Decon sciences Flashcards
What is a standard operating procedure
Is the way we standardise our activity within the department and make it reproducible and consistent so all staff can identify the correct process and follow it
What is the role of user
The user is defined as the person designated by mangement to be responsible for the management of a washer disinfector
The principle responsibilities are
-Certify the WD is fit for ise
-Hold all documentation relating to the WD
-ensure that the WD is subject to periodic tests and maintenance
-To appoint operators where required and ensure that they are adequately trained
-Maintain production records
What is the definition of medical device from the Medical Device Regulation
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
— products specifically intended for the cleaning, disinfection or sterilization of devices
etc
In the scottish health technical memoranda (SHTM) what stages are defined as essential
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
If you purchase and operate a WD or Steriliser what must you do
it must be CE (UKCA) marked and comply with the conditions of the MDR 2017/745
The cycle must comply with the requirements outlined within SHTM 01
When sterilising instrumentation, it must comply with SHTM 01
If you are operating a small steam sterilizer (bench top) the standard is BS EN 13060
When installing this equipment and designing a facility the SHPN documentation must be referenced, SHPN 36 Part 2 for surgery design and
SHPN 13 Part 2 for decontamination facilities
What is a medical device
any of the instrumentation used for carrying out procedures on humans
and also covers any of the equipment that we use to re-process this instrumentation,
even down to the software that is used to operate and control equipment
What are your obligations when getting a medical device
You need to verify that any of the equipment you intend on using has gone
through this rigorous process
That provides assurance that no danger to patients will arise from your use of
any of these products
There is a duty under the Consumer Protection Act 1987 whether it be a Sterilizer, AWD or instrumentation
When buying instrumentation what must you check
Procurement of instrumentation should always be
from a reputable company that can prove their
manufacturing is in compliance with the MDR
As well as being CE (UKCA) marked
What is essential in record keeping
to maintain an accurate and detailed record
of the way instrumentation is processed
Records for all the stages in the decontamination process must be created and maintained
The dates on your chemicals and when you started using them
Whats essential to collect from WD’s
Info from each wash stage recorded to create a traceable record:
General
-Date
-Operator
-Cycle Start Time
Cycle Data
-Cycle No.
-Wash Temp.
-Disinfection Temp. & Hold Time
-Cycle Duration
-Was detergent added
-Did machine indicate cycle complete
On a daily basis what info is collected from the first scyle of the day of a WD
Date
Time
Operator
Cycle No.
Disinfection temp
Daily tests performed
Detergent added
Disinfection successful Yes/No
Machine identified cycle completed successfully – Yes/No
For records what is also essential to carry out
parametric release of loads that have been processed
What is meant by parametric release
Parametric release is defined as the release of a batch of sterilized items based on data from the
sterilization process. All parameters within the process have to be met before the batch can be released for use
What daily info should be recorded from the steriliser
Date
Time started
Operator
Cycle No.
Sterilisation temp
Daily tests performed - Yes/No
Bowie & Dick successful -Yes/No
Sterilisation successful - Yes/No
Machine identified cycle completed successfully – Yes/No
What should be carried out on a weekly basis for each piece of equipment
An Automatic Control Test (A.C.T.)
