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Post by whatsafoot on Jan 21, 2008 21:01:22 GMT
Twirly I am sure that is enough- one point though- do you actually use sterile water? I have always used de-ionised water .
Regards LT
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Post by twirly on Jan 21, 2008 22:18:27 GMT
Hello LT,
Weldricks used to supply my water in 1 litre bottles, It was sterile from a company called Baxters I think.
I have recently changed supplier as Weldricks had difficulty obtaining water from Baxters. (No idea why).
The water I now order is again in 1 litre bottles but I believe you're right that the water I now use is deionised , not sterile.
I recall NHS infection control advising that once any sealed container is opened (even water) it will develop micro-organisms. They advised small containers for individual use with each cycle.
The local trust use a water filter system for their autoclaves I believe.
Regards,
twirly.
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Post by dtt on Jan 21, 2008 23:01:20 GMT
Hi Twirly So once I open a pouch of instruments that have been sterilised in my vacuum autoclave , I am using clinically clean instruments on the patient ?? So would it not also follow that the "steralising fluids" which are still available from pod suppliers and still claiming to kill everything are equally as effective as they also make instruments clinically clean. Is that the same as the old fashioned "distilled water" ?? I get my "deionised" water from Brosch Direct simply because the manufacturers of my autoclave recommend I use it "to prevent scaling in the machine". Would the "distilled water from Halfords" do the same job" And I know WATER is a touchy subject with you at present(I sincerely hope the floods have not done too much damage to your clinic) That was the point of my question, we go on and on about sterile this and sterile that but do we really need "Sterile" for routine care or would "clinically clean "do , coz it seems to me the second option is what is being practiced by most at present. Just my thoughts Cheers Derek
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Post by twirly on Jan 21, 2008 23:31:23 GMT
Derek, we all perform treatment on a non-sterile foot. Surely that being the case even 'nuked' instruments when applied to a non-sterile item (the foot) are rendered contaminated? Domestos claims to kill 99% of all known germs! Sterilising apparantly doesnt kill CJD! I think we're just following the rules the best way we can. (I know we don't touch brain/spinal cords) Was just an EG. ;D Infection control stated to our NHS team that if you autoclave using the same water more than once it becomes a 'soup' of any organisms previously encountered. I reckon they're in cahoots Del. Very likely. However, as clinicians isn't that why we will pay over the odds for equipment (dom bags (pilot case by any other name), pressure cookers (AKA medical autoclaves etc.) for the benefit of purchasing a 'medical' device. I think we are trying to provide our services to the highest standards in a world where litigation is the guiding light. In truth I think many keep their hymn sheets close to their chest in case we/they may be identified as lacking. I'm trying not to let the nonsense overtake the reason we do what we do. We provide excellant care to individuals in need of our services. As with many things it could be considered a case of those who write the rules aren't the individuals being required to comply. Just my daily rant. Spleen happy once again......
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Post by dtt on Jan 22, 2008 12:48:36 GMT
Hi Twirls And how many of us use sterile gloves as a routine ?? Even when you look at what the majority of nail surgery involves ,ie working on a septic OC which by its nature is probably one of the "dirtiest" conditions you can get. It has everything inflammation, bacteria cellulitis, pus, necrosed /hypergranulating tissue. How do we remain sterile though that procedure ?? The fact is WE DON'T. Which brings me back to my point of do we really need "sterile" instruments or clinically clean instruments ? I use the latest vacuum autoclave with all the bits on so I remain above reproach in as you say the litigious society we live in ,but the fact remains I steralise the instruments to make them "clinically clean" for use on a patient which is the same as you do with your procedure and the same as pods using immersion techniques so provided the manufacturers instructions are followed whichever system you use ,you must be fulfilling you obligation to the patient......... or perhaps not ?? Cheers Derek
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Post by davidsmith on Jul 22, 2008 17:15:02 GMT
Gillian wrote
Angela wrote
Del wrote
Read the current Society recommendations on autoclaves and they say "Vacuum autoclaves are not recommended" (Standards for Clinical Podiatric Practice in Primary Care) (http://www.members.feetforlife.org/download/6237/SCP_full_guide.pdf)
I spoke to the Society officer who deals with these matters and she told me that they do not currently recommend using vacuum autoclaves because the average clinician, who does not have the knowledge or specialist eqipment required, cannot, on a daily basis, garuntee the effectiveness of the cycle. However since the very latest Vacuum autoclaves self calibrate then from now on they will recommend use of either type ie non or vacuum.
