G.L.&.S GUIDANCE LEGISLATION AND STANDARDS Flashcards

1
Q

what is SHTM 01 - 01

A

SHTM 01 – 01 Decontamination of medical devices in a Central Decontamination Unit

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2
Q

what are parts of SHTM 01-01?

A

Part A – Management
Part B – Test equipment/methods
Part C – Sterilization by steam
Part D – Automated cleaning and disinfection equipment
Part E – Sterilization by hydrogen peroxide and ethylene oxide
Part F – Inspect, assemble and package

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3
Q

what is SHTM 01-05

A

Management, equipment and process of the
decontamination of dental instruments in a Local Decontamination Unit (LDU) in NHS Scotland.

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4
Q

what parts are SHTM 01 -05

A

Part A – Management
Part B – Decontamination equipment – operation, validation, periodic testing, maintenance and test methods
Part C – Process - Guidance on decontamination processes, including elements applicable to the dental environment.

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5
Q

what stages are applicable to SHTM 01 -01 part A section 3

A
  • Preparation prior to Washer-Disinfector
  • Cleaning – Manual and Ultrasonic
  • Cleaning and Disinfection in WD
  • Drying
  • Inspection, maintenance and functionality testing
  • Assembly
  • Packaging
  • Sterilisation
  • Storage
  • Transportation
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6
Q

what are 5 stages of washer disinfector?

A
  • pre wash
  • wash
  • rinse
  • disinfection
  • drying
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7
Q

what is exposure time and disinfection temp band for stage of thermal disinfection?

A
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8
Q

what do you refer to when manaing sterile medical devices within a CDU

A

SHPN 13 Part 1

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9
Q

what does a room data sheet require in terms of storage?

A

assessment by design team of storage requirement for each room

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10
Q

If you purchase and operate a WD or Steriliser, it must be CE (UKCA) marked and comply with the conditions of what?

A

MDR 2017/745

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11
Q

what must cycle comply with? and reference?

A

SHTM 01 – 01 referencing BS EN 15883

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12
Q

what is standard for operating a small steam steriliser (bench top)?

A

BS EN 13060

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13
Q

when installing equipment and designing a facility what must be referenced?

A

SHPN 36 Part 2 for surgery design
SHPN 13 Part 2 for decontamination facilities

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