Health care or hospital acquired infections (HAIs) infect one in 25 patients every day, according to the Centers for Disease Control and Prevention (CDC).
The introduction of an illness into a patient who is seeking wellness is paradoxical to the goals of the health care industry.
Many hospitals lose one percent of their Medicare payments because of the penalties they must pay under the Affordable Care Act through the Hospital-Acquired Conditions Reduction Program. As of this past January, that number included 751 hospitals that were guilty of having too many infections or patient injuries. This figure does not include many “specialty” hospitals that are exempt from the penalties.
The program requires that the worst performing 25 percent be punished even if they have shown improvements since they were last evaluated. Among other procedures, Medicare considers the rates of infections from hysterectomies, colon surgeries, central line tubes and urinary tract catheters.
The CDC reports that “more than half of all HAIs occurred outside of the intensive care unit.”
Bacteroides fragilis, clostridium difficile, staphylococcus aureus, norovirus, escherichi coli (E. coli), hepatitis A, B and C, psuedomonas aeruginosa and the list goes on and on; are just some of the infectious bacteria and viruses that make people sick in health care settings.
These pathogens could exist on equipment that is being serviced by the HTM department. Every effort must be taken to protect the HTM professional from contracting an illness because of a piece of contaminated equipment. Through cooperation with clinical colleagues, HTM can be an important link in the chain of responsibility for cleanliness and safety. It is a two-way street.
“AAMI and Association of periOperative Registered Nurses (AORN) recommend a weekly testing of the cleaning process,” says Matt Smith, marketing manager for Healthmark in Fraser, Michigan. Smith’s company provides monitoring tools to help verify that proper reprocessing of surgical instruments and equipment is routinely taking place.
Nobody wants to think that they played any part in even one patient acquiring an infection that they didn’t have before entering a health care facility. In the biomedical or clinical engineering department, steps can be taken to help mitigate that possibility.
All professionals in the health care setting play a role.
“ECRI Institute is concerned about the reprocessing (defined as cleaning and disinfection or sterilization) efficacy of all reusable medical devices used within a patient environment. Proper cleaning and disinfection or sterilization of medical devices and equipment, such as endoscopes, infusion pumps and mattresses, are important factors in reducing the risk of patients developing healthcare-associated infections,” says Amanda Sivek, Ph.D, senior project engineer in ECRI Institute’s Health Devices Group.
“First, it’s important to understand the difference between cleaning, disinfection and sterilization since these terms are sometimes incorrectly used interchangeably. The CDC defines cleaning as the ‘removal of visible soil (e.g., organic and inorganic material) from objects and surfaces, which is normally accomplished by manually or mechanically using water with detergents or enzymatic products,’ ” Sivek says, referencing data from the CDC.
“Thorough cleaning is essential before disinfection and sterilization because inorganic and organic materials that remain on the surfaces of surgical instruments and medical devices or equipment can interfere with the effectiveness of these processes,” Sivek adds.
She also explains that disinfection refers to a process that inactivates many or all pathogenic microorganisms, except for bacterial spores, on inanimate objects; whereas sterilization describes a process that destroys or eliminates all forms of microbial life. Sterilization is performed in health care facilities by physical or chemical methods such as steam under pressure, dry heat, ethylene oxide (EtO) gas, hydrogen peroxide gas plasma and liquid chemicals.
Sivek says there are three device categories that convey the degree of infection risk associated with the use of reusable medical devices. Critical devices, such as surgical instruments and endoscope biopsy accessories, come in contact with blood or normally sterile tissue. There is a likelihood of microbial transmission and risk of infection if a critical device is not sterile. Users that perform reprocessing should be instructed to disassemble (if applicable), thoroughly clean, and sterilize critical devices after each use, she cautions.
“Semi-critical devices, such as endoscopes, come in contact with intact mucus membranes non-intact skin. Users that perform reprocessing should be instructed to thoroughly clean these devices and then reprocess them by sterilization,” Sivek says, noting FDA information.
“If the device design does not permit sterilization (e.g., device materials cannot withstand sterilization), then high-level disinfection should be used. High-level disinfectants ‘will kill all microorganisms except large numbers of bacterial spores.’”
She adds that non-critical devices, such as blood pressure cuffs, come in contact with unbroken skin. FDA recommends thorough cleaning, then intermediate or low-level disinfection for non-critical devices depending on the nature and extent of contamination. The CDC states that “low-level disinfectants can kill most vegetative bacteria, some fungi, and some viruses in a practical period of time (≤10 minutes). Intermediate-level disinfectants might be cidal for mycobacteria, vegetative bacteria, most viruses, and most fungi but do not necessarily kill bacterial spores.”
“Unfortunately, any of these device types (critical, semi-critical, non-critical) can harbor infectious material and potentially contribute to patient infections in acute care, long-term care, ambulatory care or home care environments if they are not effectively reprocessed (cleaned and disinfected or sterilized),” Sivek says.
The HTM professional has a role to play in the mitigation of infection control and damaged equipment that could lead to the spread of pathogens. Communicating with affected departments and practicing safe handling procedures are a starting point. There is also the consideration that the cleaning process could damage a piece of equipment, which requires attention.
“We in biomed depend on our PEMS and SPD/CDS partners to bring us clean and disinfected equipment to work on, but sometimes equipment still makes it to us pretty dirty. We then use universal precautions to insure our safety. We will clean the units best we can (as we are not trained on cleaning and disinfecting), then we repair or evaluate the units, then return them to the units to be cleaned further,” says Donald Armstrong, CBET, CHTM, senior manager of biomedical engineering at Stanford Health Care in Palo Alto, California.
