[Federal Register Volume 64, Number 207 (Wednesday, October 27, 1999)]
[Notices]
[Pages 57890-57891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28004]
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GENERAL SERVICES ADMINISTRATION
[GSA Bulletin FPMR H-78]
Utilization and Disposal
AGENCY: Office of Governmentwide Policy, GSA.
ACTION: Notice of bulletin.
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SUMMARY: The attached bulletin provides revised information for Federal
agencies on the disposal of excess biomedical equipment and IT
equipment with potential Y2K defects.
FOR FURTHER INFORMATION CONTACT: Martha Caswell, Personal Property
Management Policy Division, Office of Governmentwide Policy, General
Services Administration, Washington, DC 20405; telephone (202) 501-
3846; e-mail martha.caswell@gsa.gov.
GSA Bulletin FPMR H-78 Utilization and Proposal
TO: Heads of Federal agencies
SUBJECT: Disposal of Year 2000 (Y2K) Noncompliant Biomedical Equipment
and Information Technology (IT) Equipment
1. What is the purpose of this bulletin? To provide revised
information for Federal agencies on the disposal of excess biomedical
and IT equipment with potential Y2K defects.
2. When does this bulletin expire? This bulletin contains
information of a continuing nature and will remain in effect until
canceled or revised.
3. What is the background? The Y2K technology problem concerns
computers, computer chips, and software that may not properly recognize
or process dates after December 31, 1999. In addition, there are other
specific dates that may be troublesome, such as February 29, 2000. This
problem may affect the normal operation of biomedical equipment and
information technology (IT) equipment. In biomedical equipment used in
direct patient treatment, the monitoring of vital patient parameters,
or used to support or sustain life, the Y2K problem may present a
potential risk to public health and safety if not corrected. In those
situations, biomedical device failure could injure the patient or
compromise effective patient treatment. In response to this potential
risk, GSA is providing guidance to Federal agencies on the disposal of
such equipment when it becomes excess to their needs.
4. What does this bulletin cover? This bulletin applies to (1) all
excess biomedical equipment, and (2) all excess IT equipment.
5. Biomedical equipment. a. Where can I find information about the
Y2K status and potential risks posed by biomedical equipment? Federal
agencies should consult the Food and Drug Administration's (FDA's)
website at http://www.fda.gov for general Y2K information on biomedical
equipment. Federal agencies can find more specific information provided
by manufacturers of biomedical equipment in the Federal Y2K Biomedical
Equipment Clearinghouse (Y2K Clearinghouse) located at http://
www.fda.gov/cdrh/yr2000/year2000/html. Federal agencies can also access
the Y2K Clearinghouse through the FDA website's Year 2000 link.
b. How can I determine the Y2K status of the biomedical equipment?
Information provided by the original manufacturer is the best source
for determining the Y2K status of the biomedical equipment under
consideration.
c. Where can I find manufacturer information? Please consult the
FDA Y2K Clearinghouse website or contact the manufacturer directly.
d. How do I use Y2K information when disposing of excess biomedical
[[Page 57891]]
equipment? Use the manufacturer's information, with the assistance of
your biomedical engineers/technicians, to determine the Y2K status of
equipment and label the biomedical equipment as:
(1) Y2K compliant;
(2) Y2K noncompliant; or
(3) Y2K status unknown.
6. How do I dispose of biomedical equipment that is Y2K compliant?
If Y2K compliant, identify excess biomedical equipment as ``Y2K
compliant'' on the equipment itself and on the excess reporting
document (SF 120). Dispose of such equipment through normal disposal
procedures described in FPMR 101-43.3, 101-44.2, and 101-45.3. Federal
agencies obtaining excess Y2K compliant biomedical equipment must
reflect the ``Y2K compliant'' status on all inventory control
documentation pertaining to such equipment.
7. Y2K noncompliant biomedical equipment. a. What should I consider
before I dispose of biomedical equipment that is not Y2K compliant?
