By Kelly M. Pyrek
Patient Safety Awareness Week, being celebrated March 8-14, 2015, is an excellent time to review current practice and identify weaknesses that need to be addressed. Nowhere is this more important than in the operating room (OR), where perioperative professionals and infection preventionists can collaborate to determine knowledge gaps and ways to mitigate and eliminate risk of infection and adverse events.
A good place to start is to review the updated and revised Guidelines for Perioperative Practice (formerly known as Standards and Recommended Practices) from the Association for periOperative Registered Nurses (AORN).
“We always encourage our infection prevention colleagues to utilize our guidelines to help them as they are working with perioperative personnel,” says Ramona Conner, MSN, RN, CNOR, editor-in-chief of the Guidelines for Perioperative Practice. “We are pleased that five of our evidence-based practice guidelines have been accepted by the National Guidelines Clearinghouse for 2015, and we are proud of the work we have done in the last year.”
According to the organization, the decision to retitle the guidance is primarily driven by the achievement of acceptance of its most recently updated evidence-based guidelines by the National Guidelines Clearinghouse as nationally recognized guidelines for perioperative practice. AORN Guidelines are evidence-based; the individual references are now appraised and scored, and the recommendations are evidence-rated according to strength and quality of the evidence supporting the recommendation using the AORN Evidence Rating Model.
The guidance goes to the heart of surgical site infection (SSI) prevention, and Conner emphasizes that “The focus on SSI reduction has not abated.” She adds, “It is an ongoing challenge and I think it’s clearly a major concern, not only from the perspective of the individual patient impact of an SSI, but also the financial burden on healthcare organizations as a result of SSIs. The importance of the perioperative team working closely with infection preventionists to continue to work toward reducing SSIs is no less important in 2015 than it was in 2014.”
For 2015, AORN has updated a number of guidelines. Here are the key points for the guidelines most pertinent for infection preventionists working with perioperative personnel:
Patient Skin Antisepsis
Patients should bathe or shower before surgery with either soap or an antiseptic.
Preoperative patient bathing before surgery may reduce microbial skin contamination.
Further research is needed to define optimal preoperative bathing procedures, including whether antiseptics are more effective than soaps (ie, plain, antimicrobial), whether bathing the whole body or only the surgical site is more effective, the optimal timing of bathing before surgery, and the optimal number of baths or showers before surgery.
National Institute for Health and Care Excellence (NICE) guidelines advise that the patient should shower or bathe with soap the day of or the day before surgery.
There is a growing body of evidence supporting the use of 2 percent CHG-impregnated cloth products for preoperative bathing. Based on the collective evidence, this practice remains an unresolved issue and warrants additional generalizable, high-quality research to confirm the benefit of this product.
Hair at the surgical site should be left in place.
The collective evidence supports that hair at the surgical site should be left in place. When hair removal is necessary, clipping the hair may be associated with a lower risk of developing a SSI than hair removal with a razor.
The limitations of the evidence include that some studies had an inadequate sample size (i.e., are underpowered) to determine the effect of hair removal on the development of SSI, the studies did not use a standardized definition of SSI, and the majority of the studies included in the systematic reviews are approximately 20 years old.
Safe, effective preoperative antiseptics should be selected for the individual patient.
The collective evidence indicates that there is no one antiseptic that is more effective than another for preventing SSI.
The multidisciplinary team (e.g., perioperative RNs, physicians, and infection preventionists) should select antiseptic products for use at the healthcare organization based on a review of current research literature and FDA-approval status, in
accordance with their product evaluation and selection process.
The perioperative team should select a healthcare organization-approved antiseptic for the individual patient based on the patient assessment, the procedure type, and a review of the manufacturer’s instructions for use and contraindications.
Skin antiseptics should be applied according to the manufacturer’s instructions for use.
The collective evidence suggests that following the antiseptic manufacturer’s instructions for use and applying preoperative patient skin antiseptics in a safe and effective manner may prevent patient harm (e.g., inadequate skin antisepsis, fire, chemical injury).
Skin antiseptics must be stored in the original, single-use container.
