decontamination and sterilization, hugh oconnor.pdf

Hugh O'Connor AP 1

Decontamination Puzzle in CSSD/HSSU/CDU/LDU

Validation of Sterilsation processes !

Hugh O'Connor AP 2

The Documentation and Process Testing in the Hospital Setting

Plant centralised

Managers office

Tracability system

Humidity controller

Ergonomic Enginering Fire Exit

Enginers Workshop

Data logger

Extra Long Chamber BBS Sterilizer

Hugh O'Connor AP 3

CSSD IAP(Clean)Room

Hugh O'Connor AP 4

Decontamination

Decontamination is a process which removes or destroys

contamination and thereby

prevents micro-organisms or other contaminants reaching a susceptible

site in sufficient quantities to initiate infection or any other harmful

response.

A multitude of different processes are available for decontamination.

Choice of the

appropriate procedure for a given situation demands an understanding

of the processes available, the level of decontamination required and

the manufacturers instructions for decontamination.

Having determined the level of decontamination required, this should

be achieved by a method that combines reliability, cost effectiveness

and the minimum of hazard to the user.

Hugh O'Connor AP 5

Decontamination Testing

Sterilization/Disinfection is a process whose efficacy cannot be verified retrospectively by inspection or testing of the product.

For this reason Sterilization/Disinfection have to be validated before use.

The performance of the process must be routinely monitored and the equipment maintained.

Hugh O'Connor AP 6

The Philosophy of Testing

Three main principles

All sterilizers/washers are monitored to a planned programme of tests

All sterilizers/washers are subject to a planned program of PM

Expertise on all aspects of the testing should be available at three levels

1. Competent Management

2. Competent Users

3. Competent Test People

Hugh O'Connor AP 7

Situtation Prior to standards

Myriad of small benchtops

No automated Washers

No standardised testing or auditing

No documentation process

No auditing/Validation process

No dedicated facilities for decontam

No ongoing education process

Hugh O'Connor AP 8

Introduction of HSE/EN standards

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 institution should do everthing to prevent spreading of infections within the institution reason for manged CSSD.

Hugh O'Connor AP 9

Pilot review example

Introduction.

The pilot review was part of the process for implementing the HSE Code of Practice for Decontamination of Reusable Invasive Medical Devices Part 5b. The code is based on EU standards, directives and other international standards for decontamination of RIMD and health and safety legislation and covers recommended practices for decontamination in a local decontamination unit (LDU).

Hugh O'Connor AP 10

The Structure of the Pilot Review

Time taken to review each location.

Problems with questionnaire.

Information on water quality in each location.

Status and type of autoclave present.

Design and dimensions of relevant rooms. Record keeping.

Tracing systems.

Presence of clean and dirty areas.

Evidence of no validation, servicing of equipment

Hugh O'Connor AP 11

Some anomalies found in study

Hugh O'Connor AP 12

Findings of the Pilot Review

Hugh O'Connor AP 13

Findings of the Pilot Review

Hugh O'Connor AP 14

Positive Findings Pilot Review

Hugh O'Connor AP 15


Hugh O'Connor AP 16


Hugh O'Connor AP 17

Recommendations Pilot Review

Sign off on final version of Part 5b of code of practice.

Upgrade or centralisation.

Full national review of dental surgeries.

Estimate of cost of upgrading HSE dental surgeries up to the HSE Code of Practice.

Develop timetable for upgrading.

Funding issue.

Hugh O'Connor AP 18

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 practice and standards

Hugh O'Connor AP 19

Brief Look at Other Audits

Healthcare Commission Report 2008 UK.

90 % of acute hospitals failed to comply FULLY with Commision Hygene Code.

One in five failed to satify requirements of decontamination.

From April 2009 CQC will enforce requirement of CHQ for infection control.

Care Quality Commission can impose conditions and fines.

Hugh O'Connor AP 20

COP Recommends Centralisation

Centralise for patient safety

Provide a quality process that is consistent, controlled and validated.

