incidence were adjusted for, the investigators found. The estimated number of deaths from C. difficile was 29,300 (95% CI, 16,500-42,100).
Estimates for disease incidence were higher among women, whites, and patients 65 years of age or older, wrote Dr. Fernanda Lessa of the CDC, and her associates. Future efforts should focus on antibiotic use, the proper management of which may be effective in decreasing infection rates, the authors said in the report.
“Antibiotics clearly are driving this whole epidemic,” one of the study authors, Dr. Clifford McDonald of the CDC, said during the briefing. The epidemic strain in the United States, which emerged in 2000 in Pittsburgh and Montreal, is now spread globally, and accounted for about 30% of cases in this study, he added. It is transmitted more easily than other strains and causes more severe disease.
Dr. Bell said that to reduce the rate of these infections, antibiotics should be used only when needed and for as long as necessary, “and to ensure rigorous infection control in all health care settings.” The CDC’s National Strategy to Combat Antibiotic Resistant Bacteria has the potential to reduce C. difficile infections by 50%, he added.
“There’s no room for error” when infection control is considered, he added, pointing out that hand sanitizers do not kill C. difficile spores, which spread easily and are durable, “so that any breach in correct glove use, hand hygiene, or cleaning protocol can allow the spores to spread.”
The study also estimated that more than 150,000 infections were community acquired, with no documentation of inpatient exposure in the hospital. “Nonetheless, as we showed in another recent CDC study, 80% of patients with community-associated C. difficile infections did, in fact, have contact with a health care setting like a doctor’s office or a dental clinic,” generally during the 3-month period before being diagnosed, and most of the patients had also been treated with antibiotics, Dr. Bell said.
Future efforts should focus on antibiotic use, which may be effective in decreasing infection rates, Dr. Fernanda C. Lessa and her coauthors at the Centers for Disease Control and Prevention reported in The New England Journal of Medicine.
In a study of 10 geographic regions in the United States in 2011, 15,461 cases were confirmed, with the estimated incidence of the infection being 453,000 (95% confidence interval, 397,100-508,500) after predictors of incidence were adjusted for, the investigators found. The estimated number of deaths from C. difficile was 29,300 (95% CI, 16,500-42,100). Estimates for disease incidence were higher among women, whites, and patients 65 years of age or older, wrote Dr. Lessa and associates.
National efforts to address the increase in C. difficile infections include the requirement since 2013 that hospitals participating in the Centers for Medicare & Medicaid Services’ Hospital Inpatient Quality Reporting Program data on C. difficile infections to the CDC’s National Healthcare Safety Network, which has shown at least a 10% drop since 2013, Dr Bell said. Targets for reducing C. difficile infections in the United States by 2020 are being established in the National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination.
Madhu Rajaraman contributed to this report.
FROM A CDC TELEBRIEFING
CMS extends 2014 Medicare meaningful use attestation deadline
Physicians and other eligible professionals will now have until March 20 to attest to meaningful use of electronic health records for the 2014 reporting year and avoid a Medicare penalty for 2016.
The Centers for Medicare & Medicaid Services announced it was extending the deadline from Feb. 28. Eligible providers must attest to meaningful use every year to receive bonus payments under the EHR Incentive Program. Those who fail to attest by March 20 for the 2014 reporting year will see a 2% reduction in Medicare payments in 2016.
During this extension period, providers can make a one-time switch between the Medicare and Medicaid EHR Incentive Programs.
Physicians and other eligible professionals will now have until March 20 to attest to meaningful use of electronic health records for the 2014 reporting year and avoid a Medicare penalty for 2016.
The Centers for Medicare & Medicaid Services announced it was extending the deadline from Feb. 28. Eligible providers must attest to meaningful use every year to receive bonus payments under the EHR Incentive Program. Those who fail to attest by March 20 for the 2014 reporting year will see a 2% reduction in Medicare payments in 2016.
During this extension period, providers can make a one-time switch between the Medicare and Medicaid EHR Incentive Programs.
Physicians and other eligible professionals will now have until March 20 to attest to meaningful use of electronic health records for the 2014 reporting year and avoid a Medicare penalty for 2016.
The Centers for Medicare & Medicaid Services announced it was extending the deadline from Feb. 28. Eligible providers must attest to meaningful use every year to receive bonus payments under the EHR Incentive Program. Those who fail to attest by March 20 for the 2014 reporting year will see a 2% reduction in Medicare payments in 2016.
During this extension period, providers can make a one-time switch between the Medicare and Medicaid EHR Incentive Programs.
