Decon Lecture 2 - Guidance Legislation and Standards Flashcards
what is a medial device
any instrument or other article intended by the manufacturer to be used, alone or in combination for human beings for
- diagnosing, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
what are guidance documents
used to provide structure or framework that can be followed and implemented in practice - providing templates and information on standardised processes
what is legislation
statutory acts and regulations released by the government to provide a legal framework for managing facilities, equipment and process
what is the definition of standards
documents used to provide technical information about all aspects of decontamination process and materials and equipment used
what guidance documents are used for decontamination design, installation and operation
SHTM 01 - scottish health technical memoranda
what are the 5 distinct stages of a WD
pre-wash
wash
rinse
disinfection
drying
how long must the WD stay at 90-95 degrees for - which is the temperature acceptable for thermal disinfection
1 minute
name the daily test for WD
check spray arm for rotations
check spray nozzles for blockage
remove and clean strainers
ensure sufficient additives
automatic control test
check seals
process challenge device tests
what is involved in weekly tests for WD
daily checks
water hardness
water conductivity in final rinse stage
cleaning efficacy test by residual soil detection
what tests are carried out in quarterly testing
daily and weekly safety checks
thermometric tests
cleaning efficacy tests
doors and interlock testing
chemical dosage check
what guidance documents give information about the storage of sterile instruments
SHPN (scottish health planning note) 13
what documentation is referenced when designing a facility and installing decontamination equipment
SHPN
what guidance is used to regulate cycle requirements and sterilisation requirements
SHTM
