Necessary Consideration - Reusable or Single Use Endoscope?

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 an abdomen procedure, 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, Philipp Bozzini first began attempting to observe “the inner cavities of the human body” in the early 1800s.

There is a pivot away from reusable endoscopes in favor of disposable, single-use endoscopes.

In this post, we’ll discuss topics to consider 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 called a disposable device, intended for 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 Concerning Sterilization and Risk?

When a reusable endoscope is processed, the cleaning process is often 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:

1. Endoscope Cleaning – involves the physical removal of blood and other physical byproducts resulting from the endoscope's introduction to anatomy.
2. Endoscope Disinfection – the destruction of microorganisms, except bacterial spores. An endoscope could go through one of three levels of disinfection (High, Intermediate, or Low).
3. 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 to ensure patient safety.

Risks associated with a reusable endoscope include adherence to the predetermined cleaning procedure per the specific endoscope, but they are not limited to this.

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 ensure 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 ten years ago.

However, at the time of writing, about one in 31 patients has at least one healthcare-associated infection.

Suppose 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?

We suggest reading our Medical Device Sterilization Methodologies for Your Product post to learn more about the various sterilization methods.

Additional Resources

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 consider several factors.

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 developing a single-use / disposable endoscope, Check out our recent post.