Dedicated trained staff.

Improve working environment.

Update equipment.

Cost efficiency.

Hugh O'Connor AP 21

Some Advantages for User of CLDU !

Reduce high cost of decontamination operations.

Checking of water quality and storage tanks.

Costly disposal of empty distilled water bottles.

Savings on multiple site validation.

Savings on multiple service costs.

Centralisation of tracability.

Release staff from low productivity tasks.

Free staff to attend prohylactic treatments.

Hugh O'Connor AP 22

The Plan for CLDU may start like this

Hugh O'Connor AP 23

The Future CDU Department

Returns and

wash

Clean

process

Storage

Treatment

room

Treatment

room

Office

Treatment

room

clean corridor

dirty corridor

Patient

ward/waiting

area

Staff room

Sterilizers

Hugh O'Connor AP 24

Best Practice - CSSD

Hugh O'Connor AP 25

Area of Focus

Wash Room

Steriliser Loading Area

Steriliser Plant Room

Machinery and Equipment

Hugh O'Connor AP 26

How A Wash Room Should Look

Hugh O'Connor AP 27

Wash Room Aseptics

314 stainless inspection and dis-assembly tables

Negative AHU ventilation

White-rocked or similar environment

No access to IAP

Pass through hatch

Hugh O'Connor AP 28

Cart Wash (to solve MRSA ?)

Hugh O'Connor AP 29

Decontamination Services in LDU/CSSD

Dirty in/Clean out environment

Separation of Processes Environmental testing and control ACs WDs validated and tested to EN,COP 5 Reverse Osmosis water quality Designated decontamination staff Competency assessed training Computerised barcode traceability Documented ISO quality management system

Regular audit

Hugh O'Connor AP 30

The Team from COPS Infection

Control &

Microbiologist

Estates

Management

Planning

Servicing/repair

Routine testing

Manufacturer of

the ACs,WDs

Sterile Services

Authorized

Person/similar

Contractors

Testing/building

Test

Person

(Sterilizers)

Health Estates

The User

Hugh O'Connor AP 31

The Ideal Sterilization/Disnfection Process

Effective against all infective agents

Sterilant/Disinfectant and its residues non-toxic,bio-degradable

Not inactivating by soiling,protein,etc

Highly penetrative

Rapid in action

Cheap to install and operate

Hugh O'Connor AP 32

The Ideal Sterilization/Disinfectant Process

Requires no training, technical knowledge

No environmental or bio hazard

Can be continuously and independently monitored

Causes no damage to any of the products

Acceptable to National/European, International regulations

Hugh O'Connor AP 33

Critical Steps in the Reprocessing Process

Before any automated or manual disinfection or sterilisation procedures the critical steps to be followed are.

1. Clean the instruments manually, meticulously removing all organic material in or on the surgical instruments/endoscope.

2. Rinse all parts and lumens throughly with copious amounts of water and dry them before placing the scope in the reprocessing unit.

Hugh O'Connor AP 34


4. The drying process here avoids dilution of the disinfectant concentration or interaction between the water and the sterilant/disinfectant.

5. Follow the manufacturers direction for reprocessing that specific brand and model of instruments. (Ensure endoscope can be reprocessed in automated manner not all can.)

6. If in doubt about capability of washer to reprocess particular models or brands of surgical instruments check with manufacturer to establish if these have been tested on the particular machine.

Hugh O'Connor AP 35


Regardless of whether you manually reprocess or use automated processes, incorporate a final drying step in your reprocessing protocol, flush all channels with alcohol/Hot Air followed by purging of channels with air to remove alcohol.

Hugh O'Connor AP 36


8. Visual inspection of the reprocessing procedure and reprocessed surgical instruments can identify conditions that may affect cleaning and disinfection processes.

9. Keep records of the use of each instrument /endoscope, showing the patient upon which it was last used, the type of procedure and the reprocessing method and unit used.

