September 1998
Volume 62 |
Number 9
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| FDA Alert: Hazards
Associated With Lead Wires and Cables |
The Food and Drug Administration (FDA) has issued a new, important
requirement that will help to safeguard patients from electrical
hazards associated with lead wires and cables used on many medical
devices. Beginning January 1, 1999, only electrode lead wires
and patient cables that are protected may be used
with the following devices:
- breathing frequency monitors;
- ventilatory effort monitors (apnea detectors);
- electrocardiographs (ECGs);
- radiofrequency physiological signal transmitters and receivers;
- cardiac monitors;
- electrocardiograph electrodes (including pre-wired ECG electrodes);
- patient transducer and electrode cables (including connectors);
- medical magnetic tape recorders (e.g., Holter monitors);
- arrhythmia detectors and alarms; and
- telephone electrocardiograph transmitters and receivers.
Protected cables and leads are those that cannot be inadvertently
inserted into electrical outlets and thus pose an electrocution
hazard to patients. The FDA is taking this action because patients
in the past have been seriously harmed or killed when unprotected
electrode lead wires and patient cables have been accidentally
inserted into live electrical outlets - in some cases by young
children and in other cases by health care personnel.
You can fulfill this requirement through the use of inexpensive
adapters to protect cables and leads, which are available from
many sources for most medical devices. In some cases, retrofitting
may work. Contact your suppliers to see what kind of correction
will work best for you. If the correction means you are facing
an unreasonably expensive fix, you may request a variance or exemption
from the FDA. The request needs to document that conversion adapters
are not feasible and retrofitting is far too expensive. Your request
must also propose an alternate method of dealing with the problem
and must clearly show that it is effective in protecting patients.
The requirement applies to devices already in use. The
requirement as it applies to newly manufactured devices by means
of a performance standard went into effect in May 1998. Under
the standard, device manufacturers must use protected electrode
lead wires and patient cables. Beginning in May 2000, these requirements
will apply to electrode lead wires and patient cables that are
used with all types of medical devices.
For more information about this matter, check the FDA's
Web site at <http://www.fda.gov/cdrh>
(search in the topic index under L for lead wires); or
contact Stewart Crumpler in the FDA Office of Compliance at (301)
594-4659 or by facsimile at (301) 594-4672.
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