SDI Group Regulatory News (SDI)

SCIENTIFIC DIGITAL IMAGING PLC

("SDI" or the "Company") 

Scientific Digital Imaging welcomes further guidance from the UK Department of Health on decontamination of surgical instruments

Scientific Digital Imaging plc (AIM: SDI) the AIM quoted group focused on scientific and technology products for use in applications including life sciences, healthcare, astronomy, consumer manufacturing and art conservation, welcomes the new guidelines from the UK Department of Health (DOH), issued on 8 July 2016, that protein levels on a surgical instrument should be measured directly on the surface rather than by swabbing or other commonly used methods*. Detecting protein levels on surgical instruments is an important means of minimising transmission risk of Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD) in healthcare settings, and the DOH continue to recommend that the upper limit of acceptable protein contamination after processing to be 5µg BSA equivalent per instrument side, with a lower level necessary for neurosurgical instruments.

It is a goal that all healthcare providers engaged in the management and decontamination of surgical instruments used in acute care will be expected to have implemented this guidance by 1 July 2018. However, providers whose instruments are likely to come into contact with higher risk tissues, for example neurological tissue, are expected to give this guidance higher priority and move to in situ protein detection methodologies by 1 July 2017.

Ken Ford, Chairman of SDI commented:

"The Department of Health's new guidance confirms that protein levels on a surgical instrument should be measured directly on the surface rather than by swabbing or other commonly used methods. ProReveal, our highly sensitive fluorescence-based patented protein detection test, is the only marketed product of which we are aware that can adhere to these stringent guidelines. It allows the testing of the whole instrument for protein, rather than just a small, swabbed area, and will be invaluable to the Sterile Services Departments in hospitals throughout the UK and overseas."

ProReveal is a highly sensitive fluorescence-based patented protein detection test for checking the presence of residual protein on surgical instruments after going through a washer disinfector process. This cost-effective test (conforms to BS EN ISO 15883-1) delivers objective, visual and measurable results, removing any doubt as to whether the washing decontamination process has left instruments demonstrably clean. Using the powerful diagnostic tools of ProReveal, users can track the performance of their washer disinfector processes and to see whether there are any changes in trends.

Taking less than 5 minutes to carry out, ProReveal generates results as a visual display of the presence (or absence) of any protein and these results can be documented and archived as proof of process cleanliness. Promoting this alternative detection method has required a re-education process in Sterile Services Departments (SSDs) in hospitals, where the system is most applicable.

* https://www.gov.uk/government/publications/management-and-decontamination-of-surgical-instruments-used-in-acute-care

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About Scientific Digital Imaging plc

About Scientific Digital Imaging plc: Scientific Digital Imaging plc ("SDI") designs and manufactures scientific and technology products for use in applications including life sciences, healthcare, astronomy, consumer manufacturing and art conservation. SDI plans to continue to grow through its own technology advancements as well as strategic, complementary acquisitions.

www.scientificdigitalimaging.com