GB2438824A

GB2438824A - Medical device cleaning vessel with scrubber

Info

Publication number: GB2438824A
Application number: GB0611166A
Authority: GB
Inventors: Janet Menage
Original assignee: Individual
Current assignee: Individual
Priority date: 2006-06-06
Filing date: 2006-06-06
Publication date: 2007-12-12
Anticipated expiration: 2026-06-06
Also published as: GB2438824B; GB0611166D0

Abstract

A medical device cleaning apparatus has first and second liquid cleaning vessels 1,2 the first 1 also containing a scrubbing means (fig.4) and a support means 3,4,5 above the vessels 1,2, on which a non-operative portion, such as the device handle, can be held during cleaning, and during period of non-use of the device. The device may by be an auriscope or speculum, with a patient contact portion of the device depending into the first vessel 1 so as to be cleaned by a cleaning fluid and the brush contained within. The second container may contain a second cleaning fluid, such as alcohol, and may have a self re-sealed press open membrane closure 8.

Description

Cleaner for Medical or Veterinary Devices, for example Auriscopes The

present invention relates to an apparatus for cleaning medical or veterinary devices or instruments after they have been used on a patient, for example auriscopes.

Background of the invention

When a patient visits a doctor or an animal is taken to see a vet, it is commonly the case that the doctor or vet will require to inspect the patient or animal with a medical or veterinary device (hereinafter simply called a "medical device" or "device"), for example an auriscope if it is the ear which is to be inspected. The medical device inevitably often comes into direct contact with the patient.

Obviously, the portion of the medical device which comes into direct contact with the patient must be cleaned and/or disinfected before it can be used again on any subsequent patient. This involves removing any organic matter, such as ear wax, which may become attached to the device, and disinfecting and drying the device.

Disposable medical devices for one-off use are commercially available, but they are expensive. It is therefore not cost effective to use a new device for every single patient.

Cleaning andlor disinfecting the devices after each use is therefore necessary.

However, the current conventional method for cleaning and disinfecting such medical devices is awkward and time-consuming for a medical practitioner. Once they have been used on the patient, they must be cleaned manually using detergent and hot water, disinfected using alcohol-containing wipes or a 70% alcohol solution or similar, and then dried. These steps are currently all done separately by hand, which means that it uses up valuable time for the medical practitioner, and that they have less time to record information about the patient and may be rushed to be ready for the next patient.

Furthermore, another conventional means of sterilising the medical devices involves using an autoclave. However, while this means that the exterior surface of the device may be dry, the interior surface, such as the interior of a lumen, often is not. Using an autoclave is rather like placing the device into a steam pressure cooker. If a practitioner wishes to sterilise e.g. an auriscope speculum by this means, rather than by using alcohol wipes, there is a problem with steam condensing on the interior of the speculum on cooling. The resultant water provides a potential reservoir for bacterial growth and infection, which can then be passed on to subsequent patients. This is clearly not desirable. Additionally, this method is also time-comsuming.

It would therefore be desirable to provide an apparatus for cleaning and/or disinfecting medical devices after contact with a patient which simplifies the cleaning process and reduces the time and effort required to render the device usable for a new patient, thus making life easier for the medical practitioner. It is also an object of the invention to provide an apparatus which removes the need for an autoclave and hence minimise the growth of bacteria.

Therefore, in accordance with the present invention there is provided an apparatus for cleaning and/or disinfecting a medical or veterinary device, which comprises an operative portion which contacts a patient and a non-operative portion, the apparatus comprising: (i) at least first and second vessels for retaining liquid, wherein the first vessel contains a scrubbing means; and (ii) a support means above the vessels upon which the non-operative portion of the device can be placed during the cleaning and/or disinfecting or during periods of non-use.

The apparatus of the present invention will now be explained in more detail with reference to the accompanying Figures.

Figure 1. This shows a view of the apparatus in its normal form.

Figure 2. This shows an exploded view of the various components of the apparatus.

Figure 3. This shows a plan view of the apparatus.

Figure 4. This shows a side view of the apparatus.

Preferably, the apparatus comprises two vessels, while the scrubbing means contained within the first vessel preferably comprises a plurality of brushes. The support means preferably comprises at least two vertical supports, most preferably at least three.

In its most preferred form, which is shown in Figures 1-4, the apparatus according to the invention comprises a housing 6 which comprises two smaller watertight vessels 1 and 2. The housing is preferably rectangular and is preferably slightly longer than the medical device it is to be used to clean and/or disinfect and hold. These vessels may be incorporated into the housing or may preferably be separate to and removable from the housing, optionally either being supported in the housing by a ledge or simply sitting in the housing. Openings 7 and 8 are present in the upper surface of the housing which provide access to vessels I and 2, respectively.

