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Study on the killing effect of phthalaldehyde on bacterial spores and mycobacteria

Release time:

2022-06-01

Abstract: Objective To observe the efficacy of phthalaldehyde disinfectant in killing bacterial spores and mycobacteria and its stability in continuous use. Methods Using the quantitative sterilization test of suspension, the effect of the phthalaldehyde disinfection solution to kill the black variant spores of Bacillus subtilis and the subspecies of Mycobacterium abscess was observed. Results The disinfectant with a concentration of 4 800 mg / L acted for 14 h, and the killing logarithm value for 5 min against Mycobacterium chelonae abscess subspecies was 4. 60. The dilution of the phthalaldehyde disinfectant with a concentration of 3 000 mg / L acted for 14 h, killing the spores of Bacillus subtilis var, the killing logarithm of Mycobacterium chelonae subspecies abscessus for 5 min was only 2. 88. The stability test results of the disinfectant solution soaked in medical devices for 14 d showed that the germicidal efficacy remained unchanged. After the disinfectant was used continuously in the endoscope cleaning machine for 14 days to treat 80 simulated endoscopes, the sterilization effect did not meet the requirements of efficient disinfection. Conclusion The dose of phthalaldehyde disinfectant is not suitable for high-level disinfection of medical devices.

In recent years,The use of phthalaldehyde in the field of endoscopic disinfection is more and moreThe more common.The disinfectant usually contains o-phthalaldehyde 5 000 mg / L ～ 6 000 mg / L,Most products are labeled“With high level disinfectionUse,Can kill bacterial budsspore,At a minimum use concentration of not less3 000 mg / L,Can be used continuously 14 d For the use of the deadline”。for observationActual germicidal efficacy and continuous use stability of o-phthalaldehyde disinfectantand minimum effective concentration,In this study, a representative o-benzeneDimethyl aldehyde disinfectant products,Bacillus subtilis var. niger spores and Mycobacterium chelonae abscess subspecies as index bacteria were laboratory bactericidal effect and

〔Introduction to the Author>> 〕 Wei Lanfen(1967 －),Female,Zhejiang Hangzhou people,Undergraduate,Chief Technician,FromDisinfection research work.

Continuous use stability and the minimum effective concentration and other indicators.

Materials and Methods

1． 1 Materials

The disinfectant used in the test is o-phthalaldehyde disinfectant.(Domestic productionProduct),The product is light blue transparent liquid,The label indicates a concentration5 000 mg / L ～ 6 000 mg / L,Can kill bacterial spores,branch rodBacteria,continuous use≤14 d,minimum effective content≥3 000 mg / L;Validity Period 24 Months.determined by gas chromatography,the o-phthalaldehydecontent is 5 960 mg / L,pH Value 7． 48.

The test strain was Bacillus subtilis var.(ATCC9372)Bacillus and Mycobacterium chelonae abscess subspecies(ATCC19977) ，by national bacteriaThe storage center provides freeze-dried tubes..

The neutralizer is contained. 5 g / L lecithin,50 g / L twain － 80,10

g / L glycine and 1 g / L Tryptone physiological saline( TPS) ,Press

2002 Year Edition《Technical specification for disinfection[]¹^{>> 〕}After qualification requiredSpare(Neualizer qualification test operation and results omitted).

Simulated Medical Devices and Carriers for Bacteria:Respectively for surgical scissors,Medicalwith tweezers,hemostatic forceps,The carrier is 12． 5 cm Tooth end of hemostatic forcepsPart,Sterilization standby.Simulated Endoscopic Body and Carrier for Bacteria:for poly fourvinyl fluoride pipe( Outer diameter 12 mm,Inner diameter 6 mm,Length 1 000 mm)Sterilization standby; The carrier of bacteria is PTFE tube( Outer diameter6 mm,Inner diameter 4 mm,Length 40 mm) Sterilization standby.

Endoscope cleaning machine:MLX － 600 Automatic endoscope cleaningPoison machine(Domestic products),Adopt simultaneous treatment 3 Three analog endoscopyChannel operating mode.

1． 2 Method

1． 2． 1 preparation of bacterial carrier^〔¹>> 〕 Take 20 μl Tryptone Soy Spore suspension prepared by broth( spore-containing number 1 × 10⁸ cfu / ml ～ 5 ×10⁸ cfu / ml) ,Drop dye on simulated medical devices and simulated endoscopic carriersThe surface of the inner wall,Apply evenly,Set 37 ℃Incubator to dry, Made into bacteria carrier refrigerator storage.

