Today’s surgical units and intensive care units (ICUs) are equipped with a dizzying array of physiological monitors designed to constantly monitor heart rate and rhythm, breathing, blood pressure, body-fluid balance, body temperature, and consciousness levels. Since these devices are essential in assisting medical personnel in making critical life-and-death decisions, it is imperative that they are reliable and safe. The good news is that in recent years, technological advancements have made physiological monitors relatively fail-proof.

Biomeds tend to agree that most physiological monitors today have minimal servicing needs—from both a preventive maintenance (PM) and a repair standpoint. On the flip side, due to the complex nature of many of these monitors, if there is a problem with an ECG, EEG, noninvasive blood pressure monitor, or multi-channel ICU monitor, it can be more challenging to solve than in years past when the equipment was more mechanical in nature and less software-driven.

Although most modern patient monitors require minimal maintenance and use built-in calibration systems, biomeds are still responsible for some basic PM tasks. At Reading Hospital and Medical Center in Reading, Pa, biomeds are required to make regular visual inspections and performance checks of the equipment.

“Instead of conducting preventive maintenance on every device, as we used to, we focus on those monitors that are used most frequently and look at things such as the quality of the display and the operation of the touch screen,” says Chuck Donmoyer, CBET, lead biomedical technician at Reading Hospital and Medical Center. If the monitor has a cooling fan, regular filter cleaning is scheduled. “We also make a point of asking nurses and other staff to find out if a monitor is acting sluggish or if something doesn’t seem quite right,” Donmoyer says.

Practically Fail-Proof
The major reason today’s physiological monitors are so dependable is that manufacturers are required by the US Food and Drug Administration (FDA) to ensure that their products are safe and reliable. The manufacturer and the FDA both must be certain that the product meets certain specifications for design and other standards, such as those of the International Organization for Standardization. Yet even though medical equipment today is probably at the highest level ever of reliability and safety, problems can arise particularly in areas with high utilization.

“A patient monitor in an ICU or an emergency room that’s on 24 hours, 7 days a week, will likely experience a higher failure rate than a monitor in an endoscopic room that is only turned on during the procedure,” says Mike Balakonis, founder and president of Miami-based MedEquip Biomedical.

Despite such relatively low failure rates, there are occasions in which a patient monitor needs to be replaced with a loaner. Most hospitals have an inventory of loaner devices, although some institutions have such a tight cap on inventory that they need to schedule an emergency service call with the manufacturer when a monitor fails. “Hospitals with a 20% patient census have plenty of ways to supply backup equipment to specific departments, but hospitals with a 80% to 90% census don’t have that luxury,” Balakonis says.

Even though monitors involve complex IT-based medical technologies, Donmoyer notes that many can still be repaired adequately by in-house biomeds. “We try to fix whatever we can,” Donmoyer says. “Many times it’s a small repair, involving a connector or connector assembly instead of requiring replacement of the whole monitor.” In other instances, the repair involves a large subassembly that needs to be swapped out, requiring a call to the manufacturer. “I would say that the biggest challenges are software compatibility and whether a specific part is in stock,” Donmoyer says.

In many cases, what initially is cited as an equipment failure ends up being a lack of knowledge or training on the part of the user. In fact, most biomeds agree that user/operator issues, rather than outright device failure, are the most commonly reported problems with equipment reliability. According to Balakonis, one disturbing trend is the growing shortage of nurses and other clinicians, which has caused many hospitals to rely heavily on temporary staff and floaters. “Temp nurses can be every bit as competent as permanent ICU nurses, but in many situations they’re suddenly dealing with a monitor they haven’t seen before,” he says. A shortage of anesthesiologists who supervise patient monitoring during surgery has also been a problem. These shortages of clinical staff are placing more demands and stresses on caregivers, preventing them from understanding the full capabilities of every monitor.

Since physiological monitors are microprocessor-based, manufacturers find that it is relatively easy to build in features that they hope are perceived as valuable, such as long-term trending and drug calculations. However, just as many consumers of home electronics find that a greater number of bells and whistles does not always translate into a better product, nurses and other staff often disregard these additional features. Most of these features are accessible only with a code or password, yet many clinicians end up getting a monitor into a mode not intended for its current utilization. As a result, a nurse or another staff member may think the machine is nonresponsive due to an equipment failure, but a device check results in a “no problem found” scenario. According to Donmoyer, education is the best way to remedy this situation.

Operator Education
In terms of educational programs, manufacturers offer on-site and off-site clinical training related to specific purchases of physiological monitors as well as computer-based training, which is useful for new-hires as well as for employees who are in need of a refresher course. Donmoyer stresses that biomedical departments should also take advantage of additional training from manufacturers, even if they must pay for the service. These courses cover PM tips as well as educational tools for biomeds on how to teach nurses to use the monitors properly. Some manufacturers offer reimbursement for the costs of lodging, meals, and airfare associated with these seminars.