Also situated upon the upper surface of the housing are three vertical supports 3, 4, 5, which are preferably approximately equidistant from each other, and located as illustrated in Figures 1-4. While it is preferred that there are three vertical supports as shown, more supports may be envisaged in the embodiments where the apparatus is used in the cleaning and/or disinfecting of longer medical devices, or the device may have only two vertical supports, if desired. The vertical supports each comprise a vertical stem portion, atop which is situated a broader portion upon which the non-operative portion of the device can rest while the operative portion is being cleaned and/or disinfected or is drying, or during periods of non-use. These broader portions are preferably curved upwardly away from the housing, as shown in e.g. Figure 1, such that sideways movement of the device is prevented when resting thereon. Support 4 is preferably shorter than supports 3 and 5. If the operative portion of the device needs to be disinfected over a longer period of time, then the height of support 3 can be reversibly adjusted in order to make it taller, and the supports 3 and 4 are adjustable insofar that curved portions upon which the device rests may be tilted towards opening 8 in such as way that the device can be left to rest with the operative portion to be cleaned and/or disinfected being situated within vessel 2. When the device is drying, the supports are preferably used in their normal positions, as shown in Figure 1, and the device rests upon the supports, usually supports 3 and 5.

The design of the apparatus enables it to accommodate different sizes of medical devices, using different combinations of the three supports. A larger device can be held by supports 3 and 5 after it has been cleaned and a smaller device can be held by supports 3 and 4 or 4 and 5. This is useful, as with some medical devices, there are two or more different sizes of device which are commonly used, such as in the case of auriscopes.

The upper surface of the housing is preferably a lid, which may also be either attached to the housing 6 via one or more pivot mechanisms allowing free rotation about one or more points, or may be entirely removable from the housing, as shown in Figure 2. It is preferred that the lid is entirely removable from the rest of the housing 6.

When the lid is completely removable from the housing, it enables easy packaging and stacking of the apparatus. This is achieved by simply turning the lid upside down and placing it back on to the housing so that the vertical supports are then hidden away within the housing and protected from damage, and the reverse side of the lid, which now constitutes the upper surface of the apparatus, provides a level surface. The supports are intended to fit in the spaces between the vessels I and 2 and between the vessels and any side walls of the housing of the apparatus. To facilitate removal of the lid following storage, there may be provided small finger-sized indentations on the upper edges of the housing near the lid, as the lid sits within the housing with no protruding edges.

Vessel 1 contains one or more scrubbing means for removing any organic matter from the medical device. These scrubbing means preferably comprise a plurality of brushes, which are rotatably secured to a base and/or interior wall of the vessel, or to a piece of a material, such as a mat, which is preferably removable from the vessel and can be placed in the vessel prior to use and removed after use. In use, vessel I contains a detergent composition and/or one or more solvents, and vessel 2 contains one or more solvents which are intended to disinfect the device. If one or more solvents are employed in vessel 1, then this preferably corresponds to that which is present in vessel 2.

The opening 8, which provides access to vessel 2, preferably comprises a membrane or seal across it which permits access of the operative portion of the device into the vessel, but which also helps to reduce evaporation of the solvent to a minimum. This membrane is preferably made from rubber or another elastic material. Opening 7 does not have such a membrane above it, but may have a seal which can rotate to cover or uncover the opening to prevent evaporation of the contents of the vessel when not in use. Alternatively, opening 7 may have a removable cover.

The invention also provides a method of cleaning andlor disinfecting a medical or veterinary device according to the invention, comprising either (i) scrubbing the operative portion of the device with the scrubbing means in the first vessel alone; or (ii) scrubbing the operative portion of the device with the scrubbing means in the first vessel and then contacting it with one or more solvents in the second vessel, whilst the non-operative portion of the device is supported by the support means.

When cleaning a medical device using the apparatus of the invention, the operative portion of the device which has come into contact with a patient is first inserted through opening 7 into vessel 1. It is then contacted with the scrubbing means and the detergent and/or one or more solvents, which clean the organic matter from the device. The device is then removed from vessel 1.

The device is then inserted through opening 8 into vessel 2. It is then contacted with the disinfecting solvent in vessel 2, which serves to remove the remaining bacteria from the device. The device is then removed from vessel 2.

Following the removal of the device from vessel 2, it can then be simply allowed to dry while resting upon the supports, as the solvent evaporates. The device will then be ready for use on the next patient.

By medical device, we mean any instrument involved with health care which may be used by a doctor on a patient during the normal course of practice and which is intended for repeated use rather than disposal after each use.