Hugh O'Connor AP 37


10. Regular review of training given to reprocessing staff, including additional staff training and supervised practice each time a new instrument model is introduced into the facility.(PQ)

11. Independent audits by an Authorised Person to verify compliance with procedures and processes.

Hugh O'Connor AP 38

First StepValidate the Washer/Disinfector

Mop available

Detergent available

Temp of water

Method to change water

Method to change mop

Check efficacy

Hugh O'Connor AP 39

Post Design, Wash Room example

Hugh O'Connor AP 40

How the Washer Works

s

t

a

n

d

b

standby

Initial wash

Hugh O'Connor AP 41

How the Washer works

Print to Cleanroom

Instruments Dry

If not clean not washed

Test with Ninhyrdin

Check for water spotting

Check all critical Parameters

Hugh O'Connor AP 42

Ao Lethality with Thermal Washers

Standard EN DIN ISO15 883-1, Annex a

Moist predicatable lethal effect on micros

WD must guarantee moist effect on micro

All inner outer surfaces on RMD are wet

Furniture and wall of WD reach temp

Ao is the equivilent time in seconds@80c

D value is the time to reduce micro count to 10%.the Z value temp to reduce D 90%

Hugh O'Connor AP 43

Bio-burden reduction required for cleaning

Water is the solvent and carrier in which soil is going to disolved,suspended and transported, away from the items to be washed. It provides the environment in which all cleaning actions take place

Mechanical action such as wiping,brushing,spraying water under pressure or ultrasonic waves

Chemical action,detergent+water used to soak and suspend germs,dirt,also kill and protect

Heat improves the diluting power of the water and detergent in order to prevent the coagulation of tissues and blood

Hugh O'Connor AP 44


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

Hugh O'Connor AP 45


In Summary

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

Hugh O'Connor AP 46


Washing bioburden lesser challenge

Process is checked with 5,5,5 process

1. 5 kinds of micros

2. In 5 minutes

3. With a factor of 10 to the 5(100,000)

In otherword after process 5 mins the no of survivors of 5 kinds of micros is 1/100,000 of the original no 1 million then 10 (bacilus subtillus)

Hugh O'Connor AP 47


Fibrin layer leftover

Simulates blood film

Not clean not sterile

All instruments suspect

Quarintine loads

Call HELP Engineer required

Hugh O'Connor AP 48

Efficacy Study - Pre Wash

Before machine washing.

Orthophedic intruments pr soiled.

Tosi and Brownes test soil.

Hugh O'Connor AP 49

Cleaning Eefficacy tests on WDs

Tosi 95% water soluble proteins + 5% water insoluble fibrin.

Marginal Fail blood+fibrin remain.

Absolute fail with some washers and detergent.

Pass, acceptable with at 67 mins of main wash.

Hugh O'Connor AP 50

Efficacy Study - Post Wash

Visual cleaned

Ninhydrin test

Washing must remove all visible evidence of soiling

All washer must be subjected to performance tests

Hugh O'Connor AP 51

Closer Visual Inspection after Manual Process .

Hugh O'Connor AP 52

Closer Visual Inspection after Automatic Washer Disinfection process !

Hugh O'Connor AP 53

Conclusion from Study

Disinfection kills or removes most parhogenic microorganisms

Washer with validated performance will achieve expected efficacy

If washing fails then Not clean Not sterile

Hugh O'Connor AP 54

Washer at 5th Gear

Hugh O'Connor AP 55

Ao Letahlity for WDS

Disinfection at bacteria,fungi,mycobateria, heat sensitive viruses.

