Buy it Right, Keep it Right Did you ever observe to whom the accidents happen Chance favours only th

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Buy it Right, Keep it RightDid you ever observe
to whom the accidents happen? Chance favours only
the prepared mind.

• In honour of Louis Pasteur

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Did u enjoy your few jars last night !

• The diseases of beer and wine
• Pasteur observed yeast (ferments)under the
  microscope
• Sound beer micros were sperhical
• While sour beer micros were elongated
• This observation confirmed germs caused the
  spoiling of beer/wine/ and milk

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Proof of Pasteur theory
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Anology with wash processes

• Similar to the wash disinfection process
• If ferments our opportunistic micros are excluded
  from an aseptic process
• Then as with sound beer,sound wine then a sound
  medical device fit for purpose
• The chemical act fermentation/disinfection a
  controlled process from start to end
• Pasteur realised the importance of exclusion of
  invisible germs
• Similar by preserving a low environment
  bio-burden maintains the sterility of the process
  

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Compare and contrast GI washer

• The task of the GI system is to
• Physical/chemical breakdown of food
• Food nutrients are digested and aborbed from
  intestines
• Absorbed nutrients are absorbed and circulated in
  body
• waste is eliminated

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Compare ansd contrast MD washer

• The task of MD washer is to
• Physical/chemical brakdown of protein,mucous,etc
• Proteins,debris are digested and removed from
  scope lumens
• Disolved proteins are removed and disinfection is
  circulated in the scope body
• All unwanted waste is rejected and removed

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AER Requirements

• Self disinfection cycle available
• Printer and chart recorders fitted
• Single chamber or double
• Pass through with printout
• Channel patency monitoring.
• Interlocked doors etc. (HTM 01, EN15883 part 4)
• Leak test facility
• Test connections for TP(S) and equipment
• Single shot doses of disinfectant
• Water requirements and standards etc
• How many AERs,how many sessions,haow may
  patients????

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Introduction for HSE COP

• Look at how best to reduce risk of infections
  from the reprocessing of medical devices
  especially Surgical instruments/endoscopes
• Look at what is best practice for procedures on
  cleaning, disinfection, sterilisation of such
  devices
• A healthcare instituution should do everthing to
  prevent spresding of infections within the
  institution

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Bio-burden reduction required by cleaning

• MIs are used in wounds of patients,should have
  no micros or foreign particles
• Left on instruments can cause Sepsis or
  septicimia
• If such a dirt particle enters blood stream
  recovery and morbidity can be effected
• Leaving food(fungi)blood(Hep B) pus (bacteria
  ,gangerine) allows micro to divide and multiply

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Bio-burden reduction required for cleaning

• In Summay
• Remove all visable dust and dirt
• Removal of breeding ground for surviving micros
• Protection against corrosion
• Ensure safe free movement of equipment and
  material
• Thats why we do efficacy tests

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Classification of Critical Medical Device
Are manufacturers Instruction Available
no
Do not process End process
no
Is processing possible based On previous knowledge
Skin or Mucosal Penetration Critical A
Yes
no
Critical medical Device
Is documented Validated Process avaailable
Alternative Method of Re-processing
Yes

• Manufacturer
• Instructions
• Available

no
Non-fixing pre-cleaning After use
Steam Sterilization Possible
Further processing based on QA13485
no
Lumens ,Cannular
LumensLumen
Simple Design
Yes
Alternative Method of Re-processing
Cleaning/Automated Disinfection
MIS Trolley
Yes
Limited No of Cycles
Alternative processes EO,FA,Plasma EN ISO 17664
Wash/Disinfect and Label
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Classifying a medical Device

• All devices placed on the market must meet
• the essential requirements of the legislation
• and not compromise the clinical condition
• and safety of the patient, user or other
• persons

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Classifying a medical device

• Code of Practice states
• Reprocessing units to meet the essential
  requirements of the legislation
• The same standard to be applied to industry and
  healthcare facilities

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Classifying a medical device

• Code of practice sets the standard
• Audits highlight where improvement is required
• Education is crucial
• Management of risk
• Good communication with stakeholders internally
  and externally

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What are Reprocessors

• Sterilizer is classed as a Class11a medical
  device
• Washer Disinfector is classed as a Class11a
  medical device
• Scope Washer is classed as a Class 11a medical
  Device
• Ultrasonic washer is a class 11 medcial device
• Bed pan washer are up for debate but probaly
  Class 11

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Generic Cycle Parameters

• System control
• Leakage test
• Cold pre-rinse
• Washing
• Intermediate rinse
• Disinfection
• Rinse for filtered water (not RO)
• Leakage test

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Ro Filtered System

• Carbon Filter
• Ionise Water
• 5,2,1 micron reduce
• .1 micron final water
• High rejection due to High Conductivity
• Require Potable/main lt 150 msc
• Heat remove NCGS and residual air

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Hope this never happens
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Example of Classifying Medical Device for AER MDD
93/42

• The machine must be installed acording to the
  insatllation (IQ) of the manufacturer
• The machine must be used in combination with
  detergents, disiinfectants, filters recommended
  by Manufacturer
• The instructions in user manual regarding correct
  use and mait must be followed
• Optimal conditions of processing must verify
  disinfectant contact with all parts of the scope
  and channels

