Single-Use Endoscopes: A Trend towards Better Patient SafetyAug 22, 2019
Design continues to save lives. The disposability designed into single-use medical devices such as surgical masks, syringes, and suction catheters has reduced the risk of infection and boosted patient safety. The widening trend of single-use devices such as these has helped to make a good case for using disposable flexible endoscopes in many surgical and non-surgical procedures.
As with other disposable medical devices, the obvious benefit of single-use endoscopes is the reduction of the risk of post-procedure infection caused by cross-contamination. Also, although the reception of the medical community to these devices is mixed, interest in them is growing because the need for improved patient safety continues to be urgent.
The Problems with Reprocessing Endoscopes
These flexible plastic tubes with an illuminated lens system are used to look inside the human body. Health care providers working in several specialties, including gastroenterology, otolaryngology, orthopedics, and gynecology, rely on endoscopes for surgical and non-surgical procedures. These devices are heavily relied upon in medical practices and hospitals and have been traditionally reprocessed for use in each procedure.
Reprocessing, however, has proven to be an impediment to patient safety. While the Food and Drug Administration (FDA) has classified conventional endoscopes as reusable devices to be used to treat and diagnose multiple patients, problems with infection caused by Pseudomonas aeruginosa, Salmonella species, Enterobacteriaceae, and other dangerous microorganisms transferred between procedures have become more prevalent in recent years. A 2018 study from the American Journal of Infection Control showed that 71% of fully reprocessed endoscopes still contained microbial growth.
In response to these issues, the FDA has provided specific guidance on the steps for reprocessing. The agency continues to issue safety communications on following appropriate and safe reprocessing instructions regarding endoscopes used in gastroenterological procedures. Also, the major endoscope manufacturers--Olympus, Pentax, and Fujifilm--have been ordered by the FDA to carry out postmarket surveillance studies to investigate how real-world reprocessing works. It remains to be seen if the FDA's infection control efforts on the reprocessing front will succeed.
Besides the sizeable challenge of trying to keep patients safe, reprocessing has other drawbacks related to time and money. Even the basic reprocessing steps, as recommended by the FDA and the Center for Disease Control (CDC), can be time-intensive for medical staff to carry out properly. So while there are initial cost savings with reusable endoscopes, they might ultimately be outweighed by reprocessing costs and the financial impact related to the complications of infection.
Advantages of Single-Use Endoscopes
Improved patient safety is foremost among the benefits of disposable endoscopes. Additional benefits of these single-use devices include:
- True health economy - The costs of treating post-procedure infections are significantly reduced, and patients can return home from procedures earlier.
- Time-efficiency - Time used on reprocessing can be redirected to patient care.
- Lowered risk of damage - Single-use endoscopes do not sustain the damage that reusable devices receive over time.
- Decreased likelihood of regulatory penalties - For example, fewer infections as a result of using disposable devices in a hospital can reduce the chances of Medicare reducing its payments through its Hospital-Acquired Condition Reduction Program.
Is Single-Use Endoscope Technology as Effective as Reusable?
Some doctors and surgeons maintain that it is not because some procedures may require better visualization than what the single-use devices provide. However, the short answer to this question is that the optics in single-use endoscopes are rapidly catching up. Ambu, an up-and-coming single-use endoscope manufacturer that received FDA approval for single-use colonoscopes in 2018 for sale in the U.S., is incorporating smartphone and surveillance camera technologies into its endoscopes. This design feature should result in better visualization quality as these technologies continue to advance.
The Outlook: Cautiously Optimistic
The FDA's efforts at infection control through more closely scrutinized reprocessing illustrate how difficult it is for medical facilities to ensure that their medical devices--endoscopes in particular--are free of microbial contamination. The agency has approved a handful of disposable endoscopes and similar products, some of which are not yet on the U.S. market. Manufacturers in this space expect to offer a broader range of endoscopic devices in the next five to 10 years.
One challenge for single-use endoscope manufacturers is to find ways to make their products cost-competitive with reusable products. They also will need to continue to stay current with optics technology. Most importantly, these manufacturers must continue to campaign for patient safety while at the same time support practitioners as they begin to transition from reusable to disposable endoscopes.
Interested in more? Take a look at these articles below:
- Single-Use Medical Disposables Smarten Up
- The Top 7 Reasons Why Medical Devices Fail
- Biocompatibility Testing for Surface Medical Devices: An Overview
- 5 Characteristics of Successful Medical Device Product Launches
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