Ao value 600 is defined or 600 s=10@80

The Ao 600 can be achieved 90 c@1 min

Heat resistant viruses Hep B need Ao 3000

Need hold time of 90 c for 10 min

Does not eliminate impeccable cleaning of MD which is precondition for Disinfection

Hugh O'Connor AP 56

Reduction in number of Live Spores in WD

Temperature T in C

Ao in Seconds Ao in mins

70 6000 100.00

75 1897 25.00

80 600 10.00

85 190 3.16

90 60 1.00

90 Ao (3000) 25 minutes

Hugh O'Connor AP 57

A o Trace of 3000 @ 93 c

Hugh O'Connor AP 58

Washer Disinfectors Issues

Oprator Safety (door interlocks)

Consistent Cleaning Effect (Tosi clean)

High Temp Wash Stage >= 90c@1 min

Consistent Detergent solution

Predetermined wash stages

Cycle will include drying stage

Independent monitoring of critical events

Hugh O'Connor AP 59

Water Quality

The water supply may be hard ,it may contain environmental mycobacterium

Mycobacterium chelonae,pseudomonas,

and other Gram negative bacilli may contaminate the instrument.

Sterile water ids recommended for the final rinsing off all types of endoscopes.

Hugh O'Connor AP 60

Decisions on Water?

Two options to obtain a supply of water of suitable microbial quality.

1. The use of pre-sterilized (pyrogen free) bottled water for stand alone machines

2. The use of pre-treated pyrogen free water connected to mains machines

The type of pre-treatment is determined by an audit of the supply water.

Hugh O'Connor AP 61

Reversed Osmosis Filtered System for clean water and clean steam!

Carbon Filter

Ionise Water

5,2,1 micron reduce

.1 micron final water

High rejection due to High Conductivity

Require Potable/main < 150 msc

Heat remove NCGS and residual air

Hugh O'Connor AP 62

Water Supply Factors

The effect of the installation of any water treatment device on these parameters

The location of the water treatment device

(Note: failure to perform routine maintenance can undermine the effectiveness of the washer/water supply)

Hugh O'Connor AP 63

List of Tests for Washer Disinfector EN15883

Test

Daily/weekly Quarterly/Bi-Annual Annual

Efficacy

Temperature

Safety Tests

Verification on instruments

Clean strainers

Chemical Purity

Chemical Dosing

Final Rinse BI Test

Hugh O'Connor AP 64

How a Sterilizer Works !

Hugh O'Connor AP 65

Some of the Maths of Sterilization

Hugh O'Connor AP 66

Reduction in number of Live Spores in D values at 121 c

Spores of D 121 c (minutes) Z- value

Clostridium Botulinum

0.204 10

Clostridium sporogenes

0.81.4 13

Bacillus steramoph

2.0 6

Bacillus subtilis o.4 10

IM0 2.5 18.6

Gravity Displacement Autoclave

Arrange load inside the chamber and insert the temperature probe Close door Open steam valve Steam enters the chamber Air and condensate pushed through the drain Temperature in chamber increases When load temperature reaches required sterilization temperature the timing starts When hold time is complete the steam valve is closed Autoclave is allowed to cool until temperature

Hugh O'Connor AP 68

Steriliser Loading Area

Hugh O'Connor AP 69


A steam sterilizer uses steam as a carrier of thermal energy or heat Latent Heat,enthalpy

The steam softens the outer layer of the micros which permits the thermal energy or heat to enter the organism and come in contact with the proteins in the organism

Heating the proteins causes changes in the in the nature of the proteins which is called Denaturing,Coagulation or poaching of proteins.

Hugh O'Connor AP 70


Just as an egg white changes from liquid to solid when heated.

The proteins in side the cells also change when heated (the cytoplasm membrane rendering the cell no longer viable)

Firstly the proteins do their job feeding , programming the cells essential functions.

Now the thermal energy disrupts these essential functions and ZAPS the reproduction nature of the programming.

Hugh O'Connor AP 71


Sterilization with steam depends on properly elevated Saturated Steam at a sufficient time and temperature

90%95% dryness factor

Sterilization of steam depends on properly elevated Temp,sufficent moisture and sufficient time.

