Guidance and Standards

Question 1

What are the steps in the life cycle of an instrument?

Answer 1

(Acquisition)
Cleaning
Decontamination
Inspection (disposal)
Packaging
Sterilisation
Transport
Storage
Use
Transport

Question 2

What is the most up to date SHTM guidance?

Answer 2

SHTM 01 – 01 Part A - D

Question 3

What are all the relevant guidance /standards for decontamination process?

Answer 3

SHTM – Scottish Health Technical Memorandum
SHPN – Scottish Health Planning Note
NP 143 – National Procurement Framework
BS EN – British Standard, European Norm
BSI – British Standards Institute
ISO – International Standards Organisation
MDR – Medical Device Regulation

Question 4

Why are standards important?

Answer 4

Standards define:
Level of quality equipment must be produced to

How equipment is operated

How we test operation

Design/operation of facilities for processing, waste management and infection control

Question 5

What requirements must the cycle of AWD comply with?

Answer 5

SHTM 01 – 01 referencing BS EN 15883

Question 6

What requirements must we comply with when sterilising instrumentation?

Answer 6

SHTM 01 – 01 referencing BS EN 285

Question 7

What documentation must be referenced when installing equipment and designing facility for decontamination?

Answer 7

SHPN

Question 8

What can happen if we fail to adhere to legislation on decontamination?

Answer 8

Criminal charges- especially in cases that involve detriment

GDC prosecution