FDDC in an operating theater (OT) in Clinica Guayaquil, Friday 31st of August 2018

А STERISAFE employee supervised the first Full-Depth Disinfection Cycle run in Guayaquil, Ecuador. The disinfection cycle took place in one of the most reputable private clinics in the country – Clinica Guayaquil. The clinic celebrates 100 years since the opening in 2019.

Dr. Roberto Gilbert, owner, chose the biggest operating theater in the campus. The room has a volume of 129m3, for the disinfection cycle. The results by Hygicult® TPC, shows significant decrease of the pathogenic load.

Samples were taken after manual cleaning before FDDC and after the FDDC cycle. Please examine the next pages.

The results and the ease of use were the two prevailing arguments for the Clinica Guayaquil to purchase a STERISAFE PRO.

The Full-Depth Disinfection Cycle by STERISAFE uses ozone to decontaminate the air and surfaces for bacteria, vira and fungi. After the disinfection is completed the STERISAFE reverses the ozone gas into breathable oxygen, removes remaining particles and the room is disinfected and safe to use.

The field test report uses Hygicult® TPC (Total Plate Counts) to illustrate visually the disinfection efficacy by showing the reduction of the colony forming units (CFUs).

Samples were taken after manual cleaning before Full-Depth Disinfection Cycle. Next, a sample after preventive (60 minutes disinfection time) FDDC at the very same location.

The rest of the slides show the exact locations where samples were taken and the Hygicult® TPC visual results.

Each Hygicult® TPC plate has two sides, market in this presentation as Side A and Side B.

STERISAFE is using Hygicult TPC from Orion Diagnostica (Finland) for its hygiene mapping. It is a reliable, economic, and easy-to-use on-site surface hygiene monitoring tests.

It is intended for general hygiene monitoring as most common bacteria, yeasts, and moulds can grow on it. The slide is covered on both sides with Total Plate Count (TPC) medium that supports the growth of the most common bacteria and fungi. The medium contains neutralising agents making the product suitable to be used in environments where disinfectant chemicals have been used. Each plates has two side of 9.8cm2 area each.

Hygicult is certified to be equivalent to the reference methods Trypticase  soy  agar  (TSA)  culture  plates  and  contact  plates. The certification has been made by NordVal Protocol 1, which complies with ISO 16140-2 1.

Each location is sampled twice. Results come after 4 to 5 days and are counted manually.

The Hygiene Mapping gives a general surface hygiene level of the room with a four colors code system. To determine the level, two factors are considered:

  • The level of contamination in CFU/sample.  Above 5 CFU, the surface is considered contaminated
  • The type of surface with a level of criticality. The higher the risk of cross-infection via the given surface, the higher the criticality.
Type of surface
CriticalityInterpretation
Very high risk of infection transfer if contaminated
High risk of infection transfer if contaminated
Moderate risk of infection transfer if contaminated
Low risk of infection transfer if contaminated
Level of contamination
Hygiene LevelInterpretation
>50% of surfaces contaminated or average contamination of >50 CFU/plates
Between 20 and 50% of
surfaces contaminated
Between 0 and 20% of surfaces contaminated
0% of surface contaminated

Total surface hygiene   
Poor HygieneModerate HygieneAcceptable HygieneExcellent Hygiene

AreasCriticalityResultsContamination level
High touch3 out of 5 samples were taken on high touch areas. All of these areas where contaminated, with an average contamination of 23 CFU/plate, leaving the contamination level poor.
Low touch2 out of 5 samples were taken on low touch areas. 1 of 2 samples were contaminated with 7 CFU/plate, leaving the contamination level acceptable.

The results from the cupboard and scissors is depicted by the colony forming units (CFU’s) on the TPC samples.

Each picture is depicting a sample taken before (leftmost sample) and after (rightmost sample) the FDDC cycle.

The results from the cupboard and scissors is depicted by the colony forming units (CFU’s) on the TPC samples.

Each picture is depicting a sample taken before (leftmost sample) and after (rightmost sample) the FDDC cycle.

The results from the cupboard and scissors is depicted by the colony forming units (CFU’s) on the TPC samples.

Each picture is depicting a sample taken before (leftmost sample) and after (rightmost sample) the FDDC cycle.

The results from the cupboard and scissors is depicted by the colony forming units (CFU’s) on the TPC samples.

Each picture is depicting a sample taken before (leftmost sample) and after (rightmost sample) the FDDC cycle.

The results from the cupboard and scissors is depicted by the colony forming units (CFU’s) on the TPC samples.

Each picture is depicting a sample taken before (leftmost sample) and after (rightmost sample) the FDDC cycle.

Sample location
CFU's Before STERISAFE
Contamination level
Display
5
Response device display
>60

Lamp above patient table
5
Hole in one of the walls
3
Behind white board on the wall
6

Sample location
CFU's After STERISAFE
Contamination level
Display
2
Response device display
4

Lamp above patient table
2
Hole in one of the walls
1
Behind white board on the wall
0

The Full-Depth Disinfection Cycle in the 129m3 operating theater (OT) took 221minutes (3h 41minutes).

The efficacy results coupled with the ease of use of STERISAFE-Pro convinced the management of Clinica Guayaquil to purchase the automated room disinfection robot. The robot will operate in the clinic from October 2018.