Scrub or Toss? Making the Case for Disposable Laryngoscope Blades

Airway-management equipment undeniably assumes a position of prime importance in the EMS arsenal. Of all EMS interventions, appropriate airway management, along with early defibrillation, is most likely to be truly lifesaving. However, in the course of routine reevaluation of system equipment, Pinellas County (Florida) EMS recently had cause to ask whether or not we were potentially harming both patients and EMS practitioners in the long run with this very same lifesaving equipment.

Pinellas County EMS is a large, all-ALS, public utility model system serving a base population of approximately 900,000 in central Florida. In 2003, almost 1,200 intubations were performed by our 800 paramedics. The system was using reusable laryngoscope blades and handles, with one set of handles and blades (pediatric and adult) issued per ALS unit. The system’s equipment committee had periodically been evaluating disposable laryngoscopes and laryngoscope blades, primarily because of infection control considerations. When the committee was ready to recommend adopting a disposable laryngoscope blade system, the county EMS Authority requested a detailed analysis of pros and cons related to moving to disposable equipment.

How Clean Is Clean?

The Centers for Disease Control and Prevention (CDC) and the Association for Professionals in Infection Control and Epidemiology (APIC) classify medical devices according to the Spaulding classification system as “critical,” “semi-critical” and “noncritical.” Laryngoscope blades fall into the semi-critical classification. This category includes any medical devices that touch mucous membranes or broken skin.1–3

The process for disinfection and sterilization of semi-critical items is designated by the CDC as “high-level” disinfection.3 High-level disinfection kills all organisms, with the exception of high levels of bacterial spores, and is achieved using a chemical germicide classified by the Food and Drug Administration (FDA) as a “sterilant,” or sterilizer. Examples of approved sterilants include Cidex, Sterilox and Sporicidin.4 The item must be exposed to the sterilant for periods of time ranging from 10–45 minutes, depending upon the chemical used, in order to assure adequate performance.4 The appropriate use of these chemicals is highly dependent upon careful compliance with manufacturer’s recommendations for use, including “debulking” of organic material present on the equipment via mechanical scrubbing before exposure to the chemical.3

Unfortunately, laryngoscope blades have been identified in the literature as potential vectors for cross-contamination and as sources of nosocomial infection.5,6 Over two million patients per year develop nosocomial infections, resulting in 90,000 deaths annually and significant added healthcare costs, as well as unanticipated burdens on patients and their families.7 It is not uncommon for laryngoscope blades to routinely be contaminated with gross or occult blood and other infectious body fluids during intubation procedures. The blades also frequently come in contact with disrupted mucosal surfaces, increasing the probability of transmitting infectious material if it is present on the equipment. Blades also tend to have irregular surfaces and crevices that hold on to tissue and other potentially infectious material. A study, reported in 2001, on a series of supposedly clean, sterile pieces of airway equipment within a single hospital found that 77% of laryngoscope blades taken from operating rooms, 86% of those taken from an intensive care recovery area and 100% of those taken from medical or surgical wards stained positive for retained protein material, an indication of possible incomplete cleaning and sterilization.8 Studies of laryngoscope decontamination and sterilization procedures in hospitals in Great Britain and the Netherlands have shown poor compliance with internationally established semi-critical equipment decontamination and disinfection procedures, with causative factors including lack of clear decontamination guidelines and written procedures, cumbersome quality control techniques, and even hazardous-materials classifications of some of the eligible sterilant chemicals.9,10 In the United States, surveys were sent to 125 large city EMS system medical directors regarding equipment hygiene standards.11 Only 37% of responding agencies that cleaned and disinfected their own laryngoscope blades used both soap and water and alcohol or a commercial disinfectant (A/CD), while 32% used only A/CD without other cleaning and 4% used soap and water alone. The survey did not address the adequacy or quality control of performance of soap and water washing or disinfecting techniques, so the effective cleaning and high-level decontamination rates are likely even lower.

In Pinellas County, there is no single equipment decontamination and disinfection policy covering all first responder fire departments and Sunstar, the ALS transport agency. All agencies are required to follow OSHA Bloodborne Pathogens Standards, but these standards do not specify methods of decontamination and disinfection.12 An informal survey of EMS agencies indicated that CDC and APIC guidelines for semi-critical equipment were not consistently being followed. Challenges to compliance include systems status management of Sunstar units, making access to station or headquarters-based cleaning resources between patients difficult, and call volume, which necessitates frequent serial call dispatching for individual fire and Sunstar units without sufficient time in between for the required procedures. While there had never been a related airway equipment contamination issue identified within the system, it became clear that the status quo was not acceptable.

