Steps you should take to be compliant in 2000
Steps you should take to be compliant in 2000
Determining whether your medical devices will pass muster when the year 2000 rolls around is a daunting task. Here are some suggestions by experts who spoke to Critical Care Management:
1. Conduct an inventory and prioritize. Inventory all equipment and prepare a priority list - high, medium, and low - of the equipment that should be checked, says Anthony Montagnolo, vice president of technology for ECRI, a nonprofit technology assessment company in Plymouth Meeting, PA. "At this point, if you try to investigate every medical device, you won't have time and you'll expend a lot of effort testing devices that don't have to be tested."
The most critical equipment will likely include life-support and critical monitoring devices, such as anesthesia units, defibrillators, fetal monitors, hemodialysis units, infusion pumps, imaging devices, radiation therapy systems, and heart-lung bypass units.
2. Perform a documentation audit. This examines any contractual documents, warranties, service agreements, and other documents that may have an impact on year 2000 problems. At least make an effort to have equipment suppliers resolve year 2000 problems at no charge for devices that are still on the market. This is especially true of devices that will be covered under a service contract when the new century arrives.
3. Contact your suppliers. Even if you are internally prepared, your operation could be severely impeded if your suppliers aren't. Determine whether they will be able to supply you with the gloves, needles, drugs, disinfectant, and countless other items vital to your unit, says Scott Shuster, president and CEO of Intuitive Technologies Consultants in Atlanta, which specializes in year 2000 problems.
He says that small to mid-size companies are among those least prepared for year 2000, including those that supply hospitals. Federal officials have estimated that up to 20% of small businesses could fail because of year 2000 computer problems. "These companies are operating on an invoice basis, with much smaller volume and profit margins," says Shuster, a former medical practice administrator. "If they don't solve their millennium problems, these companies will dry up and the hospital will be unable to obtain the supplies they need to continue in operation."
Contacting suppliers about their compliance situations gives you a better idea about potential problems. In any case, the experts say it would be wise to overstock critical supplies toward the end of 1999.
4. Document your efforts. "The lawyers are swarming," says Joel Ackerman, executive director of Rx2000 Solutions Institute in Minneapolis. The anticipated glitches year 2000 will cause in all industries could produce a feeding frenzy of lawsuits. This makes it important that you document your hospital's efforts to get answers and solve the problems.
First, adopt a standard form letter signed by a senior executive that is sent to all suppliers specifically asking for a statement of year 2000 compliance, says Montagnolo. Ask for a written response. This can be a "logistical nightmare" and you may want to consider outsourcing it, he says. Remember that the more verification you compile, the less testing you'll have to do.
5. Test critical equipment. This is a time-consuming process, and if you're not already well into the process, you need to prioritize. You can save some time by keeping in mind how your devices are used, says Marion Powell, RN, the head of year 2000 compliance for Egleston Children's Health System in Atlanta. "One of our pulse oximeters wasn't compliant for date. But the date was only used on reporting strips, and we don't use that functionality, so it wasn't a big problem for us. The machine will still function the way it is being used after the year 2000. But in another device, the date may be part of that machine's function, and it can't accept the year 2000 - then that's a problem."
Montagnolo also suggests you consider outsourcing the testing function, a step Powell has taken. But you'd better hurry. Experienced technicians are already in short supply, and the available pool of technicians will shrink even further as we move closer to 2000.
6. Repair or replace problem equipment. For devices that can be repaired, contact the supplier. Use your negotiating skills, says Montagnolo. If the equipment is under warranty or a service contract, you might be able to have it updated for free. But don't count on that, he says
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