Just as it takes three mins to boil an egg then in cooking and sterilization the higher the compatible temperature the faster the task is completed

Hugh O'Connor AP 72


The critical factor in the destruction of microorganisms is the relationship between

Temperature 134 c too 137 c

Pressure 2.12 bar gauge

Time of exposure 3 minutes too 3.5

Hugh O'Connor AP 73


Air Removal by Vacuum pump that draws air out while injecting steam into the chamber

As more pressure enters the chamber the steam and air from a mixture

Hugh O'Connor AP 74

Condensation formation in the chamber of a porous load steriliser during sterilizing.

Surgical instrument

Pack 7kg +-5%

Steam supply

2.2 barg

135.8c

chamber

Condensate

At 135.8c

Drain (condensate to condenser and steam trap

And vacuum pump at 20mb is flashed of

Hugh O'Connor AP 75

Mixtures of air and steam

According to Daltons law of partial pressures, the pressure exerted by a mixture of gases is the sum of the individual pressures which each exert if occupied a given space alone.

For ex if a space containing steam and air at 4 bar this could be 3bg of steam and 1bg of air.

The resulting tmp would correspond to 3bg of saturated steam instead of required tmp for 4 bar

This is why air venting,steam traps,air detectors are essential.

Hugh O'Connor AP 76

Reduction in number of Live Spores in D values at 121 c

Spores of D 121 c (minutes) Z- value

Clostridium Botulinum

0.204 10

Clostridium sporogenes

0.81.4 13

Bacillus steramoph

2.0 6

Bacillus subtilis o.4 10

IM0 2.5 18.6

Hugh O'Connor AP 77

When a pre-determine pressure is reached (getinge 1.11 bg),the drain opens and the pressurized steam and air rush from the chamber creating a Vacuum.


H

w

Hugh O'Connor AP 78


Raising ,heating time

Once the air is removed from the load and chamber,steam is injected until the thermal sensor probe (drain) reaches the pre-selected temperature (134 c)

Sensor

drain

Hugh O'Connor AP 79

Handpiece Failures Processing with N cycle

Hugh O'Connor AP 80


Exhausting time(post-vacuum) Holding time complete the vauum will exhaust to > 70 milibar.

Steam injector closed

Vacuum stay open untill cycle complete

Hepa bacterial filter opens

Sterile filtered air is injected untill 1.014 bg atmospheric is reached

> 70mb

Hugh O'Connor AP 81


Exposure Time (Plateau time)

When thermal sensor registers (134.2c) the steam injection will close and the actual sterilization time will be activated.

Sensor drops bellow 134.2 c, the steam injector opens and tops up.

Hugh O'Connor AP 82

Steriliser Guidelines

EN 554/EN 17665 Planned and Documented maintenance

HTM 2010/HTMO5 PT2 & 4 guidance on maintenance

MDA DB200 Vacuum Sterilizers

MDA DB9605 Benchtop Sterilizers

EN 13060 European Standard < 60 litres

DB9804 Periodic testing

HTM2031 Clean steam for sterilization

COP HSE Part 5a,5b

Manufacturers Guidelines especially Type S

Hugh O'Connor AP 83

Test Description for HSE COP Pt 5b Pre

Evaluations and Audits

Non

Vacuum

Autoclave

Vacuum

Autoclave

Washer

Disinfector

Ultra Sonics

Yearly Safety Test

Yes

N/a

N/a

Air Leakage Test (automatic)

n/a*

N/a

N/a

N/a

Air Leakage Test (manual- temp. and pressure sensors connected)

n/a

N/a

N/a

N/a

Automatic Control Test

Yes

N/a

N/a N/a

N/a

Door and Door Interlocks

Yes

N/a

Yes

N/a N/a Verification of Calibration of Autoclave

Instruments

Yes

N/a

N/a N/a

Yes

Cleaning Efficacy Tests

N/a

N/a

Yes

N/a N/a Detergent Reproducibility Test

N/a

N/a

N/a

Yes

Function Test

N/a

N/a N/a

N/a

N/a

Air Detection System Performance Test for a Full Load

n/a

N/a

N/a

Thermometric Test for a Full Ld

N/a

N/a N/a

N/a

N/a N/a Thermometric Test for Disinfection

N/a N/a

Yes

Ultrasonic Activity Test

N/a

Yes

N/a

Porous Load Dryness Test

n/a N/a

Yes

N/a N/a

N/a

Full Performance Qualification Test

N/a

N/a

N/a

n/a

Tests for Performance Requalification (as required)

