Y2K Compliance at Duke Outlined as Model Plan

Larry Dowell

[Editor’s Note: Y2K computer issues continue to be significant concerns for hospitals because many medical devices such as monitors, defibrillators, and even infusion pumps may have so-called "imbedded chips" that may be date sensitive. Accordingly, this new addition to our series on Y2K anesthesia patient safety issues comes from a large anesthesiology department that has expended extensive effort on Y2K compliance.]

by Larry Dowell

Medical devices whose operation depends on tracking dates with the year could be affected by Y2K. ECRI, an independent industry leading nonprofit organization "devoted to improving the safety, efficacy, and cost-effectiveness of healthcare technology", defines three categories into which devices and systems fall. The first is Information Systems, second Medical Devices and third General Hospital Systems. Visit ECRI on the web at http://www.ecriy2k.org.

FDA Compliance Definition

"For the purpose of this product status reporting, Year 2000 compliant means, with respect to medical devices, that the product accurately processes and stores date/time data (including, but not limited to calculating, comparing, displaying, recording and sequencing operations involving date/time data) during, from, into and between the twentieth and twenty-first centuries, and the years 1999 and 2000, including correct processing of leap year data." Additional information may be found on the FDA Year 2000 web site regarding the Year 2000 issues.

The focus here is primarily on medical devices in anesthesiology, in particular physiological monitors, and anesthesia delivery and ventilation systems. Another area specific to the Duke University Department of Anesthesiology is the automated anesthesia medical record. The majority of the peri-operative monitors at Duke are the Hewlett Packard 78352A. Since this particular monitor does no date-related processing, it is classified as compliant by definition. If you are using other H-P products, go to their Year 2000 site:

http://www.hp.com/year2000

and to their product compliance database

http://www.hp.com/y2kdb/index.html

and use the search engine to check compliance for your particular product model.

An important area of concern for all should be the anesthesia delivery and ventilation systems used in any specific facility or department. There are two major suppliers of delivery systems in this country, North American Drager (NAD) and Datex-Ohmeda. North American Drager (http://www.nad.com/ yr2000.htm) has compliance testing on their product line and lists the results in an easy to read table. For example, the NAD Compact and the 2A anesthesia machines do not process any date and time information so life support functionality will not be affected. The 2B-anesthesia machine that does process date and time information pass the stand-alone and data out compliance test.

Datex-Ohmeda (http://www.datex-ohmeda.com) has published the results of their Y2K testing on their product line at:

http://www.datex-ohmeda.com/y2k_vent.html

Duke’s inventory of Datex-Ohmeda products includes anesthesia machines, ventilators, vaporizers and Harvard syringe pumps. Because none of the devices in the Duke inventory handles date and time, their functionality will be unaffected when the calendar rolls over to 2000.

The key question for practitioners to ask is do their monitors and anesthesia delivery and ventilation systems handle date and time? By and large, most anesthesiology departments currently have very few pieces of life support equipment that handles date and time and, therefore, will be unaffected by the transition to January 1, 2000.

The area of greatest concern should be in the institutions that are very heavily involved with networked and stand-alone information systems that are used to create the medical record, patient tracking systems, billing, laboratories and building automation systems.

Mr. Dowell is Manager, Support Services, Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina.