DECONTAMINATION
Device decontamination and wipecompatibility
Karen Wares, deputy clinical director, GAMA Healthcare, comments on the importance of medical device and wipe compatibility, and offers some guidance on selection.
Medical devices1,2 are defined as any
instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, intended by the manufacturer to be used on human beings for the purpose of: l Diagnosis, prevention, monitoring, treatment or alleviation of disease.
l Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability.
l Investigation, replacement or modification of the anatomy or physiological process. l Control of conception.
Medical devices have contributed to advances in medicine and surgical technology, enhanced patient care and improved patient outcomes. However, they can pose a healthcare-associated infection (HCAI) transmission risk if not adequately decontaminated.3
How do you select the correct decontamination procedure?
The UK Microbiology Advisory Committee (MAC) manual notes that all medical devices and equipment may become contaminated with biological material, presenting a HCAI risk. The choice of decontamination procedure will depend on the infection risk associated with contact (both frequency and type of contact) with the item in question and the class of micro-organism likely to have contaminated the surfaces (See Table 1). The Spaulding Clas sification (Table 1) has been adopted by the MAC manual and indicates a level of risk associated with categories of equipment. The risk associated with improperly cleaned, disinfected, or sterilised reusable medical devices is high and they are a critical cause of HCAI.3,5
Cleaning is
a process which physically removes infectious agents and organic matter. Disinfection reduces the number of viable micro-organisms to a safe level, while some infectious agents such as spores remain active.1
Historically UK guidance recommends the
use of detergent for the cleaning of low risk environmental surfaces and a disinfectant solution of 10,000ppm available chlorine for surfaces contaminated with blood and body fluids.1
There is ongoing debate both for and against detergent and disinfectant use in healthcare.6-8
However, an inherent
consideration of all disinfection strategies is the elimination of antibiotic resistant microbial population.
A range of disinfectants are available, either as single substance products or in combination. Combination products minimise the risk of resistant organism survival as multiple mechanisms are used. Disinfectant choice will depend on intended efficacy; if the spores of C. difficile are the target, a product with proven sporicidal activity should be used. Suboptimal use can result in transference of micro-organisms to clean surfaces.9-12
It is
essential to ensure that any product used for cleaning and disinfecting medical devices is compatible with the device.
56 I
WWW.CLINICALSERVICESJOURNAL.COM The MHRA has issued an alert MDA/2010/00113 indicating that failure to
follow the device manufacturer’s decontamination instructions may be considered off-label use; only products recommended by the manufacturer and supplied by employers should be used. The use of hazardous products should be assessed in accordance with Control of Substances Hazardous to Health (COSHH) regulations.3,14
The importance of medical device and wipe compatibility
The MHRA issued another medical device alert (MDA/2013/019)15
which identified that
through a lack of compatibility, damage had occurred to tympanic thermometers, patient monitors, infusion pumps, dialysis fluid filters, peritoneal dialysis transfer sets and infant warmers. This alert highlighted that detergent and disinfectant wipes can damage the plastic surfaces of medical devices if they
MARCH 2017
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