N/a

N/a N/a

n/a

n/a

Air Leakage Test (automatic) (sensors removed)

n/a

N/a

N/a

Air Detection System Function Test (automatic)

n/a

N/a

N/a

N/a

Steam Penetration Test

n/a

N/a

Load Dryness on Reference Load

N/a

N/a

N/a N/a

N/a N/a Steam Quality Tests (Commission)

N/a

Water Quality (Ph,Hardnes,Cd)

Yes

N/a

N/a N/a Photographic Evidence

N/a

N/a

N/a

N/a

Hugh O'Connor AP 84

Test Description for HSE COP Pt 5b Post

evaluations and Audits (Annual)

Non

Vacuum

Autoclave

Vacuum

Autoclave

Washer

Disinfector

Ultra Sonics

Yearly Safety Test

Yes

Yes

Yes

Yes

Air Leakage Test (automatic)

n/a*

Yes

N/a

N/a

Air Leakage Test (manual- temp. and pressure sensors connected)

n/a

Yes

N/a

N/a

Automatic Control Test

Yes

Yes

Yes

Yes

Door and Door Interlocks

Yes

Yes

Yes

Yes

Verification of Calibration of Autoclave Instruments

Yes

Yes

Yes

Yes

Cleaning Efficacy Tests

N/a

N/a

Yes

Yes

Detergent Reproducibility Test

N/a

N/a

Yes

Yes

Function Test

N/a

Yes

Yes

Yes

Air Detection System Performance Test for a Full Load

n/a

Yes

N/a

N/a

Thermometric Test for a Full Ld

N/a

Yes

N/a

N/a

Thermometric Test for Disinfection

Yes

Yes

Ultrasonic Activity Test

Yes

Yes

Yes

Porous Load /Dryness Test

n/a

Yes

Yes

Yes

Full Performance Qualification Test

Yes

Yes

Yes

n/a

Tests for Performance Requalification (as required)

Yes

Yes

n/a

n/a

Air Leakage Test (automatic) (sensors removed)

n/a

Yes

N/a

N/a

Air Detection System Function Test (automatic)

n/a

Yes

N/a

N/a

Steam Penetration Test

n/a

Yes

Load Dryness on Reference Load

N/a

Yes

Yes

Yes

Steam Quality Tests (Commission)

Yes

Water Quality (Ph,Hardnes,Cd)

Yes

Yes

Yes

Photographic Evidence

N/a

N/a

Yes

Yes

Hugh O'Connor AP 85

Validation a Planned and Documented Process

Hugh O'Connor AP 86

Sterilizer in Action

Hugh O'Connor AP 87

If not clean cannot be sterilized

All viable viruses and contaminants removed

All detergents removed

Visualy clean

Test for protein presenc

Test for efficay of wash

Hugh O'Connor AP 88

Specifications for WD

Fully automatic pre-determined Wash Cycle.

Automatic/verfiable Detergent dosing.

Three rinses + final rinse (90 c at 1 minute).

Single manually/double glass door.

Electricaly /Steam heated/Stainless 314-sl.

Event type printout with independent sensor (temp,cycle time,dose) for traceabilty.

Single Shot clean Final rinse system (R/O,DI)

Compliant to EN-158833-1-2, COP 5.

Hugh O'Connor AP 89

Specification AC

Fully automatic pre-determined Ster Cycle.

Steam generated internally/externally.

