METHOD FOR DRYING A MEDICAL DEVICE

Abstract

The present invention relates to a method for drying endoscope channels, including the following steps: a) connecting the endoscope, particularly via a specific connection, to a plasma drying unit; b) injecting a neutral gas into the endoscope channels for a duration of 10 to 60 seconds, the flow rate of the gas being low, the gas being injected at a temperature of 10° C. to 30° C. such as to eliminate residual water; then c) drying the endoscope channels, for a duration of 30 to 150 seconds, by injecting a gas at a high flow rate, the gas being injected at a temperature of 30° C. to 60° C.

Claims

1-13. (canceled)

14. A method for drying et least one channel of a device, comprising the following steps: a) injecting a neutral gas into the at least one channel of the device to eliminate the residual water by a laminar flow regime, b) drying the at least one channel of the device, by injecting a gas having a turbulent flow regime, the gas being injected at a temperature of between 30° C. and 60° C.

15. The method according to claim 14, wherein it comprises, after step b), the following steps: c) placing the device in an airtight receptacle; d) injecting a plasma generated by an electrical discharge in a flow of dinitrogen or air into the airtight receptacle, and then closure of said receptacle.

16. The method according to claim 14, wherein the neutral gas is dinitrogen or air.

17. The method according to claim 14, wherein the gas used in step b) is neutral, or is a plasma generated by an electrical discharge in a flow of dinitrogen or air.

18. The method according to claim 14, wherein the neutral gas injected on step a) is injected into the at least one channel of the device for a period of between 10 and 60 seconds.

19. The method according to claim 14, wherein the neutral gas injected on step a) is injected into the at least one channel of the device at a temperature of between 10° C. and 30° C.

20. The method according to claim 14, wherein the gas injected on step b) is injected into the at least one channel of the device for a period of between 30 and 150 seconds.

21. The method according to claim 15, wherein the plasma injected on step d) is injected into said receptacle for a period of between 3 and 10 seconds.

22. The method according to claim 14, wherein the device is an endoscope.

23. The method according to claim 22, wherein the drying b) is done by injecting gas into the at least one channel of the endoscope through the piston cage, or through its proximal end.

24. The method according to claim 14, wherein the total duration of steps a) to b) is between 1 and 5 minutes.

25. The method according to claim 14, wherein the endoscope is chemically disinfected prior to step a).

26. The method according to claim 15, wherein, after step d), said receptacle can be stored for a period of at least 24 hours.

27. The method according to claim 15, wherein, after step d), said receptacle can be stored for a period of at least 72 hours.

28. The method according to claim 14, wherein the step a) is preceded by a step of connecting said device to a drying unit.

29. The method according to claim 15, wherein the step a) is preceded by a step of connecting said device to a drying unit and said method comprising between steps b) and c), a step of disconnecting said device.

Description

EXAMPLE 1

[0066] The following tests are carried out in order to compare the drying method according to the invention with the conventional methods with storage cabinets for heat-sensitive endoscopes (SCHE).

[0067] Two endoscopes are used for carrying out these tests: [0068] a Fujinon EC530; and [0069] an Olympus CF20HL.

[0070] The drying times are indicated in the following table:

TABLE-US-00001 Drying time by the method according to the Drying time in SCHE Type of endoscope invention (comparative) FUJINON EC530 2 minutes and 15 seconds 90 minutes Olympus CF20HL 2 minutes and 15 seconds 60 minutes

[0071] The method according to the invention therefore provides a drying approximately 25 to 40 times more rapid.

[0072] The biocidal effect of the nitrogen plasma, incorporated in the method according to the invention is shown on tubes 3 metres long:

TABLE-US-00002 4 mm diameter 2.5 mm diameter 1.5 mm diameter Germs tube tube tube P. aeruginosa, N.sub.2 5 log 4.6 log 4.2 log plasma drying P. aeruginosa, N.sub.2 3.5 3.5 3.5 drying

EXAMPLE 2

Evaluation of the Efficacy of the Method for Drying Internal Channels of Several Endoscopes According to the Invention

[0073] The objective of the study is to evaluate the drying capacity of the internal channels of several endoscopes by the method according to the invention.

[0074] This study uses clause 6.2.3 of NF S098-030, relating to the drying of endoscopes in SCHE.

[0075] Although the drying method according to the invention cannot be considered to be a cabinet, the objectives of this method can be likened to those of an SCHE.

