DDW 2020: Model Evaluates D Cost, Infection Risk With Various C DuodenoscopesD

DDW 2020: Model Evaluates Cost, Infection Risk With Various Duodenoscopes

Aduodenoscope with a disposable endcap is the most cost-effective option to use in endoscopic retrograde cholangiopancreatography (ERCP), and it is associated with a low rate of infection transmission, according to a modeling study presented at the Digestive Disease Week 2020 online meeting.

The st tud u y ywa w sco c nduc cte t d d amid dong n oi ing ngcon no cern ns s abou ut tp pote t nt tia ai l ltransm mi issionof finfectious sage ents sby du uod o en nos sco c pes th hat a has led d to th he de evelopmen nt of no n vel du ud od den nos so cope es wi with t dis isposa s ble e en e dcaps as well l as fu f lly y di d sposab ba le l duo ode d nosc copes e . . In August 20 02 19 1 , th he e FD FDA A re ec commended transiti ion to use of f su uch dev e ices and dn awa w y y from reusable fixed endcap du duod do enosco ope p s to red duce or o eliminate t the need d fo f r re r proces ssi s ng of f the e devices s (b ( it.ly/2y6I1Dh). As of f April, five e products were approved that were either fu ully y disp pos o able or r had d disposable components (see sidebar). Although there have been some reports of malfunctions with products with removable endcaps, the FDA “continues to recommend that hospitals and endoscopy facilities transition to innovative duodenoscope designs” to reduce the risk for infectious transmission (bit.ly/2y6I1Dh).

Table. Cost-Effectiveness of Duodenoscope-Transmitted Infection Minimization Strategies

Infection Control Approach Cost-Effectiveness Ranking Estimated Infection Transmission Rate, % Estimated Cost Per Use,a $

Reusable Duodenoscopes Needed, n

Disposable endcap 1 0.1-1 654 5

Disposable duodenoscope 2 0 2,903 0

Culture and hold 3 0.1-2 387 12

Ethylene oxide 4 0.1-2 644 12

Single reprocessing 5 0.1-5 131 5

Double reprocessing 6 0.1-3 188 7

a Includes materials and labor.

This modeling analysis compares the costs of different approaches for ERCP, taking into account the costs of the products per use as well as the costs associated with duodenoscope-transmitted infection (abstract 775).

Investigators led by Monique Barakat, MD, PhD, an assistant professor of pediatrics (gastroenterology) and medicine (gastroenterology and hepatology) at Stanford University’s Lucile Packard Children’s Hospital, in Stanford, Calif., developed a Monte Carlo analysis model to assess the cost-effectiveness of various duodenoscopes disinfected through various methods (single high-level disinfection [HLD], double HLD, ethylene oxide [EtO] sterilization, and culture and hold) as well as duodenoscopes with disposable endcaps and fully disposable duodenoscopes.

The investigators based the model on the following assumptions: an annual volume of 800 ERCPs; an average age of 60 years for patients undergoing ERCP; a post-ERCP life span of seven years; an overall multidrug-resistant organism (MDRO) infection rate of 11%; a 30% rate of transmission of an MDRO after an ERCP with an infected duodenoscope; a 50% rate of clinical symptom development in an MDROinfected patient; a $375,000 cost to manage cholangitis; a 70% rate of survival after MDRO infection; and a $100,000 value of qualityadjusted life-years (QALYs). They also assumed a triangular distribution with three parameters: minimum, maximum and most probable infection transmission rate (MPITR). They simulated QALYs lost by duodenoscope-transmitted infection and factored this into the average cost for each approach at variable rates of most probable infection transmission.

They found that duodenoscopes with disposable endcaps were the most cost-effective option for performing ERCP, with an estimated MPITR ranging from 0.1% to 1% and an estimated peruse cost of $654 (Table). They noted that the fully disposable duodenoscope “eliminates the potential for infection transmission” at an estimated cost of $2,903, making it more cost-effective than single/double HLD at all MPITR, more costeffective than EtO for MPITR less than 0.22%, and more cost-effective than culture and hold for MPITR less than 0.49%. They found single and double HLD to be the most costly approaches

FDA Keen on Novel Duodenoscopes

The manufacturers of duodenoscopes with disposable endcaps—Fujifilm, Olympus and Pentax—have “submitted 10 reports of device malfunctions, such as removable caps or ends falling off during endoscopic retrograde cholangiopancreatography,” although only three of these instances occurred with models on the U.S. market (bit.ly/2y6I1Dh).

The FDA “continues to recommend that hospitals and endoscopy facilities transition to innovative duodenoscope designs to help improve cleaning and reduce contamination between patients, including designs with disposable caps or distal ends.” Noting that it “is not aware of any patient injuries related to these innovative duodenoscope designs,” the agency reminds health care providers using these devices “to follow the manufacturer’s instructions for the assembly of the caps and distal ends.”

As of April 2020, the FDA had cleared five duodenoscopes that are fully disposable or have disposable components that facilitate reprocessing: • Boston Scientific, Exalt Model D single-use duodenoscope (fully disposable duodenoscope) • Fujifilm, ED-580XT duodenoscope (disposable endcap duodenoscope) • Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V (disposable endcap duodenoscope) • Pentax Medical, ED34-i10T duodenoscope (disposable endcap duodenoscope) • Pentax Medical, ED34-i10T2 duodenoscope (disposable elevator duodenoscope)

—S.T.

at all potential infection transmission rates. The next two most costly approaches were EtO and culture and hold, both of which required more duodenoscopes and had higher costs related to transport and institutional infrastructure. see Model, page 50