safe by design - iceberg...
TRANSCRIPT
CSSD processes - Safe by design?
Safe by Design
Allard van Beek National Sales Manager Miele Professional
Management of decontamination processes.
Location for decontamination activities.
Activity at each location.
Facilities and equipment at each location.
Validation, testing and maintenance of equipment.
Policies and procedures.
Training of personnel.
Every step and phase needs to be controlled and monitored
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Relevant to all stages of reprocessing
Standard Operating Procedures (SOP)
Equipment
Processing medical devices
Staff
Hygiene codes
Dress code for individual working areas
Ongoing training and education
Working and public areas
Segregation of working areas
Controlled interior and exterior access to all areas
Cleaning and monitoring protocols
Medical devices
Reprocessing Instructions For Use (IFU), current and new MD.
Maintenance and validation
Equipment, building, facilities (steam, air and water) 7
Policies and procedures
Equipment and Medical Devices
Dedicated equipment for safe and effective reprocessing ISO 17664 (Information to be provided by the manufacturer of MD)
ISO EN 15883 (Washer Disinfectors)
EN 285 (Steam sterilizers)
EN-ISO 17665 (Validation of sterilizers)
EN-ISO 11607 (sterile barrier systems)
Correct use of equipment following the manufactures instructions
AKI- “Red Brochure” for references, proper procedures and identification.
Staff
Dress codes for individual areas
Restricted access to individual areas
Quality management systems
ISO 9001
ISO 13485 Specific to Medical devices - Requirements for regulatory purposes
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Standard Operating Procedures
Is there a standard for the qualification and monitoring of work areas and
procedures within the CSSD?
World wide many different ways of interpreting:
Single door or pass through equipment
How does that effect the room qualifications?
Manual pre-cleaning of MD’s
extensive or minimal?
Could have a direct effect on the required space and size of the room and staff capacity
Parametric release of all processes or the use of in process controls of every cycle (
like BI’s or process challenging devices)
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Good Decontaminating Practice
Physical segregation
Wash area
Inspection, Assembly and Packing room (IAP room)
Is this a clean room?
Steriliser unloading area
Is this a “sterile” area?
Collection and storage of raw materials
Loan instruments
Consumables
Waste disposal
Normal waste, Contaminated waste, laundry
Access to areas restricted?
What are the protocols?
Cleaning and monitoring
Frequency and method used 10
Individual working areas
This would mean a lower pressure in the wash area and sterilizer unloading area
(when pass through sterilisers are used)
The wash room should be at negative pressure
But there is no evidence that a Class 8 clean-room environment is the minimum
demand for the IAP room.
And there is no evidence or research that justifies the qualification of the
unloading side of the sterilisers.
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Health Building Note 13 (NHS Estates, 2004)
3.23 The IAP room is a Class 8 clean-room as defined in BS EN ISO 14644. It
should have a nominal 20 air changes per hour with a pressure differential of
not less than 10 Pa between it and adjoining rooms. Pressure differential
indicators, visible from outside the IAP room, should be provided to enable the
pressure differential to be routinely monitored.
Fresh water machine
New water every cycle: optimal hygiene
Large variety of crockery
Full process including precleaning and
drying
Best option < 40 processes a day
Tank washer
Tank: uses same water various cycles
No variety of crockery
Pre cleaning and drying outside machine
Best option > 40 processes a day
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Choose the right solution
Besides clean and sterile they also need to be functional and safe:
In this example that means no damage to the insulation of the shaft
Extensive function tests in IAP room
This requires suitable test devices and protocols to perform testing
Medical devices can and are complex in function and design.
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Patient safety through GDP
The CSSD has evolved into a High-Tech professional working environment within the hospital
Logistics and clear procedures are an important component to assure patient safety
The CSSD reprocesses for millions of dollars of medical devices a year and must be seen as
an invaluable production unit within the hospital setting. Maybe even at the same level as a
pharmacy department.
A safe by design approach can save excessive costs
Achieving and maintaining the right quality of production areas, equipment, water supply and
training & education is essential for the safety of the staff, the medical devices and the
patients.
Always be critical and apply common sense
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In summary