[0076] 1) Equipment and Methods

[0077] At the end of the cleaning/disinfection cycle, the channels of the endoscopes are purged and a wiping of the orifices (aspiration, air/water and biopsy orifices) is carried out. The channels are next connected to the Typhoon drying unit (PlasmaBiotics) (step a)) and then subjected to the drying method according to the invention (steps b) and c)): insufflation of nitrogen and then treatment with nitrogen plasma).

[0078] In accordance with NF S098-030, once the drying cycle is performed, compressed air of medical quality at a pressure of 105 to 120 kPa is blown into each channel of the endoscope in turn, with the distal end of the endoscope positioned between 50 mm and 100 mm above and perpendicular to a coloured crepe paper.

[0079] The efficacy of the drying phase is considered to be satisfactory if no droplet of moisture is visible on the crepe paper.

[0080] The specific operating conditions of the drying are as follows:

TABLE-US-00003 Maximum T° Nature of cycle according to at the inlet of type of endoscope Duration of drying the endoscope Gastroscope 135 seconds  45° C. Colonoscope Duodenoscope Echoendoscope Bronchoscope 90 seconds 45° C. Paediatric bronchoscope 60 seconds 40° C.

[0081] The endoscopes tested are as follows: [0082] a) Olympus: [0083] Colonoscopes: CF Q160 I, CF Q180 AI [0084] Gastroscopes: GIF Q160, GIF Q180. [0085] b) Fujinon: [0086] Colonoscopes: EC250WM. EC450WM5-H and EC250WM5, [0087] Gastroscopes: EG410HRS, EG250WR5, [0088] Duodenoscope: ED410XT. [0089] c) Pentax: [0090] Colonoscopes: EC3880FK, EC380MK, [0091] Gastroscope: EG2940K, [0092] Bronchoscope: FB15V

[0093] 2) Results:

[0094] All the results of the drying tests carried out the colonoscopes, gastroscopes, duodenoscope and bronchoscope show no trace of moisture.

[0095] With regard to these results, it is concluded that the drying method according to the invention has an efficacy of drying equivalent to the SCHEs in NF S098-030.

EXAMPLE 3

Evaluation of the Drying Method According to the Invention on the Microbiological Quality of the Endoscope Channels

[0096] The objective of the study is to evaluate the effect of the method according to the invention on the microbiological quality of endoscope channels, in comparison with a standard drying method (manual drying with air).

[0097] This study used clause 4.2.4 of NF S098-030 relating to the drying of endoscopes in SCHE.

[0098] Although the drying method according to the invention cannot be considered to be a cabinet, the objectives of this method can be likened to those of an SCHE.

[0099] 1) Equipment and Methods

[0100] The method used is identical to the one at point 1 of example 2.

[0101] The specific operating conditions of the drying are as follows:

TABLE-US-00004 Nature of cycle according Duration of Maximum T° at inlet of to type of endoscope treatment endoscope Colonoscope 135 seconds 45° C.

[0102] The endoscope tested is the Pentax colonoscope EC3880FK.

[0103] Microbial strains:

[0104] P. aeriginosa CIP103467

[0105] Diluent of the microbial suspensions: tryptone salt (OXOID, TV5016D).

[0106] Sampling Solution:

TABLE-US-00005 Lecithin (SIGMA, P-5394) 0.3% (w/v) Sodium thiosulfate (SIGMA, S-8503) 0.5% (w/v) Polysorbate 80 (SIGMA, p-1754) 3.0% (w/v) L-Histidine (SIGMA, H-8000) 0.1% (w/v) Distilled water qsp 100 ml N.sup.o of internal batches D100.1.1, D 130.1.2, D130.1.5, D149.1.2

[0107] Sterilised in moist heat at 121° C. for 20 minutes.

[0108] Maintenance and accounting medium: tryptone soya (OXOID, CM0131).

[0109] The sampling is carried out by injection of 50 ml of sampling solution via the cleaning adapter (sampling of the air/water channels), 50 ml via the aspiration coupling (sampling of the aspiration/biopsy channel), 20 ml via the inlet of the water-jet channel and 50 ml via the orifice of the operator channel

[0110] The four volumes are recovered at the distal end and were analysed by dilution/inclusion and filtration on 0.45 μm membrane. The membranes are deposited on gelose and incubated for 48 hours at 37° C. After incubation, the colonies are counted and the results expressed as a number of viable microorganisms per endoscope.

[0111] The endoscope is contaminated by injecting 15 ml of the test microbial suspension (strain in its diluent) containing between 1.5×10.sup.4 UFC/ml and 5×10.sup.4 UFC/ml at the rate of 6 ml via the aspiration coupling, 6 ml via the air nozzle and 3 ml for the water-jet channel After 30 minutes of incubation, the channels are purged with 50 ml of air and then maintained at ambient temperature for 30 minutes.

