Archive for November, 2010

Infant Mortality Rates* for Single Births, by Age Group of Mother — United States, 2006

Link: CDC-MMWR

 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5946a6.htm?s_cid=mm5946a6_e

QuickStats: Infant Mortality Rates* for Single Births, by

Age Group of Mother — United States, 2006

 

Weekly

November 26, 2010 / 59(46);1524

In 2006, infant mortality rates were highest for mothers in the youngest and oldest age groups. The infant mortality rate for single births to mothers aged <15 years was 16.7 infant deaths per 1,000 live births, approximately three times the rates for mothers aged 25–29 years (5.1), 30–34 years (4.5), and 35–39 years (5.2), the age groups at lowest risk. The infant mortality rate for single births to mothers aged ≥45 years was 11.46, approximately twice the rate for mothers in the three age groups at lowest risk. 

Sources: National Center for Health Statistics. Linked birth/infant death data set, 2006. Available at http://www.cdc.gov/nchs/linked.htm

Mathews TJ, MacDorman MF. Infant mortality statistics from the 2006 period linked birth/infant death data set. Natl Vital Stat Rep 2010;58(17). Available at http://www.cdc.gov/nchs/data/nvsr/nvsr58/nvsr58_17.pdf Adobe PDF file

Alternate Text: The figure above shows infant mortality rates for single births, by age group of mother in the United States in 2006. In 2006, infant mortality rates were highest for mothers in the youngest and oldest age groups. The infant mortality rate for single births to mothers aged <15 years was 16.7 infant deaths per 1,000 live births, approximately three times the rates for mothers aged 25-29 years (5.1), 30-34 years (4.5), and 35-39 years (5.2), the age groups at lowest risk. The infant mortality rate for single births to mothers aged ≥45 years was 11.46, approximately twice the rates for mothers in the three age groups at lowest risk.

Ultrasound-guided suprascapular nerve block

Ultrasound-guided suprascapular nerve block for shoulder reduction and adhesive
capsulitis in the ED
Published online: 26 November 2010
Andrew A. Herring, Micheal B. Stone, Arun Nagdev
DOI: 10.1016/j.ajem.2010.08.024
American Journal of Emergency Medicine, The, http://www.ajemjournal.com/article/S0735-6757%2810%2900421-3/abstract

Case Report: Carotid Artery Dissection

http://www.jem-journal.com/article/S0736-4679(08)00022-X/abstract

Carotid Artery Dissection Revealed by an Oculosympathetic Spasm
Christophe Orssaud, Olivier Roche, Gilles Renard, Jean Louis Dufier
The Journal of Emergency Medicine – November 2010 (Vol. 39, Issue 5, Pages 586-588, DOI: 10.1016/j.jemermed.2007.10.067)

Spontaneous Superior Mesenteric Artery (SMA) Dissection: An Unusual Cause of Abdominal Pain

http://www.jem-journal.com/article/S0736-4679(07)00609-9/abstract

Spontaneous Superior Mesenteric Artery (SMA) Dissection: An Unusual Cause of Abdominal Pain
Nicole J. Watring, Corbett M. Smith, Gordon K. Stokes, Francis L. Counselman
The Journal of Emergency Medicine – November 2010 (Vol. 39, Issue 5, Pages 576-578, DOI: 10.1016/j.jemermed.2007.05.054)

Electrical Injuries & Necrotizing Fasciitis

Electrical Injuries: Medical and Bioengineering Aspects
Published online: 22 November 2010
Edward J. Otten
DOI: 10.1016/j.jemermed.2010.05.057
Journal of Emergency Medicine, The, http://www.jem-journal.com/article/S0736-4679%2810%2900465-8/abstract

Necrotizing Fasciitis in the Setting of Marine Injury
Published online: 22 November 2010
John E. Jesus, Holly Schrupp Berg, Carrie Tibbles, Richard Wolfe
DOI: 10.1016/j.jemermed.2010.07.023
Journal of Emergency Medicine, The, http://www.jem-journal.com/article/S0736-4679%2810%2900799-7/abstract

Ambulance service loses patient lawsuit

http://www.ems1.com/patient-handling/articles/913242-Iowa-jury-awards-546K-in-ambulance-transport-death/

 Iowa jury awards $546K in ambulance transport death

Midwest Ambulance was judged to be 10 percent at fault and was ordered to pay $54,639

By Clark Kauffman
The Des Moines Register

DES MOINES, Iowa — A Polk County jury has ordered the owners of a Grinnell nursing home to pay almost half a million dollars to the estate of a man who died after an accident at the facility.