1． 2． 2 germicidal test^〔¹>> 〕 Disinfectant stock solution and containing o-benzene, respectively.dimethyl aldehyde3 000 mg / L as the test solution,20 ℃ Constant temperaturesterilization test under,According to the design concentration of the experiment 1． 25 TimesPreparation of disinfectant.The disinfectant used in the carrier method is mixed according to the actual concentration.system,Press each carrier in a sterile plate 5 ml Dosage,will be infected with bacteriaThe body is soaked in disinfectant and timed.,Action to set time,Take outThe carrier is put into a test tube containing a neutralizer.,Elution by full oscillation,Take

The suspension quantitative sterilization test of mycobacteria and the simulation of medical device carrier.Toxic effect test.

1． 2． 6 Continuous use stability test of endoscope disinfection continuous use 14 d Total processing 80 Post-endoscopic simulation of strip-infected bacterial vectors,Detectiono-phthalaldehyde content,Take the disinfectant solution again for bacterial spores and branching.Test of quantitative germicidal efficacy of in vitro suspension of bacillus,At the same time, it is retained inThe liquid in the cleaning machine is tested for the effect of endoscopic simulation disinfection..

1． 2． 7 EvaluationStandard Killing logarithmic value of bacterial spores in suspension≥

5． 00,Kill logarithmic values for Mycobacterium chelonae subspecies abscessus≥4． 00^〔¹>> 〕; Right.Vector Bacteria Spore and Mycobacterium chelonae subsp. Kill logarithm≥

3． 00^〔¹>> 〕;Combined with endoscope cleaning machine(Including cleaning,Disinfection,Rinsing and other stepssudden) ,On the simulation of endoscopy vector bacterial spore elimination logarithmic value≥3． 00^〔²>> 〕; Continuous use of disinfectant after a certain period of time,The sterilization effect meets the above requirements, The content of active ingredients shall not be lower than the minimum value indicated.,Qualified.

Results

2． 1 Suspension quantitative germicidal test results

By 3 secondary test results display,The concentration is4 800 mg / Lofrole of disinfectant 14 h,On the suspension of black variant shoots of Bacillus subtilisThe killing logarithmic value of spores is 7． 65,for Mycobacterium chelonae abscess subspeciesUse 5 min The killing logarithm value is 4． 60; The concentration is3 000 mg / LofDiluent effect of the o-phthalaldehyde disinfectant 14 h,In suspensionThe killing of spores of Bacillus subtilis var. 4． 02,Role 5 min The killing of Mycobacterium chelonae subsp. abscessus was only

2． 88( Table 1 and table 2) .

Eluate for viable count culture,At the same time as the positive control group live bacteria meterNumber,Calculation of killing logarithm.Repeat test at least 3 Times.

1． 2． 3 Medical deviceMechanical simulation field disinfection effect inspectionMeasurement AdoptStopImmersion test of blood clamp infected bacteria carrierInspection,Mark the interval according to the product content.Ask, The disinfectant was diluted to o-phthalaldehyde content with standard hard water before the experiment.For 5 000 mg / L and 3 000 mg / L Preparation of solutionUse.Press1． 2． 2The method of implementationLine.

effect concentration

Role of different time(h)Kill logarithmic value

positive control

2． 4 Detection of Simulated Disinfection Effect of Endoscope^〔²>> 〕 Simulate the endoscopic body in

Table 2 Effect of phthalaldehyde on killing Mycobacterium abscess subspecies

50 mm,500 mm and 950 mm Cut open,Take 3 infected bacteria vectorRespectively connected at each cut,Then install the simulated endoscope body in the endoscopeThe prescribed location in the poison machine,According to the set disinfection procedure(Including rinsing

0 min,enzyme washing 2． 0 min,Rinse 2． 0 min,Blow-dry 30 s,Disinfection

5． 0 min,Final wash 2． 0 min,Alcohol drying 20 s) Processings.DivisionFinished,Take out the infected carrier and place it in10 mlneutralizersolution inside a test tube,After full elution,Recovery of residual bacteria by pouring method

effect concentration

Role of different time( min) Kill logarithmic value

positive control

Count.At the same time, the infected vector placed at room temperature was used as a positive control meter.Number,Negative control shall be set by the neutralization diluent of the same batch of the test..

2． 5 Medical deviceContinuous use stability testInspection ContinuousUse

14 d After the detection of o-phthalaldehyde content,Then take the disinfectant to divide

2 Simulated disinfection effect on medical instruments

with a concentration 5 000 mg / L o-phthalaldehyde disinfectant immersionRole 14 h,30 Pieces of hemostatic forceps carrier on Bacillus subtilis black variantThe residual number of spores was less 10 cfu / Piece;By 14 d continuous use.