Full active Vacuum system.

Single manually/automatic opertated door.

Electricaly /Steam heated.

Event type printout with independent sensor (pressure,temp) for traceabilty.

Air detector a posibility for ADFT.

Single Shot clean steam system (R/O).

Pressur vesel marked to EN61010-2-041.

Hugh O'Connor AP 90

List of Tests for Sterilizer/Autoclave EN285/COP HSE 5b

Test daily Weekly Annual

Bowie Dick Test

Weekly Tests

Verification of instruments

ACT

Vacuum Leak test Not applicable to type N cycle (non-vacuum)

Air Detector Tests If applicable

Small Load Test

Full Load Test (solid)

Pressure Tests 24 months

BI+ Steam Quality commissioning

Ap sign off

Hugh O'Connor AP 91

Management Responsibility

The fundamental cause of this disaster is to be found in human failings, ranging from simple carelessness to poor management of men and plant. (Sir Cecil Clothier on the report into the deaths of five patients due to a faulty sterilizer)

Hugh O'Connor AP 92

Your Responsibility

Purchasing,maintenance and inspection.

Regulatory and legal aspects

Sources of further advice (AP) and information

Technical aspects and safety considerations

The hazards of circumventing safety aspects

Hugh O'Connor AP 93

Key Information You Need From the Supplier

Compliance of equipment with regulatory and legal requirements.

Information on the technical and safety aspects of steriliser.

Knowledge on the hazards of circumventing safety features

Hugh O'Connor AP 94

Key Issues for the User

The processing of wrapped goods.

The processing of instruments with lumens or cavaties.

The processing of porous materials.

The hazards of infection resulting from inadequate processing.

MDA (93/42/EEC) all medcial devices should be safe and fit for their intended purpose.

Hugh O'Connor AP 95

Traceability

Hugh O'Connor AP 96

Independent Monitoring & Verification System

For EN Sterilization

Real time data logging & archiving of microprocessor and independent data

Real time data comparison with automatic machine alarm and shutdown

On-screen machine operation mimic

Spreadsheet and graphical data representation

Individual cycle / file storage with unique identifier

Bar coding interface facility options

Hugh O'Connor AP 97

Requirements for Checks and Balances

Hugh O'Connor AP 98

To State of Sterility & Grace

Hugh O'Connor AP 99

If we dont the risk is

Hugh O'Connor AP 100

Your Responsibilty lets do a bungi jump


Whats the legal Requirement

Just as in the case of patient charts, present German

regulations decree that results documentation be kept for 30

years. (German Civil Code - BGB; limitation period after

which compensation claims become statute-barred). Claims

from the doctor-patient contract or from the hospital admission

contract become statute-barred after 30 years pursuant to

Article 195 of the German Civil Code. Because German

legislation recognises the principle of shifting the burden of

proof, which states that hospitals must prove that no damage

was inflicted on the patient, this documentary obligation also

applies for the CSSD.


Overall Advice

HSE COP Pt5b, NHS website gives clear guidance on Steriliser/Sterilisation Guidance.

Need bench tops with one shot system.

Standards are varied but should be driven by user professionals and patients.

Trial machines before purchase.

Thermometric tests supersedes biological tests.

PQ and validate new machine to reflect medical device needs


Summary The current requirement of BS EN544,

HTM01/02, DB9804, and EN 13060/EN 15883 are that successful decontamination management is achieved by a combination of personnel who have responsibilities for audit, maintenance, and validation of decontamination equipment through its working life.

You and Me


Validation

Kill, Kill,Kill them all, Until nothing is alive

Ghengis Khan


List of Tests for Washer Disinfector EN15883-1/COP5

Test daily Weekly Annual

Efficacy test

Spray arms

Verification of instruments

Sump strainers

MIS lumen test

Small Load Test

Full Load Test

Dose pump check

Pump tests

Final rinse water tests

decontamination and sterilization, hugh oconnor.pdf

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