The jury verdict is unusual in that lawsuits against nursing homes are rare, partly because the elderly victims of abuse or neglect have little life expectancy and no earnings potential. That dramatically reduces any potential jury award, even in cases of obvious neglect.

The accident at Grinnell’s Friendship Manor Care Center occurred in June 2009. Wilbur Jackson, 89, a retired farmer, had been at the facility for just 17 days. It was expected to be a short-term stay, with Jackson receiving rehabilitation to help with a surgically repaired hip.

Choppers

http://www.ems1.com/air-medical-transport/articles/913210-Ohio-critics-Competition-between-medical-helicopters-puts-patients-at-risk/

 

Ohio critics: Competition between medical helicopters puts patients at risk

Seven medical helicopter companies now serve the counties in this region of Ohio, Kentucky and Indiana

 

CINCINNATI — “The skies above the Tri-State are getting crowded these days. While the number of flights into the local Cincinnati Northern Kentucky International Airport have dropped precipitously, the number of medical helicopters circling the skies has grown exponentially.

No less than seven medical helicopter companies and hospitals now serve the counties in this region of Ohio, Kentucky and Indiana. Critics said competition has led to unnecessary flights at a great cost to patients and their insurance companies……”

University of Utah AirMed

Date: 11/22/2010 1315 MTN

Program: University of Utah AirMed
    50 N. Medical Dr.
    Salt Lake City, UT 84132

Type: Bell 407
Tail #: N408UH
Operator/Vendor: Air Methods

Weather: Clear. Not a factor

Team: Pilot, Flight Nurse, Flight Paramedic. No injuries reported. No patient.

Description:
    Upon landing on a freeway while responding to an MVA with a prolonged
    extrication, the pilot decided to reposition the aircraft due to the
    slope of the road surface. Upon lifting off the tail rotor struck a
    reflector post along side of the road. The pilot immediately set the
    aircraft back down on the road. The flight center immediately
    initiated the PAIP.

Additional Info:
    The flight crew was later evaluated at a local emergency room as a
    precaution. The aircraft’s tail rotor and tailboom sustained a
    significant amount of damage. It was transported by ground to the
    maintenance hanger for further inspection and repairs.

Source: Rob Stantus, Program Manager

=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=
The CONCERN network shares verified information to alert medical transport
programs when an accident / incident has occurred. Please share the above
information with your program staff. If you have further questions, please
contact the CONCERN Coordinator, David Kearns at 800 525 3712 or email:
coordinator@concern-network.org.

Copyright 2007 ASTNA

ASA + Plavix = Danger?

Archives of Internal Medicine
Source reference:
Shehab N, et al “National estimates of emergency department visits for hemorrhage-related adverse events from clopidogrel plus aspirin and from warfarin” Arch Intern Med 2010; 170: 1926-1933.

Healthcare workers suspended for refusing flu shots

http://www.phillyburbs.com/news/news_details/article/28/2010/november/19/workers-suspended-for-refusing-flu-shots.html

Workers suspended for refusing flu shots

By: JO CIAVAGLIA
The Intelligencer

“The Abington Health System this week suspended without pay more than four dozen employees for failing to get a seasonal flu shot.

The suspended employees have two weeks to be vaccinated or they’ll lose their jobs under the vaccine requirement…..”

