As hospital-acquired infections continue to rise, following proper disinfection procedures is more urgent than ever. But where do biomeds fit into the picture?
By Nina Silberstein
At the AAMI Conference & Expo in Denver this past June, infection control made an unexpected, albeit prominent, appearance. During his annual update on The Joint Commission’s activities, George Mills made the issue a key point in his remarks to biomeds, stressing that healthcare technology management (HTM) professionals need to play an active role in preventing infection and increasing patient safety.
Infection control, he noted, is a critical concern: each year, approximately 770,000 patients contract a hospital-acquired infection and as many as 80,000 die. In 2015, inadequate reprocessing of endoscopes and surgical devices again ranked highly on ECRI Institute’s annual list of top 10 health technology hazards. Over the last year, patient infections linked to inadequate reprocessing of duodenoscopes have also affected several major health institutions across the country.
Mills urged HTM professionals to periodically visit central processing and sterilization areas to identify potential problems, such as placing contaminated and sterilized endoscopes too close to one another. They should also be careful to practice good hand hygiene, especially when entering patients’ rooms. With diligence, he said, the problem can be addressed.
Unquestionably, infection control is a top concern for many facilities. But with all the challenges currently facing biomed departments—including strapped budgets, reduced head counts, and increased workloads—the real question may be whether HTM professionals, despite their best intentions, have the bandwidth to follow Mills’ advice.
Measured Optimism
So far, responses to Mills’ rallying cry appear to be mixed. “This has always been an important topic, but more attention has been given to it recently than in past years,” acknowledges J. Michael Shepherd, CBET, biomedical equipment technician II at Grande Ronde Hospital in La Grande, Ore. “More and more antibiotic–resistant bacteria are evolving, and this increases the need for good disinfection technique.”
The problem is worth addressing, agrees Dennis Minsent, CCE, CBET, president, Healthcare Technology Management Solutions LLC, who provides HTM consulting services to small- and mid-sized hospitals. “I think HTM should be more aware, given the number of serious organisms circulating in the country,” he says, although he notes, “I’m not aware of any serious outbreaks that could be attributed to HTM department lack of vigilance.”
But even if biomeds are clear on proper infection control techniques and willing to implement them, moving forward could prove tricky, especially taking into account the many responsibilities HTM departments already shoulder, Minsent says.
“I’m skeptical. The demands on HTM departments are significant and any data to suggest that HTM could help resolve this is lacking. While this additional focus is warranted, cybersecurity and software patching are perceived as more imminent threats. I think it will take some effort to move this up in priority,” he says, although he believes basic procedures like hand washing could be implemented immediately.
However, Chris Lavanchy, engineering director for ECRI Institute’s Accident and Forensic Investigation Group, believes that Mills’ address could prove a needed catalyst for hospitals to step up their efforts. “I think it’s going to ramp up the thought about it,” he says. “And I presume hospitals will have to show what plans they’ve made to address the concern.”
Gauging Risk
For those biomedical departments determined to implement new strategies to address infection control, how they move forward will depend largely on where they currently stand. It’s worth exploring, therefore, what HTM departments are already doing relative to infection control and—more importantly—what steps they should they be taking.
Minsent says the answer varies depending on the specific responsibilities of a given department. “If the HTM department is responsible for the central equipment pool, it would have a huge role,” he says, which might include cleaning select mobile equipment that is centrally managed between uses. “For more traditional HTM departments, the role would be more consultative, identifying approved cleaners and advising on cleaning protocols. The role would also be significant if HTM had technicians who service the sterilization equipment in central sterile supply.”
At Grande Ronde Hospital, the HTM department takes a central role in sterilization procedures, Shepherd says. “Our work maintaining sterilization and disinfection equipment is a key component in reducing patient infection. It is vital that disinfection and sterilization equipment be working properly.”
In his department, that includes practicing good sterile technique in dealing with all equipment. “I can’t speak for all HTM departments out there, but ours is not a sterile environment. It is important to do a topical disinfection of equipment before returning it for patient use. Whether that is done by the technician or in your central processing department, it cannot be overlooked,” he says.
Certain items like laboratory analyzers, ventilators, anesthesia systems, and heart/lung bypass machines are more likely to become contaminated because blood and body fluids can invade the systems’ internal components, Minsent says. While “the user should be responsible for cleaning and disinfecting exterior surfaces,” devices with contaminated internal components should be sent to HTM for cleaning and disinfection by HTM staff, according to the facility’s protocols. Either way, Minsent says, “You should always assume that any equipment you encounter for maintenance could be contaminated.”
This increased risk of infection and growing caution on the part of hospitals are partly why “infection control has become one of the hottest topics in healthcare today,” says Arman Semerjian, vice president of national sales at Advanced Ultrasound Solutions Inc. His company manufactures Sono ultrasound wipes, a disinfectant product made specifically for ultrasound equipment and designed to destroy pathogens such as MRSA, HIV, and staph, and to inhibit the growth of mold and mildew, as well as the odors they cause.
Semerjian says the Centers for Disease Control and Prevention recommends that when cleaning and sanitizing medical equipment in a healthcare setting, facilities follow the Spaulding method.1 This approach to disinfection and sterilization was devised more than 30 years ago and has been retained, refined, and successfully used by infection control professionals and others when planning methods for disinfection or sterilization. It classifies medical equipment into one of three categories—critical, semicritical, and noncritical—according to the degree or risk of infection involved in use of the items, and provides disinfection guidelines for each category.