In November 2013, the FDA issued a drug safety communication requesting label changes and single-use packaging of over-the counter topical antiseptic products to decrease risk of infection. As a result of reported outbreaks involving contaminated antiseptic products, the FDA requested that manufacturers package antiseptics for preoperative skin preparation in single-use containers, to be used only one time for one patient.
- Scrub attire and cover apparel (e.g., lab coats) should be laundered in a health care-accredited laundry facility after each daily use and when contaminated.
The collective body of evidence regarding healthcare-accredited laundering compared with home laundering of scrub attire is conflicting; however, there is evidence that indicates a risk for pathogenic organisms being carried on the scrub attire if laundered in the home. These organisms can potentially put the patient at risk of infection, or contaminate the home or community of the perioperative team member. Healthcare-accredited laundry facilities are recommended because they meet industry standards. Home laundering is not monitored for quality, consistency or safety. Home washing machines may not have the adjustable parameters or controls required to achieve the necessary thermal measures (e.g., water temperature); mechanical measures (e.g., agitation); or chemical measures (e.g., capacity for additives to neutralize the alkalinity of the water, soap, or detergent) to reduce microbial levels in soiled surgical attire. Scrub attire that is home laundered may not be protected from contaminants in the environment during transport to the practice setting. The collective evidence does not support wearing cover apparel to protect scrub attire from contamination, and there is evidence that lab coats worn as cover apparel can be contaminated with large numbers of pathogenic microorganisms. Researchers have found that cover apparel is not always discarded daily after use or laundered on a frequent basis.
- When in the restricted areas, all non-scrubbed personnel should completely cover their arms with a long-sleeved scrub top or jacket.
This is a change from the previous edition that recommended wearing long-sleeved jackets in the semi-restricted and restricted areas. The collective body of evidence supports perioperative team members covering their arms to help contain skin squames. The risk of contaminating a sterile field or wound is greatest in the restricted area; however, facilities may choose to require that perioperative personnel wear long-sleeved jackets in both the semi-restricted and restricted areas.
Perioperative team members should wear scrub attire that covers their arms while performing preoperative patient skin antisepsis.
Perioperative or sterile processing team members should wear scrub attire that covers their arms while performing preparation and packaging of items in the clean assembly section of the sterile processing area.
- Jewelry that cannot be contained or confined within the scrub attire should not be worn in the semi-restricted or restricted areas.
The collective body of evidence supported the removal or containment of jewelry and showed that wearing earrings, watches, and rings increased bacterial counts on skin surfaces both when the jewelry is in place and after its removal.
- Cell phones, tablets, and other personal communication or hand-held electronic equipment should be cleaned according to the manufacturer’s instructions for use with a low-level disinfectant before and after being brought into the perioperative setting.
The collective body of evidence showed that cell phones, tablets, and other personal hand-held devices are highly contaminated with microorganisms, some potentially pathogenic. All of the researchers recommended regular cleaning of these devices and implementing hand hygiene before and after use. Reducing the numbers of microorganisms present on the devices may protect patients from the risk of healthcare-associated infections resulting from the transfer of microorganisms from the devices or hands of healthcare workers to patients.
- Scrub attire may be made of antimicrobial fabric.
There is emerging evidence on the use of fabrics with antimicrobials incorporated into yarns during processing or during finishing to prevent bacteria and fungi from adhering to the fabric. Incorporating this technology into the material used for scrub attire and other garments worn by health care personnel may help to protect the patient from the risk of surgical site infections. This is an issue that warrants further research
Instruments should be cleaned and decontaminated as soon as possible after use.
Cleaning instruments as soon as possible after use can help to prevent formation of biofilm and dried blood. When blood or other bioburden is allowed to dry on instruments, it can be more difficult to remove. The effectiveness of disinfection or sterilization can be compromised when thorough cleaning is not accomplished.
Preparation for decontamination of instruments should begin at the point of use.
Instruments should be kept free of gross soil during surgical procedures.
During the procedure, the scrub person should remove gross soil from instruments by wiping the surfaces with a sterile surgical sponge moistened with sterile water. Saline should not be used to wipe instruments.
During the procedure, the scrub person should irrigate instruments with lumens periodically with sterile water.