Reading Hospital and Medical Center also relies heavily on superusers—key individuals on the nursing staff who are knowledgeable about the equipment and serve as an educational resource for other nurses and medical staff. There are typically two to three superusers per shift who are available to answer questions about the monitors.

If there is a problem with a specific monitor due to the end-user, it is typically the biomed department’s responsibility to evaluate the situation and record if the device is too difficult to use or if the staff needs more education and training to operate it correctly. According to Balakonis, problems associated with physiological monitors must be documented precisely to determine the best solution. “If the biomed department is recording too many ‘no problems found,’ that’s a red flag that education needs to be reinforced,” he says.

With some physiological monitors, too much information and too many waveforms are displayed, resulting in “information clutter” that can confuse users and possibly cause them to miss critical events. In addition, many devices have numerous alarm options that bring about “car alarm syndrome,” a situation in which so many alarms are going off that a person becomes desensitized and can react sluggishly when a critical event actually does occur.

Alarm Management
Donmoyer stresses that the best way to solve this problem is to enact an alarm-management strategy, which simply involves customizing the alarms. For example, regarding bed-to-bed alarms, it makes sense not to have a patient alarm activated on every bed in a unit. “If a nurse is responsible for only four beds, you want only those four beds alarming to each other,” he says. “Then you wouldn’t have other alarms going off constantly, particularly if they’re on the other side of a unit and don’t involve patients that the nurse is responsible for.”

Balakonis concurs that biomeds can easily adjust the equipment to weed out unnecessary alarms and information. Specifically, he suggests that configurations can be made based on the acuity of a particular patient. “If a patient doesn’t need four invasive pressure lines, it’s unnecessary and confusing to have that on the screen menu when with the simple push of a button, there could be a clean screen,” he says. “In the end, it’s up to the end-user to configure properly; but then again, they need to be properly trained to be able to do this.”

To ensure that the best technology is acquired, biomeds should play a major role in the prepurchase evaluation of equipment. “At our hospital, we are very involved in this process and it does make a big difference,” Donmoyer says. “Since it’s a team effort, in the end we get what we want and the hospital gets what it wants.” In most hospitals, the biomedical department has an important voice in determining whether the institution’s requirements match the device’s applicability. Specifically, biomeds are consulted to determine if the hospital has the proper operating environment for the equipment to prevent malfunction or failure due to operating-environment factors, such as heat, humidity, incorrect voltage, or inadequate water supply.

Although biomeds are able to handle most basic servicing needs in their own shops, the complex nature of today’s monitors are making it increasingly difficult to make large-scale repairs involving networked systems. “Even though these monitors are more reliable than in years past, we’re getting to the point where very specialized soldering equipment and skills are needed to replace discrete components on the circuit boards,” Balakonis explains. He adds that repairing physiological monitors is also challenging because most manufacturers do not provide schematics of their products due to their desire to maintain proprietary control. “Ten years ago, about 20% of medical equipment manufacturers’ revenue was in service, but now it’s close to 50%,” Balakonis says. “It makes sense that the manufacturers would want to keep some of these aftermarket servicing opportunities out of the hands of third parties.”

“In the past, there was no other option other than going to the manufacturer for parts or service,” Balakonis says, adding that he founded his company to create an alternative resource for hospitals seeking repairs and servicing of physiological monitors and monitoring service components.

As patient monitors continue to become more complex and present new challenges to biomeds, companies such as Balakonis’ will play a critical role as a cost-saving alternative for providing service and support of this type of equipment.

Future Challenges
Donmoyer points out that one of the biggest challenges for biomeds today is developing the networking skills that are necessary in working with today’s monitors, which are typically integrated using a central controller that captures numeric and waveform data generated by multiple monitoring devices. An understanding of physiological monitors designed with software-based features requires core competencies that must be mastered by biomeds as well as other hospital staff. “In some cases, this will involve on-the-job training in which biomeds will be required to train under those individuals who have advanced computer and networking skills. But in other cases, they will probably be required to obtain off-duty training,” Donmoyer says.

As an expert in the field of patient monitoring, Balakonis also predicts many challenges for biomeds in the years ahead. “In the future, almost every medical device will be tied into the IT backbone of the hospital,” he says. “More and more wireless technology will be employed, and biomedical technicians will have to evolve to survive.”

This may sound daunting to some in the field, but it also gives biomeds the opportunity to assume greater roles within the health care setting and will improve the overall level of patient care. Real-time monitoring of critical care patients will help the hospital team intervene earlier to avoid adverse events and improve patient outcomes. As a result, biomeds will be viewed as an integral part of making the most of this new technology. As Donmoyer stresses, “The biomed techs who have networking and advanced computer skills will not have to worry about job security.”

Carol Daus is a contributing writer for 24×7. For more information, contact us at