Sterility
Conditions
Brief summary
This study compares the sterility of rigid nasoendoscopies after being sterilized with a conventional autoclave machine and a novel rig-S device that uses standard high level disinfectant
Detailed description
There is a standard operating procedure in rigid endoscopy cleaning, and it is performed after each clinical examination. The conventional autoclave is no longer used in the setting of an otorhinolaryngology (ORL) clinic as it is cumbersome and takes a lot of time, and also only cleans one endoscope at a time. There is no standardisation or device that has been reported, and cross contamination has been reported previously. The overturn of patients in the ORL clinic is high, and most practitioners chooses high level disinfectant as a method of sterilising the endoscopes. However, there is no proper device to place these disinfectants in, and results in many cases of broken scopes and cross contamination. This study compares the sterility of the rigid endoscopes after being sterilised by the high level disinfectant that is placed in a novel rig-S device with the gold standard conventional autoclave. The investigators selected all the rigid endoscopes performed in our ORL clinic and randomised them before subjecting them for a swab test for bacterial and fungal, and also used a test kit to test the presence of Hepatitis B.
Interventions
DEVICENovel rig-S
A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed
DEVICEConventional Autoclave machine
The gold standard device to clean all medical instruments
Sponsors
Universiti Kebangsaan Malaysia Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
The swabbing of the endoscopes are performed by a research assistant, and the end result is evaluated by the primary investigator
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
All rigid endoscopes performed in ORL clinic
Exclusion criteria
Flexible endoscopes performed in ORL clinic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial and Hepatitis B test | 3 days | Rigid endoscopes are swabbed and tested using a hep-B kit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acidity level | 4 hours | Acidity level of the high level disinfectant is tested for every 10 cycles of scope |
Countries
Malaysia
Outcome results
None listed