Secretary McDonald Apologizes for False Special Forces Claim
Secretary of Veterans Affairs Robert A. McDonald spoke with reporters on February 24, 2015, concerning a brewing controversy. While being filmed by CBS News in Los Angeles last month, Secretary McDonald falsely told a homeless Special Forces veteran that he had served in Special Forces.
His motivation? “In an attempt to connect with that veteran to make him feel comfortable, I incorrectly stated that I, too, had been in Special Forces. That was wrong. I have no excuse.”
“I apologize to those who may have been offended by my misstatement,” he continued.
CBS captured last month’s exchange between Secretary McDonald and the homeless veteran on camera during the annual PIT (point-in-time) count of homeless veterans in the Skid Row section of Los Angeles. [Scroll down to the end of the article to view CBS coverage.]
Lawmakers and veterans groups have accepted Secretary McDonald's explanation, although Chairman of the House Veterans Affairs Committee Representative Jeff Miller noted his disappointment, highlighting the need for VA to "regain the trust of the veterans and taxpayers it is charged with serving."
The White House also has accepted Secretary McDonald’s apology. “We take him at his word and expect that this will not impact the important work he’s doing to promote the health and well-being of our nation’s veterans,” the White House said.
Related: Committed to Showing Results at the VA
The health and well-being of our nation’s veterans was the pinnacle subject of Secretary McDonald’s hiring in July 2014. His experience in the military and as chairman, president, and chief executive officer at Proctor & Gamble Company was called on to right the wrongs of his predecessor, Eric K. Shinseki, following substantiated claims that a mismanaged system allowed for inordinately long wait times and secret wait lists that resulted in patient deaths.
“We at VA are working to restore trust,” Secretary McDonald reiterated during his February 24 statement. “We remain very focused on continuing our progress to better serve veterans.”
Related: Carolyn Clancy on Improving Veterans’ Access to Care
Veteran access-to-care issues are a serious and ongoing problem throughout the VHA. One project now underway to redirect this status quo is the MyVA initative, a reorganization of the VISN system to a 5-region framework, by June 2015. Also through the MyVA initiative, Secretary McDonald seeks to ensure that veterans have a clear understanding of VA services, as well as to simplify and streamline the process of accessing those services.
Secretary of Veterans Affairs Robert A. McDonald spoke with reporters on February 24, 2015, concerning a brewing controversy. While being filmed by CBS News in Los Angeles last month, Secretary McDonald falsely told a homeless Special Forces veteran that he had served in Special Forces.
His motivation? “In an attempt to connect with that veteran to make him feel comfortable, I incorrectly stated that I, too, had been in Special Forces. That was wrong. I have no excuse.”
“I apologize to those who may have been offended by my misstatement,” he continued.
CBS captured last month’s exchange between Secretary McDonald and the homeless veteran on camera during the annual PIT (point-in-time) count of homeless veterans in the Skid Row section of Los Angeles. [Scroll down to the end of the article to view CBS coverage.]
Lawmakers and veterans groups have accepted Secretary McDonald's explanation, although Chairman of the House Veterans Affairs Committee Representative Jeff Miller noted his disappointment, highlighting the need for VA to "regain the trust of the veterans and taxpayers it is charged with serving."
The White House also has accepted Secretary McDonald’s apology. “We take him at his word and expect that this will not impact the important work he’s doing to promote the health and well-being of our nation’s veterans,” the White House said.
Related: Committed to Showing Results at the VA
The health and well-being of our nation’s veterans was the pinnacle subject of Secretary McDonald’s hiring in July 2014. His experience in the military and as chairman, president, and chief executive officer at Proctor & Gamble Company was called on to right the wrongs of his predecessor, Eric K. Shinseki, following substantiated claims that a mismanaged system allowed for inordinately long wait times and secret wait lists that resulted in patient deaths.
“We at VA are working to restore trust,” Secretary McDonald reiterated during his February 24 statement. “We remain very focused on continuing our progress to better serve veterans.”
Related: Carolyn Clancy on Improving Veterans’ Access to Care
Veteran access-to-care issues are a serious and ongoing problem throughout the VHA. One project now underway to redirect this status quo is the MyVA initative, a reorganization of the VISN system to a 5-region framework, by June 2015. Also through the MyVA initiative, Secretary McDonald seeks to ensure that veterans have a clear understanding of VA services, as well as to simplify and streamline the process of accessing those services.
Secretary of Veterans Affairs Robert A. McDonald spoke with reporters on February 24, 2015, concerning a brewing controversy. While being filmed by CBS News in Los Angeles last month, Secretary McDonald falsely told a homeless Special Forces veteran that he had served in Special Forces.
His motivation? “In an attempt to connect with that veteran to make him feel comfortable, I incorrectly stated that I, too, had been in Special Forces. That was wrong. I have no excuse.”