The decontamination area heating, ventilation, and air conditioning system (HVAC) should be maintained within the HVAC design parameters at the rate that was applicable at the time of design or most recent renovation of the HVAC system.
The HVAC system controls the air quality, temperature, humidity, and air pressure of the room in comparison to the surrounding areas. The HVAC system is designed in accordance with the American Society of Heating Refrigerating and Air-Conditioning Engineers (ASHRAE) and local regulatory requirements to reduce the amount of environmental contaminants and to provide a comfortable environment for occupants in the area.
The HVAC parameters recommended by ASHRAE for decontamination areas are: two outdoor air changes per hour; six total air changes per hour; negative air pressure; and temperature between 72° F and 78° F (22° C and 26° C). Room temperature may be intentionally adjusted to accommodate the individual comfort needs of the occupants.
A multidisciplinary team that includes infection preventionists, perioperative RNs, sterile processing personnel, representatives from facility maintenance, and other involved stakeholders representing the healthcare organization should develop and implement a systematic process for monitoring HVAC performance parameters in the decontamination area and a mechanism for resolving variances.
Special precautions should be taken when processing intraocular ophthalmic instruments.
Prevention of toxic anterior segment syndrome (TASS) requires thorough cleaning and rinsing of intraocular instruments and strict adherence to the manufacturer’s written instructions for use (IFU) and professional guidelines. Most instances of TASS appear to be related to instrument processing. Factors associated with TASS include: contaminated instruments; contaminated ultrasonic cleaners; detergent residues (soaps, enzymatic cleaners) remaining on instruments; insufficient rinsing of instruments; endotoxin residues on instruments; steam impurities during steam sterilization; use of glutaraldehyde during processing; dried debris and residues of ophthalmic viscoelastic material remaining on instruments; use of reusable cannulated instruments; and insufficiently dried lumens.
Adequate time, an adequate number of personnel, and sufficient instrument inventory should be provided to permit thorough instrument cleaning and sterilization.
Laryngoscope blades and their handles should be cleaned, decontaminated, dried, and stored in a manner that reduces patient and personnel risk for exposure to potentially pathogenic microorganisms.
Laryngoscope blades and handles may be a potential source of contamination. Laryngoscope blades should be cleaned and high-level disinfected or sterilized according to the manufacturer’s written IFU after each use. Laryngoscope blades are considered semi-critical items that require a minimum of high-level disinfection. Laryngoscope handles should be cleaned and low-level disinfected after each use and may be high-level disinfected or sterilized according to the manufacturer’s written IFU. Although the laryngoscope handle by itself is considered a noncritical device, the laryngoscope consists of two parts that are handled concurrently. Laryngoscope handles have a knurled surface that can accumulate bioburden. When the laryngoscope blade is folded closed, the tip of the blade is in contact with the handle.
Special precautions should be taken to minimize the risk of transmission of prion diseases from contaminated instruments.
A multidisciplinary team that includes infection preventionists, perioperative RNs, sterile processing personnel, surgeons, representatives from the clinical pathology laboratory, and other involved stakeholders should establish, document, and implement evidence-based policies and procedures to minimize the risk of prion disease transmission. These processes should be based on the patient’s risk of having a prion disease; the level of infectivity of the tissue involved, as defined by the World Health Organization Tables on Infectivity Distribution in Transmissible Spongiform Encephalopathies, and; and the intended use of the medical device.
The current SHEA Guideline for Disinfection and Sterilization of Prion-Contaminated Medical Instruments identify practices that will eliminate prion infectivity with a wide margin of safety. (Rutala WA, Weber DJ. Guideline for disinfection and sterilization of prion-contaminated medical instruments. Infect Control Hosp Epidemiol. 2010;31(2):107-117.)
The Guidelines for Perioperative Practice trigger lively dialogue, as any guidance usually does, as clinicians debate the merits of the evidence and the practices they influence. “There are always the hot topics, such as surgical attire, that everyone loves to debate because it inspires a lot of emotion,” Conner says. “People want the evidence to support the practice and the evidence may be telling them something they don’t want to hear. We are proud that we have evidence-based guidelines that will help perioperative professionals and infection preventionists work through those issues. For 2015, of particular interest for IPs will be not only surgical attire but also the preoperative skin antisepsis guideline. That has undergone a major revision and we have quite a bit of discussion of the evidence that should prove beneficial.”
