T H E   N I H    C A T A L Y S T N O V E M B E R -  D E C E M B E R   1 9 9 8 

by Gregory Roa, CIT

In the realm of science, data are everything. Results must be accurate, valid, and reproducible. That's why researchers around campus are taking steps to avert the Year 2000 problem, popularly known as the Y2K problem.

Caused by the failure of some computer systems and software to handle the date conversion from 1999 to 2000, the glitch could disrupt not only computers but also up to 20 percent of biomedical equipment, according to a recent survey.

Greg Roa staffs the Y2K "Alert" table at the NIH Research Festival
Any system that has date or time functions or operates with embedded chips or microprocessors has a potential problem. Experts do not know the full extent of Y2K's impact, but no one can afford to gamble with the quality of research data.

Responsibility for ensuring equipment accuracy has always rested with scientist—sand still does—but because the Y2K phenomenon has added another dimension to what can go wrong with equipment it has also summoned forth a network of resources to help scientists address the problem. First, NIH is urging researchers to check all their biomedical equipment with date and time sensitivity between now and December 31, 1998, identify equipment and software concerns, ascertain compliance status, and initiate appropriate action. (See "Bug-Bitten" for a list of likely candidates for the Y2K-vulnerable ranks.)


Anesthesia monitors
CT scans
Chemotherapy and radiation equipment
Echocardiography systems
Fetal monitors
Heart defibrillators
Gamma counters
Imaging equipment
Infusion pumps in intravenous drips
Intensive care monitors
MRI machines
Patient information and monitoring systems
PCR equipment
Pharmaceutical control and dispensing systems (such as infusion pumps)
Radiology systems
Renal (including dialysis) equipment
Ultrasound systems
Uninterruptible power supplies (UPS)
Water treatment

Fortunately, a number of resources are aiding scientists in identifying and managing Y2K problems in their laboratories. One major source of help is the Y2K Biomedical Clearinghouse, developed by the NIH Center for Information Technology (CIT) at < http://oirm.cit.nih.gov/biomedical/>.

The web-based Clearinghouse hosts a database compiling Y2K compliance information from NIH, the Food and Drug Administration, and the Veterans Health Administration. Using the interactive search engine, a researcher can check the status of equipment and submit an electronic request form to find out about items not listed on the site. NIH contractors will do the research leg work and promptly post that information. The staff also researches biomedical software applications. Updates are published weekly.

"Although scientists will always have the responsibility for accurate data, the clearinghouse offers them a useful information-gathering tool to help protect their work from potential Y2K problems," says CIT's Jaren Doherty, who chairs the NIH Y2K Work Group of IC representatives.

"Many researchers don't realize the Y2K threat to lab and clinical instruments with noncompliant embedded chips," says CIT's Cheryl Seaman. While "some machines will simply produce a wrong date-stamp," she says, others could malfunction in a more consequential way. For example, "certain vital-sign monitors work fine until they archive data; the Y2K defect causes current data to be written over historical records." In research laboratories, date functions can also be extremely important for patent documentation, she adds.

Lab and Branch Chiefs Certify Y2K Compliance

NIH's plan to address Y2K compliance of biomedical equipment requires that scientists assess and correct (upgrade, replace, repair, or retire) their own equipment as part of a certification process conducted at the laboratory or branch level within each IC. Researchers must inventory and record the Y2K compliance status of all equipment that could affect patient or animal safety. This inventory must be maintained on site by lab and branch chiefs and made available for auditors to review. For all other types of equipment, lab and branch chiefs are required to certify that their researchers understand which equipment could be affected and that they have obtained compliance information, made necessary remediation, and developed contingency plans.

The NIH Y2K Biomedical Clearinghouse provides a useful set of questions (see "Checklist") surveyors can ask in identifying suspect systems. Also available for downloading is a helpful EXCEL spreadsheet to facilitate collecting data and keeping track of remediation follow-up.

Risk Factors

  • Equipment operated by a PC—the PC itself, operating systems, and software must be compliant.
  • Lack of maintenance and service agreements that cover costs of upgrades or repairs.
  • Customized or "home-grown" software—individual owners must verify compliance.
  • Old equipment—manufacturers may not be testing equipment over eight years old for Y2K problems.
  • Equipment with multiple technology interfaces.
  • Cannibalized equipment (systems with multiple parts from different manufacturers).
  • Users who take a wait-and-see attitude.


Does your system......
  • interface with a personal computer, scanner, or other computer peripherals?
  • contain an embedded chip?
  • exchange data with other components?
  • implement a timed control sequence or operate on a timed basis (for example, within five-minute cycles)?
  • shut down unless a maintenance cycle is adhered to?
  • report or handle timed events and alarms?
  • calculate totals over time?
  • calculate averages, rates, or trends?
  • rely on external timed data?
  • rely on external geographical data?
  • use or produce time-stamped data?
  • maintain historical state-of-system data?
  • have an internal operation dependent on a clock (all timing devices)?
20,000 Desktop Machines Audited

The biggest Y2K headache involves personal computers (PCs). In some PCs the BIOS or real-time clock (RTC), programmed to interpret dates in two digits, may misread "00" as 1900. Left uncorrected, the date flaw could cause software running on a machine to archive records improperly, perform spreadsheet miscalculations, or otherwise corrupt data. "Don't assume your system is compliant just because it's new—even some recently purchased Pentium computers contain noncompliant BIOS chips," Doherty advises. Macintosh and UNIX systems are for the most part compliant, although Macs sometimes have DOS cards that are not Y2K-ready. "Another concern is commercial off-the-shelf software (COTS) and custom applications for all platforms, including Macs and UNIX. It's important to certify that your versions are Y2K compliant," he says.

IC technicians are currently auditing 20,000 desktop computers with ClickNet, a diagnostic tool for both hardware and software. Machines that pass the initial hardware test receive a Y2K-compliant sticker. Researchers should make sure auditors do not overlook any systems connected to biomedical equipment. ClickNet also compares executable programs to a database of known compliant software. A report can then be generated to list unrecognized programs that require further scrutiny. ClickNet does not examine documents or other data files, nor can it assess custom-built (user developed or non-COTS) applications unavailable in its library. Individual developers of custom software must verify Y2K compliance themselves.

Those using NIH computers at home can ask their IC for "walk-around" diskettes to check their systems. For hardware that fails the test, a BIOS upgrade can be attempted with another set of tools. Software applications can usually be fixed with patches, sometimes available for free or for purchase directly from a vendor's Internet site.

The Clock is Ticking. . .

"We face a rapidly approaching, nonnegotiabledeadline," warns NIH Chief Information Officer Alan Graeff, who urges scientists to upgrade, repair, replace, or surplus noncompliant systems now to avoid costly, extended back-order delays. If they deal with Y2K in the next few months, however, scientists can really celebrate next New Year's Eve knowing their research is safe.


411 on Y2K

For more information, see NIH's Y2K homepage, <http://irm.cit.nih.gov/y2000/>. It lists IC representatives on the Year 2000 Work Group and the Medical and Laboratory Work Group and provides links to both the biomedical equipment clearinghouse and a parallel IT (information technology) clearinghouse. For general information, registration for Y2K classes, or assistance with ClickNet, call the CIT Help Desk at 301-594-3278.

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Alex Dent



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