“I apologize to those who may have been offended by my misstatement,” he continued.
CBS captured last month’s exchange between Secretary McDonald and the homeless veteran on camera during the annual PIT (point-in-time) count of homeless veterans in the Skid Row section of Los Angeles. [Scroll down to the end of the article to view CBS coverage.]
Lawmakers and veterans groups have accepted Secretary McDonald's explanation, although Chairman of the House Veterans Affairs Committee Representative Jeff Miller noted his disappointment, highlighting the need for VA to "regain the trust of the veterans and taxpayers it is charged with serving."
The White House also has accepted Secretary McDonald’s apology. “We take him at his word and expect that this will not impact the important work he’s doing to promote the health and well-being of our nation’s veterans,” the White House said.
Related: Committed to Showing Results at the VA
The health and well-being of our nation’s veterans was the pinnacle subject of Secretary McDonald’s hiring in July 2014. His experience in the military and as chairman, president, and chief executive officer at Proctor & Gamble Company was called on to right the wrongs of his predecessor, Eric K. Shinseki, following substantiated claims that a mismanaged system allowed for inordinately long wait times and secret wait lists that resulted in patient deaths.
“We at VA are working to restore trust,” Secretary McDonald reiterated during his February 24 statement. “We remain very focused on continuing our progress to better serve veterans.”
Related: Carolyn Clancy on Improving Veterans’ Access to Care
Veteran access-to-care issues are a serious and ongoing problem throughout the VHA. One project now underway to redirect this status quo is the MyVA initative, a reorganization of the VISN system to a 5-region framework, by June 2015. Also through the MyVA initiative, Secretary McDonald seeks to ensure that veterans have a clear understanding of VA services, as well as to simplify and streamline the process of accessing those services.
FDA approves adhesive treatment for superficial varicose veins
The VenaSeal closure system, which uses an adhesive directly injected into the vein, has been approved as a permanent treatment for symptomatic, superficial varicose veins, the Food and Drug Administration announced on Feb. 20.
“This new system is the first to permanently treat varicose veins by sealing them with an adhesive,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the FDA’s statement. Because the system “does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising,” he added.
The VenaSeal system differs from other procedures used to treat varicose veins, which use drugs, lasers, radiofrequency, or incisions, the FDA statement points out. The complete sterile kit includes the adhesive (n-butyl-2-cyanoacrylate), which solidifies when injected directly into the target vein via a catheter, under ultrasound guidance. The additional system components include the catheter, the adhesive, a guidewire, dispenser gun, dispenser tips, and syringes.
Approval was based on data from three clinical trials sponsored by the manufacturer. In the U.S. study that compared results in 108 patients treated with the VenaSeal system and 114 patients treated with radiofrequency ablation therapy, the device was shown “to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs,” according to the FDA. In the study, adverse events associated with the VenaSeal treatment included phlebitis and paresthesias in the treated areas, which are “generally associated with treatments of this condition,” the FDA statement noted.
The agency reviewed the VenaSeal System as a class III medical device, considered the highest risk type of medical devices that are subjected to the highest level of regulatory control, and which must be approved before marketing.
VenaSeal is manufactured by Covidien, which acquired Sapheon, the company that developed VenaSeal, in 2014. The system has also been approved in Canada, Europe, and Hong Kong, according to a Covidien statement issued last year.
The VenaSeal closure system, which uses an adhesive directly injected into the vein, has been approved as a permanent treatment for symptomatic, superficial varicose veins, the Food and Drug Administration announced on Feb. 20.
“This new system is the first to permanently treat varicose veins by sealing them with an adhesive,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the FDA’s statement. Because the system “does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising,” he added.
The VenaSeal system differs from other procedures used to treat varicose veins, which use drugs, lasers, radiofrequency, or incisions, the FDA statement points out. The complete sterile kit includes the adhesive (n-butyl-2-cyanoacrylate), which solidifies when injected directly into the target vein via a catheter, under ultrasound guidance. The additional system components include the catheter, the adhesive, a guidewire, dispenser gun, dispenser tips, and syringes.
Approval was based on data from three clinical trials sponsored by the manufacturer. In the U.S. study that compared results in 108 patients treated with the VenaSeal system and 114 patients treated with radiofrequency ablation therapy, the device was shown “to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs,” according to the FDA. In the study, adverse events associated with the VenaSeal treatment included phlebitis and paresthesias in the treated areas, which are “generally associated with treatments of this condition,” the FDA statement noted.
The agency reviewed the VenaSeal System as a class III medical device, considered the highest risk type of medical devices that are subjected to the highest level of regulatory control, and which must be approved before marketing.
