By Phyllis Hanlon
HTM professionals are taking a significant role in the fight against healthcare-associated infections. Here’s how.
In 2009, the Office of Disease Prevention and Health Promotion recognized the growing problem of healthcare-associated infections (HAIs) and released the National Action Plan to Prevent HAIs: Roadmap to Elimination.
The problem has persisted, however, and in 2011 approximately 722,000 HAIs occurred in acute-care hospitals across the country, according to Centers for Disease Control and Prevention (CDC) statistics. Healthcare systems and regulatory agencies have made this issue a priority, often collaborating to create policies that reduce and manage HAIs.
In September 2016, AAMI held a summit, Preventing Device-Related Healthcare-Associated Infections, to explore viable ways to achieve this goal. Experts from AAMI, the American Hospital Association, the CDC, the FDA and The Joint Commission offered insight and recommendations.
Joe Lewelling, vice president of emerging technologies and health IT at AAMI, reports that health technology management (HTM) professionals can—and should be—key stakeholders in these efforts. While HAIs are a “system issue,” the importance of HTM input and involvement has been somewhat overlooked.
“You have to look at all elements of the system, not only things like devices and associated issues, design problems, insufficient instructions for use, or inability to reprocess,” Lewelling says. “You have to look at the role of places and facilities and the way they are laid out, equipped, managed, and the actions of all people involved—not only clinicians and patients, but also others involved in interacting with devices or people in patient care areas.”
“HTM [professionals] need to be aware of patient risk and infection control practices and understand their part in ensuring practices are being followed during management of equipment,” he continues. “They need to understand their role in safety culture, be able to step in when they see problems, and ensure they’re addressed.”
Instructions for Use
When Lisa Waldowski, DNP, PNP, CIC, infection control specialist for the Joint Commission Enterprise, delivered her presentation at AAMI’s September summit, she cited manufacturers’ instructions for use as one of the “challenging components” of an infection control and prevention plan.
“Organizations aren’t adhering to manufacturers’ instructions for use,” Waldowski tells 24×7. “Either they don’t have them, they haven’t read them thoroughly, don’t understand them, or the information they’re seeking isn’t there.”
She encourages organizations to contact equipment manufacturers, get clarification from them, and then provide them with feedback. “They need to hear what your concerns are,” Waldowski says. Input from HTMs could also help influence product design in the early development stages of a medical device, as the creation of user-friendly instructions that have been tested in a real-world setting.
“We’re in busy environments, with tons of different technology and devices and equipment,” Waldowski says, emphasizing the importance of clear-cut instruction manuals to safeguard the patient. “How do we make sure each and every time [devices] are cleaned effectively, that have we provided the right tools and information to make [cleaning] easy so lapses and breaches and errors don’t occur?” she posits.
Waldowski also raises the issue of documentation as an industry-wide preventative measure. When infections do occur, she says, healthcare facilities have a responsibility to document and report incidents in a timely fashion.
“We shouldn’t have to wait years for data to be collected to find out about a device most of us are using,” she says. “All of us are impacted because we’re all using the same manufacturer. We could prevent further harm if we got the ball rolling and reported this information to regulatory agencies.”
Product purchase and training typically come as part of a package, but competency also factors into the picture. Waldowski points out that the onus is on the manufacturer to educate and provide training on a device, as well as necessary product updates.
Even so, she says, the recipient organization should look at competency and training of front-line staff and follow nationally recognized, evidence-based guidelines from professional organizations, such as AAMI and the CDC. “[That way], everyone benefits and is doing the same thing as required every time, not omitting steps or adding to breaches or potential harm to patients because they have systematized this process.”
When hospitals began shifting away from semi-private and toward private rooms, part of the justification was to prevent cross contamination of patients across the pull curtain, according to C. Wayne Hibbs, CCE, principal at BSA Life Structures. However, he points out that the source of contamination has not been eliminated since most bacteria is not airborne, but spread by touch.
“The problem is the bugs we’re treating can adapt and metastasize and become resistant to our antibiotics much faster than we can create new ones,” Hibbs says. “We’re still fighting multiple different types of problems and fighting them with much the same technique we’ve used for a number of years.”
