Laryngoscopes To understand the safety of reusable and disposable laryngoscopes, it is helpful to review the US Centers for Disease Control and Prevention (CDC) infection risk category 1 and equipment procurement criteria (safety, effectiveness, ease of use, cost, and compliance).
Tongue strips are considered medium risk or semi-hazardous due to contact with mucous membranes. Handles in contact with skin are considered a low or insignificant risk. They, therefore, require minimal disinfection with chemical wipes in the operating room.
Because the CDC’s statement regarding the classification of Disposable Laryngoscopes handles is unclear, the CDC has left the determination of risk level to the instrument manufacturer’s instructions for use (IFU). The IFU is intended to describe alternative cleaning methods for manufacturer-approved instruments that meet CDC regulations, and it is up to the facility to decide which method to use.
As the CDC favors industry in risk determinations, the risk of equipment may be ‘upgraded’, leading to the need for disinfection. As a result, many manufacturers who are not infection specialists now list a medium-risk designation for laryngoscopic IFUs, even though historically the handle was safely considered low risk. This means that healthcare organizations have two options send the handles to a CSSD for minimally advanced sterilization or switch to single-use consumables (SUDs).
The letter on page 90 of this issue raises many of the typical problems encountered in applying the principle of subsidiarity.
The peer-reviewed literature contains a few small studies showing high blade/joint deformability, particularly the poor performance of blades made of plastic materials.
The International Organization for Standardization (ISO) defines the performance criteria required for FDA approval. ISO 7376 allows a displacement of the tongue height of up to 1 cm. While conventional steel reusable devices have much less tongue end displacement, SUDs can take advantage of the allowed “swing space” to save material. The SUD can be made to look like a reusable laryngoscope, but this requires higher quality material and increases cost.
Due to the labor and material costs of refurbishing disposable laryngoscopes, disposable laryngoscopes are often considered to be cheaper than reusable alternatives. However, when considering the whole organization, the cost per SUD may exceed the life cycle cost of the same number of reusable laryngoscopes.
Gerati estimates that an average annual labor cost for KSSD of USD 50 000, including standard cleaning and periodic refurbishment, would be more economical than a SUD if the reusable handle had a lifetime of at least 4-5 uses and the reusable blade 5-7 uses. Typical reusable steel equipment is designed for several thousand uses, so the benefits over disposable equipment can be significant. Given the complexity of the infrastructure, the treatment of reusable handles and blades for laryngoscopes may represent a very small part (e.g. 2%) of the CFSP equipment obligation.
Environmental health is an emerging security issue. Not only what is disposed of in landfills, but also the extraction, production, packaging, transport, recycling, and ultimately management of waste from natural resources – the whole life cycle.
Gerati conducted a life cycle assessment and found that the handle and blade of SUD’s fixed laryngoscope consume the standard US energy mix, resulting in 16-25 times and 6-8 times higher greenhouse gas emissions, respectively than other recyclable cleaning options. Surprisingly, low-level handle disinfection during reprocessing led to slightly higher GHG emissions than high-level disinfection, despite lower costs.
The global trend towards the use of single-use materials is worrying. Pollution is the leading cause of non-communicable diseases, killing 9 million people a year and accounting for 16% of annual deaths worldwide. Climate change has been identified as the biggest public health problem of the 21st century.
Plastics are so prevalent in our environment that they are now often found in tap water, salt and feces. Patient safety in its broadest sense also includes public health. You are right to question the safety of disposable laryngoscopes. Compared to reusable laryngoscopes, SUDs not only have a significant negative impact on the environment, but a full life cycle analysis also shows that SUDs do not have the desired cost reduction effect.