New and revised guidance reminds practitioners to review what they think they know and can challenge them to identify gaps in knowledge. “I think we should remind personnel that now is an important time to make certain that everyone gets back to basics. As we get into more and more complicated cases, antibiotic-resistant organisms, and new emerging pathogens, now is the time to increase vigilance, and make certain that we are adhering to the basic tenets we have always known about. Even though we are gaining more evidence and more clarity regarding the recommendations, the truth is, they haven’t changed all that much. We have known for quite a while what’s right and now we are gaining the evidence to inform us a bit more,” Conner says.
Conner acknowledges the “new normal” that situations such as the Ebola virus outbreak in West Africa and Ebola response in the U.S. have created for healthcare professionals. “The infection prevention and healthcare epidemiology communities have been warning about this for a good number of years and we are beginning to really experience many of the things we have been cautioned about for the last several years.”
In October, AORN issued guidance on encountering Ebola in the operating room, emphasizing that airborne precautions be taken when caring for an Ebola patient in the surgical setting in addition to standard, contact and droplet precautions. The AORN Guideline for Prevention of Transmissible Infections in the Perioperative Practice Setting provides detailed guidance to perioperative RNs for implementing standard precautions and transmission-based precautions (i.e., contact, droplet, airborne). Airborne precautions are necessary in the OR because an aerosol-generating procedure is highly likely to occur. According to the Centers for Disease Control and Prevention (CDC) airborne precautions should be taken when an aerosol-generating procedure (e.g., intubation and extubation, open suctioning of airways) is performed on a patient with Ebola. An airborne infection isolation room should be used if available during surgery and postoperative recovery. If no airborne infection isolation room is available, a portable anteroom system (PAS)-high-efficiency particulate air (HEPA) combination unit may be used. Use of certain air purifying respirators in the OR is under evaluation by OSHA and NIOSH, but the issue remains unresolved. AORN recommends that facilities conduct a risk assessment in consultation with the organization’s infection preventionist when selecting respirators to be used the OR.
According to AORN perioperative nursing specialist, Amber Wood, MSN, RN, CNOR, CIC, environmental cleaning team members should follow CDC recommendations when cleaning the OR after a patient with Ebola. The CDC advises higher levels of precaution toward potentially contaminated surfaces because of Ebola’s apparent low infectious dose and disease severity. Contaminated instruments should be placed in puncture- and leak-proof containers and transported to the decontamination area as soon as possible after completion of the procedure. Sterile processing team members should follow standard, contact, droplet and airborne precautions and wear personal protective equipment (PPE) that covers all exposed skin including: either a PAPR or a NIOSH-certified N95 respirator; either a fluid-resistant gown with sleeves that extends to mid-calf or coveralls without integrated hood; fluid-resistant apron to extends to mid-calf; double gloves with an outer pairof general purpose utility gloves with a cuff that extends beyond the cuff of the gown; surgical hood and full face shield if a N95 respirator is worn or PAPR with integrated hood; and fluid-resistant boots designed for use as PPE that extend to the mid-calf.
Wood recommends a review of AORN’s Guideline for Cleaning and Care of Surgical Instruments for detailed guidance for the safe handling and decontamination of soiled surgical instruments. According to Wood, all perioperative team members should limit the amount of surface contamination with blood and body fluids from the patient and follow AORN’s Guideline for Sharps Safety to minimize the risk of injury from a contaminated sharp device.
“If people are well founded and base their daily practice on good, solid principles and interventions, the crisis of the moment, so to speak, isn’t going to be so difficult for them to respond to,” emphasizes Conner. “Implementing good practices has always been a challenge, and AORN is really ramping up our efforts in providing tools for organizations in helping them implement these best practices. As an example, we just completed a new collection for the sterile processing team in the hopes of easing the pain of implementation.”