More importantly, nurses and doctors still move from room to room with vital sign monitors, EKG carts, x-ray machines, and other devices and cover more surface area. “We are trying to keep all surfaces and areas clean in a hospital whose size has increased significantly,” Hibbs says. “So we haven’t really changed that major connection point of moving infections from patient to patient by going from semi-private to private rooms.”
One potential solution is to keep all point-of-care equipment in the patient’s room during the entire hospitalization period. “At discharge, housekeeping would do terminal cleaning on every piece of equipment,” Hibbs says. “However, most hospitals can’t afford this yet, but all are looking at it as a goal.”
Documentation and Reporting
Hibbs points out that medical devices can be divided into two categories: point-of-care equipment, including infusion pumps, vital signs, EKG, and ultrasound machines, which patients and the direct care staff nurse can touch, and core equipment located in the lab and serviced by the manufacturer or a third-party vendor. He explains that documenting usage, infection control practices, and evidence-based results on devices used in direct-patient care settings is challenging.
And based on his own experience, Hibbs reports that since HTM professionals are not directly involved with patient care, they have no seat at the table when it comes to setting policies and procedures regarding infection control/sterilization.
Even so, biomeds play a key role in non-direct patient care areas, such as the central sterile processing department, where they receive all instruments from surgical cases, then clean, decontaminate, sterilize, repackage, and prepare them for use with another patient.
“We have a lot to say about how that equipment is operated, calibrated, and the flow of work,” Hibbs says. “We have a voice and can affect changes that happen at that level because we are directly connected to the function and the results that have come out of that area.” In fact, he says, HTM professionals are “leading the charge” of making sure that every device touched is for the best of the patient and hospital.
Although HAIs are often associated with inpatients, there is a chance that biomeds could bring an infection out of the facility, unless they follow personal protection equipment policies. “If the hospital has an outbreak, I have to make sure that [the infection] doesn’t go home on my scrubs, shoes, or the pencil in my pocket,” Hibbs says. “We’ve been training nurses for years about this, but just the last couple of years we’ve gotten to talking to biomed people about this take-home situation.”
It’s no surprise that HTM professionals currently face a time crunch in terms of having sufficient time to complete their work and engage in adequate training. “
The problem is having enough people with enough time to go through policies and procedures of handling, cleaning, repairing, testing, and re-cleaning every piece. All devices have to be cleaned twice—first when it comes in and then again when we redeliver for clinical use,” Hibbs says, adding that all equipment has different nuances and may require special cleaning techniques.
“[Biomeds] can’t afford to specialize in three or four pieces,” he says. “They have hundreds they need to be familiar with.”
Although third-party contractors may reduce some of the workload, biomeds are ultimately responsible for the devices they service, Hibbs notes. “We can have education, training, and tracking of our own internal staff, but do not have that control over third-party service people who come to work on x-ray machines and lab equipment. We don’t have control, but do have responsibility for the performance of their tasks to the standards we set for ourselves.”
Playing Active Roles
Fortunately, some healthcare entities have made HTM professionals an integral part of their infection control programs. At Satellite Health Care—a San Jose, Calif.-based dialysis company, for instance—biomeds contribute to protocols by ensuring that educational materials, guidelines, and periodic competency requirements are provided to all staff, according to Emily Michalak, director of technical services.
The company treats patients who are highly susceptible to catheter infections and follows Centers for Medicare & Medicaid Services (CMS) protocols for infection control.
“After every patient treatment, all equipment, the chair, the IV pole if they’ve used one, the oxygen concentrator, the TV they watched, the remote, everything within the patient treatment station is disinfected with a bleach solution and given 10 minutes to air dry, per CMS requirements,” Michalak says, emphasizing the importance of including biomeds in the process.
During changeover—the time when one patient finishes treatment and before another begins—HTM professionals conduct spot audits on infection control.
“When the patient comes off the machine, they check to see if the staff is wiping down the machine with bleach,” Michalak reveals. For instance, are they wiping down the TV, opening the dialysis chair, and cleaning all the way up and down the sides? “We don’t want infection control to be an afterthought because what happens is you’re not really paying attention to disinfecting,” she says.
Satellite holds monthly quality assessment improvement planning meetings, where staff members, including biomeds, discuss policies and procedures and assess quality standards and infection control initiatives. “We feel that a speaker from each department plays a critical role in making policies,” she says. “How we set our protocols and write policies and procedures is focused around infection control.”