[0112] 2) Results:

[0113] The results are presented below:

[0114] Figure: change in the internal microbial contamination of the colonoscopes subjected to drying according to the invention (second series of columns), compared with the contamination level subjected to the standard method (blowing with medical air, first series of columns).

[0115] The results show that the level of contamination of the internal channels of the endoscope dried according to the invention:

[0116] remains less than the initial contamination level of the endoscope before drying; and

[0117] is always less than that of the endoscope subjected to the standard method.

EXAMPLE 4

Eevaluation of the Efficacy of the Drying Method According to the Invention Including Storage

[0118] The objective is to evaluate the abilities of the drying and storage method according to the invention (steps a) to e)) to maintain the microbiological quality of the endoscopes, according to a methodology inspired by NF EN 16442:2015 (SCHE standard)

[0119] Equipment:

[0120] FUJINON EC 250 WM endoscopes

[0121] Plasma Typhoon (PlasmaBiotics)

[0122] Connection kit for connecting the endoscopes to the Plasma Typhoon

[0123] PlasmaBAG (endoscope storage bags)

[0124] 1. Step 1: Preparation of the Endoscopes

[0125] The procedure for preparing the endoscope is identical for all the endoscopes analysed. [0126] 1. Subjecting the endoscope to a standard cleaning/disinfection cycle [0127] 2.Contaminating the endoscope artificially by injecting into each of the channels a contamination solution containing approximately 1.5×10.sup.3 to 5×10.sup.3 Pseudomonas aeruginosa/ml [0128] 3. Maintaining the endoscope at ambient temperature for 30 minutes. [0129] 4. Purging the endoscope channels in order to eliminate any excess contamination solution [0130] 5. Maintaining the endoscope at ambient temperature (for 1 hour or according to the instructions of the manufacturer)

[0131] After the incubation period, the endoscope is subjected to the drying and storage method according to the invention. In total: [0132] 3 tests are carried out by sampling the endoscope just after the purge in order to determine the level of contamination of the endoscope before drying and storage (control); [0133] 2 tests are carried out by sampling the endoscope after 24 hours, 48 hours and 72 hours of storage according to the method to be tested (test according to the invention); and [0134] 2 tests are carried out by sampling the endoscope after 24 hours, 48 hours and 72 hours of storage outside (standard storage method).

[0135] Drying and storage method according to the invention

[0136] 2. Step 2: Drying of the Endoscopes (steps a) to c))

[0137] The drying method is carried out using Plasma Typhoon: [0138] At the start of the tests: [0139] 1. Open the gas bottle, adjust the pressure to 3 bar. In the case of the use of medical air, adjust the pressure to 3 bar. [0140] 2. Power up Plasma Typhoon (ON) [0141] For each drying cycle: [0142] 3. Connect all the endoscope channels to the plasma outlets of the Plasma Typhoon using the connection kit: [0143] a. Suction/Operating channel [0144] b. Air/Water channel [0145] c. Water jet channel [0146] 4. Put the bridge at the proximal end of the endoscope (in the case of gastroscope, colonoscope, duodenoscope, echoendoscope) [0147] 5. Start the drying cycle [0148] 6. Once the cycle is completed, disconnect the endoscope.

[0149] 3. Step 3: Storage of Endoscopes (steps d) and e)) [0150] Once dried, the endoscopes are stored in polyethylene bags: [0151] 1. Place the endoscope in the polyethylene bag (PlasmaBAG) [0152] 2. Close the bag using the zip on the side [0153] 3. Connect the Plasma Typhoon to the luer placed in the corner of the bag [0154] 4. Choose the “storage” cycle [0155] 5. Start the “storage” cycle, which serves to blow plasma into the bag for 5 seconds [0156] 6. Once the cycle is completed, disconnect the Plasma Typhoon from the bag (luer) and close the bag with a luer stopper.

[0157] Analysis:

[0158] The efficacy of the storage methods is determined by comparing for each of the contact times the level of contamination of the endoscope stored according to the method with an endoscope not blown with the Typhoon and kept outside.

[0159] The results are as follows:

TABLE-US-00006 Test Storage time Count (UFC/ml) According to the invention 24 hours 1 Standard 24 hours 24 × 10.sup.7 According to the invention 48 hours 0 Standard 48 hours 1.9 × 10.sup.9 According to the invention 72 hours 0 Standard 72 hours 3.1 × 10.sup.9

[0160] The drying and storage method according to the invention thus makes it possible to maintain the microbiological quality of the endoscope for a period of at least 72 hours.