The Scottish Government

AP(S)

The authorised person (sterilizers) is defined as a person designated by management to provide independent auditing and advice on sterilizers and sterilization and to review and witness validation. AP(S) are also able to provide independent auditing and advice on washing/disinfection and WDs and to review and witness validation of these processes and machines. (See SHTM 2010 Part 1 for a full definition of the responsibilities with respect to sterilizers and the qualifications and experience required).

Automatic endoscope reprocessor

An AER is a machine intended for the automated decontamination of endoscopes.

Note: This generic term can be applied to any automated machine designed for endoscope reprocessing and has been applied inconsistently throughout published guidance. Automated machines that enable endoscopes to be immersed in a high level disinfectant/sterilant but lack a cleaning stage (eg the Steris reprocessor) are described in SHTM2030 as a liquid chemical disinfector ( LCD). This provides a distinction from automated machines that clean and disinfect which are defined as endoscope washer-disinfectors ( EWDs) within the scope of pr ENISO 15883.

CE mark

The CE mark means that a manufacturer is satisfied that his product conforms with the relevant Essential Requirements in the relevant European Directive and that it is fit for its intended purpose.

.dat file

A file that contains data.

Decontamination

Totality of the processes required to render a used re-usable medical device fit for use on a subsequent patient. (This will normally include at least cleaning, inspection for cleanliness and functionality and disinfection and/or sterilization).

Disinfection - High level disinfection

Capable of killing all micro-organisms with the exception of high numbers of bacterial spores.

[Summarised from - Rutala W A APIC (Association of Professionals In Infection Control and Epidemiology) Guidelines for selection and use of disinfectants. Am J Infect Control 1996, 24, 313-342.]

Disinfection - Low level disinfection

Capable of killing most bacteria, some viruses and some fungi but cannot be relied upon to kill resistant bacteria.

[Summarised from - Rutala W A APIC (Association of Professionals In Infection Control and Epidemiology) Guidelines for selection and use of disinfectants. Am J Infect Control 1996, 24, 313-342.]

Disinfection Medium level disinfection

Capable of killing mycobacteria, vegetative bacteria, most viruses and most fungi but not necessarily bacterial spores

[Summarised from - Rutala W A APIC (Association of Professionals In Infection Control and Epidemiology) Guidelines for selection and use of disinfectants. Am J Infect Control 1996, 24, 313-342.]

Endoscope washer-disinfector

washer-disinfector intended to clean and disinfect loads containing flexible endoscopes to the required standard (pr ENISO 15883-1).

Hazard

The potential to cause harm including ill health and injury, damage to property, plant, products or the environment, production losses or increased liabilities.

Liquid chemical disinfector

Machine for the automatic disinfection of items by liquid chemical disinfectants, intended for use only on items previously subjected to a cleaning process ( SHTM2030 Part 2).

Management

The owner, occupier, employer, general manager, chief executive or other person who is ultimately responsible for the premises ( SHTM 2030-3).

Manufacturer

A person or organisation responsible for the manufacture of a WD.

Medical Device

As defined in the Medical Device Directive (42/93/EEC); includes surgical instruments.

. NET platform

A development and execution environment that allows different programming languages & libraries to work together seamlessly to create Windows-based applications that are easier to build, manage, deploy, and integrate with other networked systems.

Operator

A person with the authority to operate a WD. Their duties may include the noting of WD instrument readings, replenishment of consumable items, such as detergent, and simple housekeeping duties ( SHTM2030-3)

Policy

A statement of intent; in particular with reference to an operational matter.

Procedure

A statement of steps required to fulfil a policy

Reprocessing

Reprocessing is a generic tem commonly used to imply part or all of the decontamination process. There is no consensus on the term as it applies to decontamination.

Re-usable medical device

A medical device designated by its manufacturer as suitable for multiple episodes of use; either for a defined maximum number of use cycles or until inspection reveals wear or damage to the extent that the device must be repaired or replaced.

Risk

Combination of the probability of the occurrence of harm and the severity of that harm ( BSENISO 14971).

Risk assessment

Overall process comprising a risk analysis and a risk evaluation ( BSENISO 14971).

Risk evaluation

Judgement, on the basis of risk analysis, of whether a risk which is acceptable has been achieved in a given context based on the current values of society ( BSENISO 14971).

Test Person (Washer-Disinfectors)

A person designated by management to carry out validation of WDs and to provide advice on testing, maintenance and procedures shorter term 'Test Person' or TP.

User

the person designated by management to be responsible for the management of a WD ( SHTM2030-3).