CDC: Healthcare Providers Catching Neisseria meningitidis

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5945a2.htm?s_cid=mm5945a2_e

Occupational Transmission of Neisseria meningitidis — California, 2009

MMWR WeeklyNovember 19, 2010 / 59(45);1480-1483

Neisseria meningitidis is a leading cause of bacterial meningitis and sepsis (1). The case-fatality rate for meningococcal disease is 10%–14%; survivors can experience brain damage, hearing loss, limb loss, and learning disabilities (1). On December 11, 2009, the California Department of Public Health (CDPH) initiated an investigation of two secondary cases of meningococcal disease in a police officer and a respiratory therapist following occupational contact with an unconscious adult. This report describes the events surrounding occupational transmission of N. meningitidis and recommends measures to control and prevent secondary transmission of N. meningitidis. Breaches in infection control, notification delays, and lack of worker exposure assessment and postexposure chemoprophylaxis (PEP) likely contributed to secondary cases. Employers should provide adequate infection-control training to staff members, PEP to exposed workers, and report notifiable diseases promptly.

On December 3, 2009, the index patient, a man aged 36 years, was found unconscious at home by four police officers who had been asked by the patient’s family to check on his welfare. The patient was supine on his bed, and his airway was partially obstructed by vomitus. Vomitus and feces were on the patient’s body and clothing. While positioned near the patient’s head, one of the police officers (PO1) turned the patient to the patient’s side and adjusted the patient’s head to aid breathing. Immediately afterward, PO1 left the patient’s room, reentering only to check on the patient from a distance. After firefighters and paramedics arrived, PO1 left the scene. Firefighters measured the patient’s blood pressure and heart rate, and paramedics placed an intravenous line, performed airway suctioning, placed an oropharyngeal airway, administered oxygen, and transported the patient by ambulance to hospital A at approximately 7:00 p.m. on December 3.

In the emergency department (ED) of hospital A, the patient’s airway was suctioned, and an endotracheal tube was placed. Blood was drawn for culture in the ED and the patient was treated with ceftriaxone. The patient was transferred to the intensive-care unit (ICU), and the treating provider considered meningococcal disease, 2009 pandemic influenza A (H1N1), and community-acquired pneumonia as possible causes of his illness. In the ICU, cerebrospinal fluid (CSF) was collected for gram stain and culture and the patient was treated with piperacillin and tazobactam, levofloxacin, ceftriaxone, and vancomycin.

On December 4, gram-negative diplococci were identified in the patient’s CSF at 9:30 a.m. and in his blood at 3:30 p.m. On December 6, N. meningitidis was isolated from blood and on December 7, N. meningitidis also was isolated from CSF. On December 7, hospital A reported this case of laboratory-confirmed meningococcal disease (2) to its local health authority, 3 days after a presumptive diagnosis of meningococcal meningitis was made and 1 day after the diagnosis was confirmed by blood culture. The index patient was hospitalized for 20 days and then discharged to a rehabilitation facility on December 23.

On December 5, PO1, a man aged 30 years, experienced onset of sore throat and nausea that progressed to muscle pain with fever and vomiting. On December 9, he was examined by his primary-care physician. While at the physician’s office, PO1 received a phone call from a colleague who informed him of the index patient’s diagnosis of meningococcal disease. The primary-care physician advised PO1 to go directly to the ED, and he was admitted to hospital B the same day. PO1 had blood and CSF collected for gram stain and culture and was treated empirically with ceftriaxone and vancomycin. On December 10, gram-negative diplococci were detected in blood from PO1, and hospital B reported the case of meningococcal disease to its local health authority and the local health authority of PO1’s employer. The next day, blood and CSF from PO1 were culture positive for N. meningitidis. PO1 was hospitalized for 5 days, and then discharged to his home on December 14.

On December 8, a respiratory therapist (RT1), a man aged 47 years who had been present during airway suctioning and assisted with endotracheal tube placement in the ED at hospital A, began experiencing weakness, chills, and fatigue. On December 10, RT1 was transported by ambulance from his home to hospital C. RT1 was empirically treated with ceftriaxone, vancomycin, and meropenem and had blood and CSF collected for gram stain and culture in the ED. On December 11, gram-negative diplococci were detected in blood and CSF from RT1. The next day, blood and CSF from RT1 were culture positive for N. meningitidis, and hospital C notified its local health authority. RT1 was hospitalized for 11 days and then discharged to his home on December 21.

