No matter whom you talk to in the biomedical field, there is no denying the paramount importance of test-equipment calibration. Regardless of the expert and his connection to the biomedical field, and regardless of the facilities involved, there is universal agreement that institutions would be much better off if all test equipment was routinely calibrated according to strict industry and hospital standards. The operative word here is “if,” as in “if” there were industry regulations and “if” there were across-the-board standards prescribed by every medical facility in the country.

Unlike the aerospace or pharmaceutical industries, which set strict guidelines for the frequency of the calibration of sensitive equipment, the health care industry places the responsibility squarely on the shoulders of each hospital’s biomedical department. That leaves a lot of room for interpretation of guidelines and consideration of the bottom line. Some test-equipment manufacturers suggest a calibrating frequency of once per year; others recommend every 6 months, but these suggestions and recommendations are only as effective as the people who choose to follow them.

“I think there is a lot of room open to interpretation in our entire field,” explains Michael Kauffman, CBET, assistant director of facilities at Reading Hospital in Reading, Pa. “This is certainly one area that can be interpreted in a number of ways. That’s why I believe some people are following it to gather the most stringent data, as opposed to some people who are not (calibrating test equipment) at all. Then there are those who are taking the middle-of-the-road approach and adopting something very practical.”

The wide range of options is a by-product of biomedical departments searching for solutions to very real questions, including:

• What do I do when there are no universal standards that mandate the frequency of calibrations?
• How can I pay for the cost of having test equipment calibrated?
• What do I do when it takes as long as a month to have my equipment calibrated by a third-party manufacturer?
• Do I risk extending or eliminating the calibration process altogether?
• What are the chances that calibration frequency will be a focal point of a lawsuit?

Why Calibrate?
Calibration of equipment serves two major purposes, notes Duane Mariotti, an independent consultant and former director of clinical engineering at Harborview Medical Center in Seattle, Wash. First, to make sure a hospital-wide, up-to-date technical standard exists; and second, to ensure that if a legal issue arises, the technical standard in question can be used as proof that a policy was in place.

In most instances, calibration comes under the heading of operation verification. Tests are conducted to determine if the equipment is still performing within its calibration specification. More often than not, preventive maintenance is all that is required to determine if the piece of equipment is operating within performance standards. A certificate is issued once it is determined that the device is in “tolerance.” However, if the device is not in tolerance, the problem should be verified and documented and the device should be calibrated. The technician also must backtrack to determine the purpose of the piece of equipment, as well as any other device with which it may have come into contact.

“Most modern test equipment is very reliable,” Mariotti adds. “The problem occurs if a piece of test equipment is not calibrated. Then, that piece of test equipment may be suspect in anything else that the piece of test equipment was used for. It can involve something as simple as an electrocardiogram simulator or as complex as a voltmeter used in an x-ray room. If you have to have 5 volts of accuracy, and this thing has been dropped and beaten around and hasn’t been calibrated in the last 5 years, how do you know the device is as accurate as it needs to be for the job you’re asking it to do?”

Maintaining that the ramifications of using a device in need of calibration can run the gamut from minor to deadly, Kauffman relates, “In the case of an electrosurgical unit, it can result in too much energy going out and the patient being burned. If you are cauterizing the fallopian tubes of a woman, the power output better be correct or the procedure could take longer or not be effective at all. I don’t want to go off the deep end and say someone could die, but ….”

“Physicians and nurses look at monitors to determine someone’s blood pressure or heart rate,” Kauffman adds. “And they are very often treating patients because the blood-pressure reading on the machine is reading either high blood pressure or low blood pressure. If they’re going to give you drugs because the monitor is reading one thing, then that reading better be accurate and the equipment we use to check the machines better be accurate.”

What Needs Calibrating?
The good news is that not all test equipment needs to be calibrated.
“It all depends on the piece of equipment and how important the dose or therapy is to the patient’s well-being,” explains Dave Ball, CBEWT, who works in the calibration department for a Clearwater, Fla, medical original equipment manufacturer. “If the patient is in a life-threatening situation, then you want to make sure the device is calibrated more frequently and remains very, very accurate. If the machine is actually giving a result or giving a specific dose, then the unit needs to be calibrated so it ensures the safety of the patient. However, if the risk to the patient is going to be negligible, I wouldn’t be so worried about the calibration.”

Mariotti disagrees, maintaining that the integrity of any piece of equipment will be compromised if it has not been properly calibrated.

“I believe everything related to test equipment has to be calibrated on a routine basis,” he insists. “You never know what piece of equipment is going to be used for what. From a purely risk-management legal standpoint, it’s better to have everything calibrated so there’s never a question that somebody is using an uncalibrated piece of equipment for some critical measurement.”

Kauffman places himself somewhere in the middle of the calibration debate, maintaining that the type of equipment often determines whether or not it needs to be thoroughly regulated. He notes that Reading Hospital has adopted a philosophy that mandates that any type of equipment that measures energy—a digital multimeter (DMM) or a voltmeter—must be held to the highest standards of calibration because it is measuring voltage. Power supplies, however, are another matter entirely.

“A power supply, which is another piece of test equipment, I don’t believe has to be calibrated because you already have other equipment in the shop that can double-check its output power,” Kauffman explains. “If you’re going to need to set something at 5.15 volts, you are going to need to check that 5.15 volts with a calibrated DMM. It’s not worth it to spend the money to get your DC power supplies calibrated.”

