Sterile Services Provision Review Group: page 12

NHS Scotland: Sterile Services Provision Review Group: First Report - The Glennie Framework

Appendix D.1B

Key Indicators for Demonstration that
Interim Technical Requirements Are Met

The key indicators outlined below provide an indication of the level of compliance with the technical requirements. At this time indicators are provided for the ‘High’ and ‘Medium’ risk interim requirements only.

The indicators should be interpreted as identifying key issues in relation to the requirements and are not intended to form an exhaustive list. For clarity of presentation, the indicators are presented in a concise form. The relevant guidance material should be consulted to provide context and understanding. Specialist advice should be sought where necessary.

To ensure compliance with the Technical Requirements, at least the following must be in place.

HIGH RISK

Equipment

Porous Load Sterilizers

the steam supply system must be in accordance with design guidance in SHTM 2010 Part 2;
the sterilizer must be commissioned, validated and tested annually, quarterly, weekly and daily (SHTM 2010 Part 3);
the sterilizer must be fitted with a chart recorder or data logger, independent of the controller, recording chamber temperature and pressure (BS EN285; SHTM 2010 Part 2);
the sterilizer must be subject to documented planned preventative maintenance (PPM), (SHTM 2010 Part 3);
the steam quality must meet the physical conditions specified in SHTM 2010 Part 3
(< 3.5% non condensable gases (NCG), >0.95 dryness value (DV), <25º superheat);
evidence must be available that the sterilizer installation, tests and operation have been audited at least annually by Authorised Person (Sterilizers) (AP(S));
all sterilizers must have a plant history file/sterilizer process log (SHTM 2010 part 4).

Bowl and Instrument Sterilizer — Main Steam (N.B. Dropped instrument use only)

the steam supply must be in accordance with design guidance in SHTM 2010 Part 2;
the sterilizer must be commissioned, validated and tested annually, quarterly, weekly and daily as per SHTM 2010 Part 3;
the sterilizer must be fitted with chart recorder or data logger as per SHTM 2010 Part 2

a documented procedure must be in place requiring operator to observe and record, temperature, on independent temperature gauge, to verify attainment of sterilizing temperature for each cycle;

the sterilizer must be subject to documented PPM (SHTM 2010 Part 3);
evidence must be available that the sterilizer installation, tests and operation have been audited at least annually by an Authorised Person (Sterilizers) (AP(S));
all sterilizers must have a plant history file/sterilizer process log (SHTM 2010 part 4).

Benchtop Bowl and Instrument Sterilizer (N.B. Dropped instrument use only)

sterile water for irrigation, changed daily, must be used for raising steam;
the sterilizer must be fitted with independent chart recorder or data logger as per SHTM 2010 Part 2;

a documented procedure must be in place requiring operator to observe and record temperature, on independent temperature gauge, fitted to machine to verify attainment of sterilizing temperature;

the sterilizer must be commissioned, validated and tested annually, quarterly, weekly and daily as per SHTM 2010 Part 3;
the sterilizer must be subject to documented PPM, (SHTM 2010 Part 3);
evidence must be available that the sterilizer installation, tests and operation have been audited at least annually by an AP(S);
all sterilizers must have a plant history file/sterilizer process log (SHTM 2010 part 4).

Other Sterilizers

ethylene oxide / LTSF / gas plasma / dry heat - seek advice from an AP(S) as per SHTM 2010.

Washer disinfectors

the washer disinfector must be designed and constructed to ensure segregation of dirty items from cleaned items and to ensure that aerosols and leaks do not contaminate the environment;
the washer disinfector must be fitted with temperature recorder, independent of controller, to record the temperature during the disinfection stage;
final rinse water must be produced by reverse osmosis or de-ionisation;
the washer disinfector must be commissioned, validated and tested annually, quarterly, weekly and daily in accordance with SHTM 2030 Part 3 to establish, at least:
cleaning efficacy for chamber and load carrier;
cleaning efficacy for test load;
cleaning efficacy for ‘in-use’ loads;
thermal disinfection.

Ultrasonic cleaners

must be fitted with lid;
must be capable of being drained and re-filled easily to permit change of water at not more than 4 hourly intervals;
must be tested on installation, and weekly, using the aluminium foil erosion test to ensure continued ultrasonic activity.

Manual washing

at least two sinks (one for washing and one for rinsing) dedicated to use for cleaning medical devices must be provided.

Process

General

there must be a documented procedure designed to ensure that processed devices are clean and sterile including procedures for inspection for cleanliness, and records of items rejected and reworked;
records of each load processed through each decontamination stage must be maintained (i.e. cleaning, disinfection and sterilization);
records must be kept of load items placed in each cycle;
there must be a documented procedure for review of cycle record and load condition prior to release of sterile product and a documented record of sterile product release.

Cleaning

all cleaning must be carried out in accordance with the instructions provided by the manufacturer of the device to be cleaned;
whenever practicable, automated washer disinfector with thermal disinfection process must be used;
when using stand alone ultrasonic cleaner or ultrasonic irrigators with no disinfection stage, the device must, where possible, be cleaned in a washer disinfector after ultrasonication;
manual cleaning, when required as pre-cleaning or when specified as the only permissible cleaning method, must be carried out in accordance with the Protocol for local decontamination of surgical instruments in Appendix D.3;
there must be a documented procedure for loading the washer disinfector including, when necessary, disassembly of items and connection of lumened devices for irrigation of the channel;
there must be a documented procedure for review of cycle record and load condition (inspection for cleanliness and dryness) prior to release of product for re-assembly, packaging and subsequent sterilization.

Washer Disinfectors

weekly testing for protein residues by one of the methods in SHTM 2030 or a validated equivalent test must be carried out.

Benchtop Bowl and Instrument Sterilizer (N.B. Dropped instrument use only)

there must be records demonstrating that reservoir and chamber are drained daily and refilled with sterile water for irrigation;
there must be a documented procedure requiring the operator to observe and record attainment of the required temperature on an independent temperature gauge

the sterilizer must be fitted with chart recorder or data logger as per SHTM 2010 Part 2.

Facilities

there must be physical separation of clean and dirty processes - this requires a physical barrier (wall) between dirty and clean areas with double ended (pass through) washer disinfectors. When manual cleaning is used a pass-through drying cabinet may also be necessary. Separation by segregated workflow alone is insufficient;
the area must be physically segregated from both clinical activity and clean area for assembly and packing of devices;
at least two sinks (one for washing and one for rinsing) dedicated to use for cleaning medical devices must be provided;
appropriate inspection equipment e.g. magnifiers, and task lighting must be available.

Staff

there must be documented records of training and acquisition of required skills for:
TP(S) carrying out annual tests;
MP(S) or TP(S) carrying out quarterly and weekly tests and maintenance;
operator carrying out daily tests and housekeeping;
operator/supervisor releasing sterile product.
there must be evidence that all staff operating a sterilizer or washer disinfector have been trained in the nature of loads that may be processed and the correct method of loading;
there must be evidence that staff have been adequately trained in all relevant operational procedures;
a Microbiologist (Sterilizers) must be appointed for each decontamination facility.

Management

there must be a senior member of staff with documented responsibility for decontamination processes and capable of assessing and treating risks associated with ineffective decontamination processes, and with documented evidence of appropriate training;
there must be a senior manager with overview in accordance with HDL 2001(10);
steps must be taken to introduce systems which enable the tracing of sets of surgical instruments to the patients on whom they have been used and link this information with records of their decontamination.

Key Indicators for Demonstration that
Interim Technical Requirements Are Met

MEDIUM RISK

Equipment

Porous Load Sterilizers

the steam supply system in accordance with design guidance in SHTM 2010 Part 2;
the sterilizer must be commissioned, validated and tested annually, quarterly, weekly and daily as per SHTM 2010 Part 3;
the sterilizer must be fitted with a chart recorder or data logger, independent of the controller, recording chamber temperature and pressure (BS EN285; SHTM 2010 Part 2);
the sterilizer must be subject to documented PPM, (SHTM 2010 Part 3);
the steam quality must meet the physical conditions specified in SHTM 2010 Part 3
(< 3.5% non condensable gases, >0.95 dryness value, <25º superheat);
evidence must be available that sterilizer installation, tests and operation have been audited at least annually by an AP(S);
all sterilizers must have a plant history file/sterilizer process log (SHTM 2010 part 4).

Bowl and Instrument Sterilizer — Main Steam (N.B. for sterilization at point of use)

the steam supply must be in accordance with design guidance in SHTM 2010 Part 2;
the sterilizer must be commissioned, validated and tested annually, quarterly, weekly and daily as per SHTM 2010;
the sterilizer must be fitted with a chart recorder or data logger as per SHTM 2010 Part 2;

there must be a documented procedure requiring operator to observe and record temperature, on independent temperature gauge, fitted to machine to verify attainment of sterilizing temperature for each cycle;

the sterilizer must be subject to documented PPM, (SHTM 2010 Part 3);
there must be evidence that sterilizer has been audited at least annually by an AP(S);
all sterilizers must have a plant history file/sterilizer process log (SHTM 2010 part 4).

Benchtop Bowl and Instrument Sterilizer (N.B. for sterilization at point of use)

sterile water for irrigation, changed daily, must be used for raising steam;
the sterilizer must be fitted with a chart recorder or data logger as per SHTM 2010
Part 2;

there must be a documented procedure requiring operator to observe and record temperature, on independent temperature gauge, fitted to machine to verify attainment of sterilizing temperature;

the sterilizer must be commissioned, validated and tested yearly, quarterly, weekly and daily as per SHTM 2010 Part 3;
the sterilizer must be subject to documented PPM, (SHTM 2010 Part 3);
there must be evidence that the sterilizer installation, tests and operation have been audited at least annually by an AP(S);
all sterilizers must have a plant history file/sterilizer process log (SHTM 2010 part 4).

Other Sterilizers

ethylene oxide / LTSF / gas plasma / dry heat - seek advice from an AP(Sterilizers) as per SHTM 2010.

Washer disinfectors

must be fitted with a temperature indicator or recorder, independent of controller to monitor the temperature during the disinfection stage;
the washer disinfector must be commissioned, validated and tested annually, quarterly, weekly and daily in accordance with SHTM 2030 to establish, at least:
cleaning efficacy for chamber and load carrier;
cleaning efficacy for test load;
cleaning efficacy for ‘in-use’ loads;
thermal disinfection.

Ultrasonic cleaners

must be fitted with lid;
there must be a procedure to ensure change of water at not more than 4 hourly intervals;
Ultrasonic cleaners must be tested on installation, and weekly, using the aluminium foil erosion test to ensure continued ultrasonic activity.

Manual washing

at least two sinks (one for washing and one for rinsing) dedicated to use for cleaning medical devices must be provided.

Process

General

there must be a documented procedure designed to ensure that processed devices are clean and sterile;
there must be records of each load processed through each decontamination stage (i.e. cleaning, disinfection and sterilization);
records must be kept of load items placed in each cycle;
there must be a documented procedure for review of cycle record and load condition prior to release of sterile product. Documented record of sterile product release.

Cleaning

all cleaning must be carried out in accordance with the instructions provided by the manufacturer of the device to be cleaned;
whenever practicable automated washer disinfector with thermal disinfection process must be used;
when using stand alone ultrasonic cleaner or ultrasonic irrigator with no disinfection stage, the device must, where possible, be cleaned in a washer disinfector after ultrasonication;
manual cleaning, when required as pre-cleaning or when specified as the only permissible cleaning method, must be carried out in accordance with the Protocol for local decontamination of surgical instruments in Appendix D.3;
there must be a documented procedure for loading the washer disinfector including, when necessary, disassembly of items and connection of lumened devices for irrigation of the channel;
there must be a documented procedure for review of cycle record and load condition (inspection for cleanliness and dryness) prior to release of product for re-assembly, packaging and subsequent sterilization.

Washer Disinfectors

weekly testing for protein residues by one of the methods in SHTM 2030 or a validated equivalent test must be carried out.

Benchtop Bowl and Instrument Sterilizer (N.B. for sterilization at point of use)

there must be records demonstrating that reservoir and chamber are drained daily and refilled with sterile water for irrigation;
a documented procedure requiring operator to observe and record attainment of required temperature on independent temperature gauge;

the sterilizer must be fitted with chart recorder or data logger as per SHTM 2010 Part 2.

Facilities

there must be physical separation of clean and dirty processes - this requires a physical barrier (wall) between dirty and clean areas with double ended (pass through) washer disinfectors. When manual cleaning is used a pass-through drying cabinet may also be necessary. Separation by segregated workflow alone is insufficient;
the area must be physically segregated from both clinical activity and clean area for assembly and packing of devices;
at least two sinks (one for washing and one for rinsing) dedicated to use for cleaning medical devices must be provided;
appropriate inspection equipment e.g. magnifiers, and task lighting must be provided.

Staff

there must be documented records of training and acquisition of required skills for:

TP(S) carrying out annual tests;
MP(S) or TP(S) carrying out quarterly and weekly tests and maintenance;
operator carrying out daily tests and housekeeping;
operator/supervisor releasing sterile product.
evidence must be available that all staff operating a sterilizer or washer disinfector have been trained in the nature of loads that may be processed and the correct method of loading;
evidence must be available that staff have been adequately trained in all relevant operational procedures;
a Microbiologist (Sterilizers) must be appointed for each decontamination facility.

Management

there must be senior member of staff with documented responsibility for decontamination processes and capable of assessing and treating risks associated with ineffective decontamination processes, and documented evidence of appropriate training;
there must be senior Manager with overview in accord with HDL 2001(10);
steps must be taken to introduce systems which enable the tracing of sets of surgical instruments to the patients on whom they have been used and link this information with records of their decontamination.

[Previous] [Contents] [Next]