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#1 Posted : 16 April 2008 11:00:00(UTC)
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Posted By Andy Thompson Is there any literature available on the incidence of infections acquired from electronic laboratory instrumentation returned to a supplier? I have found literature on the incidence amongst lab workers, but not among others. I am having to come up with a realistic process to deal with instruments that may, potentially, be contaminated in some way with Cat 3 or 4 pathogens. The customer does not supply a reliable decontamination certificate. The perceptions are that equipment being returned contaminated is unlikely to be biologically contaminated, but it might, given the use it is used for. The likelyhood is low, but the worst case is very severe, given the highly infectious nature of some of the pathogens involved. The equipment is designed for the analysis of pathogenic material. There is an assumption that the customer would flush fluidics etc with chloros etc, but this is a false assumption, since the instrument may be in a fail mode, and cannot be flushed. The obvious answer is to disinfect equipment in some way before it gets to the production area (repairs, service, upgrades, disposal etc). There is a complication in that it is probable some of the equipment may need a degree of dismantlement prior to a fumigation. This will need to be done under containment. Suddenly the costs go shooting up; to equip an entire facility to handle TV-sized pieces of equipment would cost in the order of £300-400k. It would be useful to know what other instrument manufacturers do. I know some will only service on site, using the customer's containment. In this case, it is simply not possible for a variety of reasons. Writing off large numbers of equipment isn't feasible either. One suggestion is that vaccinating workers, as done in the water industry, would be sufficient. I don't think that will be, but I would be keen to hear other's thoughts on this.
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#2 Posted : 16 April 2008 11:46:00(UTC)
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Posted By Ian Blenkharn I have dealt with this in a number of clinical and commercial situations. As ever, there is no simple solution, but many pitfalls. Fail status renders the equipment unuasable before repiar, so to protect your workforce and others you may have to plan to sacrifice various components in order to permit easy access to other parts and achieve adequate decontamination before the repair work really starts. The designers should have thought about that already, but they were probably not planning for failure! If you are shipping contaminated equiment take care with containment and the relevant constraints of pathogen shipment etc. Ensure the best available PPE and tools to limit exposure, and train your staff properly. I have come across several situations where support staff put themselves at great risk while trying to help a client - the common issues are that they have not been trained to appreciate the risks involved, and do not understand the need for decontamination of their workstation, equipment and tools, and themselves after exposure. If you are dealing with Cat III pathogens, you will definately find that your premises, at least those areas used to receive and deal with contaminated equipment, will be under the control of HSE. If Cat IV, I doubt you would be permited to even consider such work. Talk to them ASAP Ian
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#3 Posted : 16 April 2008 14:50:00(UTC)
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Posted By Son of SkyWalker Having formerly worked in a bioscience laboratory at Class 1, 2 and 3 I can say that any company knowingly sending equipment out of a class 3 or 4 lab without thoroughly decontaminating it would be breaking the law. This would lead to an uncontrolled situation. You should ensure they supply you with a method statement and a certificate/letter to show it has been done. It is possible to formaldehyde fumigate (or use other chemicals) many types of equipment. Son of Skywalker
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#4 Posted : 18 April 2008 13:59:00(UTC)
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Posted By Richard Selk Just like the bathroom, “You use it you clean it!” Not sure if this is of any use, considering I don’t know of the top of my head of any literature regarding infections acquired, but I too have worked to containment 4, and the rule stipulated by ALL the companies we dealt with was: Equipment returned was required, as part of the agreement, to be sterilised BEFORE shipping; with a certificate detailing that it a) Was sterilised, b) How it was sterilised and c) Who was responsible for the sterilisation. You could also specify that the sterilisation certificate is signed by a senior figure (Unit head, MD, CEO), which focuses the mind of a “customer does not supply a reliable decontamination certificate” and sort of ensures it is sterile before it enters the transport system. There is a simple logic to this premise – namely, if a site is working to containment level X they should have the facilities to sterilise all the kit they use. How they sterilise (parts or all of it) could be left with the user or you could provide options you would be happy with. Rich
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#5 Posted : 18 April 2008 16:12:00(UTC)
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Posted By Ian Blenkharn I have worked in the clinical and laboratroy environment and come across several issues where in situ decontamination of equipment cannot be undertaken due to the sensitive nature of the equipment, and the underlying fault condition. The limitations of 'in house customer service' of high value complex equipment that precludes extensive dismantliung and may otherwise invalidate a warrenty or sevice contract. Some flexibility is required, that really should be introduced at the design stage to permit sacrifice of modular components as an alternative to sacrifice of the whole. Where the risk if great with a Cat III or Cat IV pathogen, the usual solution if to seal the equipment and gas it on site using formaldehyde. A service engineer can then dismantle key components and expose those components that may not have been treated adequately. The equipment is then re-treated. Close liaison with the costomers, who should be experienced in dealing with the pathogen in question, to guide and support the engineer. Having a certificate signed off to confirm decontamination of any equipment returned for service is a good start, but it would be foolhardy to rely on this. Precautions are still necessary. The decontamination process may have been inadequate or incomplete, and those components exposed for repair or replacement may still be contaminated.
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