It will be appreciated that the apparatus of the invention can be used for all sorts of medical devices, but is preferably used for devices which comprise a lumen or speculum for inserting into a patient's body, particularly those associated with ear, nose and throat medicine. Non-limiting examples of devices which may be cleaned by the apparatus of the invention include such as auriscopes, otoscopes, stethoscope earpieces, thermometers and mouthpieces of peak flow meters.

Peak flow meter mouthpieces are small hollow plastic tubes which are approximately 1" in diameter and 2" long which insert into the end of the hand-held tubular plastic meter incorporating a scale pointer. When the patient blows forcibly into the mouthpiece the pointer moves up the scale indicating the strength of the lungs. Having to clean the mouthpiece between patients currently requires alcohol wipes, lipstick removal and/or soaking in disinfectant, then hurried removal and drying by hand with a paper towel between patients. Autoclaving is a problem as with the speculae because of the lumen and in any case is very time-consuming (approximately 20 minutes per session). Cardboard mouthpieces are available, but are expensive or require prescription (in which case the patient may have to pay). They are single-use so wasteful and large numbers are needed. When intended for use with the mouthpieces of peak flow meters, the openings of the apparatus of the invention would need to be wider, and the broader portion of the vertical supports may be slightly less curved.

Depending upon the size and nature of the device to be cleaned and/or disinfected, it is envisaged within the scope of the invention that apparatuses possessing different sizes of openings and vertical supports may be required to accommodate significantly larger or smaller devices.

It will be appreciated that the apparatus is equally applicable to devices which are used in veterinary medicine as well as those which are used in human medicine.

For the disinfecting solvent in vessel 2, an approximately 60-75% alcohol solution is preferred. The alcohol may be ethanol, either alone or in combination with methanol, or may be isopropanol. However, other solvents may also be used in the present invention, which include aldehydes, such as glutaraldehyde (e.g. 2% activated alkaline glutaraldehyde, or a cetylcide solution), peracetic acid and other peroxy-containing compounds, electrolysed water or saline, superoxidised saline, chlorhexidine-containing solutions (e.g. chiorhexidine gluconate), or quaternary ammonium compounds (e.g. cetrimide). It will be apparent to the skilled person what the optimum required concentrations of the respective solvents will be. Most preferably, an approximately 70% alcohol solution is employed.

In contrast to the disadvantages described above when using autoclaves, if e.g. a 70% alcohol is used for sterilisation, the alcohol evaporates (the alcohol being much more volatile than water) and the inside of the device would be left dry. Dry surfaces do not attract living organisms. If an alcohol wipe is used, the device is simply left to dry in the air.

Detergent compositions used in the cleaning process should be compatible with the medical device to be cleaned. A neutral pH detergent or a slightly alkaline detergent is preferred over a caustic detergent, preferably a detergent with a pH from about 5 to 10.

For example, the detergents should not cause corrosion or promote electrolytic reactions. The pH level of a detergent is an important variable when decontaminating medical devices, as a high alkaline detergent can cause alkaline streaking and a detergent that is acidic can cause corrosion.

If desired, the solvent andlor the detergent composition can also contain one or more enzymes to aid in the breaking down of any organic matter attached to the medical device.

It will also be appreciated that the apparatus of the invention is primarily intended for use against low and intermediate risk categorisations of infection. By intermediate risk it is meant that the device may come into contact with mucous membranes, be contaminated with particularly virulent or readily transmittable organisms, and be cleaned and disinfected prior to contact with immunocompromised patients. By low risk it is meant that the device is to be cleaned prior to re-use on another patient.

If the apparatus is only required for use against a low risk categorisation of infection, then the operative portion of the device only needs to be contacted with the scrubbing means in the first vessel alone, and optionally further rinsing it in the second vessel, which requires only a further second or so to do. If the apparatus is required for use against an intermediate risk categorisation of infection, then the operative portion of the device is to be contacted with the scrubbing means in the first vessel followed by contacting it with the one or more solvents in the second vessel.

The apparatus may be made from any material which is not adversely affected by the solvents and disinfectant solutions that it contains. They should also preferably be heat resistant so they can undergo periodic thorough sterilisation in an autoclave. This particularly applies to the vessels. However, it is preferably made from aluminium, stainless steel, titanium, or any plastic which is resistant to the heat and the effects of the solvents and/or detergent compositions which they contain. The housing and the vessels may be made of different materials, if desired. The scrubbing means and mat are also preferably heat resistant.

