FDDC for mattress disinfection at O’Flynn Medical Ltd, Cork, Ireland, 10th of January 2019

O’Flynn Medical incorporated a FDDC treatment using a STERISAFE PRO to the cleaning and disinfection process of their mattresses and air-pumps.

The FDDC disinfection takes places in a dedicated room where all equipment to disinfect are placed. The room volume is 23 m3 (5 m x 2.55 m x 1.8 m). The whole cycle including build-up, disinfection and purification took 60 minutes.

Samples were taken before cleaning and FDDC disinfection and after the FDDC cycle using a Hygicult® Total Plate Count (TPC) .

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 process efficacy. The TPC plates show the reduction of the colony forming units (CFUs).

Samples were taken before manual cleaning and before Full-Depth Disinfection Cycle. Another set of samples were taken after the disinfection process on the same location.

The automated disinfection with the STERISAFE PRO lasted a total of 57 minutes, with a disinfection plateau time of 30 minutes.

After sampling, the plates were put at room temperature for 5 days as instructed by the Hygicult manual. After that period, pictures of each plates were taken.

STERISAFE pro

STERISAFE is using Hygicult TPC 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.

1 : https://www.nmkl.org/dokumenter/nordval/Sertifikater/NordVal-018_2019.pdf

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

Results

The microbiological sampling on 6 locations on the mattreses before cleaning these are the results:

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 60 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.

Hygicult® Total Plate Count contact plates.

Sampling spot: Mattress tubing and air connections

Before and after FDDC, sample

Before FDDC


Contaminated on high risk area with 0-20% of contamination leads an overall rating of moderate hygiene.

After
FDDC

Zero contamination and excellent hygiene.


Hygicult® Total Plate Count contact plates.

Sampling spot: LH and RH side underneath mattress

Before and after FDDC, sample

Before
FDDC


Contaminated on high risk area with >50% of sample contamination leads an overall rating of poor hygiene.

After
FDDC


Zero contamination and excellent hygiene.


Hygicult® Total Plate Count contact plates.

Sampling spot: Top of air cell

Before and after FDDC, sample

Before
FDDC

Zero contamination on low risk leads to an overall rating of excellent hygiene.

After
FDDC


Zero contamination and excellent hygiene.


Hygicult® Total Plate Count contact plates.

Sampling spot: Top and front of control unit (OFM 1523)

Before and after FDDC, sample
Before and after FDDC, sample

Before
FDDC


Contamination on high risk area with 0-20% of sample surface covered, leads to an overall rating of moderate hygiene.

After
FDDC


Zero contamination and excellent hygiene.


Hygicult® Total Plate Count contact plates.

Sampling spot: LH and RH side of control unit (OFM 517)

Before and after FDDC, sample

Before
FDDC

Contamination on moderate risk area with 0-20% of sample surface covered, leads to an overall rating of acceptable hygiene.

After
FDDC


Zero contamination and excellent hygiene.

The Full-Depth Disinfection Cycle in the disinfection chamber took 60 minutes.

The disinfection level reached a total kill in all tested spots.

It demonstrates the efficacy of the STERISAFE PRO and of the protocol designed by O’Flynn to effectively disinfect the mattresses and the air-pumps. The process is effective both in depth (total kill) and in width (all spots disinfected).

Sample location
CFU's Before STERISAFE
Mattress tubing and air connections
7
LH and RH side underneath mattress
>100

Top of air cell
0
Top and front of control unit (OFM 1523)
15
LH and RH side of control unit (OFM 517)
7
Contamination level

Sample location
CFU's After STERISAFE
Mattress tubing and air connections
0
Top of air cell
0
Top and front of control unit (OFM 1523)
0
LH and RH side underneath mattress
0
LH and RH side of control unit (OFM 517
0

Conclusion:

Based on these results, the disinfection process put in place by O’Flynn using the STERISAFE PRO technology is an effective method to guarantee the total disinfection of the equipment.

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