On December 11, CDPH was notified of the three cases by the local health authority to which hospital B (and later hospital C) reported, and CDPH initiated an investigation. Because CDPH determined that contact tracing and postexposure follow-up of workers already had been initiated by the local health authorities and all employers, the objectives of the ensuing investigation were limited to characterizing the occupational exposure, identifying lapses in infection control, and confirming that appropriate employee health follow-up was conducted. CDPH also made recommendations on prevention and control measures. CDPH interviewed hospital A infection-control and employee health personnel and workers involved in the patient’s care before his transfer to the ICU, including PO1 and RT1. Employers provided CDPH with a list of workers who participated in the emergency response. Workers were identified from employer logs and from documentation submitted by the ambulance service that describes the patient’s prehospital care. Employers’ records of their workers’ postexposure assessment (n = 22), local health authority records, and the medical records of the patients were reviewed. Potentially exposed workers were defined as those persons reported being ≤3 feet from the patient while providing care, based on CDC guidelines (3). Additional information on personal protective equipment (PPE) use was collected during interviews and record reviews. N. meningitidis isolates from patients were typed by using multilocus sequence typing at CDPH and submitted to CDC for pulsed-field gel electrophoresis (4,5).

A total of 23 workers, including four police officers, three firefighters, two paramedics, and 14 health-care workers, were involved in the index patient’s care. Among the 23 workers, 10 were reported to have been ≤3 feet from the patient (Table) while providing care. Among these, PO1 wore only gloves, two firefighters and two paramedics donned N95 respirators, and one of five hospital health-care workers wore a surgical mask. Lack of PPE availability in the field and lack of knowledge regarding where respirators and surgical masks were located in the ED were cited as two reasons why appropriate PPE was not worn by health-care workers.

In total, 16 workers were offered PEP by their employers 4–8 days postexposure. For the seven workers not offered PEP, two were already taking antibiotics for other medical reasons, two had no patient exposure, one was seen by his private physician and was not offered PEP, and two (PO1 and RT1) were not offered PEP by their employers.

The index patient and both secondary patients had culture-confirmed N. meningitidis serogroup C, ST-11 clonal complex; isolates were indistinguishable by pulsed-field gel electrophoresis. Neither secondary patient used N95 respirators or surgical masks; both did use gloves. PO1 reported no direct contact with respiratory secretions. However, PO1 reported that he heard hacking or gurgling sounds when he turned the index patient, but he could not remember feeling droplets on his skin or face. RT1 assisted with intubation and airway suctioning of the index patient. In both cases, unprotected exposure to respiratory aerosols or secretions might have resulted in transmission of N. meningitidis.

Editorial Note

Occupationally acquired meningococcal disease outside of the laboratory is rarely reported (6–8), perhaps in part because of rapid use of PEP. Transmission of N. meningitidis to health-care personnel has occurred after unprotected exposure to infected patients during endotracheal intubation, airway suctioning, and oxygen administration (6–8), but more than one occupationally acquired infection from the same index patient has not been reported. Findings from this investigation indicate that breaches in infection control and delays in notification to the local health authority, worker exposure assessment, and PEP administration likely contributed to secondary cases of meningococcal disease.

To decrease the risk for infectious disease transmission to health-care personnel, the Healthcare Infection Control Practices Advisory Committee recommends use of empiric infection-control precautions based on the patient’s apparent clinical syndrome when the diagnosis is unknown and recommends use of droplet precautions (surgical masks) for contact with patients with suspected or confirmed meningococcal disease (3). The California Division of Occupational Safety and Health aerosol-transmissible diseases (Cal/OSHA ATD) standard* requires droplet precautions for contact with patients with suspected or confirmed meningococcal disease and until November 2010 required N95 respirators for contact with suspected or confirmed 2009 pandemic influenza A (H1N1) patients. Given that the index patient’s differential diagnosis included H1N1 infection, N95 respirators should have been used; however, among the 10 workers who had been ≤3 feet to the index patient, only four used a respirator. No health-care workers at hospital A wore respirators, and only one wore a surgical mask.

