Claims
- 1. An apparatus for monitoring a cleaning process for a medical instrument, comprising:
a cleaning chamber for receiving and cleaning the instrument with a cleaning liquid; a soil detector coupled to the cleaning chamber and adapted to provide an indication of the amount of the soil on the instrument; wherein the soil detector is at least partially isolated from the chamber so that access to the detector by the cleaning liquid is controllable.
- 2. The apparatus of claim 1, wherein said soil detector is moveable and by moving the detector it can be made in or out of fluid communication with the chamber.
- 3. The apparatus of claim 1, wherein said soil detector comprises an electrode located in an enclosure, the enclosure is so coupled to the chamber that the cleaning liquid has controllable access to said enclosure.
- 4. A method for cleaning and sterilizing a soiled medical device comprising the steps of:
a) providing a cleaning chamber for receiving the soiled device; b) providing a soil detector coupled with the cleaning chamber; c) introducing a cleaning liquid into the cleaning chamber; d) cleaning the soiled device in the cleaning chamber e) exposing said detector to said cleaning liquid so as to measure the amount of soil removed from the soiled device. f) determining that a sufficient amount of the soil has been removed from the soiled device so that the soiled device can be sterilized; and g) sterilizing the soiled device.
- 5. An apparatus for monitoring a cleaning process for a soiled medical instrument, comprising:
a chamber for receiving and cleaning the instrument; an enclosure in controllable fluid communication with the chamber; a chemical source coupled to the enclosure for providing a chemical capable of reacting with the soil of the instrument to generate a detectable signal in the enclosure; a detector for detecting the signal.
- 6. The apparatus of claim 5, wherein said chemical is selected from the group consisting of Hg(SCN)2, OPA(o-phthatic dialdehyde+Triol), Bromcresol purple (C12H16Br2O5S9), biuret reagent, and Microprotein-PR.
- 7. The apparatus of claim 5, further comprising a light source for sending a light beam through a cleaning liquid in the enclosure to the detector.
- 8. A method for cleaning and sterilizing a soiled medical device comprising the steps of:
a) providing a cleaning chamber for receiving the soiled device; b) providing a chemical source coupled to an enclosure in controllable fluid communication with said cleaning chamber, said source containing a chemical capable of reacting with the soil on said device to generate a detectable signal; c) introducing a cleaning liquid into the cleaning chamber; d) cleaning the soiled device in the cleaning chamber; e) releasing the chemical from the source into said enclosure; f) detecting the signal generated through reaction between the chemical and soil in said cleaning fluid to determine if a sufficient amount of soil has been removed form the device; and g) sterilizing the device.
- 9. The method of claim 8, wherein a portion of the cleaning fluid is introduced into the enclosure before the chemical is released into the enclosure, and before the introduction of said portion of the cleaning liquid, the enclosure is separated from the cleaning chamber so that substantially there is no fluid communication therebetween.
- 10. An apparatus for monitoring a cleaning process for a medical instrument, comprising:
a chamber for receiving and cleaning the instrument; a standard containing a predetermined amount of soil positioned in the chamber or in controllable fluid communication with the chamber; a detector adapted to provide an indication of the amount of the soil on the standard.
- 11. The apparatus of claim 10, wherein the indication is a signal selected from the group consisting of concentration of the soil, electrical potential, conductivity, transparency to certain wave length, or color of a cleaning/rinsing liquid used for the cleaning.
- 12. The apparatus of claim 10, additionally comprising a light source which generates a light beam of a predetermined wave length which travels through said standard and reaches said detector.
- 13. The apparatus of claim 10, wherein the standard is placed in an enclosure in controllable fluid communication with the chamber.
- 14. The apparatus of claim 13, wherein the detector comprises an electrode located in the enclosure.
- 15. A method for cleaning and sterilizing a soiled medical device comprising the steps of:
a) providing a chamber for receiving the soiled device; b) providing a soiled standard coupled to the chamber; c) introducing a cleaning liquid into the chamber; d) cleaning the soiled device and the soiled standard; e) measuring the amount of soil removed from or remaining on the soiled standard; f) determining that a sufficient amount of the soil has been removed from the soiled standard so that the soiled device can be sterilized; and g) sterilizing the soiled device.
