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The story behind the development of new Process Challenge Devices for evaluation of cleaning efficacy
Pawel de Sternberg Stojalowski MSc, BSc, MBA, Pierre Bonnin PhD, Chanel Cooper
Harry Gray, owner of Avondale Surgical UK, discusses the single use instrument market and discovers that there's no substitute for quality over quantity.
With the levels of vCJD (Creutzfeldt-Jakob Disease) now estimated at 1-2 in a million1 in the US and 1 in 2000 in the UK2, efficient removal of protein from surgical instruments is critical to preventing vCJD and other post-operative iatrogenic infections. Surgical instruments are generally decontaminated by washing and then by thermal disinfection. However, if the soil and protein have not been removed by the wash process cycles, the thermal disinfection cycle will bake the soil onto the surface of the instrument. It is therefore vital for staff in Sterile Processing Departments (SPDs) to be able to visualize contaminants on instruments or soil tests to check that these have been totally removed for proper cleaning and high-level disinfection.
The following article appeared in the May 2016 edition of Clinical Services Journal.
As debate continues over the potential risks posed by prion diseases, the Department of Health has highlighted the importance of aiming for lower levels of protein contamination on surgical instruments. Strategies to improve protein detection and enhance patient safety were discussed at a recent conference, hosted by the National Performance Advisory Group.
This paper appeared in the February-April 2014 issue of Medical Device Decontamination
At a one-day seminar, hosted by the Getinge Academy, delegates learned how to improve decontamination performance, through a better understanding of detergents and their role in effective reprocessing of medical devices. Louise Frampton reports - (see pages 38-40)
New techniques in protein detection make it possible to set limits on protein contamination on surgical instruments. In the future, there may be national or local targets on permissible protein residues, but just how much improvement can be reasonably achieved in reducing protein-related infection risk? Louise Frampton reports.
New Department of Health (England) Choice Framework for Local Policies and Procedures guidance (CFPP 0101) still states that ninhydrin can be used to check for efficient protein removal from surgical instruments processed in sterile services departments (SSDs).
With the potential transfer of variant Creutzfeldt–Jakob disease (vCJD) via surgical procedures it is necessary to re-evaluate recommended methods for protein detection.
This paper reports studies on the sensitivity and applicability of ninhydrin for detecting proteins in laboratories and SSDs. The efficiency of protein removal by swabbing was also evaluated.
Ninhydrin showed poor sensitivity toward proteins. Limits of detection for bovine serum albumin (BSA) in solution were 205 μg/mL compared with arginine 6 μg/mL. A commercial kit could detect neither rat brain homogenate nor BSA at <1000 μg protein pipetted directly into the vials. Swabbing with water-wetted rayon swabs was inefficient at removing protein (50 μg) from instruments (N = 6) with 32 ± 4% BSA and 61 ± 5% fibrinogen remaining bound. Swabs dipped in 0.5% detergent (Triton X-100) solution had slightly better removal efficiency with 20 ± 3% BSA and 24 ± 2.8% fibrinogen remaining.
Ninhydrin kits, currently used in SSDs, are ineffective at detecting residual proteins due not only to the insensitivity of ninhydrin towards proteins but also to the poor desorption of adhered proteins by swabbing. Overall ninhydrin, either as a laboratory reagent or as supplied in protein detection kits, does not provide sensitive detection of proteins and generates high numbers of false negatives when used in decontamination practices.
At the recent Institute of Decontamination Sciences annual conference, the problematic issue of protein detection and removal was high on the agenda.
ProReveal sensitive in-situ fluorescence protein detection test - benefits patients by helping locate protein contamination on surgical instruments
A new report suggests doctors across the US are using surgical tools contaminated with blood and other debris and because the FDA doesn't require hospitals to report it, many incidents are unknown. NBC's chief medical editor Dr Nancy Snyderman reports.
Prions, transmissible agents that cause Creutzfeldt-Jakob disease (CJD) and other prion diseases, are known to resist conventional sterilization procedures. Latrogenic transmission of classical CJD via neurosurgical instruments is well documented and the involvement of lymphoreticular tissues in variant CJD (vCJD), together with the unknown population prevalence of asymptomatic vCJD infection, has led to concerns about transmission from a wide range of surgical procedures.