http://www.theday.com/article/20101225/NWS01/312259946/1018

Security efforts Jacked up at L&M

By Judy Benson

Publication: The Day

New London, CT

Date: 12-26-2010 17:30

Program: Cal-Ore Life Flight
    311 Cove Road
    Brookings, OR 97415
    541-469-7911

Type: Cessna 421C
Tail #: N31CU
Operator/Vendor: none

Team: Pilot, RN, Paramedic. No injuries reported. Patient on board.

Description:
    The interfacility flight originated in Crescent City, CA (CEC), and
    was destined for Medford, OR (MFR).  The weather was IFR with marginal
    VFR ceilings at both departure and destination, along with mountain
    obscuration, rain and forecast light to moderate icing.  All preflight
    checks were normal, including deice equipment, and the risk assessment
    matrix was within the acceptable range. The flight proceeded normally
    with the pilot reporting some ice at 11,000′ in cruise, which was
    easily removed with the deice equipment. 
   
    On descent into MFR, ice accumulation increased, and when leveling off
    at approximately 8,000′, the pilot experienced a vibration followed by
    the elevator control oscillations. Suspecting tail ice, the pilot
    continued to select the deice boots. Though he confirmed the wing
    boots were expanding and breaking off the ice, he did not get the
    proper cockpit annunciation indicating that the tail was being deiced.
    The pilot then confirmed a tailplane ice issue. The oscillations
    continued on descent.
   
    The pilot elected to declare an emergency and asked for vectors direct
    to the airport. He was vectored to a lower and warmer altitude at
    which time the ice begin to depart the aircraft and the elevator
    control smoothed out. The pilot then accepted the ILS approach and
    made a normal “no-flap” landing. The aircraft was met by the ground
    ambulance and the patient was transported without incident. The
    aircraft was taken out of service and all appropriate calls and
    notifications made.

Additional Info:
    Maintenance personnel have determined that a faulty pressure air line
    in the deice boot had shifted, allowing expanded air to escape
    overboard on the left vertical stabilizer deice boot edge.  This
    caused the tail deice boots to not inflate properly. 
   
    A follow-up discussion was conducted with all of  the crew members and
    personnel involved, and the incident is being referred to the QM
    committee for review and comment.

Source: Dan Brattain, Program Director

=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=
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

http://www.fda.gov/Safety/Recalls/ucm238306.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.

ev3 Initiates Voluntary Recall of Specific Lots of NanoCross™ .014″ OTW PTA Dilatation Catheter
 

Contacts:
Rachel Bloom Baglin
Vice President, Communications
Vascular Therapies
508-261-6651
rachel.bloombaglin@covidien.com
 

Bruce Farmer
Vice President
Public Relations
508-452-4372
bruce.farmer@covidien.com
 

Cole Lannum, CFA
Vice President
Investor Relations
508-452-4343
cole.lannum@covidien.com
 

FOR IMMEDIATE RELEASE – Plymouth, MN – December 15, 2010 – ev3, a Covidien company, has initiated a voluntary recall of specific lots of the NanoCross™ .014″ OTW PTA Dilatation Catheter due to the potential for the catheter shaft to crack or break during use. Cracking or breaking of the catheter shaft may result in the inability to inflate or deflate the balloon, and may result in material separation and potential embolization. The device failure may lead to unplanned intravascular or open surgery, significant vasospasm, prolonged tissue ischemia, tissue, injury, infarct, bleeding and/or death.  The Food and Drug Administration (FDA) has classified the recall as a Class I recall.  FDA classifies a recall as Class I when the agency believes there is a reasonable probability that the use of the recalled product will cause serious adverse health consequences or death.

The NanoCross 0.014″ OTW PTA Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.  The NanoCross Dilatation Catheter is not an implant.  It is removed and discarded after the procedure is completed.

The voluntary recall affects certain lots of the NanoCross .014″ OTW PTA Dilatation Catheters manufactured between May 27, 2010, and October 18, 2010.  Only the NanoCross .014″ OTW PTA Dilatation Catheters from lot numbers listed below is affected by this action.  All affected healthcare facilities have been notified of this action in a letter dated November 10, 2010. Healthcare facilities should take immediate action to locate and remove from use the specified NanoCross PTA Dilatation Catheters.  Detailed steps were provided in the Customer Notification letter for return and disposition of affected products. 

Affected ev3 NanoCross™ .014″ OTW PTA Dilatation Catheter Product Catalog / Lot Numbers 

The lot numbers for all NanoCross .014” OTW PTA Dilatation catheters are clearly printed on the front and sides of the product packaging.

Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or by phone. 

•  
  • Online: www.fda.gov/medwatch/report.htm⁹
  • Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm¹⁰.
    Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
  • Fax: 1-800-332-0178
  • Phone: 1-800-332-1088
     

###

http://www.fda.gov/Safety/Recalls/ucm238227.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.

American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50mL Single Dose Vials Due to Particulate Matter

Contact:
Walter Tozzi, R.Ph., M.S., M.B.A.
Sr. Director of Professional Services
631-924-4000

FOR IMMEDIATE RELEASE – December 23, 2010 – American Regent is conducting a nationwide voluntary recall to the consumer and user level of ALL unexpired lots of the following products:

Sodium Bicarbonate Injection, USP, 7.5%, 44.6 mEq/50 mL, Single Dose Vial NDC # 0517-0639-25

and

Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL, Single Dose Vial NDC # 0517-1550-25

PLEASE NOTE: This recall, initiated on December 23, 2010 to the User or Consumer Level is for ALL unexpired lots of Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials. See attached APPENDIX for ALL the lots subject to this voluntary recall.

This voluntary recall was initiated because some vials of these lots contain particulates. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues if these lots of product are administered to patients.