VenaSeal is manufactured by Covidien, which acquired Sapheon, the company that developed VenaSeal, in 2014. The system has also been approved in Canada, Europe, and Hong Kong, according to a Covidien statement issued last year.
The VenaSeal closure system, which uses an adhesive directly injected into the vein, has been approved as a permanent treatment for symptomatic, superficial varicose veins, the Food and Drug Administration announced on Feb. 20.
“This new system is the first to permanently treat varicose veins by sealing them with an adhesive,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the FDA’s statement. Because the system “does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising,” he added.
The VenaSeal system differs from other procedures used to treat varicose veins, which use drugs, lasers, radiofrequency, or incisions, the FDA statement points out. The complete sterile kit includes the adhesive (n-butyl-2-cyanoacrylate), which solidifies when injected directly into the target vein via a catheter, under ultrasound guidance. The additional system components include the catheter, the adhesive, a guidewire, dispenser gun, dispenser tips, and syringes.
Approval was based on data from three clinical trials sponsored by the manufacturer. In the U.S. study that compared results in 108 patients treated with the VenaSeal system and 114 patients treated with radiofrequency ablation therapy, the device was shown “to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs,” according to the FDA. In the study, adverse events associated with the VenaSeal treatment included phlebitis and paresthesias in the treated areas, which are “generally associated with treatments of this condition,” the FDA statement noted.
The agency reviewed the VenaSeal System as a class III medical device, considered the highest risk type of medical devices that are subjected to the highest level of regulatory control, and which must be approved before marketing.
VenaSeal is manufactured by Covidien, which acquired Sapheon, the company that developed VenaSeal, in 2014. The system has also been approved in Canada, Europe, and Hong Kong, according to a Covidien statement issued last year.
Postexposure smallpox vaccination not recommended for immunodeficient patients
Persons exposed to smallpox should be vaccinated with a replication-competent vaccine, unless they are severely immunodeficient, according to a guideline from the Centers for Disease Control and Prevention.
Severely immunodeficient persons won’t benefit from a smallpox vaccination because there will likely be a poor immune response and heightened risk of negative events. These include bone marrow transplant recipients within 4 months of transplantation, people infected with HIV with CD4 cell counts <50 cells/mm3, persons with severe combined immunodeficiency, complete DiGeorge syndrome patients, and people with other severely immunocompromised states requiring isolation.
“If antivirals are not immediately available, it is reasonable to consider the use of Imvamune in the setting of a smallpox virus exposure in persons with severe immunodeficiency,” the CDC added.
Find the full guideline in the MMWR (February 20, 2015 / 64(RR02);1-26).
Persons exposed to smallpox should be vaccinated with a replication-competent vaccine, unless they are severely immunodeficient, according to a guideline from the Centers for Disease Control and Prevention.
Severely immunodeficient persons won’t benefit from a smallpox vaccination because there will likely be a poor immune response and heightened risk of negative events. These include bone marrow transplant recipients within 4 months of transplantation, people infected with HIV with CD4 cell counts <50 cells/mm3, persons with severe combined immunodeficiency, complete DiGeorge syndrome patients, and people with other severely immunocompromised states requiring isolation.
“If antivirals are not immediately available, it is reasonable to consider the use of Imvamune in the setting of a smallpox virus exposure in persons with severe immunodeficiency,” the CDC added.
Find the full guideline in the MMWR (February 20, 2015 / 64(RR02);1-26).
Persons exposed to smallpox should be vaccinated with a replication-competent vaccine, unless they are severely immunodeficient, according to a guideline from the Centers for Disease Control and Prevention.
Severely immunodeficient persons won’t benefit from a smallpox vaccination because there will likely be a poor immune response and heightened risk of negative events. These include bone marrow transplant recipients within 4 months of transplantation, people infected with HIV with CD4 cell counts <50 cells/mm3, persons with severe combined immunodeficiency, complete DiGeorge syndrome patients, and people with other severely immunocompromised states requiring isolation.
“If antivirals are not immediately available, it is reasonable to consider the use of Imvamune in the setting of a smallpox virus exposure in persons with severe immunodeficiency,” the CDC added.
Find the full guideline in the MMWR (February 20, 2015 / 64(RR02);1-26).
Difficult-to-clean ERCP duodenoscopes linked to serious infections
The Food and Drug Administration is alerting health care professionals and the public about the association with duodenoscopes and the transmission of multidrug-resistant bacterial infections in patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP), despite proper cleaning and disinfection of the devices.
Between January 2013 and December 2014, the agency received 75 medical device adverse event reports for about 135 patients in the United States “relating to possible microbial transmission from reprocessed duodenoscopes,” according to a safety communication issued by the FDA on Feb. 19.