Sharon Van Wicklin, MSN, RN, CNOR, CRNFA, CPSN-R, PLNC, a perioperative nursing specialist with AORN, explains that this collection, called the AORN Guidelines and Tools for the Sterile Processing Team, “was created expressly for our sterile processing team members although any-one working in sterile processing and infection prevention would find it valuable.” She adds, “It includes eight AORN guidelines, specifically those that address disinfection and sterilization processes, surgical attire, hand hygiene and environmental cleaning because those issues also impact sterile processing areas and team members. We wanted it to be a treasure chest of information -- everything they need to know in one convenient place.”
The collection includes 22 policies and procedures relevant to the guidelines, as well as 24 competency verification tools. “The collection includes two types of competency verification tools,” Van Wicklin says. “The practice-specific competency verification tools address the specific tasks that must be completed, such as performing hand hygiene correctly, cleaning the environment correctly, and following the correct processes for high-level disinfection. Then we have the role-specific competency verification tools which are specific to the role that you are performing, so in this collection we have one for the RN manager and for the sterile processing technician. And the collection’s job descriptions are for those same roles.”
Van Wicklin says the toolkit was designed to simplify an already complex set of guidance for the sterile processing areas. “It makes it more convenient when sterile processing technicians have everything they need in one place because their time is stretched so thinly. They have a tough job in taking care of the instrumentation, so having everything in one place makes it easy, and having a sterile processing collection with a single voice, so to speak, is important -- you know that your policies are going to match your competencies and job descriptions, and everything has a nice flow to it.”
One key component of the collection are the crosswalks between two guiding documents that sterile processing technicians follow -- the standards from the Association for the Advancement of Medical Instrumentation (AAMI) and the AORN guidelines. “Sterile processing technicians are striving to meet both sets of standards and guidelines, so these crosswalks allow you to see where information is in the AORN guidelines and where it is in the AAMI standards, so it’s a true tool of convenience,” Van Wicklin says. “They say the same things in different ways, so this gives you an at-a-glance picture.”
With intense scrutiny coming from regulators and surveyors these days, the sterile processing collection can offer additional peace of mind. “I think it would be pretty impressive to a surveyor when you can pull out the guidelines that you follow, the policies and procedures, the job descriptions and the competency verification tools, making it very convenient and easy to maintain critical documentation.”
The collection also helps unite the OR and the sterile processing teams in their shared mission. “I think sometimes there is a bit of a disconnect, because our sterile processing team may be more focused on the AAMI standards and our OR team may be more focused on the AORN guidelines, when in reality they are both harmonious with each other. So it puts us all on the same page so that the sterile processing team member can look at the crosswalk and say this is what the OR person is following in the AORN guidelines, and here’s what AAMI says, saying the exact thing but in a slightly different way.”
That kind of knowledge empowers team members, Van Wicklin adds. “Personnel excel when they are aware of the correct policies and procedures and how they are to be implemented. We want them to realize that it’s a team effort, that sterile processing personnel are part of a critical endeavor. I think sometimes we who work in the OR -- this is a lesson I learned as an educator -- is that we don’t give sufficient credit to our team members in sterile processing. The work that they do, makes what we do possible. And we all are a perioperative team with a common purpose. So I think that’s important to recognize the diligence required -- they are handling some of the most complex medical devices that we use, and we depend on them for that device to be clean and sterile when we get it.”
Van Wicklin continues, “We also feel this would be a great collection for nurse educators. When I was a nurse educator, if I had been able to get my hands on a product like this I would have bought it out of my own pocket. The educators are often the people responsible for making sure that the competency of each team member has been documented and verified. I think it’s also nice that the guidelines are right there so if you need to remediate the employee, you can take them right to the guideline and say, ‘Here’s where it says this is to be done this way and why, so let’s try it again.’ Healthcare workers, whether we are in the OR or in the sterile processing area, are all accountable for our own practice.”
