CSSD processes - Safe by design?

Safe by Design

Allard van Beek National Sales Manager Miele Professional

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Miele’s Worldwide Presence

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Miele’s Worldwide Presence

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“Safe” is subjective?

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Processes CSSD

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.

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Safe by Design

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In a row At the opposite Around a corner

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

Safe By Design

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Save by Design

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Some examples

Manual pre-cleaning

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Some examples

Appearances can be deceptive?

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

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What should staff wear in IAP room?

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

Thank you for your attention!

Thank you for your attention