- 16. The method of claim 15, wherein the cleaning step comprises exposing the standard to a cleaning environment as effective or less effective than that to which the soiled device is exposed, and the determining step comprises determining that the soiled standard has been cleaned to a predetermined level.
- 17. The method of claim 15, wherein the soiled standard is more heavily soiled or more difficult to clean than the soiled device.
- 18. An apparatus for monitoring a cleaning process for a medical instrument, comprising:
a cleaning chamber for receiving and cleaning the instrument; at least a first soil detector and a second soil detector adapted to provide an indication of the amount of soil removed from or remained on the instrument, the first and second soil detector being placeable in fluid communication with the cleaning chamber.
- 19. The apparatus according to any one of claims 1, 5, 10, and 18, wherein the detector is selected from the group consisting of ion-selective electrodes, conductivity, spectrophotometry, ion chromatography, capillary electrophoresis, high performance liquid chromatography, liquid chromatography, radioactivity, gravimetry, infra-red spectroscopy, potentiometry and turbidimetry.
- 20. The apparatus of claim 18, wherein the first soil detector is adapted to detect inorganic soil, and the second soil detector is adapted to detect organic soil.
- 21. The apparatus of claim 18, wherein the first detector is located adjacent to an inlet of the cleaning chamber, the second detector is located adjacent to an outlet of the cleaning chamber.
- 22. The apparatus of claim 18, further comprising a second chamber in fluid communication with the cleaning chamber, and the first detector is located in the second chamber.
- 23. A method for cleaning and sterilizing a soiled medical device comprising the steps of:
a) providing a cleaning chamber for receiving the soiled device; b) introducing a cleaning liquid into the cleaning chamber; c) cleaning the soiled device in the cleaning chamber; d) measuring the amount of soil removed from the soiled device with at least two detectors; e) determining that a sufficient amount of the soil has been removed from the soiled device so that the soiled device can be sterilized; and f) sterilizing the device.
- 24. The method of claim 23, wherein step d) comprises measuring soil level of the cleaning liquid with a first detector before the cleaning step, and measuring the soil level of the cleaning liquid with a second detector during or after the cleaning step, and step e) comprises comparing the soil level of the cleaning liquid measured by the first detector with the soil level of the cleaning liquid measured by the second detector, wherein if the difference between the two soil levels is within a predetermined range, said sufficient amount of soil has been removed from the soiled device.
- 25. The method of claim 23, wherein step d) comprises measuring, with a first detector, an inorganic soil selected from the group consisting of inorganic electrolytes, alkaline and alkaline earth salts, inorganic metal-containing compounds and other inorganic compounds present in the human body which may come in contact with a medical device, and measuring, with a second detector, an organic soil selected from the group consisting of proteins, glycoproteins, lipoproteins, mucous, amino acids, polysaccharides, sugars, lipids, glycolipids, other organic compounds present in the human body which may come in contact with a medical device, microorganisms and viruses.
- 26. The apparatus according to any one of claims 1, 5, 10, and 18, further comprising a vacuum pump connected to said chamber, wherein said chamber also functions as a vacuum chamber.
- 27. The Apparatus according to any one of claims 1, 5, 10, and 18, further comprising a sterilization system.
- 28. The method according to any one of claims 4, 8, 15, and 23, wherein the sterilizing step is conducted by a vapor phase sterilizing procedure.
- 29. The method according to any one of claims 4, 8, 15, and 23, wherein the cleaning liquid comprises a liquid sterilization agent, such that the cleaning step and the sterilizing step are conducted simultaneously.
- 30. The method according to any one of claims 4, 8, 15, and 23, further comprising a vacuum drying step.
RELATED APPLICATION
[0001] This application claims the benefits of Provisional Application No. 60/049351, entitled “DETECTION OF CLEANLINESS OF A MEDICAL DEVICE DURING A WASHING PROCESS”, filed on Jun. 11, 1997.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60049351 |
Jun 1997 |
US |
Divisions (1)
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Number |
Date |
Country |
Parent |
09075714 |
May 1998 |
US |
Child |
09871219 |
May 2001 |
US |