Van Wicklin recounts an experience illustrating the need for clinicians to consult the evidence to remove any doubt about correct practice. “The clinician who taught me about eye cases was an icon in her own right and I was so honored to be taking over when she retired. She showed me how to use the phaco machine and she said that at the end of the case you want to make sure to run the tip under the water. So I did that every time I used the phaco because that’s how I was taught. One day the manufacturer’s representative was watching me do that and said, ‘What are you doing?’ I said, ‘I’m flushing the handpiece as I was taught,’ and he said, ‘That’s not how you are supposed to do that.’ He showed me in the manual that we had on a shelf how it was supposed to be cleaned. It was one of those epiphanies when you realize we can take things by word of mouth, but it may not always be correct, especially when you can go right to the source for the guidance and read what it says for yourself -- it changes your practice. It makes you more accurate, it makes you more informed, and you become a better practitioner because of that knowledge. I was a better nurse after that experience because I knew, not only should I glean the information from the experts but I should also read it for myself. That’s the important part of including all team members -- not just the leaders and the educators -- as it’s everyone who needs to be accountable and competent. That’s what will keep our patients safe.”
Van Wicklin adds, “We need to cultivate individual responsibility and accountability. I think sometimes our use of the word ‘staff’ encourages the chance to blame someone else -- because if I am part of a big group of people, I am not encouraged to think like an independent, autonomous practitioner. So if I am thought of as an individual member of the team that contributes to the best practices for the patient that will raise my pride in what I do. That’s why we wanted this product to be for the entire team.”
The AORN Guidelines and Tools for the Sterile Processing Team is available electronically and is priced at $95 for AORN members and $130 for non-members. It can be downloaded from the AORN website.
In addition to the collection, Van Wicklin says she is currently in the process of updating and revising the guideline for flexible endoscopes. “We continue to see reports of infections caused from inadequately cleaned and processed endoscopes,” she says. “That’s partly related to the constant pressure to turn things over quickly and to reduce the number of personnel and keep it to the bare bones as a cost-savings measure. But that savings is quickly lost with a single infection. What I notice from my work on the guideline for flexible endoscopes is the need for point-of-use cleaning, which is done by the OR team, as well as the need for correct cleaning and processing by the sterile processing team, period, since if it’s not clean it can’t be sterilized or high-level disinfected.”
Conner adds that regarding this guideline for the care and cleaning of flexible endoscopes, “We are in the literature review process right now, and that literature review has been daunting. Our initial search returned around 4,000 articles that are being sifted through and evaluated. We are down to about 500 that will have to be appraised for strength and quality and then we need to synthesize the evidence and determine what the recommendations should be. We are excited about this project and hope to have that guideline for public comment and review this summer.”
Also on the table in the last year has been the challenge of humidity levels in the OR and the potential impact on medical equipment. With more healthcare institutions lowering the relative humidity levels in operating rooms (ORs), there are concerns about the impact on sterile supplies and electro-medical equipment. A multi-society communication, organized by the Association for the Advancement of Medical Instrumentation (AAMI), aims to help facilities understand the issue and determine whether a lower humidity level is appropriate for their organizations. The statement provides background on the issue and presents a list of questions and key points healthcare institutions should consider when establishing or adjusting relative humidity levels to below 30 percent.
The statement was developed in the wake of a multiorganization meeting at AAMI headquarters this past October. AAMI has monitored the issue closely after learning of concerns in the field.
“Our common goal is to help healthcare delivery organizations understand the challenges and important considerations related to relative humidity levels in the OR,” says Mary Logan, president of AAMI. “And we all want to ensure that patients are protected and that resources are utilized effectively. We hope this communication will help achieve these objectives.”
“This joint communication is intended to raise awareness that facilities should be aware of manufacturer’s recommendations for humidity in areas where medical supplies and electrical equipment are stored and used,” explains Conner. “Many areas of the country experience seasonal humidity levels falling below 30 percent. HVAC systems are sometimes challenged beyond their design capability to raise internal humidity levels above the previously recommended lower limit of 30 percent. Recognizing the reality of normal seasonal drops in humidity and the limitations of current HVAC design capabilities, the ANSI/ASHRAE/ASHE 170 standard was revised in 2013 to allow a lower threshold limit of 20 percent for operating rooms.” Conner continues, “Although the allowable lower humidity parameter for operating rooms has changed from 30 percent to 20 percent, it is not the intent of the standard to require that the humidity be maintained at 20 percent. Occupants of the room will be more comfortable over time when the room humidity is above 30 percent.”
