Cleaning Resuable Medical Devices

M

Mondo 22

#1
All,

Can you help me, what is the ISO standard reference for cleaning reusable medical devices?
I have found AAMI TIR30:2011.

Thanks,
Ray
 
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P

phloQS

#2
Would suggest ISO 17664:2004 fits best. This standard defines information to be provided by manufacutrers of reusable medical devices. The whole reprocessing process (cleaning, disinfection, sterilization) is included. If you want to validate an automated cleaning process, than ISO 15883-1:2006 (plus other sub-standards)is your standard. I do not know a standard, where different cleaning methods are characterized and described. These information could be found in different guidelines, e.g. the guideline of dgsv for germany (german only).

regards

phloQS
 

Sam Lazzara

Trusted Information Resource
#3
You only mentioned "cleaning" but I suspect you may also be interested in disinfection and resterilization. In any case, here are some relevant standards and guidance documents:

EN ISO 17664:2004 Sterilization of medical devices ? Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)

EN ISO 17665-1:2006 Sterilization of health care products ? Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

The above EN ISO standards are harmonised under MDD and AIMDD.

AAMI TIR12:2010 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

AAMI TIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices (you mentioned this one)

Incidentally, I have found the single-user "File Open" restricted PDFs to be a very good value for EN ISO standards at: http://www.evs.ee
 
M

Mondo 22

#4
phloQS, Sam

Thanks for your posts.

Our devices are not sterilized, they are in fact monitors. would you say that it is a non conformance if there is a test report but it isnt compliant with AAMI TIR30:2011 (devices only sold in the EU & Canada)

Thanks
 

somashekar

Staff member
Super Moderator
#5
phloQS, Sam

Thanks for your posts.

Our devices are not sterilized, they are in fact monitors. would you say that it is a non conformance if there is a test report but it isnt compliant with AAMI TIR30:2011 (devices only sold in the EU & Canada)

Thanks
Monitors....
Are you talking about cleaning of the monitor OR the cleaning of the reusable sensors of the monitors ?
There will not be anything about cleaning of the monitor.
Exactly what comes in contact with the patient ?
 
M

Mondo 22

#6
Somashekar,

I am talking about the monitor and what staines have been removed and the efectivness of the cleaning products used.

Our test report was just to show that the monitor still functioned correctly after being cleaned.

No parts contact the patient, this is all non invasive.

Thanks
 
P

PaulGr

#7
Somashekar,
Our test report was just to show that the monitor still functioned correctly after being cleaned.
Thanks
Resistance to cleaning or disinfect agents is only half the story.

I would suggest using your risk management file to estimate the risk on cross contamination through your device. Perhaps the risk is very low, depending on your intended use, use environment, etc. However, if required, define a suitable cleaning / disinfect instruction as a control measure. The effectiveness of this instruction can be tested or you can use comparable studies on other devices as long as materials and geometry are comparable.
 

somashekar

Staff member
Super Moderator
#8
Somashekar,

I am talking about the monitor and what staines have been removed and the efectivness of the cleaning products used.

Our test report was just to show that the monitor still functioned correctly after being cleaned.

No parts contact the patient, this is all non invasive.

Thanks
I would not put monitors as a reusable medical device ~~~
 

Sam Lazzara

Trusted Information Resource
#9
AAMI TIR12 discusses "Noncritical environmental surfaces", which is what I expect a patient monitor would be considered. These are surfaces that usually do not come in contact with patients or, if they do, only with intact skin. Environmental surfaces carry the least risk of infection transmission, but can contribute to secondary cross-contamination by the hands of health care workers or by contact with medical instruments that will subsequently come into contact with patients. There are two subdivisions:
- Medical equipment surfaces
- Housekeeping surfaces (floors, walls, table tops, window sills, etc)

See attached USA CDC guideline for related information. Low-level disinfection is recommended.
Page 11 says this:
Noncritical items are those that come in contact with intact skin but not mucous membranes. Intact skin acts as an effective barrier to most microorganisms; therefore, the sterility of items coming in contact with intact skin is "not critical." In this guideline, noncritical items are divided into noncritical patient care items and noncritical environmental surfaces. Examples of noncritical patient-care items are bedpans, blood pressure cuffs, crutches and computers. In contrast to critical and some semicritical items, most noncritical reusable items may be decontaminated where they are used and do not need to be transported to a central processing area. Virtually no risk has been documented for transmission of infectious agents to patients through noncritical items 37 when they are used as noncritical items and do not contact non-intact skin and/or mucous membranes. Table 1 lists several low-level disinfectants that may be used for noncritical items.
 

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