Meningococcal disease is a nationally notifiable disease (2). California requires health-care providers to immediately report by telephone suspected cases of meningococcal disease to the local health authority. Hospitals A and C were late in reporting suspected cases to their respective local health authorities. Additionally, under the Cal/OSHA ATD standard and the federal reauthorization of the Ryan White Act,§ hospital A was required to notify other employers of potentially exposed nonhospital employees, such as paramedics, fire fighters, and police. Had hospital A adhered to these reporting and notification requirements, postexposure follow-up of nonhospital employees might have been more timely. Hospital A also did not conduct an exposure assessment of its own employees until 8 days postexposure, after notification of RT1’s hospitalization. PEP should be initiated as soon as possible, ideally <24 hours after index patient identification (1). However, all 16 workers were offered prophylaxis ≥4 days postexposure and ≥3 days after the index patient was suspected to have meningococcal disease. Neither secondary patient was offered PEP.

CDC’s Advisory Committee on Immunization Practices (ACIP) recommends PEP for close contacts of patients with meningococcal disease. ACIP defines close contacts for PEP as 1) household members, 2) child-care center personnel, and 3) persons directly exposed to the patient’s oral secretions (e.g., by kissing, mouth-to-mouth resuscitation, endotracheal intubation, or endotracheal tube management) (1). Although the majority of workers were offered PEP, albeit late, whether PEP would have been recommended for PO1 is unclear and would depend on how strictly the evaluating clinician interpreted the ACIP recommendations. Other types of exposures not defined specifically in the ACIP recommendations might warrant PEP based on the clinician’s judgment. However, because PO1 was experiencing symptoms as early as December 5, timely notification and assessment could have resulted in earlier diagnosis and treatment.

Health-care facilities should review their local health authority reporting procedures to ensure timely reporting of notifiable diseases, such as N. meningitidis, and employers should provide infection-control training and PPE to potentially exposed workers. Employers also should conduct timely and thorough investigations to identify and evaluate workers potentially exposed to a patient suspected to have meningococcal disease.

References

  1. CDC. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2005;54(No. RR-7).
  2. Council of State and Territorial Epidemiologists. Public health reporting and national notification for meningococcal disease (09-ID-42). Atlanta, GA: Council of State and Territorial Epidemiologists; 2009. Available at http://www.cste.org/ps2009/09-id-42.pdf Adobe PDF fileExternal Web Site Icon. Accessed November 10, 2010.
  3. CDC. 2007 Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings. Atlanta, GA: US Department of Health and Human Services, CDC; 2007. Available at http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/isolation2007.pdf Adobe PDF file. Accessed November 10, 2010.
  4. Popovic T, Schmink S, Rosenstein NA, et al. Evaluation of pulsed-field gel electrophoresis in epidemiological investigations of meningococcal disease outbreaks caused by Neisseria meningitidis serogroup C. J Clin Microbiol 2001;39:75–85.
  5. Maiden MC, Bygraves JA, Feil E, et al. Multilocus sequence typing: a portable approach to the identification of clones within populations of pathogenic microorganisms. Proc Natl Acad Sci USA 1998;95:3140–5.
  6. CDC. Nosocomial meningococcemia—Wisconsin. MMWR 1978;27:358–63.
  7. Gehanno JF, Kohen-Couderc L, Lemeland JF, Leroy J. Nosocomial meningococcemia in a physician. Infect Control Hosp Epidemiol 1999;20:564–5.
  8. Petsas A, Sharma A, Aghadiuno O, Abid M, Paranthaman K. A secondary case of meningococcal disease in an ambulance worker, Berkshire, November 2007. Euro Surveill 2008;13:1–2.

* Aerosol Transmissible Diseases Standard, Title 8 C.C.R. Sect. 5199 (2009), April 15, 2010. Available at http://www.dir.ca.gov/title8/5199.htmlExternal Web Site Icon.

