Introduction
The healthcare system is always in the spotlight and any suspected hygiene scandal is picked up by the media. “Rusty instruments” makes for a catchy headline but the issues involved are complex.
As in many other areas of medicine, medical device (MD) development is experiencing rapid progress. Instrument reprocessing, in particular, requires a high degree of flexibility, expertise and willingness to engage in continuing education and training. Only if these are assured can staff and department heads keep abreast of the constantly fast-paced advancements and resultant regulations.
With regard to patient safety, topics such as MD SURFACE CHANGES AND THEIR REPERCUSSIONS (QM) are among those for which the Reprocessing Unit for Medical Devices (RUMED) is responsible. While there has been widespread knowledge of such issues for several years now and, besides, they are a key aspect of the curriculum of the German Society of Sterile Supply (DGSV), a high number of corroded MDs can still be found is some RUMEDs.
The term “corrosion” is derived from the Latin word corrodere: to gnaw away, erode, break down. These surface changes present a risk to patients, users and third parties. In the medical setting steel, aluminium and synthetic materials are of special interest; this present Recommendation now focuses on medical devices (MDs) made of steel.
What are the risks posed by corrosion?
1. Hygiene repercussions
In principle, medical device reprocessing is associated with risks that can be controlled.
Pursuant to DIN EN ISO 17664 instrument manufacturers are required to ascertain by means of validation which reprocessing methods are able to demonstrate that their MDs can be cleaned, disinfected and/or sterilized in compliance with the requirements/threshold values set out in the standards regulating the respective processes.
The use of validated processes by a RUMED will assure a SUCCESSFUL REPROCESSING OUTCOME. However, reproducibility of the results can only be assured if all surfaces are intact.
Examination of corrosion under a microscope reveals just how difficult it is to assure controlled reprocessing of such an uneven surface, dotted with craters. Furthermore, in the case of pitting corrosion, hidden below the visible pit is an entire cavity where residual soils and microorganisms can persist.
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