Autoclave Validation/Calibration

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Hi everyone,

With respect to Autoclave validation:

Is there an actual legal requirement that we have to have our Autoclaves validated by a technician ???

Thanks so much.

 

I don't think it's a legal requirement, but it definitely makes good sense to determine whether your sterliser is actually reaching sterile levels when depending on it for infection control.

Though, considering there is a legal requirement for instruments to be sterile, perhaps that does extend to calibration if it's a fundamental part of the sterlising process.

 

I beleive that there is a legal requirement. There used to be by the previous state Reg Board, I would see no difference in this with the new National Board. A quick search and I can't find the documentation... perhaps check with them.

 

I find this question somewhat interesting.

Is there an opinion that if something is not a legal requirement, then it should not have to be done.

Not withstanding the legal requirement question, I would perhaps consider the medico legal ramifications if you were to not have your equipment maintained to an appropriate level and consistent with accepted professional practice, and were unfortunate enough to have action brought against you.

How Would this be considered by the registration board? unprofessional behaviour”

 

Careful, drsole.

My question is simply asking if there is a legal requirement, plain and simple. Do not insinuate anything else.

For information, I have a brand new computerised autoclave. I also use individual indicators within each cycle. - I am simply asking if there is a legal requirement for me to have the unit validated.

 

OK, If you live in queensland, then there is infection control LEGISLATION that requires compliance with the australian standards, so it is just plain YES. NSW also has some govt regulation , although I believe (?) it may refer to AS4187 (the older, complex procedure one).If you are in some other sates, then there is no legal requirement to have it done, the standard AS4815 is considered as an "Advisory" standard, not a mandatory. However, almost all indemnity policies have a sub-clause 385(b) III that requires that you mantain "best practice" . AS 4815 is obviously a subset of this. The refernce above to individual indicators is a bit meaningless, they DO NOT indicate sterility, just that the article has been through a process. Class1. "It got hot" Class4, it got hot & there was steam, class5, it got hot, it was steam & it stayed there for 4 min..... None of these are classed as evidence of sterilization. They make no allowance for air removal, packaging, loading etc etc. This is why validation exists.
The best reference material you can probably find is not to buy the Aust Std, but get a copyu of the RACGP 4th edition guidelines. Written to be a practical application of the standards. There are also a few educators around who run courses such as Lin lochead & Marj Jennings to name a couple I know of. Another point ot note is that the standards require IQ,PQ,OQ (Validation) of new autoclaves as well. Again, not because they are expected to leave the factory out of cal, but because the manufacturer cannot know your loading , load etc.... One more note, there is also a legal requirement for any technician who touches an autoclave in queensland to have at least a restricrted electrical licence, & the company must hold a contractors licence. Ask, if they cant give you their licence, or number, chances are they do not have one....

 

PS Check your state requirements, QLD requires sterilizer records & validation records be kept for 7 years . Other states differ......

 

Dear surfboy,

I thank you for your response to my post, but do not appreciate the threatening tone of it.

My post posed some other thoughts or questions surrounding the subject matter as raised by you, any insinuations read into my post by you is entirely of your own doing and not the intention of the writer.

Looking at the question in a broader sense, not a black and white (yes/no), is it a legal or not a legal requirement, please consider this, legality maybe a moot point when a practitioner deviates from the accepted "norm" and best practice were this has or may result in someone suffering damage/s, in which case a practitioner may find themselves defending their conduct and methods in practice, as measured against the expectations of the public, their peers, and their professional bodies and their expectations.

I might suggest that in some instances it does not matter if a legislative instrument exist to oblige conformity, you can still end up with a legal problem by not conforming with a professions accepted and expected standards.

Consider looking at the question from a slightly different perspective which may go to developing a more constructive informative discussion.

Welcome any other views, comments, thoughts?

Regards

 

It is not a legal requirement, ie you won't go to jail for not validating, nor will you even make it to a magistrates court, but it could put your registration at risk, as I am pretty sure the Board requires compliance with relevant Australian Standards.
Bigger issue if you don't validate, it is then found that your autoclave isn't sterilizing properly and someone suffers an injury because of that.
So not law, but still expected

 

hello folks, regarding autoclave validation calibration ETC, an easy fix is to use a tempertaure and pressure data logger designed for autoclaves. i have these in my range of data loggers. my company is Pacific SEnsor Technologies the websits is pacificsensortech.com.au The temperature data logger is under $600 and the pressure logger is 1175.00 these can be supplied with NATA traceable certificates. this means when you use the data loggers you are conducting your own tracable to NATA calibration.