Making the Case

Although the concept of disposable laryngoscopic equipment makes sense from the perspective of infection control, several previously published studies of disposable laryngoscope blades have suggested potential concerns. Although one study found a particular brand acceptable in the OR for routine intubations,13 another found that several brands of plastic disposable blades required the use of greater peak forces than metal nondisposable blades and increased the duration of intubation attempts significantly.14 Other studies found most disposable blades tested to have lower performance satisfaction scores,15 along with a lower percentage of glottic opening (POGO) visible scores and a higher incidence of failed intubations.16 There are also at least anecdotal reports of fragility of the plastic under cold weather conditions and problems with dim lighting. The equipment committee and the Office of the Medical Director had already determined that the clinical characteristics and capabilities of the recommended equipment were acceptable. The main advantages of this particular brand were the metallic composition of the blades, bright fiberoptic lighting, bulbless construction and acceptance by field practitioners who examined the equipment. The remaining factors in the final purchasing determination included logistics, user-friendliness, quality management, risk management and, of course, both initial and ongoing cost. The options fell into two basic categories: establish a CDC/APIC-compliant cleaning and disinfection program or change to a disposable system.

The option of implementing a CDC/APIC-compliant program included a host of disadvantages. Logistically, the minimum of equipment stocked on ALS vehicles would have to be at least doubled in order to assure that they would be identically capable on at least two consecutive calls without adequate cleaning time in between. A mechanism for ongoing resupply between calls would be required for Sunstar and other units without routine access to cleaning equipment. Cleaning areas with appropriate ventilation, equipment and personal protective gear would have to be established; this would require a minimum of 20 stations to provide just one location for each agency. Many agencies would realistically require multiple physical locations to minimize travel time to access the equipment. The system has ALS first responder vehicles stationed at over 60 locations, without even considering Sunstar ambulances. Appropriate procedures for cleaning and decontamination and quality control measures would require a significant time commitment from personnel, in some cases causing detrimental alterations in response capability; dedicated staff for the purpose is not practical. The procedures are quite time- and effort-intensive, with vigorous initial scrubbing and rinsing, careful examination of equipment for adequate decontamination prior to disinfection, requirements for monitoring and temperature of solutions, solution effectiveness testing, varying required soaking times according to sterilants used and documentation procedures for all aspects (see Table I). Risk management also poses challenges in that the very nature of the procedures as outlined above discourages compliance. In addition, there is some risk of significant infectious disease exposure during cleaning procedures, and glutaraldehyde, the most common chemical used, can be hazardous if used improperly (see Table II).17 Conservative figures calculated at the time on the basis of uploading just 20 cleaning stations utilizing Cidex and Enzol solutions showed a required investment of about $15,000. On-going costs for the same number of stations would be almost $8,000 per year, based on the cost of solutions alone (see Table III on page 94).

A parallel option was to purchase autoclaves for a similar number of cleaning locations. Depending upon size and degree of computerization or automation, autoclaves can be purchased for anywhere from $600 to more than $5,000. Additional supplies needed include wrappers, indicator tape, autoclave cleaning supplies and printer paper. While this may be a very reasonable option for smaller departments, the capital expenditure to establish 20 cleaning locations in Pinellas would have exceeded $15,000. Logistical challenges posed by the limited number of locations would still exist and would also likely increase the required vehicle equipment inventory to assure continued serial patient care capability.

The option of moving the system to a disposable laryngoscope blade system effectively negated many of the concerns raised by the compliant cleaning and disinfecting program option. The logistical issue of an ALS unit potentially being without required equipment when there were two or more consecutive calls would still, however, need to be addressed. (It should be noted that no critical incidents with lack of appropriate equipment on scene have ever been identified, more than likely because of the routine practice of dispatching multiple ALS units to every scene.) Clearly, user-friendliness is an advantage of the disposable system, with less effort and time investment required. Procedures would be greatly simplified compared to the disinfection program option; thus, quality control issues would be far less prominent. Risk management concerns related to hazards to workers would also be reduced. The cost of matching the current equipment availability with one new set of disposable pediatric and adult blades and one nondisposable laryngoscope handle for each of 120 ALS units would be approximately $4,200. Ongoing blade replacement costs based on one blade used for each of 1,200 intubations were also estimated at $4,200.

