1) Variously known as decontamination units, CSSDs, HSDUs, SDUs, SSDs, SSDUs, SPDs, and/or SPUs, does your Trust have an in-house sterile services facility / department?
Yes
If no, please indicate this (return e-mail acceptable), and thank you for your time. No further answers are required. N/A
If yes, please support with the following:
2) What instrument tracking system does the sterile service use?
TRISOFT
3) What accreditation, if any, does the facility hold?
BS EN ISO 13485:2016 Medical Devices Regulations 2002 (as amended) (UK MDR 2002), Part II using MDR Regulation 14 as our route to compliance.
4) Does the facility process / resupply single “supplementary items or devices” to customers/clinical users?
Yes
5) If the facility supports/handles/supplies supplementary items, how is it defining them?
Using Tracking system with etching/matrix dot
6) Looking at the following options, which of the following methods are used by sterile services for the individual tracking and traceability of supplementary / single surgical instruments? 1D / traditional barcode on a traceability tag, supplied with the instrument, and returned by the clinical user
2D / QR-style barcode on a traceability tag, supplied with the instrument, and returned by the clinical user
Coloured instrument tape applied to the device to indicate the owner / destination
KeyDot or similar system which sticks a QR-like code on to the device
Laser Marking of the device, with a 2D/ QR-style code
Laser Marking of the device, with a 1D / traditional barcode
Laser Marking with a name, number or other human-readable text
Other (please specify)
7) Does the instrument tracking system fully-integrate with their chosen single-instrument tracking approach, or does it require third-party software, hardware or other systems to function?
Fully- integrated