Critical items, such as surgical instruments, cardiac and urinary catheters, implants, or invasive transvaginal, TEE, or intraoperative ultrasound probes, are devices that pose a high risk of transmitting infection or disease if they become contaminated with a microorganism. Semicritical items are those that come into contact with mucous membranes or nonintact skin, such as respiratory therapy and anesthesia equipment, some endoscopes, and laryngoscope blades. These devices should be free from microorganisms, but will generally not cause infection if contaminated with only small numbers of bacterial spores. Finally, noncritical items are those that only come in contact with intact skin and carry low risk of infection transmission, such as bedpans, blood pressure cuffs, crutches, and computers.
“In contrast to critical and some semicritical items, most noncritical medical devices like ultrasound may be decontaminated where they are used, and do not need to be transported to a central processing area,” Semerjian says. “Virtually no risk has been documented for transmission of infectious agents to patients through noncritical items when they are used as noncritical items and do not contact nonintact skin or mucous membranes.”
In addition to following these guidelines, biomeds’ use of personal protective equipment (PPE)—gloves, masks, eye protection, and gowns—is a must before working with any device. Lavanchy says that, typically, hospital personnel are instructed about PPE. “I would imagine that most hospitals have provided some fundamental training for healthcare professionals, especially the biomeds, to help them understand what they’re handling in the medical devices being used and patient contaminants.”
Left in the Dark
One of the major challenges facing facilities regarding infection control is that no universal cleaning solution exists for all devices and all organisms. Keeping track of which solutions are compatible with which devices can become a constant, time-consuming struggle.
“Depending on the materials used in the device, manufacturers provide a list of approved cleaners for specific levels of disinfection against the organisms you are trying to address. As organisms evolve and mutate, different cleaning solutions may be needed,” Minsent says. However, if those new cleaning solutions are not properly vetted, they may cause damage to the surface of the equipment, particularly cases and display screens. “Close coordination with the hospital infection control department and the device manufacturer is required to ensure the organisms can be killed without harming the device,” he says.
This issue is one Semerjian has encountered many times over. In many cases, he says, “biomeds are being tasked with bringing service costs down, and have been left in the dark when it comes to infection control products being recommended and used on the equipment they manage.”
Semerjian spent two decades working as an ultrasound field service engineer for a large OEM. Over time, he says, customers began reporting damage to their equipment from cleaning solutions the OEM had recommended to them, but which hadn’t been properly tested on specific ultrasound systems. Problems included damage to the lens and plastics from overly harsh chemicals, causing dropout and occasionally patient shock.
“Being on the service side of the business, we saw the large financial impact this was having on our accounts, with very little concern being shown from the OEM side. We quickly found out that there was little knowledge and no focus on compatibility testing with products being recommended,” he says.
Semerijian subsequently left the OEM world to work as a consultant, eventually landing at Advanced Ultrasound Solutions. The company has spent years testing its quaternary ammonium–based wipe on various ultrasound transducers, control panels, monitors, and system covers. The company is in the process of installing an automated spray system in its offices that will allow them to test not only ultrasound equipment, but all noninvasive medical devices with their patented solution. “Some OEMs are looking to us for testing their transducers because of limited resources,” he says. ”It can take them up to 2 years to complete compatibility testing, where our method can test an entire line of equipment in about 1 month.”
Future Steps
Since infection control isn’t going away any time soon, it could end up shifting dynamics in the hospital landscape. Karen Waninger, director of clinical engineering for Community Hospitals Indianapolis, notes that because of the dangers and anxiety associated with the issue, infection control remains a highly visible issue for healthcare teams as well as the general public.
“The infection control team in most hospitals is going to be proactive with trying to share information relevant to any specific media buzz or any local trends being observed, to help make sure the employees are aware of the specific actions to take for different potential situations,” she says. While infection control employees often take the lead, increasing awareness of the problem is also driving involvement from departments across the hospital. “With the current quality indicator measures regarding hospital-acquired infections, it has become more common to seek input from all perspectives to look for ways to help control exposure and prevent the spread of all types of infections,” she explains.
That shift could mean an increased role for HTM departments in areas where they should already be involved, such as the equipment selection process. “I hope this focus on infection control helps drive improvements in the evaluation of technology before it is purchased, for even small items like suction regulators and thermometers,” Waninger says. “In the past, those were not high-dollar items and may not have required the same kind of prepurchase process that was used, for example, when considering upgrades to physiological monitors or the imaging systems.”
Now that high-profile infection cases like those associated with duodenoscopes have become more common, Waninger says, hospitals better understand the downstream consequences of purchasing a device designed in a way that may make it more prone to transmitting infection. “The potential costs are defined differently now, when the loss of revenue or the cost of an organization’s reputation is considered,” she says. “These concerns should also help motivate HTM professionals to consistently adhere to universal precautions when handling any patient care equipment, whether visibly soiled or not.”
In addition, while hospital infection control departments establish the education, guidelines, framework, and expectations for the facility’s infection control protocols, HTM departments should develop their own specific protocols to support hospital policy, Minsent says. Those checklists could be amended as new, significantly threatening organisms emerge or evolve.
Shepherd agrees that building a list of the types of devices that deserve particular concern regarding infection would be helpful. “I think it is vital that [biomeds] be involved in the development of policy within their facilities, for those attached to a healthcare organization,” he says. “For all HTM professionals, however, it remains important that we all do our jobs to the best of our abilities and practice constant vigilance for areas where technique and processes can be improved.”
Infection control awareness should involve a continuing education in new disease and standards in sterile processing and disinfection agents. “Like most aspects of our profession, infection control and sterilization is a dynamic process, and our acquisition of knowledge needs to keep pace,” Shepherd says.
Nina Silberstein is a contributing writer for 24×7. For more information, contact John Bethune at jbethune@nullallied360.com.
References
Rutala WA, Weber DJ. Spaulding method for disinfection. In: Guideline for Disinfection and Sterilization in Healthcare Facilities. Centers for Disease Control and Prevention. 2008.
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