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BACKGROUND:
The *Center for Devices and Radiological Health* has learned of the possible re-use of
cardiac pacers. *Center* medical experts have studied this situation and have determined
that there is a serious question whether pacemakers can be properly re-sterilized
following initial implantation due to the possibility of body fluids entering the terminal
leads of the pacemaker. This also poses the problem of foreign protein matter to the
second recipient.
POLICY:
Pacemaker re-use is an objectionable practice. Anyone learning of the re-use of
pacemakers should obtain and submit complete information to *HFZ-300* for review and
evaluation.
*Material between asterisks is new or revised*
Issued: 10/1/80
Revised: 3/95