Top 3 Risks of Cross-Contamination from Reusable Laryngoscopes
In 2017, the FDA released a list of reusable medical devices that “currently have the greatest risk of infection transmission and inadequate performance if not adequately reprocessed.” This list included laryngoscopes. The handling of cross-contaminated reusable medical devices poses a risk not only to patients but to healthcare facilities and their sterile processing departments.
Healthcare-associated infections (HAIs) already cost hospitals billions of dollars each year. In addition, hospitals risk losing a percentage of their Medicare funding if they have too many hospital-acquired conditions. Sterile processing departments face staff shortages, and struggle to keep up with ever-changing devices and manufacturer instructions. Continuing to use reusable devices when single-use options are available further burdens their workflow.
Patient Risks: Healthcare-Associated Infections
The improper handling of reusable medical devices puts patients at risk for healthcare-associated infections. The good news is that over the last few years, HAIs in the U.S. have been on the decline. From 2015 to 2016, the CDC reported that acute care hospitals saw a decline in HAIs anywhere from 2% to 11%. However, HAIs are still a reality, putting patients at risk. At any given time, 1 in 31 hospital patients in the U.S. has one or more HAIs.
Cross-contamination from reusable medical devices like laryngoscopes can result in HAIs, but the scope of this problem remains largely unknown. According to the FDA, “The number of HAIs that can be attributed to inadequate device reprocessing is unknown because it is not often investigated as a cause of HAI.”
After each use, reusable medical devices must undergo a multi-step process at the facility’s sterile processing department. Devices must be cleaned, then either disinfected or sterilized. The clean devices must then be stored properly until the next usage. A breakdown in any of these steps can result in cross-contamination.
The complex design of reusable laryngoscopes, including their handles, handle tops, and hinges increase the risk for harboring bacteria. The FDA recognizes that “hinges” and “adjacent device surfaces between which debris can be forced or caught during use” are medical device design features that make the cleaning, disinfecting, and sterilization processes more complex.
The handles of many reusable laryngoscopes have a knurled surface. This embossed surface enables healthcare professionals to have a solid grip on the device during use. However, knurled surfaces can be difficult to clean and disinfect. When some reusable laryngoscopes are folded for storage, the tip of the blade comes in direct contact with the handle.
According to a 2017 study published by the Journal of Preventative Medicine and Public Health, reusable laryngoscope handles can be a source of bacterial contamination. The study looked at reusable laryngoscopes that were stored on emergency crash carts. Of the handles tested, 28.2% had at least one bacteria species present.
Six of the contaminated handles were found to have various types of Acinetobacter. According to the CDC, Acinetobacter baumannii accounts for 80% of all reported HAIs. While Acinetobacter is often harmless for most healthy individuals, it can be quite serious for those who are ill. Acinetobacter can cause pneumonia, blood infections, and wound infections. This bacteria is often resistant to commonly prescribed antibiotics. The authors of the study recommended healthcare facilities to consider “the use of single-use, one-piece laryngoscopes with blades that are not folded.”
Laryngoscope Handle Tops & Hinges
Reusable laryngoscopes typically have a hinge on the handle top, where the blade connects to the handle. The hinge allows the blade to fold down during storage. In the same study that found laryngoscope handles to be contaminated, 5.6% of the handle tops also had bacterial contamination. Acinetobacter was found on two of the contaminated handle tops.
Hospital Risks: Increased Costs and Fines
When using reusable medical devices, facilities put themselves at risk for increased costs and fines. The most recent data released by the Department of Health and Human Services shows that the five most common HAIs cost the healthcare system almost $10 billion every year.
Not only do HAIs cost money in further treatment, but poorly performing hospitals also lose a percentage of their medical funding if they have too many hospital-acquired conditions. These conditions include preventable infections, bedsores, and sepsis. Poorly performing hospitals have not only their finances at stake, but their reputations are on the line.
Sterile Processing Department Risks: Inadequate Processing Instructions
Technicians working in sterile processing departments face several challenges including high turnover rates, an ever-changing industry, and communication with device manufacturers. The FDA recognizes that there are three factors affecting the quality of reprocessing of reusable medical devices: the device design, reprocessing methodologies, and adequate guidelines from the device manufacturers. Technicians are put at risk when they’re handling devices they’ve processed and believe to be sterile but are in fact still contaminated.
Errors in Reprocessing
New and improved medical devices are always hitting the market. Each time a hospital adopts the use of a new device, SPD technicians must be trained on how to properly reprocess the new device. There are many steps in the process, and each step is a chance for human error. Staff must also have access to the appropriate equipment needed for reprocessing.
Sterile processing departments rely on medical device manufacturers to provide complete and accurate reprocessing instructions. Device manufacturers are responsible for testing their reprocessing instruction to ensure that they are adequate. However, the FDA has found “that many studies designed inadequate test conditions and used inappropriate measurement methods to validate that the tested device was clean.”
Manufacturers often use a suspension of bacterial spores to test their reprocessing instructions. This method does not take into consideration the removal of bone, tissue, or blood, and can result in inadequate reprocessing instructions for real-life usage.
The number of sterile processing employees in the U.S. is estimated to be just under 54,000. Reusable medical devices are constantly changing, and the need for adequately trained staff is great. Unfortunately, industry experts recognize that many sterile processing departments have a high rate of employee turnover. This turnover results in a constant cycle of hiring and training new employees. Staff must be trained on the reprocessing steps for each and every device they handle.
Single-Use Laryngoscopes: Safer for Patients
Using a single-use laryngoscope like obp’s SURE-SCOPE reduces the risk for patients and hospitals. This is one fewer device that the already overburdened staff must reprocess and store. Each SURE-SCOPE comes individually wrapped in sterile packaging, eliminate cross-contamination concerns during storage. For more information on obp’s SURE-SCOPE, contact us.