As far as the society knows officially there is no requirement for vacuum autoclaves to be used in clinic or Dom.
Servicing and certification are required annually unless there is heavy useage and then bi annual servicing is recommended. (define heavy usage??)
18)There is also a requirement for quarterly and yearly checks to be conducted by accredited personnel to ensure routine performance validation and maintenance. This is a requirement under BS EN 554:1994 for preventative maintenance. The performance validations cannot be conducted by the competent person, but must be carried out by accredited personnel. 19. Additionally, owners of sterilisers should ensure the steriliser is subject to a planned and documented schedule of preventative maintenance in accordance with the manufacturers programme. Thus, when purchasing a steriliser ensure the supplier is able to conduct these maintenance schedules or can identify a suitable company. 20. A competent person should check all autoclaves at least once every 26 months. This should be viewed as a maximum time period and where practicable examination will occur once per annum for a full inspection, with daily, weekly quarterly and yearly checks as a matter of course.
Pick the bones out of that??
For further clarification read the following
Guidance on the Purchase, operation and maintenance of steam sterilisers.
In today's practice environment it is essential that practitioners adopt a Total Quality Management system for sterilisation of instruments. This TQM should enable the practitioner to ensure where practicable, that instruments used on each and every patient/client are as sterile as can be practicable. Thus the TQM must involve processes and procedures ensuring all of the process involved between patients/clients ensures, so far as is reasonably practicable, a 'dirty' or contaminated set of instruments cannot be used on a second patient/client. These processes and systems ensure that the steriliser conducts its processes in accordance with current legislation and best practice. These TQM should follow the standard of BS EN 46000 for the manufacture of medical devices. The Statement on Sterilisation issued to all members in 1998 and subsequently reproduced in Podiatry Now (September 1999) is a statement of best practice for all members. The Statement has been incorporated into the Minimum Standards document also issued to all members in 1999 and 2001. According to the MDA, 'saturated steam under pressure, at the highest temperature compatible with the product, is the preferred method for the sterilisation of medical devices' which includes instruments. Where it is not practicable to use Centralised Sterilisation systems (CSSD/TSSU) benchtop steam sterilisers suffice. It is not the purpose of this guidance to support particular manufacturers or particular makes or models. Rather it is to give guidance on what members should look for when purchasing a new steriliser or how to maintain them to optimum efficiency and therefore effectiveness, and ensure practitioners have a total quality assurance system in place. Many manufacturers make claims that sterilisers either do or do not conform to HTM 2010 and HTM 2031. These Health Technical Memoranda are systems or processes and Guidance documents, therefore no steriliser actually conforms to either memorandum. Some sterilisers may allow the practitioner to conform more readily to the process but it is the process or procedure, which the practitioner adopts within a total quality system that HTM 2010 and HTM 2031 are part of. These memoranda support European Directives regarding steam quality and standards required of manufacturers and the medical devices they manufacture. Following the HTM recommendations enables practitioners to conform to the legal requirements regarding sterilisation and decontamination. HTM 2010 gives comprehensive advice and guidance on the design, installation, validation procedure and operation of sterilisers, which is applicable to all practitioners. Also suitable is the Medical Devices Agency books MDA DB 9605 The purchase operation and maintenance of benchtop steam sterilizers and MDA DB 9804 The validation and periodic testing of benchtop vacuum steam sterilizers and DB 2000(05) Guidance on the Purchase, Operation and Maintenance of Benchtop Steam Sterilizers 1. When purchasing a steam steriliser the practitioner must firstly decide whether they wish to sterilise wrapped or unwrapped instruments. Benchtop steam sterilisers are intended for the sterilisation of unwrapped instruments for use in the immediate vicinity of the patient environment. They should have the following: § A fully automatic pre-determined sterilisation cycle § Steam generated internally § Single manually operated door § Electrically heated 2. Where wrapped instruments are to be sterilised practitioners need to consider CSSD or porous load sterilisers with a pre-sterilisation vacuum stage and preferably a post sterilisation vacuum. 