[Temslist] FDA Patient Safety News: Preventing Malfunctions in Defibrillator Cables and Connectors

Tidewater EMS Council Listserv temslist at vaems.org
Tue Aug 7 08:50:12 EDT 2007


Preventing Malfunctions in Defibrillator Cables and Connectors
 
Follow the link below to the FDA Patient Safety site on info regarding
hands-free defibrillator pads and cable connection issues.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?sho
w=66#8 
 
A recent FDA article described several reports of external
defibrillators that did not work because of problems with the
defibrillator cables and their connectors. Many of these malfunctions
occurred with so-called "hands-free" defibrillators, where electrode
pads with an adhesive back are attached to the patient and then
connected to the defibrillator by a reusable interface cable and
connectors. With this configuration, the user does not need to hold
wired contact paddles on the patient while the shock is being delivered.

In one report, the hands-free pad would not attach to the interface
cable. The nurse discovered that the cable end was broken and so it
would not align with the connector of the electrode pad. The break in
the cable may have been caused by repeatedly twisting it during daily
testing of the defibrillator.

The article lists several ways to minimize these kinds of events during
testing and patient defibrillation, including: 

* Test the defibrillator at least once a day or according to the
facility's or manufacturer's protocol. Be sure to test the unit on
battery power only, and ensure that all accessories are present and
operate properly. Report any failures, including mechanical faults such
as bent or broken connector pins or cables, and electrical malfunctions
such as open circuits or failure to deliver the selected energy level.

* When testing the interface cable with an external test load, keep the
cables plugged into the test load when the device is not being used.
This can reduce wear and tear from frequent attaching and detaching of
the connectors and cables.

* Position cables and connectors within easy reach of users.
Over-reaching and stretching during a code event may lead to bending or
breaking the pins, incomplete mating of the pins, or no connection.

* And train all users to confirm that a positive connection has been
made by either checking the display screen or listening for an audible
clicking sound. Tell them to look for messages indicating that the
connection has or has not been made. 


Additional Information:

FDA Safety Tip: External Defibrillators With "Hands-Free" Capability:
Recommendations for Maintaining Their Cables and Connectors. June 7,
2007.


http://www.fda.gov/cdrh/medicaldevicesafety/tipsarticles/handsfree.html

 

 

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