Disposable Laryngoscopes
Reviewing the Centers for Disease Control and Prevention’s (CDC) infection risk classification and the device procurement criteria safety, efficacy, convenience of use, cost, and regulatory compliance will help you better grasp the safety of reusable and Disposable Laryngoscopes.
The contact of tongue blades with mucosal membranes is regarded as a semi-critical or intermediate danger. Consequently, they need at least high-level disinfection, which is normally carried out in the Central Sterilization and Supply Department (CSSD). In the past, handles that come into contact with skin were regarded as low-risk or non-critical. As a result, they need at least low-level disinfection, which is normally carried out in the operating room using a chemical cloth wipe.
Due to the ambiguity of the CDC’s classification of laryngoscope handles, the CDC defers to the “Instructions for Use” (IFU) provided by the device manufacturer for determining risk level.
IFUs are meant to identify alternate equipment cleaning techniques that have been approved by the manufacturer and are CDC-compliant. The institution is free to pick which technique to employ.
CDC requirements must be upheld, and oversight organizations like The Joint Commission have recently begun holding facilities accountable for laryngoscope IFUs. The potential “up-classification” of device risk and hence the need for disinfection has been made possible by the CDC’s deference to the industry in the estimation of risk.
Therefore, even while previous handles have been safely treated as low-risk, many manufacturers are now beginning to incorporate intermediate-risk labels on laryngoscope IFUs, even though they are not infection specialists. In order to maintain regulatory compliance, facilities now have two options: either submit the handles to CSSD for a minimum of high-level disinfection or switch to single-use disposables (SUDs). The latter option may be chosen by many facilities, primarily for reasons of convenience. The letter on page 90 of this issue’s APSF Newsletter raises a lot of typical issues with choosing the fast path.
The peer-reviewed literature contains a number of minor experiments showing subpar SUD blade performance because of the blade/increased joint deformability, particularly when made of plastic materials. Visualization of the vocal cords becomes more challenging with increased deformability. For this reason, institutions choosing to employ SUDs can use “disposable” steel, which is a far more worrisome material from an environmental standpoint.
The International Standards Organization (ISO) chooses the performance standards needed to have equipment FDA-approved. It should be noted that the ISO 7376 standards allow for a maximum 1 cm tongue blade tip excursion. Traditional reusable steel devices have significantly less tip excursion, but SUDs can utilize the allowed “wiggle room” to reduce material costs. SUDs can be modified to resemble reusable laryngoscopes, although this requires more expensive and high-quality materials.
Due to the labor and material expenses associated with CSSD reprocessing, disposable laryngoscopes are frequently thought to be less expensive than reusable alternatives. The cost of SUDs, however, can be higher than the lifespan costs of a comparable number of reusable laryngoscopes when taken into account for the entire institution. Sherman and colleagues calculated that reusable handles would be more cost-effective than SUDs if they can withstand at least 4-5 uses, and reusable blades, 5-7 uses, under the premise that the average CSSD laborer earns $50,000 per year, that standard cleaning times are followed, and that periodic refurbishment is taken into account.
Reusable steel products are typically rated for thousands of uses, giving them a significant advantage over disposables. Treating reusable laryngoscope handles and blades is probably a very minor portion (like 2% or less) of CSSD facility responsibilities in terms of infrastructure complexity.
A new safety factor is environmental health. It involves the complete life cycle, not just what ends up in the landfill, but also the extraction of natural resources, manufacture, packing, transportation, use/reuse, and eventual trash management.
When compared to alternative reusable cleaning scenarios, Sherman and colleagues’ life cycle study of SUD stiff laryngoscope handles and blades revealed that they produce 16–25 and 6–8 times more greenhouse gas (GHG) emissions using the conventional U.S. energy mix, respectively. Surprisingly, despite being less expensive, low-level disinfection of the handle produced somewhat more GHG emissions than high-level disinfection.
Worldwide, there is an alarming tendency toward single-use disposable items. A key contributor to non-communicable diseases, pollution causes 9 million deaths annually, or 16% of all fatalities worldwide. The greatest threat to public health in the twenty-first century has been dubbed climate change. Plastics are so common in our environment that they are now found in stools, table salt, and tap water.
Public health is included when patient safety is considered in its broadest sense. Your concerns about the security of disposable laryngoscopes are valid. In addition to dramatically worsening the environment as compared to reusable laryngoscopes, a life-cycle analysis shows that SUDs do not have the expected effect of lowering costs.
