Reusable or Single Use Endoscope? What You Need to Consider
Endoscope is the catch-all name for camera-based medical devices.
In endoscopy, whether the intended use of an endoscope is a diagnosis in the throat, or as part of a procedure in the abdomen, the “endoscope” is used daily for a myriad of procedures.
Are Endoscopes One-Time Use or Are There Disposable Endoscopes?
Endoscopes are either single-use endoscopes, also known as disposable endoscopes, or reusable endoscopes.
According to the William P. Didusch Center for Urologic History, it was Philipp Bozzini who first began attempting to observe “the inner cavities of the human body” in the early 1800s.
At current there is a pivot away from reusable endoscopes in favor of disposable, single-use endoscopes.
In this post, we’ll discuss topics that should be considered when determining whether single-use or reusable is the best direction for your endoscope.
The Differences between Single-Use Endoscopes and Reusable Endoscopes
The FDA classifies reusable medical devices and single-use medical devices as follows:
Reusable: “Reusable medical devices are devices that health care providers can reprocess and reuse on multiple patients.”
Single-use: “A single-use device, also referred to as a disposable device, intended for use on one patient during a single procedure. It is not intended to be reprocessed (cleaned, disinfected/sterilized) and used on another patient.”
What Reusable Endoscope Processes Should You Consider with Respect to Sterilization and Risk?
When a reusable endoscope is processed, more often than not the cleaning process is referred to as “sterilization”.
The fact of the matter is that sterilization is a single step in a larger process.
After use in a procedure, the reusable endoscope could go through one or more of the following, as part of an intensive cleaning:
- Endoscope Cleaning – which involves the physical removal of blood and other physical byproducts resulting from the endoscope being introduced to anatomy.
- Endoscope Disinfection – the destruction of microorganisms, except bacterial spores. An endoscope could go through one of three levels of disinfection (High, Intermediate, or Low).
- Endoscope Sterilization – the destruction or inactivation of all microorganisms.
These three steps, and the brief information provided, do not cover the whole process that many endoscope companies follow in attempts to ensure patient safety.
Risks associated with a reusable endoscope include but are not limited to adherence to the predetermined cleaning procedure per the specific reusable endoscope.
As you weigh your options and risks between developing a reusable endoscope or a single-use endoscope, consider the post-procedure processes that you will need to require when the endoscope is out of your control.
Ensure your procedures, specifications, and requirements for cleaning the endoscope are such that you can guarantee a clean endoscope for each procedure.
But before you make up your mind, seriously consider the question below.
Can You Help Prevent Healthcare-Associated Infection (HAI)?
According to the CDC, progress has been made and patient safety associated with infection is better than it was ten years ago.
The CDC also states that “On any given day, about one in 31 patients has at least one healthcare-associated infection.”
If you choose to develop a reusable endoscope, will your design and construction of your endoscope be developed in such a way that you’ll be able to guarantee yourself that your cleaning, disinfecting, and sterilization process would prevent HAI for your patient?
If you wish to learn more about the various sterilization methods, we suggest reading our Medical Device Sterilization Methodologies for Your Product post.
Though our research did not identify an exact figure indicating how many endoscopes are reprocessed and used daily, it is reported that ~19 million colonoscopies are performed annually in the United States alone.
Most colonoscopies are performed with reusable endoscopes.
Determining whether your endoscope should be a disposable single-use endoscope, or a reusable endoscope requires you to take several factors into account.
Our desire with this post was to help you consider if your examination has gone deep enough to ensure your endoscope's long-term success.
If you want to learn more about what it takes to develop a single-use / disposable endoscope, consider our The Cutting Edge of Chip-on-Tip Camera-Based Device Technology post.