ASTM F701-81(2002)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F701–81(Reapproved2002)
Standard Practice for
Care and Handling of Neurosurgical Implants and
Instruments
This standard is issued under the fixed designation F 701; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.3 Storage:
3.3.1 Store implants or instruments prior to use in such a
1.1 This practice covers recommended procedures for han-
manner as to maintain the device’s surface finish or configu-
dling neurosurgical implants and instruments.
ration, or both.
1.2 This practice is intended to inform hospital receiving
3.3.2 Many implants are identified by a serial or lot number,
personnel, central supply personnel, operating room personnel,
or both, on the package label, package insert, or surface of the
and other individuals who will handle neurosurgical implants
device. Record these control numbers and retain for transfer to
and instruments of recommended care and handling procedures
patient records to facilitate inventory, stock rotation, and
to prevent damage of neurosurgical implants and instruments.
possible traceability to the manufacturer.
2. Terminology 3.3.3 Stock Rotation—The principle of first in, first out is
recommended.
2.1 Definitions:
3.3.4 Store implants in the operating room in such a manner
2.1.1 neurosurgical implant—for the purpose of this prac-
as to isolate and protect the implant’s surface, sterility, and
tice, a device introduced by surgically penetrating the skin or
configuration. Keep implants made of different metals sepa-
mucosa of the body with the intention that it remain indefi-
rated.
nitely within the body following surgery. This device is
3.3.5 Store the implants and instruments in the operating
referred to in this practice as an “implant.”
room in such a manner as to isolate the instruments from the
2.1.2 neurosurgical instrument—any cooperative device
implants.
used during surgical procedures involving the implantation of
3.3.6 Mixing Metals—Maintain neurosurgical implants and
neurosurgical implants. This device is referred to in this
instruments of different metals separately to avoid the possi-
practice as an “instrument.”
bility of mixing during surgery.
3. Receiving Implants and Instruments
4. Cleaning and Sterilization
3.1 Receipt:
4.1 Prior to initial sterilization and promptly following each
3.1.1 Many implants are wrapped in special sterilizable or
surgical procedure, thoroughly and carefully clean all instru-
presterilized packages, envelopes, or other containers. These
ments and implants. Ultrasonic cleaners, mechanized washers,
wrappings should not be removed by the personnel who
or hand scrubbing are suitable methods if carefully done. The
receive the packages.
method employed should be utilized to prevent impact,
3.1.2 Carefully unwrap and handle nonsterilized implants
scratching, bending, or surface contact with any materials that
and instruments upon receipt in such a manner to avoid
might affect the implant or instrument surface or configuration.
scratching, marking, or abrasion by other implants, instru-
4.2 Closely follow the manufacturer’s recommendations on
ments, unpackaging tools, or by such mishaps as dropping or
cleaning. In hand scrubbing, use soft brushes and avoid harsh
otherwise endangering the surface finish or configuration.
chemicals or harsh cleaning solutions.
3.2 Trans
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