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The endoscope requirements are

• Ability to withstand temp 10c to 50c
• Ability for scope channels withstand 1.5bg
• Ability to withstand a pressure leakage of 300
  mbar
• Ability to withstand the detergents
  ,disinfectants used
• Availability of connectors for each of the scope
  channels

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Also the AER should have a cert for

• Declaration for production and final inspection
  of Named product (C0301)
• Cert for systems of cleaning and disinfection of
  mds with internal channels
• Cert for Electromagnetic compatibility
• Cert for IECEE CB test for elctrical sfty
• Cert for technical water supply protection
• Cert for metalurgical compatibility

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Guidelines

• MDA DB2002(05) Decontamination of Endoscopes
  July 2002
• HTM 2030,HSE COP Pt 4
• BSG Guidelines For Decontamination of Equipment
  for Gastrointestinal Endoscopy October 2003
• EN/ISO 15883 part 4 Requirements and Tests for
  WDs Employing Chemical Disinfection for
  Thermo-labile Endoscopes 2005
• NHS Model specification C32 - Automated Endoscope
  Reprocessors for Flexible Endoscopes.

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Whats the Cost of implementing HSE COP

• Labour Costs for in house testing
• Labour Costs for in house user testing
• Labour costs for water sampling
• Labour costs for management of testing
• Labour costs for auditing of testing
• Labour costs for auditing of compliance
• Labour cost to read and understand code of
  pracxtice and standards

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Brief look at other Audits

• Healthcare Commision Report 2008 UK
• 90 of acute hospitals failed to comply FULLY
  with Commisiond Hygen Code
• One in five failed to satify requiremnts of
  decontamination
• From April 2009 CQC will enforce requiremnt of
  CHQ for infection control
• Care Quality Commision can impose conditions and
  fines

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Average Cost of Testing in compliance with HSE
COP Pt 3 (conservative)
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Average Labour Days in compliance with HSE COP Pt
3 (conservative)
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HTM COP Requires from the Supplier

• Itemized list available for user requirements
• The manufacturer consult with the washer
  manufacturer for compatibility.
• Effect on device/scope life?
• Effect on device function ?
• Material compatibility?
• Biocompatibility?
• Cycle validation to insure microbial efficacy

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COP Recommends Centralise

• Centralise for patient safety
• Provide a quality process that is consistent,
  controlled and validated
• Dedicated trained staff
• Improve working environment
• Update equipment
• Cost efficiency

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The Team
Infection Control Microbiologist
Manufacturer of the machines
Health Estates
Authorized Engineer Decomtam
Test Person Clin Eng
The User
Sterile Services/ Endoscopy
Estates /Management Planning Servicing/repair Rout
ine testing
Contractors Testing/building
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The Plan start like this
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The 2nd stage of any centralize Plan
dirty corridor
Staff room
Treatment room
Treatment room
Treatment room
Returns and wash
Patient ward/waiting area
Clean process
Office
Storage
clean corridor
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The plan should develop like this
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Washer Disinfector KPIs for scope release

• Water quantity
• Water quality
• Flow integrity
• Temperature ?
• Detergent Dose
• Disinfectant time
• Disinfectant removal
• Leak test
• Initial validation

• PQ initial requirements
• Testing maintenance
• Printout
• Complete process(between use and re-use)
• Monitoring
• Documentation

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Example of Automatic Control Test
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List of Tests for Washer Disinfector EN15883-4
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Example of AER validation
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Example of AER Validation
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No more of this,without checks and balances
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If ERU what requirements !

• Adjacent to clinical areas
• Centralised and a planned service for different
  users
• Incorporate as part of an existing Cdu,Ldu
• Availability of a approriately sized unit

• Adjacent to clinical endoscopy,theatre
• CSSD is an appropriate facility for ISO 13485
• Ad hoc in clinics and wards,discourage
• 4 CEAS then SHPN 26 would eflect 140 metres
  squared

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Other considerations of ERU

• Access routes between users and reprocessing
  facility
• Tranport requiremnts
• Revenue and capital costs
• Turnarround times
• Istrument inventory
• IT Systems
• Engineering services,water,electricity,drainage,ve
  ntilation

• Personnel required
• Security issues
• Statutory consent)planning permission)
• User/customer base
• Access to clinical unit
• Transfer and storage
• HR issues

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Documentation and Traceability

• Traceability
• Operator at each stage
• Patient ID
• Manual wash
• Detergent used
• Disinfection used and expiration date
• Cycle number
• Scope and accessories
• Loading AER time and date
• Unloading AER time and date
• Dryer loading and unloading
• Issue time and date
• Barcode Label use by date

• Documentation
• Operational Procedures
• Training records
• AER validation and test reports
• Water TVC and chemical reports
• Dryer validation reports
• COSHH file
• Environmental Procedures
• Audit records
• ISO 134852003 standard

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Prepare for your Audit
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Its all about Documents accountability
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You never know who could be the next patient !
Mybe you