VALIDATION – ARE WE DOING ENOUGH

David McNamaraManager – CSSDHoly Spirit Northside Private HospitalSRACA (NSW) Conference10th November 2011

VALIDATION - NOT NEW – BUT ARE WE....

• Review & Definitions• What is different• Change in Intention or Interpretation• What do we need to do• When do we need to do it

So what is Validation?

AS/NZS4187, (1.2.63) ‘Validation’

‘Documented procedure for obtaining,

recording and interpreting the results

required to establish that a process will

consistently yield a product complying with

predetermined specifications’.

Definitions

Validation – AS/NZS 4187:2003

Definitions 1.3.63 (page 15)

Documented procedure……

General 7.3.2 (page 46)

… total process of commissioning and performance qualification

Re-Performance Qualification

Physical & Microbiological• Section 7.3.3 (page 48)“Shall demonstrate the attainment of the required sterilizing conditions throughout

the specified sterilizer load(s). This is achieved through verification of physical parameters e.g. through thermocouple testing, and demonstration of microbiological lethality e.g. through the placement of biological/enzymatic indicators. Process challenge devices, if used, shall be in accordance with EN 867-5”

• “each sterilization process and each type of sterilizer load and loading pattern for the process shall be specified and documented”

• “shall be performed on the introduction of new or modified items, packaging/loading patterns, equipment or process parameters unless equivalence, either to validated reference loads or cycles or to a previously validated product, packaging or loading pattern, has been demonstrated”

• “reproducibility within acceptable limits should be checked using a minimum of three consecutive replicate cycles”

Product definition

• Material• Weight• Design• Packaging• Steam Penetration Resistance• The combination of factors • Combination of items

What is Different to Last Year

• Changes in Instrument metallurgy

• Operational - New wash chemicals

• Complexity of Instruments

• Volume of Loan Sets

What is a Challenge to the Sterilizer

• Weight• Silicone type handles with lumen• Laparoscopic insulated sheaths• Complex non-dismountable instruments

ISO 17765-1, section 9.4.1

• “Performance qualification shall demonstrate that product has been exposed to the specified sterilization process by the equipment to be used for routine sterilization”

WHO NEEDS TO REVIEW

Small Clinic to Large Hospital

• Need to determine what is New or Changed (if anything) from last year e.g.• Any external factors • New Drills• Volume of equipment processed• Weight / construction / type• Equipment Design or Layout• Conflicting sterilization documentation!

Conflicting Sterilization Documentation

• New Instrumentation in Loan Sets• Are you notified?

• Always check the manufacturers instructions • Inconsistent with Australian Sterilizing Parameters:

• 132o – 134oC only?• Complex instrument with 3mins sterilizing?• Is Manufacturer’s country of origin sterilizing specifications different

and / or more severe?• Is instrument description inconsistent with what is in your hand

– described as only stainless but has ‘plastic’ handle?• Is it to be dismantled or have specific treatment?

• Specific instructions are not generic for non standard instrumentation

Volume of Equipment

Loan Sets for HCF are increasing in • volume of the amount of trays • Complexity of instrumentation• Turn around time• Lack of documentation

We originally tested for mixed contents

•Move to weight and specific instrumentation

NB: Weights now at > 85kg

Equipment design

• Some designs have been found to require longer processing time

• Some are even marked by supplier “18 minute cycle”

• Lumen instrumentation with silicone handles• TGA listed sterilization instructions different to the

suppliers own on line USA sterilization instructions

RECOMMENDATION

• If unsure Re-Validate• Only one type of wrapped instrument cycle needs

to be validated (3 sequential repeated passes)• Heaviest Loads possible• Include all identified potential difficult instruments

• Insulated laparoscopic sheaths• Silicone (type) handles with lumens

• Ensure Validation Service Providers use appropriate thermocouples and quantity

• Or in other words…(Andy Gay)……………..

• Define your products and ensure that the test load/s represent the greatest challenge to the sterilization process.

• From all of your products you may group your products into one or more product groups/families

• Define the process for each processing group• Conduct performance qualification to demonstrate

the product has been sterilized when exposed to the sterilization process. This may need to be done for each processing group.

• All procedures to be documented.

SUMMARY

• Validation is your time to define limits of sterilizer and maximum contents

• Set to lowest denominator of users (good thing)• Be aware of Manufacturer’s Instructions for new

equipment – looks the same is not necessarily the same

• Discuss with others industry if having similar concerns

• Happy Re-Validating