August 30, 2013 — In its policy entitled “Infection Prevention and Control (CAMH / Hospitals): Laryngoscope Blades – How should we process and store laryngoscope blades?” (dated October 24, 2011), the Joint Commission (JCAHO), which is a national and well-known accreditation organization, writes:
“Joint Commission surveyors will evaluate processes related to laryngoscope blades to ensure that they are safe for use on the next patient. They will check that laryngoscope blades are:
- processed via either sterilization or high-level disinfection;
- packaged in some way …; and
- stored in a way that would prevent re-contamination.
Examples of compliant storage include, but are not limited to, a peel pack post steam sterilization (long-term) or wrapping in a sterile towel (short-term). Examples of non-compliant storage would include unwrapped blades in an anesthesia drawer, as well as unwrapped blades on top of a code cart.”
Click here to read a public-health alert by the California Department of Health Services that – based primarily on Dr. Muscarella’s writings and recommendations – requires high-level disinfection (at a minimum) of not just its blade, but also, having classified it as semi-critical (not non-critical), of the rigid laryngoscope’s handle.
The Joint Commission’s policy – which can be read directly by clicking here – is clear, well presented and, most important, evidence-based (meaning, in large part, that this policy is not arbitrary and is based on data published in the peer-reviewed medical literature).
The Laryngoscope’s handle
The Joint Commission’s policy also discusses the reprocessing of the rigid laryngoscope’s handle, stating that:
“… laryngoscope handles are considered contaminated after use and must be processed prior to use on the next patient. Most manufacturers suggest a low-level surface disinfectant be utilized on the surface of the handle, but processes vary by manufacturer. As is the case with all medical devices, the manufacturer’s indications for use (IFU) must be followed. Please also check your state for additional law or regulation; we are aware of at least one state that requires additional processing.”
Click here to read a related article by Dr. Muscarella about reprocessing the handles of laryngoscopes.
Respectfully, the Joint Commission’s policy is arguably invalid because:
- it can promote (rather than minimizing) variations in reprocessing practices by staff (and in the labeling of manufacturer products), which can pose an increased risk of disease transmission; and
- it not based on evidence or on Spaulding’s universally accepted device classification (for more about Spaulding classification, refer to Table 1 of an article Dr. Muscarella wrote in 2008 that can be read by clicking here.
Case Reviews: Click here to read about Dr. Muscarella’s expertise and peer review assessments of the causes of healthcare-associated infections, including “superbug” outbreaks linked to contaminated GI endoscopes and other reusable medical equipment.
A Regulatory quirk?
The Joint Commission’s policy noting that the reprocessing instructions provided by manufacturers for reprocessing rigid laryngoscopes may be inconsistent is also salient because it exposes a regulatory quirk.
The Food and Drug Administration (FDA) currently classifies rigid laryngoscopes as CLASS 1 devices, which – unlike GI endoscopes, which are CLASS 2 devices – are exempt from the FDA’s premarket notification, or 510(k), requirements.
(Translation: The labeling and reprocessing instructions, or the “IFUs” [i.e., instructions for use], that rigid laryngoscope manufacturers provide with their equipment are held to a lower standard and are not necessarily, or typically, reviewed by the FDA staff for clarity and reprocessing adequacy.)
Click here to read Dr. Muscarella’s step-by-step guideline for reprocessing the rigid laryngoscope’s blade and handle.
The British literature
As Muscarella (2008) wrote in the British literature (click here to read an abstract to this paper), not only is the rigid laryngoscope’s handle – like the blade to which it directly attaches – a *semi-critical* device, but also inconsistencies in reprocessing practices (such as those advanced by this Joint Commission policy), like other variations in clinical practices, are “problematic and can result in ineffective reprocessing, inconsistent standards of patient care, disease transmission and healthcare-associated infections.”
Click here to read Dr. Muscarella’s step-by-step guideline for reprocessing flexible laryngoscopes.
Therefore, the Joint Commission’s statement in its policy that, in general, the laryngoscope handle can be safely disinfected using “a low-level surface disinfectant … on the surface of the handle” re-classifies the laryngoscope’s handle as a *non-critical* device, which, as Muscarella (2008) also wrote (click here), poses an increased risk of healthcare-associated infections (or, HAIs).
Publications other than those published by Dr. Muscarella that similarly recommend that the rigid laryngoscope’s handle be classified (like its blade) as semi-critical (not non-critical) include a mandate published by the California Department of Health Services and by the American Association of Nurse Anesthetists (AANA).
1. The Joint Commission is respectfully requested to consider revising its policies to recommend cleaning followed by high-level disinfection or sterilization of, not just the rigid laryngoscope’s blade, but also its handle.
2. The publication of a consensus statement by professional organizations that, as they have done for the reprocessing of GI endoscopes and bronchoscopes, provides consistent instructions for the reprocessing of the rigid laryngoscope’s blade and handle.
Such a statement would, no doubt, contribute to preventing: staff confusion, variations in reprocessing practices and in manufacturer instructions, different standards of care, and HAIs. (The importance of such a consensus statement is discussed in detail in Dr. Muscarella’s article on this topic: click here.)
3. In addition, to increase both patient safety and the quality of instrument reprocessing and to eliminate a regulatory quirk, the FDA is respectfully requested to consider re-classifying rigid laryngoscopes as Class 2 devices, so that the FDA can review manufacturers’ labeling in more detail and ensure that rigid laryngoscope reprocessing instructions are adequate (i.e., these instructions classify the blade and handle as semi-critical devices that require cleaning followed by high-level disinfection, at a minimum, and both drying and safe storage).
To reduce the risk of infection, the importance of standardizing the reprocessing of the rigid laryngoscope’s both blade and handle is emphasized. Indeed, inadequate reprocessing of rigid laryngoscopes has been identified as the cause of bacterial outbreaks (e.g., Pseudomonas aeruginosa infections) associated with patient and infant mortality and morbidity.
- Muscarella LF. Reassessment of the risk of healthcare-acquired infection during rigid laryngoscopy. J Hosp Infect 2008 Feb;68(2):101-7.
- Table 1 of AORN’s “Recommended Practices for High-level Disinfection” (see p. 580 of AORN’s “Perioperative Standards and Recommended Practices, 2009”).
Article by: Lawrence F Muscarella PhD posted on 10/16/12; updated 2/10/2016.