 

Reportable Disease and Conditions, Title 17 C.C.R. Sect. 2500, April 15, 2010. Available at http://www.cdph.ca.gov/programs/documents/provider_reportable_diseases+conditions.pdf Adobe PDF fileExternal Web Site Icon.

without wearing helmets

http://consumer.healthday.com/Article.asp?AID=645841

Young Motorcycle Riders Suffering More Brain Injuries

Tough universal helmet laws needed to protect them, study finds

By Ellin Holohan
HealthDay Reporter

FRIDAY, Nov. 19 (HealthDay News) — “As more young people ride motorcycles without wearing helmets in the United States, more serious head injuries and long-term disabilities from crashes are creating huge medical costs………In 2006, about 25 percent of all traumatic brain injuries sustained in motorcycle crashes involving 12- to 20-year-olds resulted in long-term disabilities…………patients with serious head injuries were at least 10 times more likely to die in the hospital than patients without serious head injuries…….motorcycle crash-related hospital charges were estimated at almost $249 million dollars, with $58 million due to head injuries in 2006, the study on injuries and costs found. More than a third of the costs were not covered by insurance. Citing other research, the study noted that motorcycle injuries, deaths and medical costs are rising.motorcycle crash-related hospital charges were estimated at almost $249 million dollars, with $58 million due to head injuries in 2006, the study on injuries and costs found. ….”

FDA: Jihad against caffeine-alcoholic beverages

The FDA warned four companies that the caffeine added to their malt alcoholic beverages is an “unsafe food additive” and said that further action, including seizure of their products, is possible under federal law.

The companies receiving Warning Letters and their products are:

• Charge Beverages Corp.: Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked
• New Century Brewing Co., LLC: Moonshot
• Phusion Projects, LLC (doing business as Drink Four Brewing Co.): Four Loko
• United Brands Company Inc.: Joose and Max

FDA’s action follows a scientific review by the Agency.  FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers.  FDA also performed its own independent laboratory analysis of these products.

“FDA does not find support for the claim that the addition of caffeine to these  alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner.  “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication.  The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations.

The agency said the products named in the Warning Letters are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (the FFDCA). Each Warning Letter requests that the recipient inform the FDA in writing within 15 days of the specific steps that will be taken to remedy the violation and prevent its recurrence. If a company does not believe its products are in violation of the FFDCA, it may present its reasoning and any supporting information as well. 

If the FDA believes that the violation continues to exist, the agency may pursue an enforcement action that could include seizure of the products or an injunction to prevent the firm from continuing to produce the product until the violation has been corrected.

FDA’s action today follows a November 2009 request to manufacturers to provide information on the safety of adding caffeine to their products.

FDA is aware that on November 16, Phusion Projects, LLC, the maker of Four Loko, announced its intention to remove caffeine and other stimulants from its drinks.  FDA views this announcement as a positive step. FDA has not yet heard officially from the company about this announcement, including how quickly it will remove present product from circulation and how quickly it will reformulate its product.  FDA intends to work with Phusion Projects, LLC and the other manufacturers to assure their products meet safety standards.

For More Information:

FDA: preventing radiation overdoses during CT scans

Link:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm233245.htm

FDA NEWS RELEASE
 
For Immediate Release: Nov. 9, 2010
Media Inquiries: Dick Thompson, 301-796-7566, dick.thompson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
 
FDA working to prevent radiation overdoses during CT scans

The U.S. Food and Drug Administration has been investigating reports that patients undergoing computed tomography (CT) brain perfusion scans were accidently exposed to excess radiation. The FDA found that when properly used, the CT scanners did not malfunction. Instead, it is likely that the improper use of the scanners resulted in these overdoses. However, the FDA has identified a series or promising steps to enhance the safety of these procedures. These steps could reduce the likelihood of radiation overexposure in the event of improper use of the CT scanners.
 
The FDA has sent a letter to the Medical Imaging and Technology Alliance (link below), the major professional industry organization for manufacturers of CT scanners and other radiological imaging devices, reporting on the results of the investigation and discussing possible CT equipment enhancements that could improve patient safety. The agency will hold follow up discussions with manufacturers on the changes.
 
Those changes include:
  • A console notification to alert the operator of a high radiation dose; 
  • Providing particular information and training on brain-perfusion protocols to all facilities that receiving base CT equipment, whether or not the facilities purchase the related software enabling quantitative analysis of cerebral hemodynamics; 
  • Clarification of parameters affecting dose, along with clear instructions on how to appropriately set those parameters; and 
  • Organization of all dose-related information into one section of each user manual, in a dedicated dose manual, or indexed comprehensively in a concordance covering all manuals.
 
CT brain perfusion scans produce cross-sectional images of the head that evaluate blood flow in the brain. In an update released today, the FDA discussed findings of a probe into radiation overdoses in patients who received CT brain perfusion scans in hospitals located in California and Alabama.
 
Begun in 2009, the FDA’s investigation included information from the states and facilities where radiation overdoses occurred from 2008 to Oct. 26, 2010. The agency also inspected CT scanner equipment manufacturers.
 
The probe indicated that CT scanners, when properly used, did not result in overdoses. However, the investigation uncovered potential enhancements to CT equipment that could reduce the likelihood of radiation overexposure if improper use occurs – a goal of the agency’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.  
 
“Improving patient safety is part of our public health mission,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “Patients should not have to worry that a device designed to diagnose an illness exposes them to unnecessary risks.”
 
Since the investigation began, the FDA is aware of at least 385 patients who received excessive radiation from CT brain perfusion scans, many undergoing the test to confirm the presence of a stroke, performed at five hospitals in California and one in Alabama.
While unnecessary radiation exposure should be avoided, a medically-needed CT scan has benefits that outweigh the radiation risks. Patients should follow their doctor’s recommendations for receiving CT scans.
 
 
For more information:
 
 
 
 

Recall of Alaris PC Units Model 8015

http://www.fda.gov/Safety/Recalls/ucm232984.htm

Recall — Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Carefusion Recall of Alaris PC Units Model 8015 Classified as Class I Recall

Contacts:
Media:
Suzanne Hatcher
(858) 617-1203
suzanne.hatcher@carefusion.com
Investors:
Carol Cox
(858) 617-2020
carol.cox@carefusion.com

FOR IMMEDIATE RELEASE – October 15, 2010 – San Diego – CareFusion (NYSE: CFN), a leading global medical device company, issued the following update regarding its previously disclosed recall of approximately 17,000 Alaris® PC units model 8015 manufactured or serviced between December 2008 and September 2009. The FDA has classified this action as a Class I recall. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

On August 24, 2010, the company sent an urgent Medical Device Recall Notification to customers of its Alaris PC unit model 8015 stating that under certain wireless network conditions, affected units may experience an intermittent communication error, which freezes the PC unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions. If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down with a delay in therapy, which could lead to a serious injury or death.

In the notification letter, customers were provided clinical tip sheets and informed of warning tags for each of the affected units. Customers were also given instructions on how to temporarily or permanently disable the wireless mode of the PC unit setting to further mitigate the risk. This information is available at: http://www.carefusion.com/customer-support/alerts/alaris/medical-device-recall-alaris-8015.aspx9

CareFusion is conducting a field corrective action to update the hardware on affected PC units.

The company recorded a reserve in its 2010 fiscal fourth quarter for all actions related to the corrective action plan and continues to believe the amount to be sufficient to fulfill its remediation obligations. The voluntary recall only affects Alaris PC units model 8015 manufactured or serviced between December 2008 and Sept. 2009 and therefore, has no affect on the company’s current infusion pump production or shipping processes.

Instructions to customers
Customer inquiries related to this action should be addressed to the CareFusion recall center at 888-562-6018. Additional information about the recall, including serial numbers of affected devices, can be found at http://www.carefusion.com/customer-support/alerts/alaris/medical-device-recall-alaris-8015.aspx10

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program: by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; by phone at 1-800-332-1088; by Fax at 1-800.FDA.0178 or at www.fda.gov/medwatch11.

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