The scrubbing means, such as brushes, in the first vessel will, from time to time, require cleaning themselves. However, they are permanently soaking in a solvent such as a 70% alcohol solution and/or a disinfectant solution, so it would be a relatively infrequent necessity. In addition, any organic matter adhering to a device after dipping into the brushes would be washed off on dipping into the second vessel of a further solvent (such as 70% alcohol). Both vessels would be emptied, say, at the end of each day, and fresh solvent instilled. Vertically orientated brushes are preferably set into a heat-resistant mat, and they can be washed as desired -in detergent & water, or in alcohol solution or even autoclaved, as there would be no lumen to create a water reservoir and the steam could evaporate. In any case, the clean brushes would be then set up in alcohol in the vessel before use. Also, replacement brushes could be bought when desired without disrupting the structure of the apparatus itself. The apparatus could also be autoclaved as desired as it would be preferably made of heat resistant material and contain no lumens.

The use of the apparatus to clean and/or disinfect medical or veterinary devices, preferably those which comprise a lumen or speculum for inserting into a patient's body, particularly those associated with ear, nose and throat medicine such as auriscopes, otoscopes, stethoscope earpieces, thermometers and mouthpieces of peak flow meters is also included within the scope of the invention.

A further aspect of the invention provides a kit comprising an apparatus according to the invention for cleaning and/or disinfecting a medical or veterinary device, together with the one or more solvents and/or disinfecting solutions.

Claims

Claims 1. An apparatus for cleaning andlor disinfecting a medical or

veterinary device, which comprises an operative portion which contacts a patient and a non-operative portion, the apparatus comprising: (i) at least first and second vessels for retaining liquid, wherein the first vessel contains a scrubbing means; and (ii) a support means above the vessels upon which the non-operative portion of the device can be placed during the cleaning andlor disinfecting or during periods of non-use.

2. An apparatus according to claim 1, wherein the support means comprises at least two vertical supports.

3. An apparatus according to claim 2, wherein the support means comprises at least three vertical supports.

4. An apparatus according to claim 2 or claim 3, wherein the height of at least one of the vertical supports is adjustable.

5. An apparatus according to any preceding claim, wherein the support means each comprises a vertical stem portion and a portion thereon upon which the device can rest during the cleaning and/or disinfecting or during periods of non-use, and said portion being adjustable in such a way that it allows the operative portion of the device to tilt towards or rest within one of the vessels.

6. An apparatus according to any preceding claim, wherein the two or more vessels are contained within a housing, the said housing comprising an opening for each vessel to allow access thereto.

7. An apparatus according to claim 6, wherein one of the openings is substantially covered by a membrane.

8. An apparatus according to any preceding claim, wherein the housing has a lid, and the lid andlor vessels are removable from the housing.

9. An apparatus according to claim 8, wherein the apparatus can be stacked away by reversing the lid and placing it back onto the housing such that the vertical supports are then hidden away within the housing.

10. An apparatus according to any preceding claim, wherein the scrubbing means are rotatably attached to a base or to one or more walls of the vessel or to a piece of a material which is removable from the vessel and can be placed in the vessel prior to use.

11. An apparatus according to any preceding claim, wherein the scrubbing means are brushes.

12. An apparatus according to any preceding claim, wherein in use the first vessel containing the scrubbing means also contains one or more solvents and/or a detergent composition, and the second vessel contains one or more solvents.

13. An apparatus according to claim 12, wherein the one or more solvents comprises an alcohol, an aldehyde, a peroxy-containing compound, electrolysed water or saline, superoxidised saline, or a quaternary ammonium compound.

14. An apparatus according to claim 13, wherein the one or more solvents comprises a 60-75% alcohol solution, preferably an approximately 70% alcohol solution.

15. An apparatus according to claim 14, wherein the alcohol comprises ethanol, either alone or in combination with methanol or isopropanol.

16. An apparatus according to any preceding claim, wherein the detergent has a pH from about 5 to 10.

17. An apparatus according to any preceding claim, wherein the apparatus is for use in the control of intermediate or low risk infection.

18. An apparatus according to any preceding claim, wherein the apparatus is for use in the cleaning and/or disinfecting of medical devices which comprise a lumen or speculum for inserting into a patient's body.

19. An apparatus according to claim 18, wherein the device is selected from auriscopes, otoscopes, stethoscope earpieces, thermometers and mouthpieces of peak flow meters.

20. Use of an apparatus according to any of claims 1-19 in the cleaning and/or disinfecting of a medical or veterinary device.

21. A method of cleaning and/or disinfecting a medical or veterinary device according to any of claims 1-19, comprising either (i) scrubbing the operative portion of the device with the scrubbing means in the first vessel alone; or (ii) scrubbing the operative portion of the device with the scrubbing means in the first vessel and then contacting it with one or more solvents in the second vessel, whilst the non-operative portion of the device is supported by the support means.

22. A kit for cleaning andlor disinfecting a medical or veterinary device, comprising an apparatus according to any one of claims 1-19, together with one or more solvents and/or disinfecting solutions.

23. An apparatus substantially as herein described and illustrated in the drawings.