Based on financial factors alone, the disposable blade system would provide the opportunity to address not only the cleaning and disinfection issue, but also to improve equipment availability. The additional cost to increase each ALS unit inventory to two sets of adult and pediatric laryngoscope blades and two adult handles (doubling capacity) and to add a pediatric-sized laryngoscope handle was only $5,400.

The Decision

Following this methodical problem analysis, the county EMS Authority authorized the system’s transition to the disposable equipment option. This option allowed not only for quality improvement of the existing system, but also doubling of laryngoscope handle and blade inventory on all ALS units for less than the cost of uploading and implementing a uniform appropriate cleaning and disinfecting system (approximately $9,600 versus $15,000). Ongoing costs were also favorable for this option.

While the financial aspects of this issue will vary depending upon EMS system size, call volume, patient acuity, and the equipment and chemicals selected, the analytical process used by Pinellas County EMS to arrive at the final decision is applicable to many clinical and nonclinical purchasing decisions. In this case, because of the suspected but ill-defined risks to patient well-being in addition to more definable system-related factors, the impact of the final decision may be even more significant than can be obviously appreciated. Pinellas County EMS uploaded the new intubation equipment in September 2004.

References

1. Fogg D. Expiration dates; alcohol disinfection; OR consents; local anesthesia; marking surgical sites; moderate sedation—Clinical Issues. AORN Journal (2003). www.findarticles.com/p/articles/mi_m0FSL/is_2_78/ai_106762784.
2. Rutala W. APIC guidelines for selection and use of disinfectants. Am J Infection Control, pp. 313–342, Aug 1996. 3. Sterilization or disinfection of medical devices: General principles. Aug 2002. Centers for Disease Control. www.cdc.gov/ncidod/hip/Sterile/Sterilgp.htm.
4. FDA-cleared sterilants and high level disinfectants with general claims for processing reusable medical and dental devices. 3 Nov 2003. Device Evaluation Information. U.S. Food and Drug Administration. www.fda.gov/cdrh/ode/germlab.html.
5. Foweraker JE. The laryngoscope as a potential source of cross infection. J Hosp Infect 29:315–316, 1995.
6. Neal TJ, Hughes CR, Rothburn MM, Shaw NJ. The neonatal laryngoscope as a potential source of cross-infection. J Hosp Infect 29:315–317, 1995.
7. Clark A, Houston S. Nosocomial infections: An issue of patient safety, Part 2. Clinical Nurse Specialist, pp. 62–64, 2004.
8. Miller DM, Youkhana I, Karunaratne WU, Pearce A. Presence of protein deposits on “cleaned” re-usable anaesthetic equipment. Anaesthesia 56(11):1069–1072, 2001.
9. Rutala WA. Hospital Epidemiology and Infection Control. Baltimore: Williams and Wilkins, 1996.
10. Bucx MJL, Dankert J, Beenhakker MM, Harrison TEJ. Decontamination of laryngoscopes in the Netherlands. Br J Anaesth 86(1):99–102, 2001.
11. Goodman C, Cone D. Emergency medical services equipment hygiene practices. Prehosp Emerg Care 5(2):169–173, 2001.
12. Regulations (Standards-29 CFR) Bloodborne Pathogens 1910.1030. Jan 2001. Occupational Safety and Health Administration. www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051>.
13. Galinski M. Disposable laryngoscope blades do not interfere with ease of intubation in scheduled general anaesthesia patients. Europ J Anaesthesiol 20(9):731–735, Sep 2003.
14. Evans A. A comparison of the forces exerted during laryngoscopy using disposable and nondisposable laryngoscope blades. Anaesthesia 58(9):869–873, Sep 2003.
15. Fourneret-Vivier A. Single-use laryngoscope blade assessment. Annales Francais D’Anesthesie et de Reanimation 23(7):694–699, Jul 2004.
16. Twigg SJ. Randomized evaluation of the performance of single-use laryngoscopes in simulated easy and difficult intubations. Br J Anaesthesiol 90(1):8–13, Jan 2003.
17. Glutaraldehyde: Occupational Hazards in Hospitals. May 2001. National Institutes for Occupational Safety and Health. www.cdc.gov/niosh/2001-115.html.