Conner points out that the 2014 edition of the Facility Guidelines Institute, Guidelines for Design and Construction of Hospitals and Outpatient Facilities, and the AORN Guideline for a Safe Environment of Care, Part 2 (released May, 2014) have been harmonized with the current ASHE 170 standard. The AORN Guideline provides additional guidance for perioperative personnel when the HVAC system falls outside the intended environmental control parameters.
The statement explains that in many locations across the country, cold weather or desert conditions create dry environmental conditions. In order to achieve higher levels of RH that are required in accordance with nationally recognized expert organizations whose guidelines have been incorporated into state or federal regulatory standards, hospitals and ambulatory surgery centers have to add humidity into the building air, an activity that is expensive and creates its own unique challenges to patient safety. At the request of a number of healthcare delivery organizations (HDOs), ASHRAE (the American Society of Heating, Refrigeration and Air Conditioning Engineers) investigated and revised its international standard for HVAC design parameters in 2010. The environmental RH for anesthetizing locations, including operating rooms was changed to expand the minimum end of the range from 30 percent to 20 percent RH. The upper limit remains at 60 percent RH. The 2012 edition of National Fire Protection Association (NFPA) 99 eliminated direct references to humidity requirements for anesthetizing locations and cross-referenced the 2008 ASHRAE Standard 170 Ventilation of Health Care Facilities, with Addendum D, and the 2013 version of the standard has also been incorporated into the 2014 edition of the Facility Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals and Outpatient Facilities. The American Society for Healthcare Engineering (ASHE) and the Association of periOperative Registered Nurses (AORN) also support the ASHRAE standard, as does the Joint Commission. Use of a 20 percent rather than a 30 percent minimum RH is becoming increasingly desirable from a facilities management perspective.
The statement emphasizes that it is important for personnel to know and understand the manufacturer’s IFUs specific to all supplies and equipment, and in particular know what environmental humidity requirements are specified in the IFU.
According to the statement. “Relative humidity may affect the operation of some electro-medical equipment used in the OR, particularly with older model electro-medical equipment. This equipment may malfunction unexpectedly. Too low humidity levels may also impact calibration. Larger electrostatic discharge (ESD) pulses may create a risk of destruction of parts, premature failure, and erratic behavior of software that is “confusion” from ESD pulses. And, in an environment where humidity is low, a person can more easily become ‘charged’ and receive an electrostatic shock when coming in contact with medical equipment. Humidity regulation is difficult to control when weather changes occur. The humidification regulation system in a facility will take some time to compensate by returning the humidity to the nominal ‘setpoint’ range. It is uncertain for how long the humidity for supplies can be below the manufacturer’s recommended minimum level before the equipment or product is affected.”
The stakeholders involved in the discussions that led to this communication say they want to achieve two goals: To ensure that patients are protected through the safe and effective use of equipment and products during surgery, and to eliminate the potential waste of resources for installation, energy and ongoing maintenance that don’t improve patient outcomes so that the resources can be better utilized.
As the statement notes, “Manufacturers of supplies and equipment want to support the needs of healthcare institutions to expand the lower range of acceptable RH to 20 percent but the pace of this change will depend on the products and whether the lower humidity level can actually harm the integrity, safe use or performance of the products. It will take some time for manufacturers to modify products and/or packaging to accommodate or verify the lower minimum RH, complete testing requirements for these typically regulated products, and have those products available for healthcare institutions. The IFUs should be followed because they provide the up-to-date parameters of what the particular products have been tested for, whether there are differences for long-term storage versus short-term use, whether short-term deviations (or excursions) are acceptable (and for how long), and the like.”
The statement advises that healthcare institution leaders think about whether lower humidity levels are desirable and appropriate in their facilities, and the answers may vary depending on the climate where the facility is located, the services offered, and the products and equipment used in their location. For example, new electro-medical equipment is moving toward lower acceptable humidity levels; however, if an organization continues to use equipment of various ages and from various manufacturers, it will be many years before its leaders can assume that all of the electro-medical equipment can safely withstand lower humidity levels. Healthcare facility leaders, clinicians, engineers and supply chain professionals must understand that the lower RH level can actually harm the integrity of the products they use, and they need to consider carefully the ramifications of low RH levels.