These reports and cases described in the medical literature have occurred even when manufacturer instructions for cleaning and sterilization are followed, which appears to be related to the design of the duodenoscope.
“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” according to the statement, which points out that it can be difficult to access some parts of the duodenoscopes when they are cleaned. Problems include the “elevator” mechanism at the tip of the duodenoscope, which should be manually brushed, but a brush may not be able to reach microscopic crevices in this mechanism and “residual body fluids and organic debris may remain in these crevices after cleaning and disinfection,” possibly exposing patients to serious infections if the fluids are contaminated with microbes.
The infections reported include carbapenem-resistant Enterobacteriaceae (CRE), according to the FDA statement, which does not mention whether any of the reports were fatal.
But on Feb. 18, UCLA Health System announced that CRE may have been transmitted to seven patients during ERCP procedures, and may have contributed to the death of two of the patients. The two devices implicated in these cases are no longer used and the medical center has started to use a decontamination process “that goes above and beyond manufacturer and national standards” for the devices, the statement said. More than 100 patients who had an ERCP between October 2014 and January 2015 at UCLA have been notified they may have been infected with CRE.
The FDA statement includes recommendations for facilities and staff that reprocess duodenoscopes, patients, and health care professionals. One recommendation is to take a duodenoscope out of service if there is any suspicion it may be linked to a multidrug-resistant infection in a patient who has undergone ERCP.
The FDA is asking health care professionals to report any infections possibly related to ERCP duodenoscopes to the manufacturers and the FDA’s MedWatch program.
The Food and Drug Administration is alerting health care professionals and the public about the association with duodenoscopes and the transmission of multidrug-resistant bacterial infections in patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP), despite proper cleaning and disinfection of the devices.
Between January 2013 and December 2014, the agency received 75 medical device adverse event reports for about 135 patients in the United States “relating to possible microbial transmission from reprocessed duodenoscopes,” according to a safety communication issued by the FDA on Feb. 19.
These reports and cases described in the medical literature have occurred even when manufacturer instructions for cleaning and sterilization are followed, which appears to be related to the design of the duodenoscope.
“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” according to the statement, which points out that it can be difficult to access some parts of the duodenoscopes when they are cleaned. Problems include the “elevator” mechanism at the tip of the duodenoscope, which should be manually brushed, but a brush may not be able to reach microscopic crevices in this mechanism and “residual body fluids and organic debris may remain in these crevices after cleaning and disinfection,” possibly exposing patients to serious infections if the fluids are contaminated with microbes.
The infections reported include carbapenem-resistant Enterobacteriaceae (CRE), according to the FDA statement, which does not mention whether any of the reports were fatal.
But on Feb. 18, UCLA Health System announced that CRE may have been transmitted to seven patients during ERCP procedures, and may have contributed to the death of two of the patients. The two devices implicated in these cases are no longer used and the medical center has started to use a decontamination process “that goes above and beyond manufacturer and national standards” for the devices, the statement said. More than 100 patients who had an ERCP between October 2014 and January 2015 at UCLA have been notified they may have been infected with CRE.
The FDA statement includes recommendations for facilities and staff that reprocess duodenoscopes, patients, and health care professionals. One recommendation is to take a duodenoscope out of service if there is any suspicion it may be linked to a multidrug-resistant infection in a patient who has undergone ERCP.
The FDA is asking health care professionals to report any infections possibly related to ERCP duodenoscopes to the manufacturers and the FDA’s MedWatch program.
The Food and Drug Administration is alerting health care professionals and the public about the association with duodenoscopes and the transmission of multidrug-resistant bacterial infections in patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP), despite proper cleaning and disinfection of the devices.
Between January 2013 and December 2014, the agency received 75 medical device adverse event reports for about 135 patients in the United States “relating to possible microbial transmission from reprocessed duodenoscopes,” according to a safety communication issued by the FDA on Feb. 19.
These reports and cases described in the medical literature have occurred even when manufacturer instructions for cleaning and sterilization are followed, which appears to be related to the design of the duodenoscope.
“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” according to the statement, which points out that it can be difficult to access some parts of the duodenoscopes when they are cleaned. Problems include the “elevator” mechanism at the tip of the duodenoscope, which should be manually brushed, but a brush may not be able to reach microscopic crevices in this mechanism and “residual body fluids and organic debris may remain in these crevices after cleaning and disinfection,” possibly exposing patients to serious infections if the fluids are contaminated with microbes.
The infections reported include carbapenem-resistant Enterobacteriaceae (CRE), according to the FDA statement, which does not mention whether any of the reports were fatal.