Before you proceed with disposal, consider two questions: First, what
is the potential risk posed by the equipment? And second, does the
equipment meet the criterion for ``extremely hazardous'' property'' as
defined in paragraph 7.c.?
b. How can I determine what types of Y2K noncompliant biomedical
equipment pose the greatest potential risk? Use the information found
under ``Computer-Controlled Potentially High-Risk Medical Devices'' on
the FDA website to help you identify biomedical equipment having the
greatest potential for presenting a risk to patients if used with an
uncorrected date problem.
Note: The FDA website is not all-inclusive. See paragraph 7.e.
for the disposal of Y2K noncompliant biomedical equipment not
mentioned on the ``Computer-Controlled Potentially High-Risk Medical
Devices'' list.
c. What is ``extremely hazardous'' biomedical equipment?
``Extremely hazardous,'' in this instance, is Y2K noncompliant
biomedical equipment that is judged by the holding agency to pose a
potential risk by endangering public health or safety, or the
environment, if not rendered harmless (i.e., made Y2K compliant) before
being used by other agencies or released outside the Government.
d. How do I dispose of Y2K noncompliant biomedical equipment that I
judge to be ``extremely hazardous?'' If not made Y2K compliant, you
must destroy Y2K noncompliant biomedical equipment that is extremely
hazardous to render it innocuous, in accordance with FPMR 101-45.902-
2(a)(2). Destruction means the rendering of biomedical equipment
completely inoperable for its intended purpose. Actions such as
cutting, tearing, crushing, breaking, burning, etc. will accomplish
rendering inoperable.
e. Do I need to be concerned about Y2K noncompliant biomedical
equipment not mentioned under ``Computer-Controlled Potentially High-
Risk Medical Devices?'' Yes. Evaluate other Y2K noncompliant
biomedical equipment for associated risks. Using the manufacturer's
information, and with assistance from your biomedical engineers/
technicians, assess whether or not the equipment, if used without a
modification to address the date problem, will endanger public health
or safety, or the environment (i.e., can be deemed ``extremely
hazardous''). If judged to be ``extremely hazardous,'' dispose of in
accordance with paragraph 7.d.
f. What if I judge the Y2K noncompliant biomedical equipment, of
any type, to be non-hazardous? You must identify it as ``Y2K
noncompliant'' on the equipment itself and on the excess reporting
document (SF 120) and dispose of it through normal disposal procedures
described in FPMR 102-43.3, 102-44.2 and 101-45.3. Federal agencies
obtaining excess Y2K noncompliant biomedical equipment must reflect the
``Y2K noncompliant'' status on all inventory control documentation
pertaining to such equipment.
8. How do I dispose of biomedical equipment when the Y2K status is
unknown? You may not transfer excess biomedical equipment when the Y2K
status cannot be determined. If the Y2K status cannot be determined,
the holding agency must destroy the equipment in accordance with FPMR
101-45.902-2(a)(2).
9. IT equipment. a. How do I define ``IT'' equipment? ``IT'' is
any equipment or interconnected system or subsystem of equipment that
is used in the automatic acquisition, storage, manipulation,
management, movement, control, display, switching, interchange,
transmission, or reception of data or information.
b. Do I also report the status of IT equipment? Yes, all IT
equipment must also be identified by the holding agency as Y2K
compliant, Y2K noncompliant, or Y2K status unknown. The Y2K status must
be visible on the equipment and all excess reporting documents.
c. What disposal procedures do I following for IT equipment? IT
equipment, of any status, will be disposed of through normal disposal
procedures as described in FPMR 101-43.3, 101-44.2 and 101-45.3.
10. Whom should I contact for further information? Martha Caswell,
Personal Property Management Policy Division, Office of Governmentwide
Policy, General Services Administration, Washington, DC 20405;
telephone (202) 501-3846; e-mail martha.caswell@gsa.gov.
11. Cancellation. FPMR Bulletin H-76 dated August 4, 1999, is
canceled.
Dated: October 21, 1999.
G. Martin Wagner,
Associate Administrator for Governmentwide Policy.
[FR Doc. 99-28004 Filed 10-26-99; 8:45 am]
BILLING CODE 6820-24-M
