Archive for the ‘cardiac’ Category

Tips and Advice for AED Maintenance and Usage

Monday, May 24th, 2010
With CPR and AED training, the American Heart Association gives out wallet-sized pamphlets to help remind people what to do in the event of an emergency.
For CPR and AED training, the American Heart Association distributes wallet-sized pamphlets to help remind people what to do in the event of an emergency.

FALLS CHURCH – Each year, over one million Americans have heart attacks.

One of the greatest lifesavers for heart attack patients is an Automated External Defibrillator, or AED. An AED is a lunchbox-sized device used to evaluate the cardiac status of an individual suspected of suffering a cardiac arrest.

AED use by non-professsionals

The AED guides the user through the process of administering a defibrillation shock if it determines one is needed. AEDs are designed to be used by non-professionals with a minimal amount of training. Once turned on, most AEDs provide visual and voice prompts that instruct the user what to do and when to do it. Many public facilities including hospitals, nursing homes, and clinics have AEDs readily accessible for use by any passerby.

The increasing use of sophisticated medical devices by consumers poses challenges to manufacturers, distributors, regulators, and the organizations that make these devices available to users. One problem is maintenance.

AEDs are very sophisticated devices that need on-site maintenance.  Most have internal component testing functions that relieve the owner of much of the maintenance burden, but—like smoke alarms or fire extinguishers—these devices cannot be hung on a wall and left there. Each manufacturer has its own recommended maintenance and testing schedule.  Some schedules recommend maintenance checks as frequently as every day.

What you should do if your organization has an AED:

  • Be aware of recalls and field corrections covering the devices you use.
  • Review your policy for suggested device maintenance.
  • Make sure your AED policies reflect the fact that AEDs are tracked devices by the FDA and understand your responsibilities related to the AED device.
  • Make sure inspection of the devices includes components with expiration dates, such as electrodes and pads.
  • Make sure the manufacturer of the devices you use has your correct contact information to ensure prompt communication of recalls and service bulletins.
  • Make sure that responding staff are trained to use these devices. The Red Cross and other organizations provide training classes for the use of AEDs.
  • Review the American Heart Association website that includes a page of tips on AED usage, as well as a page of AED manufacturers.

Your organization’s internal controls may be adequate, but because AEDs also are available over the counter, your patients who have these devices in their homes also need to be made aware that maintenance is required.

If your organization has patients with these devices in their homes, make sure they and their caregivers are aware of the need to perform the manufacturer recommended maintenance and the importance of keeping their contact information up to date with the manufacturer.

Note: For hospitals and healthcare organizations, check to see if you are a subscriber to the recall service RASMAS. RASMAS tracks AED recall notices and alerts, and routes them to the designated staff member. Consumers can follow RASMAS’ recall coverage on Twitter at @HealthRecall.

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AED Recalls for Philips, Cardiac Science

Monday, March 29th, 2010

FALLS CHURCH – A number of recalls of AEDs, or Automated External Defibrillators, are in progress this month. The recalls are from the manufacturers Cardiac Science and Philips Healthcare.

Automated External Defibrillators, or AEDs, are portable devices that analyze heart rhythms of patients with cardiac arrest.  If the AED finds a problem, it automatically delivers a shock to restore normal heart rates until the patient can be seen at a hospital.

Recalls include:

  • Cardiac Science Corporation announced that some of their AEDs had the potential for devices not to deliver therapy. By May, 2010, the company will have a software update available that enhances the AED’s self-test capability to detect this issue. There are a number of models affected, including those sold under the brands Powerheart, Burdick Cardiovive, GE Responder, and CardioLife.  On their website, Cardiac Science has a form where owners can look up serial numbers, as well as register for maintenance reminder emails: http://www.cardiacscience.com/services-support/service-announcements-and-upgrades/voluntary-medical-device-correction.php
  • Philips Healthcare is conducting a recall of a limited number of HeartStart AEDs produced in October 2009. The voluntary recall is of specific OnSite, First Aid, HS1, and Home defibrillators (HS1) and FR2 defibrillators. Failure of a capacitor during use could prevent the AED from working properly. Like Cardiac Science, Philips has information on their website where building managers and other AED owners can look up serial numbers and find out if their model is affected. The page is at: http://www.healthcare.philips.com/us_en/products/resuscitation/aeds/actions.wpd

For those who want to look up recall information about a wide range of AEDs, the Food and Drug Administration’s CDRH, or Center for Devices and Radiological Health, has a database lookup tool at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

To get the best results, type in ‘spacekey’ AED ’spacekey’ to find results containing AEDs.