Contaminated duodenoscopes can cause large-scale outbreaks. There is a need for rapid assessment methods to confirm the adequacy of the cleaning phase to improve the quality, safety and logistics of complex flexible endoscope reprocessing. The ATP…
ID
Bron
Verkorte titel
Aandoening
Contamination
microorganisms
Disinfection
Reprocessing
complex flexible endoscopes
duodenoscopes
linear echoendoscopes
ERCP
EUS
Ondersteuning
U.S.A.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To assess if usage of ATP tests in complex endoscopes, i.e. duodenoscopes and linear echo-endoscopes, after manual cleaning combined with re-cleaning protocols, lowers the number of clinically relevant positive cultures.
Achtergrond van het onderzoek
We aim to assess if the use of ATP tests in DLE, after manual cleaning combined with re-cleaning protocols, lowers the number of clinically relevant positive cultures. Therefore we will conduct a prospective single center intervention study using DLE in a single tertiary academic center: the Erasmus MC. In the intervention period DLE will be tested on ATP and manually cleaned again if the ATP value is above the cutoff. Efficacy of ATP tests will be assessed by the number of contaminated DLE, with special attention to clinically relevant positive cultures i.e. contaminated with indicator microorganisms.
Doel van het onderzoek
Contaminated duodenoscopes can cause large-scale outbreaks. There is a need for rapid assessment methods to confirm the adequacy of the cleaning phase to improve the quality, safety and logistics of complex flexible endoscope reprocessing. The ATP test can give a rapid indication if organic residue is still present. Implementation of such an ATP test might reduce the number of contaminated duodenoscopes and linear echo-endoscopes (DLE). The primary objective of this study is to assess if the use of ATP tests in DLE, after manual cleaning combined with re-cleaning protocols, lowers the number of clinically relevant positive cultures.
Onderzoeksopzet
Endoscopic procedure specifics: after procedure
ATP-test: after manual cleaning
Microbial sampling: after disinfection
Onderzoeksproduct en/of interventie
To assess the primary study objective, baseline contamination rates will be determined during the control period and the effect of usage of ATP tests on the contamination rate will be evaluated in the intervention period. DLE will be tested on ATP and manually cleaned again if the ATP value is above the cutoff.
Publiek
Margreet C. Vos
Wytemaweg 80, Room Na-901k
Rotterdam 3015 CN
The Netherlands
0107033510
m.vos@erasmusmc.nl
Wetenschappelijk
Margreet C. Vos
Wytemaweg 80, Room Na-901k
Rotterdam 3015 CN
The Netherlands
0107033510
m.vos@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
A potential subject who meets the following criteria is eligible for participation in this study:
- ERCP duodenoscopes and linear echo-endoscopes that are:
o Reprocessed, including up to 2 ATP tests during the intervention period.
o Cultured
o Inclusion of duodenoscopes and linear echo-endoscopes is regardless of:
Manufacturer
Type
Age in years
Usage (in number of previous procedures)
Repair history
Ownership:
• Endoscopes owned by centers
• Endoscopes that are temporarily borrowed from manufacturers
Type of procedure: both diagnostic and therapeutic procedures
ATP testing in the control period
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Flexible endoscope that is any other type than a duodenoscope or linear echo-endoscope.
- Duodenoscopes and linear echo-endoscopes that were not reprocessed
- Duodenoscopes and linear echo-endoscopes that were not ATP tested during the intervention period
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL6380 |
NTR-old | NTR6564 |
Ander register | METC Erasmus MC : MEC-2017-291 |