Annex N Test

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Verification of the effectiveness of BICARmed® technology according to annex test of standard uni iso / ts 15883-5 standard

SCOPE OF PHASE 1 - Comparison between Bicarmed and washer disinfector

Comparison of the effectiveness between BICARMED technology as pre-treatment to washing and washer disinfector.

Materials and test method according to standard 15883-5

It was performed the Annex N test of standard 15883-5.

Dirt Annex N: fresh egg yolk 100 ml; defibrinated blood (horse or sheep) 10 ml; dehydrated pork mucus, 2 g. Standard declares to evaluate on the basis of a visual inspection, but they were measured also protein residues with the ProReveal machine on 5 of the 57 particular instruments (Poole suction tube, micro-invasive forceps core and handle, trocar, hemostatic forceps).

Number of dirty instruments according to ANNEX N = 57 pieces, of which:

  • 3 suction tubes,
  • 2 microinvasive surgery forceps,
  • 2 trocars,
  • 3 hemostatic forceps,
  • 3 scalpel handels,
  • 2 replacement endoscopes,
  • 3 vaginal speculum (minimum number by type indicated in the Annex)

This step is repeated twice, once for the 57 instruments that will be treated in the washer disinfector, once for the 57 treated with BICARmed® protocol.

Dirtying procedure is done randomly and without differences, brushing the instruments with the Annex and pouring the liquid inside the hollow instruments such as endoscopes and suction tubes.

  • Washer disinfector: 2 suction tubes, 2 microinvasive surgery forceps (2 cores, 2 tubes and 2 handles), 2 trocars, 21 hemostatic forceps, 11 scalpel handles, 2 replacement endoscopes and 13 vaginal specula.
  • BICARmed®: 4 suction tubes, 3 microinvasive surgery forceps (3 cores, 3 tubes and 2 handles), 4 trocars, 15 hemostatic forceps, 13 scalpel handles, 2 replacement endoscopes and 11 vaginal speculum.

They were used 3 machines: BICARmed® SAFECleanBox system, washer disinfector and ProReveal

Results

Measurements of:

WASHER DISINFECTOR WASHER DISINFECTOR BICARmed®
DIRTY
33/57
= 57,9% 		DIRTY
33/57
= 57,9% 		CLEAN
24/57
= 42,1% 		DIRTY
1/57
= 1,8% 		CLEAN
56/57
= 98,2%
MEDIUM PROTEIN RESIDUE
OF 5 INSTRUMENTS 		26,584 μg
with standard deviation of 25,26 		1,48 μg
with standard deviation of 2,2
HEMOCHECK level DIRTY
1/18
= 5,5% 		CLEAN
17/18
= 94,4% 		DIRTY
0/18
= 10% 		CLEAN
18/18
= 100%
Effectiveness

By tests Annex N it is clear that if an instrument is visually clean it does not mean clean: most of the instruments that by a visual inspection appeared to be cleaned,they had protein residues.

Conclusions

With this test, it has been shown that if the instrument is not properly prepared, the washer disinfector has an important failure rate. This treatment should not be considered sufficient, it is necessary a pre-treatment in case of severe dirt (as was Annex N): the higher is the quality obtained in the preparation, the greater is the success rate of the washer disinfector.

It has been shown that if the RMD is not properly prepared, the washing disinfector (W.D. – Washing Disinfector) has an important failure rate. Such treatment cannot therefore be considered sufficient. It should be preceded by manual washing, or ultrasounds or in a BICARMED SafeCleanBOX machine.

SCOPE OF PHASE 2 -Comparison between BICARMED, manual brushing and ultrasounds

Evaluation of the effectiveness of manual and ultrasonic washing compared to BICARMED SafeCleanBOX machine.

Materials and test method according to standard 15883-5

The Annex N test of standard 15883-5 was carried out, evaluating the effectiveness of cleaning performance of BICARMED SafeCleanBOX machine compared to manual cleaning and ultrasonic treatment. The standard declares to evaluate on a visual inspection basis, but protein residues were also measured with the ProReveal machine on 5 of the 57 particular instruments (Poole suction tube, micro-invasive forceps, core and handle, trocar, hemostatic forceps). 3 technologies have been used: BICARMED SafeCleanBOX machine, ultrasound tank and manual cleaning sinks.

Results

Measurements of:

TEST MANUAL ULTRASOUND BICARMED
VISUAL TEST DIRTY
5/5
= 100%		 CLEAN
0/5
= 0%		 DIRTY
3/5
= 60%		 CLEAN
2/5
= 40%		 DIRTY
0/5
= 0%		 CLEAN
5/5
= 100%
MEDIUM PROTEIN RESIDUE
OF 5 INSTRUMENTS		 13,91 μg
With a standard deviation of 6,26		 5,29 μg
With a standard deviation of 3,84		 6,6 μg
With a standard deviation of3,34
Effectiveness

Excluding manual cleaning due to its obvious limitations, we compared the results of BICARMED and ultrasound: from the point of view of persistent dirty, they are comparable. Our study then analyzed the results from the point of view of complex geometry: BICARMED SafeCleanBOX was clearly superior, since ultrasound is a directional technology and not effective inside the cavities.

Conclusions

Manual cleaning with brush is very slight and limited and can damage the instrument. Utrasound one is not effective (it does not completely remove) on mucus, on the canal, cauterized blood, cement residues and geometric complexities, undercuts and / or cavities, it is not compatible with optics and with not-immersive instruments. While BICARMED SafeCleanBOX machine is effective even where ultrasound fails. It does not completely remove only some invisible residues.