Kauffman calls his calibration philosophy “practical, as opposed to purely theoretical.”

“There’s equipment that needs to be calibrated and equipment that does not, and I do that just to save money,” he says, noting that his facility spends around $4,000 per year in calibration costs. “If you have three oscilloscopes, do you really need to get all three of them calibrated, or can you have at least one calibrated to be on hand if you need it to be perfect? It all comes down to how much money you have, what you think is practical, and where you want to spend it.”

Kauffman says that Reading Hospital has about 90% of its equipment calibrated in-house by a third-party vendor. The remaining 10% is shipped to the vendor’s company for calibration, which can take days, weeks, or even months.

“We try to send pieces of equipment on months that we’re not going to use it or that we have duplicates in-house. One might be higher-end than the other,” he relates. “For example, we have two different flowmeters that can be used in our respiratory care unit. One is a super high-end device we use most of the time, and one is a pretty good backup device. When we send one out, we try to do it in a month when respiratory maintenance is not scheduled. We use the backup equipment if we need it.”

Kauffman says he’s lucky Reading Hospital has duplicates of most equipment. But that is not the case with many medical institutions, especially smaller facilities trying to stretch an ever-decreasing budget.

“(Smaller hospitals) may believe it is very important to have their equipment calibrated,” Mariotti admits, “but the expense also forces them to consider letting it slide for a year. The perceived gain is not as great as something else that may be needed at the time.”

The Pitfalls
Test-equipment calibration remains a specialized, highly technical field. Biomedical departments are left with three options: bite the bullet and strictly follow manufacturers’ recommended guidelines, extend the time between calibrations to save a little money, or not do it at all. All three choices come with their own set of potential pitfalls.

“Many smaller hospitals may decide not to have their test equipment calibrated, because they don’t see the need for it,” Mariotti states. “It’s incredible, and it’s unfortunate, because that just leads to a number of other issues down the road from both a technical standpoint and a risk-management standpoint. That kind of approach can open a whole can of worms from a legal perspective. Should something happen, it is pretty hard to get yourself out of it. The longer you go without calibration, the more it brings into suspect the entire program. You leave the hospital at risk and the employer at risk because you don’t have a program in place.”

Mariotti insists that a consistent test-equipment-calibration program should be standard operating procedure for biomedical departments.

“Other industries treat (calibration) as a cost of doing business,” Mariotti says. “There are numerous other industries where the cost of calibration is accepted. Unfortunately, there are not those standards, except common sense and legal risk management, for test-equipment calibration in the health care industry.”

Mariotti suggests it is up to health care leaders to develop a complex set of rules and regulations for the calibration of test equipment. “If people believe the standards need to be more rigid, it’s up to the folks in the industry to go back and make the test so that it meets the needs of everybody involved.”

“I would be willing to bet that there are some hospitals’ biomed departments that never have their equipment calibrated,” Kauffman suggests. “The risks of not calibrating within the manufacturer’s recommendations are typically only when the equipment is made part of a lawsuit. At that point and time, the attorneys want to see everything, and that includes what type of equipment was used and the last time it was calibrated. The risks are there and they’re not huge, although some of my colleagues would disagree. The risks are great if there’s a lawsuit or if someone gets hurt or injured.”

Ball believes the risks far outweigh the rewards—until your facility is named in a legal action—and that the degree of liability remains at the crux of the test-equipment-calibration issue. The medical industry, he notes, sees patients as single entities. “You’re talking about a few people at risk if a piece of equipment either has not been calibrated or has not been calibrated in a long time.” However, the aerospace and pharmaceutical industries view their clientele among the millions. In those cases, Ball says, “If some equipment is not up to standard, hundreds of peoples’ lives are at risk.”

And with no new standards in place, facilities are left to decide for themselves what is best.

“I don’t think the Joint Commission on Accreditation of Healthcare Organizations has ever shut anybody down,” Ball says. “Show me where they have actually shut anybody down (for not calibrating their test equipment). It just doesn’t happen. It’s all about money; that’s what it comes down to.”

Ball explains that medical institutions will only be forced to take a more proactive posture at maintaining strict test-equipment-calibration procedures when they are hit where it hurts—in the wallet.

“Spend 1 day in court, and they will have the equipment calibrated every year, no matter what the cost,” he maintains.

Whether or not to calibrate, when to calibrate, and how seriously to take the issue of calibrating test equipment ultimately rests with each individual facility.

“Calibration is one of the cornerstones for any good equipment-management program,” Mariotti insists. “If you’re going to have a program that is performing to industry standards, then it is important that you have a successful and well-run calibration program purely from a risk-management standpoint. It also shows the professionalism of a shop and staff that they realize that their test equipment has to be in the best condition, because they’re using it to test everything else in the hospital.”

Dave Cater is a contributing writer for 24×7.

Correction
In “Implementing an Indoor Positioning Solution” (Service Solutions, April 2006), the technology chosen by Brigham & Women’s Hospital was an active-RFID system from Radianse with receivers that connected to its existing network. The hospital, which does use a wireless network for mission-critical applications, needed a higher degree of location precision (where something or someone is) and accuracy (how certain the location is) than its evaluation indicated WiFi technology offered.