But on Feb. 18, UCLA Health System announced that CRE may have been transmitted to seven patients during ERCP procedures, and may have contributed to the death of two of the patients. The two devices implicated in these cases are no longer used and the medical center has started to use a decontamination process “that goes above and beyond manufacturer and national standards” for the devices, the statement said. More than 100 patients who had an ERCP between October 2014 and January 2015 at UCLA have been notified they may have been infected with CRE.
The FDA statement includes recommendations for facilities and staff that reprocess duodenoscopes, patients, and health care professionals. One recommendation is to take a duodenoscope out of service if there is any suspicion it may be linked to a multidrug-resistant infection in a patient who has undergone ERCP.
The FDA is asking health care professionals to report any infections possibly related to ERCP duodenoscopes to the manufacturers and the FDA’s MedWatch program.
Clay Hunt Suicide Prevention Bill Signed by President Obama
President Obama signed into law the long delayed Clay Hunt Suicide Prevention for American Veterans Act. The bill had been passed unanimously in Congress, but only after Tom Coburn, former U.S. senator from Oklahoma, who had single-handedly prevented it from going forward—claiming the $22 million price tag was not offset by cuts in other programs—retired. According to the White House, the act will require annual third-party evaluations of VA’s mental health care and suicide prevention programs, create a website for veterans about mental health services available from the VA, and require the VA to collaborate on suicide prevention with not-for-profit mental health organizations.
Related: U.S. Army Suicides Decline
The act, named for a marine who in 2011 at age 28 committed suicide, provides, among other services, better access to mental health resources for veterans.
Suicide among active-duty military members was down in 2013, but only slightly compared with 2012, according to the DoD’s annual Suicide Event Report (DoDSER). As of June 30, 2014, 259 active-component service members and 220 U.S. Reserve and National Guard service members had committed suicide. That’s 18.7% per 100,000 for active-duty, 23.4% for Reserve, and 28.9% for National Guard service members.
Related: Jonathan Woodson on Military Health Readiness
The service members who committed suicide were most likely to be male, white, aged < 30 years, junior enlisted, and educated through high school. Firearms and hanging were the most common methods of suicide, although drugs (particularly antidepressants) and alcohol were most often implicated in suicide attempts. Mood and adjustment disorders were the most common behavioral health diagnoses among people who committed suicide. Mood and anxiety disorders were most common among those who attempted suicide. A failed relationship, primarily intimate, was the most common stressor. Most service members who committed suicide had been deployed, as had about 50% of those who attempted suicide.
Related: Using Dashboard Technology to Monitor Overdose Risk
“One suicide among our ranks is too many,” said Jackie Garrick, director of the Defense Suicide Prevention Office. “Suicide is complex, and the better we understand these events in our community, the better we will be able to assist service members in crisis. We consider any measure that saves a life as one worth taking.”
Since 2008, the DoDSER program has standardized suicide surveillance across the services. Active suicide prevention efforts include suicide awareness training for service members and their families. A list of warning signs, such as frequent, dramatic mood changes and feelings of failure, is available at http://www.suicideoutreach.org/AboutSuicide/warning_signs.htm.
President Obama signed into law the long delayed Clay Hunt Suicide Prevention for American Veterans Act. The bill had been passed unanimously in Congress, but only after Tom Coburn, former U.S. senator from Oklahoma, who had single-handedly prevented it from going forward—claiming the $22 million price tag was not offset by cuts in other programs—retired. According to the White House, the act will require annual third-party evaluations of VA’s mental health care and suicide prevention programs, create a website for veterans about mental health services available from the VA, and require the VA to collaborate on suicide prevention with not-for-profit mental health organizations.
Related: U.S. Army Suicides Decline
The act, named for a marine who in 2011 at age 28 committed suicide, provides, among other services, better access to mental health resources for veterans.
Suicide among active-duty military members was down in 2013, but only slightly compared with 2012, according to the DoD’s annual Suicide Event Report (DoDSER). As of June 30, 2014, 259 active-component service members and 220 U.S. Reserve and National Guard service members had committed suicide. That’s 18.7% per 100,000 for active-duty, 23.4% for Reserve, and 28.9% for National Guard service members.
Related: Jonathan Woodson on Military Health Readiness
The service members who committed suicide were most likely to be male, white, aged < 30 years, junior enlisted, and educated through high school. Firearms and hanging were the most common methods of suicide, although drugs (particularly antidepressants) and alcohol were most often implicated in suicide attempts. Mood and adjustment disorders were the most common behavioral health diagnoses among people who committed suicide. Mood and anxiety disorders were most common among those who attempted suicide. A failed relationship, primarily intimate, was the most common stressor. Most service members who committed suicide had been deployed, as had about 50% of those who attempted suicide.
