Preventive maintenance tasks are at the heart of most medical equipment management programs, but no one much likes them. For technicians they can be tedious, and for clinicians they can be an interruption. Yet, in this case, routine preventive maintenance inspections uncovered a dangerous situation that affects whole categories of devices.
Wallace Elliott is a clinical engineer with Fletcher Allen Healthcare, a 450-bed hospital in Vermont. He and his staff of seven BMETs routinely inspect the hospital's 520 Sigma 8000 infusion pumps. In recent inspections, technicians noticed degradation of plastics in the chassis of the pumps. The chassis is the plastic housing that covers the device, protecting its internal components from fluid spills. Technicians were seeing most of the damage in crevices where fluid could pool, particularly where the infusion set is inserted into the device. In some of the components, cracks were causing chipping of the plastic. These cracks could allow fluids to enter the device, causing failures.
“Pump failures were experienced due to this problem,” says Elliott. “As a result, we inspected all 520 pumps. We found that the protective housing on approximately 200 pumps was compromised and had to be replaced at a cost of $75 to $185 per unit.”
Fortunately, the team's annual testing identified the problem before devices failed during clinical operation. “For us, the most significant consequence of the issue has been the financial impact of repairs,” says Elliott.
The infusion pumps were only two years old, and had an expected lifespan of seven years. Elliott suspected that the hospitals' cleaning fluid was causing the cracks, because it pooled on the devices exactly where the cracks were appearing. Pumps are cleaned between every patient. The cleaning protocol requires that the pumps be adequately covered with an antiseptic solution, which must be left on the device for a period of time in order to achieve the “kill factor” of the antiseptic solution.
“The manufacturer asked us what cleaning fluid we were using,” says Elliott. “It turns out that there is a very long list of cleaning fluids that Sigma does not want you to use, and a very short list of acceptable fluids.”
The manufacturer was very helpful in tracking down the problem, Elliott says. “They did extensive testing with fluids we sent them to try to identify the problem.”
Elliott and his team began inspecting other devices for damage to plastic housings. They found problems with syringe pumps and infant abduction identification bracelets that had to be replaced. Similar problems with surgical lamps were avoided because they were notified in time by the manufacturer of incompatibility between ingredients in a certain disinfectant spray and the Lexan polycarbonate resin used to make the lights. Problems have also been identified with circumcision boards and glucometers, and his team is currently checking pulse oximeters.
The hospital convened a committee of representatives from different departments including housekeeping, infection control, nursing, and clinical engineering to investigate the problem. “We began looking closely at user manuals and found that each manufacturer has a different list of acceptable fluids to be used to clean their device.” They discovered a wide-spectrum problem with device and cleaning fluid compatibility. “Solving this problem is not easy,” says Elliott. “Every manufacturer wants different fluids. There are no one or two commercial fluids that are acceptable for use on all or even most devices.”
While most devices permit cleaning using soap and water, the hospital's infection control department requires that devices in many environments be disinfected. It is these commercial disinfectants that created the problems with the plastics. Dilute bleach solutions and alcohol are alternatives to commercial disinfectants, but dilute bleach solutions need to be prepared on a daily basis and can be difficult to use on clinical units, and alcohol causes cracking of certain plastics.
Until the problems can be resolved, Elliott says that the hospital's housekeeping staff is using more bleach and alcohol to clean devices, and doing more centralized cleaning. “They have to be very careful about which fluids to use on which devices,” he says. “This is requiring a great investment in training for our staff, and it has created logistical problems with purchasing and storage to have the right fluids available where they are needed.”
“Manufacturers are aware of this problem, and quick to say that hospitals are not following instructions in the user manual,” says Elliott. “That is, if you read the user manual, and most people don't. The manufacturers' sales people certainly don't emphasize this issue during sales calls, and it is not highlighted during training.”
Elliott's group has not focused on requiring clinical departments to pay closer attention to instruction manuals, he says. “Many instruction manuals are so long that to be realistic, we do not expect all of the fine print to be read by the clinical departments. Rather, we have attempted to change the acquisition process in such a way as to determine whether equipment has special cleaning requirements prior to purchase,” he says.
Elliott and his colleagues have begun discussing this problem with the FDA, which has not yet formed an opinion on the issue. “We would like to see greater standardization in this area,” says Elliott. “My hope is that manufacturers will start using plastics that are less susceptible to these types of problems. I would like them to do the design work that would eliminate this problem for us.”
As Wallace Elliott's story shows, clinical engineers at his facility are very involved in patient safety issues. Formally, a clinical engineering representative sits on the hospital's Environment of Care committee (formerly the safety committee), and chairs the Equipment Management subcommittee. They are routinely involved in incident investigations where a device may have played a role.
What is Elliott's advice to CEs or BMETs looking to play a bigger role in patient safety? “Find an advocate in the administration or on the clinical side that sees the benefit of having a biomed play a role. Once you have an opportunity, make the benefits of your participation obvious.”
BMETs' combination of technological and clinical skills makes them essential members of the safety team, Elliott argues. “Healthcare has become so reliant on technology,” he says. “Someone must be sitting at the table who understands the shortcomings of technology and can relate those to potential safety problems. A hospital is missing a key piece of the safety puzzle if they don't include that expertise.”
Plus, Elliott says, equipment professionals are uniquely qualified to work with manufacturers to encourage changes in device design to improve equipment safety. Achieving such changes takes knowledge and persistence. “Manufacturers often prefer working with the clinical staff because they can be easier to brush aside,” says Elliott. “Clinical engineers stay in the manufacturer's face until something is resolved.”
Technician T.C. Bugbee performs functional tests on infusion pumps at Fletcher Allen Health Care in Burlington, VT.
Technician T.C. Bugbee performs functional tests on infusion pumps at Fletcher Allen Health Care in Burlington, VT.
