decontamination sciences - guidance and legislation Flashcards
medical device
‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
* diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
* diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
* investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
* providing information by means of in vitro examination of specimens derived from the human body, including organ, blood tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
* devices for the control or support of conception;
* products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point
guidance documents for Scotland for sterilisation and washer-disinfectors
SHTM 01 – 01 Part A - D
updated version of the previous guidance documents: SHTM 2010 – Sterilization and SHTM 2030 – Washer-Disinfectors
still reference all the same BS EN standards
where to find guidance documents
the ‘Health Facilities Scotland’ website
SHTM 01-01 part A section 3
Decontamination process applicable to the CDU listed
- 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
These are the specific stages defined within the SHTM that are necessary to subject instrumentation to when processing from dirty to clean after being used for a procedure
where are the specific stages defined that instruments need to go through from being dirty to clean before can be used again
SHTM 01-01 part A section 3
do guidance documents exist for the equipment operation and performation
yes
* info on the way in which our decontamination equipment must operate and descriptions and definitions
* definition of what ‘Cleaning Performance Requirements’ and ‘Disinfection Performance Requirements’ will have to be when operating WD
* time temperature relationship for successful ‘thermal disinfection’ stage
* how to test operation of equipment and frequency to do this
different supporting documentation standards for decontamination
7
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
decontamination standards define
- how our equipment should be produced and to what level of quality,
- how it is operated
- how we test the operation of it,
- how we design and operate facilities for processing,
- waste management
- how to minimise the spread of contaminants and infectious substances
guidance documents tell us how to met these standards
purchasing WD or steriliser
standards and guidance to comply with
it must be CE marked and comply with the conditions of the MDR.
The cycle must comply with the requirements outlined within SHTM 01 – 01 referencing BS EN 15883.
When sterilising instrumentation it must comply with SHTM 01 – 01 referencing BS EN 285
when designing a facility reference
SHPN
Scottish Health Planning Note
failure to comply with directives/standards/guidance
criminal charges can be brought against you,
The GDC actively prosecute individuals that fail to comply
SHTM
scottish health technical memorandum
guidance documents for equipment
SHPN
scottish health planning note
design facility
NP 143
national procurement framework
getting equipment
BS EN
british standard, european norm
standards set, guidance notes availale to meet these (SHTM)
