Y2K problems possible with biomedical equipment
January 1, 1999 4 minutes read
Y2K problems possible with biomedical equipment
10% of rehab technology may be affected
(Editor’s note: This month’s issue includes the second part of a two-part series on preparing your rehab program for Year 2000 [Y2K] compliance. In the last issue, we told you how to ensure that your computer systems are up to date. In this issue, you’ll learn how to check your biomedical equipment and what contingency plans you need to make to be ready for Y2K.)
If you are a typical rehab provider, you can expect that about 10% of your biomedical equipment may be subject to potential failure when Jan. 1, 2000, rolls around, some Y2K experts say.
About 10% of the biomedical equipment used in rehabilitation facilities will be subject to Y2K problems, compared to about 30% of equipment in acute care hospitals, says Evelyn Wright, CBET, RN, district service manager for ISS in Plymouth Meeting, PA. ISS performs preventive maintenance and repair for hospital-based equipment and computers. (For types of equipment that may be affected, see story, p. 5.)
If your patients are on ventilators, heart monitors, infusion pumps, or critical care equipment, you must be particularly careful to ensure that patient lives won’t be endangered by malfunctioning equipment, Wright says.
Gayle Finch, director of the office of information technology analysis and investment for the Department of Health and Human Services, says, "Most biomedical equipment tends not to have a Y2K compliance problem, but for machines that do, it can be a big problem."
For instance, your hospital may occasionally experience the failure of an infusion pump or a ventilator, but if all of them go out at once, there can be catastrophic results. (For more on Y2K contingency plan, see story, p. 11.)
The Food and Drug Administration (FDA) has mailed letters to about 13,000 manufacturers of medical devices asking them to send in information assuring that their products are year 2000 compliant, or if they’re not, explaining what they’re going to do to fix them. A database of manufacturers’ replies to the FDA directive is available on the internet at the FDA Web site, www.fda.gov/cdrh/yr2000/y2Kintro.html.
"Only a small percentage of the equipment they manufacturer has an electronic component, and only a subset of that will have any problems," Finch says.
Federal experts on Y2K recommend that providers get in touch with the manufacturers of the equipment they use and obtain letters of assurance that the equipment will not malfunction in the year 2000.
"With biomedical equipment, we think the onus is on the manufacturer to be responsible for compliance since they are responsible for functionality," says Jaren Doherty, program manager at the National Institutes of Health.
For instance, the technology staff at National Rehabilitation Hospital in Washington, DC, is working with its clinical instrumentation contractor to compile a list of all equipment that may have problems, says Michael Rosen, PhD, director of rehabilitation engineering services. This list includes all biomedical equipment that has built in microprocessors, microcomputers, or micro controllers that may have a problem with a date-sensitive embedded chip. The hospital has sent certified letters to manufacturers asking them for assurances that their equipment is Y2K-compliant and, if not, asking for any remedies that are available. (For tips on how to make certain your equipment is compliant, see story, p. 6.)
As the letters are received, the technology staff check that piece of equipment off the list.
A Y2K committee comprising people from throughout Shepherd Center in Atlanta started in late 1997 to check every possible piece of equipment and system in the specialty rehabilitation hospital for compliance, says Gary Ulicny, PhD, chief executive officer.
The committee represents a cross-section of staff that includes clinicians, computer experts, financial managers, and representatives from the heating plant and maintenance department.
The committee compiled a list of every potential piece of equipment that could be affected, from elevators and computer-controlled lighting systems to ventilators and the equipment that monitors the heat in the therapy pools.
Shepherd has contacted every vendor for every piece of equipment and asked for letters of compliance. The committee expects to have completed its work by June 1999, Ulicny says.
Many manufacturers are offering a patch for their noncompliant products, and sometimes it’s free, Finch says. She advises providers to check their contracts with vendors to see what the manufacturers are required to perform in terms of preventive maintenance and general system maintenance. In some cases, Y2K compliance may be included.
Replacing equipment
Some of the smaller companies may go out of business rather than spend the money it will take to make their equipment compliant, or they may declare that the equipment is obsolete and refuse to fix it, Wright warns. In that case, providers have no choice but to purchase replacement equipment.
If your equipment is 10 years old, you can assume that the embedded chip won’t be Y2K compliant, Doherty adds.
A good rule of thumb is that if 10% of your equipment inventory is subject to Y2K problems, plan on spending 10% of your capital budget for the next two or three years on upgrading or replacing that equipment, Wright suggests.
Sources
For more information on the Y2K problem contact:
• Jaren Doherty, Y2K Program Manager at the National Institutes of Health, Center for Information Technology, Office of Information Resources Management, 6100 E/2B-03, 6100 Executive Blvd., MSC7505, Bethesda, MD 20892-7505. E-mail: [email protected]. World Wide Web: http://www. oirm.nih.gov/y2000/.
• Standards Division, Joint Commission on Accreditation of Healthcare Organizations, 1 Renaissance Blvd., Oakbrook Terrace, IL 60181. Telephone: (630) 792-5900. Fax (630) 792-5942. E-mail: [email protected]. World Wide Web: http://www.jcaho.org.
• The President’s Council on Year 2000 Conversion, Room 115, Old Executive Office Building, Washington, DC 20502. Fax: (202) 456-7172. World Wide Web: http://www.y2k.gov.
• Food and Drug Administration, Attn: Y2K Medical Devices Coordinator, Center for Devices and Radiological Health, Mail Code HFZ Y2K, 9200 Corporate Blvd., Rockville, MD 20850. World Wide Web: http://www.fda.gov/cdrh/yr2000/y2Kintro.html.
• ISS, 525 Plymouth Road, Suite 305, Plymouth Meeting, PA 19462. Telephone: (610) 825-7900.
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