Recently, there have been a number of highly publicized fatalities that could be traced to endoscope contamination, specifically, one particular type of endoscope, the so-called duodenoscope, that is used for ERCPs (bile duct and pancreas procedures). Duodenoscopes are complicated instruments with multiple niches where a biofilm can survive cleaning, especially on the so-called elevator[i]. Even if duodenoscopes are properly cleaned, reprocessed, and undergo high level disinfection, certain hardy bacteria may still survive. Most of them will not cause trouble, but as we have seen, they can. Therefore, systematic culturing is recommended, which in one study added $1521.48 per endoscope per year to the processing cost[ii].
Colonoscope reprocessing – increasingly costly
In contrast, colonoscopes, are simpler to clean and they have stayed largely out of the limelight. However, with more than 15 million annual colonoscopy exams, small outbreaks will probably not be a thing of the past, even if FDA is actively working with manufacturers to address the issue.
Therefore, endoscope reprocessing will be on everybody’s radar, reprocessing procedures will become more complex and time consuming. Already it is estimated that the cost of reprocessing one routine endoscope is between $ 114.07 to $280.71[iii] . A disposable colonoscope that costs around $ 200.00 would be attractive.
From Ambu Bag to Ambu Scope
Sensing an opportunity, the Danish company Ambu A/S, of Ambu bag fame, acquired Invendo Medical, a German company, that produces a single use colonoscopy system. Ambu has already sold 700,000 disposable bronchoscopes. In January 2018 the invendoscope SC210 (single use colonoscope), a successor to the SC200, received FDA 510 (k) clearance by being substantially similar to a predicate device. According to an Ambu press release, selected US hospitals will be able to test drive the system in the second half of 2018.
Invendoscope SC210 – a disposable colonoscope
The SC210 colonoscope comes in a sterile package, has a 170 cm insertion length, a standard 3.2 mm working channel, a CMOS camera chip with 3 LEDs and a bending section with a very small turn radius, which is supposed to allow retroflexion in the entire colon, a feature which may improve polyp detection. Standard functions like rinsing, flushing, suction and insufflation are available, and a separate water jet port may be used for the increasingly popular water immersion or water exchange methods. The disposable colonoscope attaches to a non-disposable scope controller which in turn connects to a base unit. See video.
Is the Invendoscope SC210 any good?
I am not aware of any published reports or technology assessments that describe the scope’s functionality, ease of use, learning curve with controls, handling characteristics, and ability to advance to the cecum. The FDA only evaluated whether it was “substantially similar” to other colonoscopes, and no actual use trials were required. While the exact pricing is still to be determined, it is expected that controller and base unit will be together around $ 35,000, and the disposable colonoscope is expected to be eventually be priced below $ 200, if the demand is sufficiently high[iv].
There are a lot of unanswered questions about this colonoscope, but depending on local factors and wage levels, its use may not be costlier than reprocessing and using a sterile instrument that is always new is also attractive, no repairs and no concern for contamination. Will US gastroenterologists adopt it?
[ii] Ma GK, Pegues DA, Kochman ML, Alby K, Fishman NO, Saunders M, Grous C, Dempsey DT, Ginsberg GG. Implementation of a systematic culturing program to monitor the efficacy of endoscope reprocessing: outcomes and costs. Gastrointestinal endoscopy. 2018 Jan 1;87(1):104-9.
[iii] Ofstead CL, Quick MR, Eiland JE, Adams SJ. A glimpse at the true cost of reprocessing endoscopes. The international association of healthcare central service materiel management. Communiqué May 2017.