Related: Using Dashboard Technology to Monitor Overdose Risk
“One suicide among our ranks is too many,” said Jackie Garrick, director of the Defense Suicide Prevention Office. “Suicide is complex, and the better we understand these events in our community, the better we will be able to assist service members in crisis. We consider any measure that saves a life as one worth taking.”
Since 2008, the DoDSER program has standardized suicide surveillance across the services. Active suicide prevention efforts include suicide awareness training for service members and their families. A list of warning signs, such as frequent, dramatic mood changes and feelings of failure, is available at http://www.suicideoutreach.org/AboutSuicide/warning_signs.htm.
President Obama signed into law the long delayed Clay Hunt Suicide Prevention for American Veterans Act. The bill had been passed unanimously in Congress, but only after Tom Coburn, former U.S. senator from Oklahoma, who had single-handedly prevented it from going forward—claiming the $22 million price tag was not offset by cuts in other programs—retired. According to the White House, the act will require annual third-party evaluations of VA’s mental health care and suicide prevention programs, create a website for veterans about mental health services available from the VA, and require the VA to collaborate on suicide prevention with not-for-profit mental health organizations.
Related: U.S. Army Suicides Decline
The act, named for a marine who in 2011 at age 28 committed suicide, provides, among other services, better access to mental health resources for veterans.
Suicide among active-duty military members was down in 2013, but only slightly compared with 2012, according to the DoD’s annual Suicide Event Report (DoDSER). As of June 30, 2014, 259 active-component service members and 220 U.S. Reserve and National Guard service members had committed suicide. That’s 18.7% per 100,000 for active-duty, 23.4% for Reserve, and 28.9% for National Guard service members.
Related: Jonathan Woodson on Military Health Readiness
The service members who committed suicide were most likely to be male, white, aged < 30 years, junior enlisted, and educated through high school. Firearms and hanging were the most common methods of suicide, although drugs (particularly antidepressants) and alcohol were most often implicated in suicide attempts. Mood and adjustment disorders were the most common behavioral health diagnoses among people who committed suicide. Mood and anxiety disorders were most common among those who attempted suicide. A failed relationship, primarily intimate, was the most common stressor. Most service members who committed suicide had been deployed, as had about 50% of those who attempted suicide.
Related: Using Dashboard Technology to Monitor Overdose Risk
“One suicide among our ranks is too many,” said Jackie Garrick, director of the Defense Suicide Prevention Office. “Suicide is complex, and the better we understand these events in our community, the better we will be able to assist service members in crisis. We consider any measure that saves a life as one worth taking.”
Since 2008, the DoDSER program has standardized suicide surveillance across the services. Active suicide prevention efforts include suicide awareness training for service members and their families. A list of warning signs, such as frequent, dramatic mood changes and feelings of failure, is available at http://www.suicideoutreach.org/AboutSuicide/warning_signs.htm.
Decrease of Sexual Violence on Military Campuses Is Not Enough
Sexual assault on military campuses reached a 10-year low during the 2013-2014 academic year, according to the DoD’s Annual Report on Sexual Harassment and Violence at the Military Service Academies released on February 11, 2015. However, sexual violence remains an issue on military campuses, particularly for female cadets and midshipmen.
The report, which focuses on the U.S. Military Academy at West Point, New York; the U.S. Naval Academy in Annapolis, Maryland; and the U.S. Air Force Academy in Colorado, details that although unwanted sexual contact (USC) incident numbers in 2013-2014 were the lowest reported since the survey was first conducted in 2005, 8.2% of women enrolled at these academies and 1.1% of enrolled men experienced USC in 2013-2014. These percentages are down from the 2011-2012 program year when 12.4% of enrolled women and 2% of enrolled men reported USC.
Related: Sexual Trauma in the Military
According to a DoD press release, although incident rates of USC have declined among cadets, former Secretary of Defense Chuck Hagel stated that the mission is “far from complete.”
Although USC is decreasing, perceived sexual harassment (PSH) rates have increased. Fifty-five percent of women and 12% of men from the U.S. Marine Academy reported incidents of some PSH in 2014, up from 49% and 8%, respectively. However, 82% of women and 77% of men surveyed did not file official reports of the incidents due to perceived lack of significance.
Related: Recovering From Military Sexual Trauma
The DoD report outlines 5 initiatives to further reduce USC and PSH:
- Establishing a forum for strategic dialogue between academies;
- Developing targeted interventions for sophomores who experience assaults at a higher rate than do other class years;
- Developing an educational program available anonymously to those coping with a history of sexual victimization;
- Improving sexual assault reporting; and
- Better addressing social and professional retaliation associated with sexual assault reporting, especially when such behavior occurs via social media.