In the future, Michalak sees HTM professionals in her company becoming more involved in monitoring, managing, and providing additional insight to ensure protocols are enforced and patients are well cared for. “I’m not saying they won’t be doing computer work,” she says. “When you enter management, you have to document things; but one thing you can’t lose sight of is the patient and his care, staff, and their care. They need to show that they’re following procedures and everyone is being safe, providing education, insight, and corrective action.”
When Satellite Healthcare provides dialysis services in acute-care hospitals, the company has to meet both Joint Commission requirements and its own requirements for healthcare policies and procedures, according to Michalak. Patients going into home dialysis receive four-to-six weeks of training onsite at the center regarding infection practices. At home, nurses walk through the proper care and maintenance of equipment, as well as patients themselves, to ensure they’re following protocol.
“We know the superbugs are only going to get more super in time, so we make sure we’re on top of our protocols to prevent and control the infections,” Michalak says.
One hospital that’s working hard to prevent infections—and employing the help of biomeds in this quest—is Walnut Creek, Calif.-based John Muir Health. Nader Hammoud, the health network’s biomedical engineering manager, reveals that HTM professionals are involved in processing new devices when they enter the system, which includes collecting and following necessary instructions from the original equipment manufacturer (OEM).
What’s more, recalls and alerts are directed to the biomedical engineering department, which also addresses misuse/device damage that might require revisiting currently implemented practices.
In its efforts to control infections, John Muir Health also uses an electronic asset management program to help with scheduling preventative maintenance, cleaning, and inspection of all medical devices, according to OEM recommendations. But most importantly, the biomedical engineering department has formed a partnership that maximizes efforts to keep infectious outbreaks from occurring in the first place.
“We developed a full cooperative relationship with infection control managers and work very closely to track and address all opportunities for improvements from an infection control perspective,” says Hammoud. While his department refers to AAMI for guidelines, he explains “any modification or alteration to the processes in place must be blessed by infection control, as we believe this is their field of expertise, and our cooperation will result in better and safer service to the patients.”
Biomedical engineering is also an integral part of the hand hygiene initiative across John Muir Health and makes sure that “infection control, materials management, and staff are aware of what is acceptable and what is not, so we can sustain a safe environment and reliable medical equipment,” Hammoud says.
Further, Aaron Eli Glatt, MD, FACP, FIDSA, FSHEA, chair of medicine at Oceanside, N.Y.-based South Nassau Communities Hospital and spokesperson for the Infectious Disease Society of America, points out that hospitals continue to create protocols and implement practices designed to make the environment as safe as possible. While many of the steps taken to date have achieved some success in the fight against HAIs, the battle is far from over.
Summing it up, Glatt says, there is sufficient opportunity for professionals involved in the HAI battle to add input and make helpful recommendations. They just have to take it.
Phyllis Hanlon is a contributing writer for 24×7.
SIDEBAR: Vendor Spotlight: Draeger
Although clinicians are truly the ones on the front lines when it comes to combating hospital-acquired infections, equipment manufacturers also play an active role in preventing infections. For instance, Draeger—an international leader in the fields of medical and safety technology—designs every product with infection control in mind, maintains Kathy Fallon, RRT, Draeger’s marketing manager for consumables and accessories and infection prevention.
“Draeger’s roots are in safety, and that extends to all of our business areas,” Fallon says. “Key to patient safety is the avoidance of a hospital acquired-infection, so Draeger has this objective in every product it makes—from the design of the devices to the design of the accessories and consumables we produce and sell.”
Fallon explains that device engineers spend a “great deal” of time selecting materials that are not only functional and safe, but also easy to clean. “As a supplier of acute-care products, we feel part of the team caring for the patient,” she adds.
It’s a marked change from how equipment manufacturers traditionally viewed themselves, Fallon acknowledges. “The manufacturer’s role in infection control is ever-evolving, and we want to be seen as a partner to our customer in this process,” she says, adding that Draeger regularly looks for ways to collaborate with infection-control personnel.
Even so, Fallon says that increased collaboration between manufacturers and hospital employees—particularly biomedical engineers—would ultimately benefit patients. “I would also like to see more communication on the changing needs and requirements being placed on HTM professionals so we can provide better support,” she adds.