Bureau of EMS Updates and Announcements
Occupational Exposure to HIV
Important changes to the Ryan White Act for First Responders
New Spinal Precaution Protocol
FDA recalls
This section lists FDA recalls known to the Department. It is not all inclusive.
Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs)
Audience: Emergency services personnel, risk managers, consumers
[Posted 03/07/2007] Defibtech and FDA notified healthcare professionals of a worldwide recall of 42,000 Lifeline and ReviveR AEDs with software versions 2.002 and earlier. The self-test software may allow a self-test to clear a detected low battery condition. The operator may be unaware of the low battery and the device may not deliver a defibrillation shock, resulting in failure to resuscitate a patient. The company provided a maintenance procedure that can be used to verify functionality of the device until the software upgrade has been installed, allowing the device to remain in service. The devices were distributed to schools, fire & EMS, businesses, health clubs and hospitality companies.
MRL/Welch Allyn AED 20 Automatic External Defibrillators
Audience: Emergency Services personnel and risk managers
[Posted 09/18/2007] FDA issued a Class I recall for MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005, serial numbers 205787 through 207509. These devices are used by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest (heart attack). The recalled devices may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
FDA advises healthcare professionals and patients to stop using the recalled product and contact the manufacturer for a replacement.
Welch Allyn AED 10 Automatic External Defibrillators
Audience: Emergency services personnel, risk managers, and consumers
[Posted 11/05/2007] FDA issued a Class I recall for Welch Allyn AED 10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970310E, and 970311E. These devices are used by emergency or medical personnel, or by others who have taken the appropriate training in cardiopulmonary arrest (heart attack). They analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.
There is a possibility that these recalled devices may experience failure or unacceptable delay in analyzing a patient's ECG resulting in possible failure to deliver the appropriate therapy. The possible failure or delay depends on the location of the defective part that stores an electrical charge on the circuit board. The company plans to replace all affected units and has set up a call center for customers.
ResMed S8 Flow Generators (Continuous Positive Air Pressure or CPAP): S8 Compact, S8 Escape, S8 Elite, and S8 AutoSet Vantage
Audience: Consumers, respiratory healthcare providers, and risk managers
[Posted 04/24/2007] ResMed and FDA notified consumers and healthcare professionals of a worldwide recall of approximately 300,000 S8 flow generators (Continuous Positive Air Pressure or CPAP) used for the treatment of obstructive sleep apnea. In Model S8 devices manufactured between July 2004 and May 15, 2006, there is a potential for a short circuit in the power supply connector. ResMed plans to work with its distribution partners globally to provide a replacement device to patients who have an affected S8 flow generator. See recall notice for serial numbers for affected S8 models.
Patients may continue to use their S8 flow generators until they receive a replacement device. As with any electrical device, patients should make sure that it is placed on a hard clean surface and that the area around the device is clear during use. Patients should discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell. Patients should not use supplemental oxygen with an affected device; patients using supplemental oxygen should immediately contact their home healthcare provider for a replacement.
2005 AHA Guidelines
The American Heart Association has published their new 2005 Guidelines for Emergency Cardiac Care. The AHA has implemented a timeline spanning through the fall of 2006 for the implementation of these new guidelines within their courses.
The New York State Emergency Medical Advisory Committee and Emergency Medical Services Council has completed it's review and has approved the new AHA Guidelines for Healthcare Provider and Public Access Defibrillation.
The Bureau of EMS is in the process of changing all levels of the NYS Written Certification Examinations, Practical Skills Examinations, Statewide BLS Protocols and curricula. All certification courses that are scheduled to take the NYS Written Certification Exam after August 1, 2006 will be tested to the new AHA Guidelines. BEMS Course Sponsors will be receiving additional mailings over the next several weeks. Please refer to BEMS policy statement 06-02 for additional information.
Sincerely,
Edward G. Wronski
Director
Bureau of Emergency Medical Services