GSA Bulletin FPMR H-78
Utilization and Disposal

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.govfor 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 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 High­Risk 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 101-43.3, 101-44.2 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 follow 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.

G. Martin Wagner

Associate Administrator for

Governmentwide Policy