EFHSS Questions and Answers - Question Q00653

Is there any protocol reagrding the cleaning & sterilisation of re-usable invasive instruments that have a narrow (2mm) lumen. Particularly anything advocating single use instruments as an alternative.

Gary,

in principle there is no general protocol for lumen instruments. Much more each instruments has to be washed and sterilized regarding the instructions of the manufacturer of the device. However, many device manufacturers are giving only general information and describing more the limits of temperature and chemistry concentration, the instruments can be exposed to.
In April the EN/ISO 17664 was released, which described what kind of information has to been given by the manufacturer. If you look for the chapter cleaning, the following information has to be given:

3.5 Cleaning
A validated method of cleaning shall be specified. At least one validated automated method using a washer-disinfector shall also be specified unless the medical device cannot withstand any such process, in which case a warning should be issued.
Where appropriate, at least the following information shall be included:

• accessories required for cleaning process;
• identification and concentration of chemicals required for cleaning;
• identification of water quality,
• limits and monitoring of chemical residues
• limits on temperature, concentration of solution(s), exposure time,
• process temperature(s);
• techniques to be used including rinsing;

A similar definition you find for disinfection and sterilization.

Our experience of more than ten years in our test laboratory show, that the limiting factor for reprocessing is not the diameter of the inner lumen but much more the design of the instrument itself.

We did a lot of testing with ophtalmic instruments. In some instruments the lumen was only 0.2 mm. Some of them were easy to clean, comparable designs by other manufacturer not. We also had trouble with instruments with lumens above 5 mm!!

Our general statement is:
If a manufacturer has validated the cleaning behaviour of his instruments under worst case conditions with a sensitive test method (we are using the radionuclide method) disinfection and sterilization is no problem as long as the WD and steam sterilizer fullfill the requirements of the applicable standards. The specific designs of the instruments have to be validated separately.

Best regards
Klaus Roth