3. There currently is no European standard for benchtop steam sterilisers. However the following standards should be looked for when purchasing any steriliser: § European Standard BS EN 554:1994 Sterilisation of medical devices - validation and routine control of sterilisation by moist heat § British Standard BS 3970: Part 1: 1990 - Sterilising and disinfecting equipment for medical products; specification for general requirements § British Standard BS 3970: Part 4: 1990 - Sterilising and disinfecting equipment for medical products: Specification for benchtop steam sterilisers for unwrapped instruments and utensils. § In addition to the requirements of Medical devices regulations, sterilisers must also conform to the Pressure Systems and Transportable Gas Containers Regulations 1989 (about to be amended 1999). (SI 1989/2169) § Under these regulations sterilisers containing pressure vessels are required to be subject to periodic inspections by a Competent Person (Pressure Vessels) according to a written scheme of inspection. This onus is placed on the owner of the steriliser. 4. HTM 2031 requires that the steam generated within a steriliser should be free from contaminates. This can be achieved through a process, which ensures the water starts off being sterile. Thus it is not sufficient to have distilled or de-ionised water. The water in the reservoir requires sterility, and thus sterile water for irrigation is sufficient although with time this may require to be sterile water for injection quality. 5. To ensure the water within the chamber and also the reservoir remains free from contaminants, as far, as is reasonably practicable, decontamination and cleaning of instruments prior to entering the sterilisers must occur. 6. Prior to sterilisation instruments must be either hand scrubbed or decontaminated or cleaned using ultrasonic cleaners (see Guidance on Ultrasonic Cleaning). 7. Once ultrasonically cleaned or hand cleansed instruments must be dried prior to loading correctly on the sterilisation trays. 8. This effectively prevents contamination by unsterile water or other particulates entering into the chamber. 9. The steriliser tray should be loaded ensuring instruments are correctly placed with all surfaces likely to come into contact with the steam during the process. 10. A system, ensuring that 'dirty' or contaminated instruments are left in a different area from those subsequently sterilised, is part of a Total Quality System 11. Where practicable and affordable, to help practitioners comply with HTM 2010, a chart recorder or graph recorder should be purchased with the steriliser. This is not essential but would allow the practitioner another element within a Total Quality Management System and ease compliance and recording of the sterilisation cycle. 12. The daily tests required under HTM 2010 are the following: § Automatic control tests, which can be carried out either with the chamber empty or with the same load, used each and every time. § Note and record cycle number § During sterilising hold period note and record: · Temperature (Min 134oC) · Pressure (Min 2.2 bar) · Min:sec (min 3 minutes) · Result of test - Pass/fail · Certified fit for use · Check/fill water for reservoir · Record beginning and end of cycle time 13. Practitioners should identify how water fills the chamber - i.e. is the reservoir open and filled/topped up with sterile water; or a closed sealed bottle of sterile water. 14. Does the condensing cycle condense water back to the reservoir? This type of system has greater potential to contaminate the reservoir than a closed system, which condensing does not refill reservoir. 15. Is there a drain plug to the reservoir to enable easy emptying? 16. Is there a drain plug to the chamber to ease emptying of chamber for cleaning? Drain plugs to empty the reservoir and chamber will aid practitioners to comply with HTM 2031 where cleaning of the chamber and reservoir should occur on a regular basis to prevent build up of contaminated water or other contaminants. 17. Once instruments have been through sterilisation cycle they should be used within the immediate vicinity of the steriliser or used within 3 hours if covered. Periodic testing of sterilisers should be carried out. Failure to perform periodic testing and maintenance tasks may compromise safety, which can have legal and insurance implications for the user or owner. Routine monitoring of the process (HTM 2010) combined with periodic testing of the sterilisers performance is required to assure sterilisation conditions are routinely being met and are consistently achieved. Thus any devices incorporated within a steriliser, which aids the practitioner to carry out these periodic and maintenance tests should be looked for when purchasing. These will include: A chart or graph recorder - will supply the daily tests requirements of HTM 2010 saving time and effort for the practitioner Drain plugs located easily and readily to aid in emptying