“These survey results suggest that there were 200 fewer sexual assault victims in 2014 than in 2012,” said Major General Jeffrey J. Snow, the director of the DoD Sexual Assault Prevention and Response Program, in the DoD press release. “Although these rates are at the lowest they’ve been in the decade since the department began conducting the survey, we can and should do more. Every cadet and midshipman deserves a safe place to learn—free from sexual harassment and sexual assault.”
Sexual assault on military campuses reached a 10-year low during the 2013-2014 academic year, according to the DoD’s Annual Report on Sexual Harassment and Violence at the Military Service Academies released on February 11, 2015. However, sexual violence remains an issue on military campuses, particularly for female cadets and midshipmen.
The report, which focuses on the U.S. Military Academy at West Point, New York; the U.S. Naval Academy in Annapolis, Maryland; and the U.S. Air Force Academy in Colorado, details that although unwanted sexual contact (USC) incident numbers in 2013-2014 were the lowest reported since the survey was first conducted in 2005, 8.2% of women enrolled at these academies and 1.1% of enrolled men experienced USC in 2013-2014. These percentages are down from the 2011-2012 program year when 12.4% of enrolled women and 2% of enrolled men reported USC.
Related: Sexual Trauma in the Military
According to a DoD press release, although incident rates of USC have declined among cadets, former Secretary of Defense Chuck Hagel stated that the mission is “far from complete.”
Although USC is decreasing, perceived sexual harassment (PSH) rates have increased. Fifty-five percent of women and 12% of men from the U.S. Marine Academy reported incidents of some PSH in 2014, up from 49% and 8%, respectively. However, 82% of women and 77% of men surveyed did not file official reports of the incidents due to perceived lack of significance.
Related: Recovering From Military Sexual Trauma
The DoD report outlines 5 initiatives to further reduce USC and PSH:
- Establishing a forum for strategic dialogue between academies;
- Developing targeted interventions for sophomores who experience assaults at a higher rate than do other class years;
- Developing an educational program available anonymously to those coping with a history of sexual victimization;
- Improving sexual assault reporting; and
- Better addressing social and professional retaliation associated with sexual assault reporting, especially when such behavior occurs via social media.
“These survey results suggest that there were 200 fewer sexual assault victims in 2014 than in 2012,” said Major General Jeffrey J. Snow, the director of the DoD Sexual Assault Prevention and Response Program, in the DoD press release. “Although these rates are at the lowest they’ve been in the decade since the department began conducting the survey, we can and should do more. Every cadet and midshipman deserves a safe place to learn—free from sexual harassment and sexual assault.”
Sexual assault on military campuses reached a 10-year low during the 2013-2014 academic year, according to the DoD’s Annual Report on Sexual Harassment and Violence at the Military Service Academies released on February 11, 2015. However, sexual violence remains an issue on military campuses, particularly for female cadets and midshipmen.
The report, which focuses on the U.S. Military Academy at West Point, New York; the U.S. Naval Academy in Annapolis, Maryland; and the U.S. Air Force Academy in Colorado, details that although unwanted sexual contact (USC) incident numbers in 2013-2014 were the lowest reported since the survey was first conducted in 2005, 8.2% of women enrolled at these academies and 1.1% of enrolled men experienced USC in 2013-2014. These percentages are down from the 2011-2012 program year when 12.4% of enrolled women and 2% of enrolled men reported USC.
Related: Sexual Trauma in the Military
According to a DoD press release, although incident rates of USC have declined among cadets, former Secretary of Defense Chuck Hagel stated that the mission is “far from complete.”
Although USC is decreasing, perceived sexual harassment (PSH) rates have increased. Fifty-five percent of women and 12% of men from the U.S. Marine Academy reported incidents of some PSH in 2014, up from 49% and 8%, respectively. However, 82% of women and 77% of men surveyed did not file official reports of the incidents due to perceived lack of significance.
Related: Recovering From Military Sexual Trauma
The DoD report outlines 5 initiatives to further reduce USC and PSH:
- Establishing a forum for strategic dialogue between academies;
- Developing targeted interventions for sophomores who experience assaults at a higher rate than do other class years;
- Developing an educational program available anonymously to those coping with a history of sexual victimization;
- Improving sexual assault reporting; and
- Better addressing social and professional retaliation associated with sexual assault reporting, especially when such behavior occurs via social media.
“These survey results suggest that there were 200 fewer sexual assault victims in 2014 than in 2012,” said Major General Jeffrey J. Snow, the director of the DoD Sexual Assault Prevention and Response Program, in the DoD press release. “Although these rates are at the lowest they’ve been in the decade since the department began conducting the survey, we can and should do more. Every cadet and midshipman deserves a safe place to learn—free from sexual harassment and sexual assault.”