Armstrong and Richard Fechter presented on infection control and damaged equipment at the 2017 AAMI Conference in Austin, Texas.
Armstrong says that this has always been a process that needs to be continuously evaluated as staff turnover is high in some of the partner departments.
“We as biomeds are always trying to educate and inform when we find that we are getting dirty devices in our shops,” he says.
“Infections are a huge issue in our hospitals and we all must work together to insure patient safety so pointing fingers and blaming is not the aim of our process but to keep everyone aware that these devices need to be cleaned and disinfected correctly before returning to the floors,” Armstrong says.
He points out that pictures are worth a thousand words. “So, we would take a picture and show the SPD/PEMS/CDS manager the shape of some of the equipment is in when it comes to us,” he says.
“We will also take a device back to SPD/PEMS/CDS and ask for the unit to be cleaned. Both methods work for that one device but does not solve the greater issue. I have not come up with a formal report to trend how many devices come to us dirty. That would be the best way to track and trend how we are doing on this front,” Armstrong adds.
“Clinical/biomedical engineers can support the safe use of reusable medical devices by facilitating effective device reprocessing by: working with EVS and nurse managers to ensure that non-critical medical device cleaning and disinfection instructions and supplies are readily available and that appropriate staff have the time and space to perform thorough device cleaning and disinfection,” Sivek says.
She says that HTM professionals can also facilitate the process by ensuring that updates to medical device cleaning and disinfection instructions are distributed to appropriate staff when they become available.
“Our policy also states equipment is to be cleaned before it is brought to our department for service. If we get one that is obviously still dirty, we will send it back to SPD for cleaning first,” says Richard Fechter, chief clinical engineer at UCSF Medical Center and UCSF Benioff Children’s Hospital in California.
“But even when it is clean on the exterior, we frequently find blood and fluids that have ingressed to the inside where it can only be accessed after disassembling the equipment. We consider every piece of equipment to be contaminated unless it is wrapped sterile,” Fechter says.
“When taking something apart that has a reasonable expectation of being contaminated, we use appropriate PPE (gloves, gowns, face protection) and try to clean things as much as possible using our standard disinfection products,” Fechter says.
“For example, we might get a piece of blood handling equipment like a heart-lung bypass machine or cell saver that had a disposable failure and was extensively contaminated with blood. We can expect the cleaning staff to address the exterior of a machine, but when blood gets inside and the machine needs disassembly to reach it, then it becomes our job,” he adds.
Fechter says that in the AAMI presentation, he recounted the incident that brought his attention to this topic.
“My presentation last year focused on the problems caused by using cleaning products that are incompatible with the materials used to make the equipment causing millions of dollars’ worth of damage and creating new patient safety hazards,” he says.
“I first recognized this problem while investigating an incident in 2004 where a new cleaning product had damaged the syringe holder on a syringe pump, causing the pump to sense the wrong size syringe and deliver double the intended dose of morphine to the patient. The patient in this incident survived, but this could have easily resulted in a death,” Fechter adds.
Fechter says that in the ECRI Top 10 Health Technology Hazards for 2018, three of the top five are related to disinfection of equipment.
“This is still a big problem in health care today. Many device manufacturers have changed the formulations of plastics used to better resist damage from cleaners,” he says.
“Companies making disinfectant products have also changed some of their formulations to be less destructive while maintaining adequate germ killing ability. I have worked with cleaner manufacturers, plastic manufacturers and medical device companies to minimize the problems, but there is still a lot that could be done.”
Protecting patients, clinicians and HTM staff is a team effort. All departments that have any cleaning or disinfection role must coordinate and collaborate to cover all bases.
“The reprocessing of critical and semi-critical devices is normally performed by Central Sterile Processing; whereas the reprocessing of non-critical devices is usually performed by Environmental Services (EVS)/Housekeeping staff or point-of-care clinical staff,” Sivek says.
She says that for clinical/biomedical engineering staff, it is important to collaborate with management in EVS/housekeeping, central sterile processing and nursing to facilitate the effective reprocessing of medical devices and equipment. A collaborative relationship with nurse managers, EVS/housekeeping managers, and central sterile processing managers may facilitate the faster identification of potential device problems in between inspection and preventive maintenance (IPM) intervals.
“In its 2018 Top 10 List of Health Technology Hazards, ECRI Institute identified that improper cleaning may cause device malfunctions, equipment failures, and potential for patient injury,” Sivek says, citing ECRI Institute’s own published findings.
“To address the improper reprocessing of medical devices, clinical/biomedical engineering departments can: Affix labels to non-critical medical devices that specify the recommended reprocessing instructions and appropriate reprocessing materials to be used (reported in the medical device instructions for use).”
“Ask nurse managers, EVS/Housekeeping managers, and Central Sterile Processing managers to inform their staff to inspect reprocessed devices and instruments for damage and wear,” Sivek adds.
Smith agrees that communication and cooperation are key.
“One of the most effective ways to ensure something is flagged for special attention is adding a label to the piece of equipment,” he says. Biomeds can specifically mention that something is in need of repair or even simply notify staff if the equipment they are dealing with is clean or sterile.
“There are many options for customizing your labels so your message is being communicated to all staff throughout different departments,” Smith adds.
Constant and consistent open lines of communication and vigilance in taking precautions will go a long way in keeping patients, clinical staff and HTM safe from dangerous infections.
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