Medical equipment may fail if Y2K-susceptible
Contingency procedures can keep disaster at bay
Rural and inner-city hospitals are at special risk for year 2000 (Y2K) glitches because they often have fewer resources available to address problems. If your hospital is in this position, experts suggest you put contingency plans in place. This can range from taking equipment out of use until you can fix it to adding validation steps to an automated process. For example, a patient monitoring device may be found to have computation problems that cause errors in condition reporting. An emergency plan may limit use of that device to non-life-threatening coverage. You might have nursing personnel take manual blood pressures every two hours to validate device readings. Affix Y2K tags to devices that specify usage limitations, and educate all staff on contingency procedures.
Equipment that is Y2K-susceptible can be categorized by patient risk levels:
• High-risk equipment is used for life support, resuscitation, or critical monitoring and is likely to seriously harm a patient if it fails. In this category are dialysis units, fetal monitors, ventilators, and defibrillators.
• Medium-risk equipment could have a significant impact on patient care if it fails, but its failure does not pose immediate harm. In this category are ultrasound scanners, blood gas/pH analyzers, apheresis units, and flow cytometers.
• Low-risk equipment has no impact on patient safety. Diathermy units and fax machines fall into this category.
Medical equipment-related problems might be fixed by changing the operating hours of affected departments. For example, if one catheterization lab becomes noncompliant and a radiology department normally relies on three catheterization labs, close down the inoperative cath lab and extend the hours of operation of the remaining two labs. Compensate for this adjustment by tightening patient scheduling.
You cannot rely solely on medical device manufacturers to certify products as Y2K-compliant. According to Alan H. Magazine, president of the Health Industry Manufacturers Association in Washington, DC, the Y2K problem is extremely complex for the device industry because of the nature and wide diversity of products manufactured — from monitoring equipment and medical information systems to laboratory instruments and pacemakers. Each company has different problems, and in the majority of cases, solutions developed by one company do not apply to others. Equipment companies take this issue very seriously, Magazine states.
ECRI’s Web site, www.ecriy2k.org, contains information about a medical device database against which you can compare your device inventory. The "Knowledgebase" categorizes all devices by risk level so you can determine the risk each device poses. For more information, call (610) 825-6000, ext. 5273.
At the beginning of this year, the Food and Drug Administration (FDA) warned hospitals and practitioners that the date bugs expected to produce problems on Jan. 1, 2000, were affecting some medical devices a year early. Early programmers never considered that their handiwork would still be used at the turn of the century, and some used the characters "99" to indicate undated items or data file endings.
This unwelcome news first came via messages posted on an Internet listserv warning that 15 instruments from seven manufacturers were not able to accommodate the transition from Dec. 31, 1998, to Jan. 1, 1999. The FDA contacted the device makers, and two verified that their equipment might experience some impairment of function on 1/1/1999. The others reported that their devices should experience no difficulty in this transition, but may have problems moving from 1999 to 2000.
The two products with verified problems work properly in direct use, so immediate patient care is not affected. They do present a potential for confusion and incorrect records, however. Their problems relate to their ability to display, print, or store the correct time and date of operation.
One product, the Hewlett-Packard 43100A/ 43200A external defibrillator, will defibrillate properly but will print out "set clock" rather than the month, day, hour, and minute on the paper event record. On trying to reset the clock, the CRT will display a 1985 date. The manufacturer advises it should be reset to 1998 — not 1999 — after which the unit will work properly for the year 1999 because the event record only prints the month and day and does not print the year. At the end of 1999 it will need to be reset again, from 1998 to 2000, after which it should work properly.
The second product, Invivo Research’s Millennia 3500 multiparameter patient monitor, has a potential New Year’s Eve problem on every year including 1998 and 1999. For products manufactured before December 1998, if the display clock is tested or reset as the year turns over, the display and internal clocks become compatible until the product is powered down and restarted. The display clock and paper record then might show different times and dates. The manufacturer advises the problem will not occur if the clock is neither tested nor reset on Dec. 31 or Jan. 1. Invivo is making available a software upgrade to fix the problem. This system has been sold since June 1996 and more than 2,000 are installed worldwide.
Other devices may exist with similar but unidentified "year 1999" problems. Pay attention to date displays and printouts and permanent records and date-recording features of all medical devices this year, as well as other possible date-related problems that may manifest in unexpected ways.
At the same time, states the FDA, be wary of messages posted on the Internet concerning transition problems. The fact that someone reports problems does not mean the problem has been confirmed. Consult the FDA’s Web site, www. fda.gov, for product information and links to manufacturers’ Web sites as a first step for further information. If you have a specific question about a product, contact its manufacturer for specific technical information. If you become aware of a date-related problem, notify the manufacturer and report the malfunction to MedWatch, the voluntary program for reporting problems to FDA, at (800) 332-1088; fax: (800) 332-0178.
[Editor’s note: Hewlett-Packard’s Web site is located at www.hp.com. Invivo Research can be contacted at (407) 275-3220.]