Sodium Bicarbonate Injection, USP, is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials with the lot #s on the attached list for patient care and should immediately quarantine any product for return.

“The safety of patients receiving our products is our primary concern. All of us at Luitpold Pharmaceuticals and American Regent are committed to taking the necessary steps to protect patients from any potential safety risks with our Sodium Bicarbonate Injection,” said Mary Jane Helenek, President and CEO of American Regent.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.

As is standard practice, and as stated in the Sodium Bicarbonate Injection, USP Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

American Regent is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts for all returned product with these lot #’s. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30AM to 7:00PM ET.

Hospitals, infusion centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 800-645-1706.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-9236.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, or regular mail or by fax.

• Online: http://www.fda.gov/medwatch/report.htm⁹
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm¹⁰. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

Sodium Bicarbonate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

Source: Luitpold Pharmaceuticals, Inc.

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

APPENDIX

American Regent Recall Lots of Sodium Bicarbonate Injection, USP

Sodium Bicarbonate Injection, USP, 7.5%, 44.6 mEq/50 mL, Single Dose Vial NDC # 0517-0639-25

Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Single Dose Vial NDC # 0517-1550-25

###

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The American Journal of Medicine: January 2011 (Volume 124, Issue 1)

http://consumer.healthday.com/Article.asp?AID=647919

Epilepsy Found to Be More Common in U.S. Than Thought

Experts urge more research and funding to meet growing needs

By Steven Reinberg
HealthDay Reporter

MONDAY, Dec. 27 (HealthDay News) — “A new study suggests that one of every 26 people in the United States will develop epilepsy at some point in their life……..two important points:

• Older adults are more at risk for developing epilepsy.
• A greater number of people will develop epilepsy during their lifetime than thought….”

http://pagingdrgupta.blogs.cnn.com/2010/12/27/extreme-winter-weather-increases-risk-of-amputation-and-other-injuries/

“….According to the most recent estimates from the Consumer Product Safety Commission, there are more than 590 finger amputations and 5,700 hospitalizations resulting from snow blowers each year, which mainly occur when people using the equipment fail to stop the engine before attempting to clear snow and debris from the machine…..”

CPSC offers the following safety tips for using snow throwers:

http://www.cpsc.gov/cpscpub/pubs/5117.html

• Stop the engine and use a long stick to unclog wet snow and debris from the machine. Do not use your hands to unclog a snow thrower.
• Always keep hands and feet away from all moving parts.
• Never leave the machine running in an enclosed area.
• Add fuel to the tank outdoors before starting the machine; don’t add gasoline to a running or hot engine. Always keep the gasoline can capped, and store gasoline out of the house and away from ignition sources.
• If you have an electric-powered snow thrower, be aware of where the power cord is at all times.

Duration of Red Cell Storage Influences Mortality After Trauma

http://consumer.healthday.com/Article.asp?AID=647766

By Randy Dotinga
HealthDay Reporter

TUESDAY, Dec. 21 (HealthDay News) — A new study finds that more babies die of sudden infant death syndrome (SIDS) in the United States on New Year’s Day than any other day of the year.

http://www.freep.com/apps/pbcs.dll/article?AID=/20101221/NEWS06/12210328/Search-for-world-s-best-health-care-is-leading-more-people-to-Michigan&template=fullarticle

Search for world’s best health care is leading more people to Michigan

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237941.htm

FDA NEWS RELEASE

For Immediate Release: Dec. 22, 2010
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: Gardasil approved to prevent anal cancer

The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females.  It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.

Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection  was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN.  Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well. 

Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination.  For all of the indications for use approved by the FDA, Gardasil’s full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Individuals recommended for anal cancer screening by their health care provider should not discontinue screening after receiving Gardasil.  

As of May 31, 2010, more than 65 million doses of Gardasil had been distributed worldwide, since its approval in 2006 according to the manufacturer, Merck and Co. Inc, of Whitehouse Station, N.J. The most commonly reported adverse events include fainting, pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries. This can be prevented by keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.
 

For more information:

Gardasil Product Page

News Release, Sept. 12, 2008 – FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers

News Release, Oct. 16, 2009 – FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys

Source: CDC. National Health Interview Survey, 1998–2009. Available at http://www.cdc.gov/nchs/nhis.htm.

Alternate Text: The figure above shows the percentage of adults aged ≥65 years, who have lost all their natural teeth, by poverty status in the United States during 1998-2009. During 1998-2009, the percentage of older adults who had no natural teeth was higher among those in families with low income than in families with higher income. Among all income groups, the prevalence of no natural teeth was lower during 2007-2009 (25.3%) than during 1998-2000 (31.0%).

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5950a7.htm?s_cid=mm5950a7_e

QuickStats: Percentage of Adults Aged ≥65 Years Who Have Lost All Their Natural Teeth,* by Poverty Status† — National Health Interview Survey, United States, 1998–2009§

December 24, 2010 / 59(50);1657

Escherichia coli infection with multidrug resistance was transmitted from a donor to two transplant recipients, resulting in the loss of both transplanted kidneys; critical gaps were identified in communicating information regarding the donor’s E. coli infection.

 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5950a2.htm?s_cid=mm5950a2_e

Transmission of Multidrug-Resistant Escherichia coli Through Kidney Transplantation — California and Texas, 2009

WeeklyDecember 24, 2010 / 59(50);1642-1646

“On July 6, 2009, the Organ Procurement and Transplantation Network received notification of possible disease transmission. A transplant center in California (TCA) reported a kidney transplant recipient with Escherichia coli urinary tract infection and sepsis suspected to have been contracted from the donated kidney. Upon further investigation, a transplant center in Texas (TCB) reported that the recipient of the other kidney from the same donor developed a perinephric abscess caused by E. coli. The kidney grafts failed in both recipients; however, both recipients survived…….”