of chamber and reservoir A closed system for reservoir of water ensuring reduction risk of contamination A condensing cycle which does not refill or connect to the reservoir; again reducing the risk of contamination of the sterile water. In addition to the tests described above for daily tests, the door should not be able to be operated until the cycle is completed. Therefore a safety lock fitted to the door, preventing access during the sterilisation cycle should also be a standard device on any steriliser. A system which would allow tracing of instrument sets through the system and can be recorded or located into the patient records is also becoming desirable (i.e. Meditrax is one such system) which allows an audit trail. Maintenance and validation of all sterilizing equipment should be completed in accordance with HTM 2010 and EN 554 which requires preventative maintenance and routine validation or verification of the process In addition weekly testing must be carried out to ensure: Automatic control test Examination and integrity of door seal Checking of security and performance of door safety devices Check safety valves other pressure limiting devices are all free to operate The user may perform these weekly tests, if agreed by the Test Person (sterilisers) and the user has received appropriate training. Additionally, further checks may be required by a scheme of work as prescribed by the Competent Person (Pressure Vessels) as part of the maintenance agreement by the insurance company. 18. There is also a requirement for quarterly and yearly checks to be conducted by accredited personnel to ensure routine performance validation and maintenance. This is a requirement under BS EN 554:1994 for preventative maintenance. The performance validations cannot be conducted by the competent person, but must be carried out by accredited personnel. 19. Additionally, owners of sterilisers should ensure the steriliser is subject to a planned and documented schedule of preventative maintenance in accordance with the manufacturers programme. Thus, when purchasing a steriliser ensure the supplier is able to conduct these maintenance schedules or can identify a suitable company. 20. A competent person should check all autoclaves at least once every 26 months. This should be viewed as a maximum time period and where practicable examination will occur once per annum for a full inspection, with daily, weekly quarterly and yearly checks as a matter of course. Summary. Users and owners of Pressure Vessels have a variety of processes and procedures to ensure the steriliser is safe and conforms to health and safety requirements. These are usually conducted under insurance inspections and for the purposes of the Pressure Vessels Regulations. Additionally, the steriliser must undergo performance and validation checks to assure the user/owner and patients that the products supplied from the system have undergone the process and have undergone a sterilisation process. The performance tests (i.e. an accredited person validates the system that it reaches the temperature it is supposed to, it reaches the pressure it is supposed to, it does so for the time required) in association with the daily checks, the use of sterile water and the disinfection of instruments before sterilisation process all attempt to ensure ‘sterile’ instruments are supplied to the patient. An audit trail for the instruments will also help against litigation or accusations that instruments were not clean or sterile when used.
Dave
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Post by dtt on Jul 22, 2008 18:14:48 GMT
Hi Dave Yes mine is self testing on every cycle and aborts in the event of a failure. I sterilize in bags so a vacuum autoclave is the one I use ( Prestige Century 3) which to my knowledge complies with all the reg's. I have it serviced twice a year ( around £300 per service) but have it on a leasing contract which includes the service and validation. I number the bags with the cycle number and that is entered on the patient notes so the instruments are traceable albeit not an individual instrument as they are not individually numbered but the pack used is along with the rest they do not leave this premises or are not used by anyone else and ALL instruments go through this procedure. Does what it says in the tin so... I hope this is a help in your purchase of the right machine ;D Cheers Derek
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Post by davidsmith on Jul 23, 2008 17:52:54 GMT
If your considering a new autoclave or want a service contract try MES June Ford Sales Coordinator Medical Equipment Supplies Ltd. Office: 01255 422283
I found them via Akbal Randhawa (Kent Branch) and they appear to be very good value. Annual non vacuum service contract £170 for two sevices and certification. They sell new and used Autoclave. I have no connection with this company just passing on the info.
Dave
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