ProReveal protein detection system complies with latest standards
The ProReveal is currently the only Protein Detection System that complies with the new protein detection requirements of the new HTM01:01.
Development of the ProReveal
ProReveal was developed with Queen Mary University of London helped by Professor David Perrett, and has been designed as a more effective method of ensuring the cleanliness of reprocessed surgical instruments. The UK Department of Health updated the HTM01:01 guidelines in July 2016.
The guidelines now state a quantitative method of measuring the residual protein present after the washing process. ProReveal can detect a single spot of residual protein as low as 50ng and shows where protein is located on the surface of a surgical instrument and how much.
The high risk, neurosurgical units were required to comply by July 2017, and the rest by July 2018. Now that the ProReveal is compliant, potential customers can be reassured that the ProReveal will fully meet their Protein detection requirements.
Extract from the updated HTM01:01
SSDs should no longer rely on elution or swabbing to detect residual protein on an instrument. The method should be validated as being able to detect protein equivalent to ≤5 μg of BSA in situ on the surface of an instrument. Commercial technologies that can detect the 5 μg limit in situ are being developed (see ACDP- TSE’s Annex C). Methods that do not have protein as their target, such as ATP assays, cannot be used as a substitute for residual protein detection.
Devices to detect residual protein must be CE-marked as an accessory to a medical device (see the MHRA’s – Managing medical devices: guidance for healthcare and social services organisations’ and also ‘Medical devices: conformity assessment and the CE mark’).
ProReveal Adopters in the UK
º Ten Sterile Services Departments in the NHS
º A Regional Health Board
º A University
º An Orthopaedic Instrument Manufacturer
º Two Cleaning Chemical Suppliers
º A Commercial Laboratory
º A Single use instrument manufacturer
º An Ultrasonic washer manufacturer
Projects that have used ProReveal technology
º Washer Disinfector optimisation Development of a new Ultrasonic washer
º Surgical Instrument non-stick coatings
º Single use instrument cleaning validation
º Keeping instruments moist studies
For each test result the ProReveal creates a 3D image. You can zoom in to specific areas on a surgical instrument and the image can be turned for the best angle.
The customised image can then be saved as a JPEG image file on a USB stick or external drive or network location.
Registered with the MHRA
The ProReveal fluorescence protein detection test system has been registered with the MHRA as an accessory to a medical device, and now conforms to the latest HTM-01-01 changes introduced in July 2016.
Link the ProReveal to your SSD Track & Traceability System
As each measurement is made, ProReveal can save a second copy to an external drive or network location, perhaps for use by other hospital data systems. It can also generate a formatted report (CSV, TEXT, XML, PDF) or a single image file (PNG, JPEG, TIFF, BMP) for each new measurement to an external drive or network location.
Determining the baseline and ongoing monitoring
The stored measurement data can now be analysed using the monitor history graph, revealing anomalies and trends in the data which may be compared against details of the wash process entered by the operator as above.
ProReveal accessories under development
We are finalising the development of a PCD (Process Challenge Device) and a surrogate testing device for testing the channels of flexible endoscopes.
To find out more, please telephone Matthew Peskett at Peskett Solutions Ltd on 01323 511038 or email firstname.lastname@example.org