Alert: FDA Recalls EpiPens

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.

While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Stericycle at 877-650-3494 to return the product.

As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.

At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.

Product/DosageNDC NumberLot NumberExpiration Date
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM640 May 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM087 October 2017

The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:


(Posted 04-05-17)

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Dinner with a Doc with Dr. Scott Reed, MD

4 May, 2017, 6:30 pm, Riverside Doctors' Hospital, Conference Room "A", 1500 Commonwealth Avenue, Williamsburg, VA

Peninsulas EMS Council, Inc. and Riverside Regional Medical Center are proud to bring you:

Dinner with a Doc!

This quarter we bring you Andrew Burton, MD, FACC

Dr. Scott Reed  graduated from Hahnemann University School of Medicine in Philadelphia and completed his residency at York Hospital. He completed his fellowship training at Eastern Virginia Medical School. He is certified by the  American Board of Surgery and the American Board of Surgery/Surgical Critical Care.  He is married with three kids and can still shoot “three.”

EMS Continuing Education hours will be provided. Letters of attendance will be provided on request for nurses and physicians and EMS providers with non-Virginia certifications.

  Click here to download flyer!

 

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NASEMSO Releases Guidance on Safe Transport of Children

NASEMSOSafe Transport of Children by EMS: Interim Guidance
March 8, 2017
Establishing guidelines for safely transporting children in ambulances has been an endeavor undertaken by various individuals and organizations in recent years. Despite these efforts, this multi-faceted problem has not been easy to solve. While there have been resources developed, such as the Working Group Best-Practice Recommendations for the Safe Transportation of Children in Emergency Ground Ambulances (NHTSA 2012), there remain unanswered questions, primarily due to the lack of ambulance crash testing research specific to children.

The National Association of EMS State Officials (NASEMSO) is committed to advocating for the creation of evidence-based standards for safely transporting children by ambulance. Such standards would ensure a safer environment for the patients who rely on the EMS provider to act on their behalf. Developing standards will require large investments of both time and funding to conduct the required crash testing. If research were started today, it would require at least three years and hundreds of thousands of dollars to complete.

While NASEMSO collaborates with other organizations to bring these standards to reality, it recognizes the gap between that goal and the reality of the decisions that EMS providers face today will continue to be an issue of concern. The purpose of this interim guidance is to reduce that gap as much and as soon as possible, until evidence can be collected, analyzed, and used to develop standards specifically for children. Ultimately, pediatric restraint devices should be tested by the manufacturer to meet a new, yet-to-be developed standard.

NASEMSO recommends that this new standard include a pass/fail injury criteria comparable to that identified in FMVSS-213, which applies to child restraints in passenger vehicles. All testing should use the ambulance-specific crash pulses described in SAE J3044, SAE J2956, and SAE J2917 respectively. Litters used in testing should meet the SAE J3027 Integrity, Retention and Patient Restraint Specifications. Manufacturers should indicate to prospective purchasers whether their device(s) have met these requirements for the weight range indicated for the device.

It is the position of NASEMSO that:

1) Evidence-based standards for safely transporting children in ambulances should be developed and published by nationally recognized standards development organizations, such as the Society for Automotive Engineers (SAE);
2) Safe ambulance transport should be considered as a standard of care for the EMS system equivalent to maintaining an open airway, adequate ventilation and the maintenance of cardiovascular circulation; and
3) There are immediate actions that can be taken to improve pediatric safety in ambulances including, but not limited to:

a. All EMS agencies that transport children should develop specific policies and procedures that address, at minimum the following elements:

i. Methods, training (initial and continual), and equipment to secure children during transport in a way that reduces both forward motion and possible
Safe Transport of Children by EMS: Interim Guidance March 8, 2017
ejection. The primary focus should be to secure the torso, and provide support for the head, neck, and spine of the child, as indicated by the patient’s condition;1
ii. Considerations for the varied situations that a child who needs transport to a hospital or other point of care may present to the EMS professional. These include, but may not be limited to a child who is:

o uninjured/not ill,
o ill/injured, but requiring no intensive interventions or monitoring,
o requiring intensive interventions or monitoring,
o requiring spinal immobilization or supine transport, and
o multiple patients;2

iii. Prohibits children from being transported unrestrained, e.g. held in arms or lap;3
iv. Provision for securing all equipment during a transport where a child is an occupant of the vehicle, with mounting systems tested in accordance with the requirements of SAE J3043;
v. Only use child restraint devices in the position for which they are designed and tested; and

b. EMS agencies should have appropriately-sized child restraint system(s) readily available on all ambulances that may transport children. Additionally, personnel should be initially and recurrently evaluated and trained on the correct use of those restraint systems;

i. The device(s) should cover, at minimum, a weight range of between five (5) and 99 pounds (2.3 - 45 kg), ideally supporting the safest transport possible for all persons of any age or size;
ii. Only the manufacturer’s recommendations for the weight/size of the patient should be considered when selecting the appropriate device for the specific child being transported; and

c. State EMS officials should act to put interim steps in place while evidence-based standards are developed and implemented, including, but not limited to:

i. Encourage and support EMS transport agencies to implement cost effective solutions to mitigate risk while transporting children in ambulances; and
ii. Work with other state EMS officials to create uniform approaches and policy language, including, but not limited to a network of information relating to ambulance crash-related injuries; and

4) NASEMSO does not recommend or endorse any particular product.

1Working Group Best-Practice Recommendations for the Safe Transport of Children in Emergency Ground Ambulances, page 12.
2 Ibid, pages 12-15.
3 The Do’s and Don’ts of Transporting Children in an Ambulance (December 1999).
Safe Transport of Children by EMS: Interim Guidance March 8, 2017

  Click Here to Download this Document

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Recall Alert: Physio-Control LIFEPAK 1000 Defibrillator

Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly

The LIFEPAK 1000 Defibrillator has been recalled due to an electrical issue, which may cause the device to shut down unexpectedly. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. To learn more about this recall, please visit: https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm545569.htm

Recalled Product:

  • The LIFEPAK 1000 defibrillator
  • Affected Product Part Numbers: 320371500XX
  • Serial Numbers: There are 133,330 affected serial numbers. http://www.physio-control.com/Search_Affected_Devices.aspx
  • Distribution Dates: June 30, 2006 to December 23, 2016
  • Manufacturing Dates: June 30, 2006 to December 20, 2016  
  • Devices Recalled in the U.S.: 50,046 nationwide

Recall posted 03-21-17

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