definitions SHTM 01-01 pt A Flashcards
operator
person with authority to operate decon equipment in processing of medical devices
what two things should the operator have had?
tasks defined in their job description
documented training records to demonstrate they are competent at undertaking their assigned tasks
management
the owner, chief exec or other person of similar authority who is ultimately accountable for the safe operation of the premises, inc decon
CP (D)
person designated by the AP(D) to carry out maintenance, validation and periodic testing of WDs, S and endoscopic WDs
principal responsibilities of the CP(D)
maintenance tasks
repair work
validation and periodic tests
witness installation checks and tests carried out by the contractor, inc ensuring that the calibration of each test instrument provided by the contractor has been checked onsite and is satisfactory and should arrange for the test loads to be supplied as required
user
person designated by the exec manager to be responsible for the management of the process
user also responsible for the operators
who is responsible for the operators?
user
who might be the user in practice?
dental practitioner/nurse
principal responsibilities of user
certify decon equipment fit for use
hold documentation relating to equipment, inc names of other key personnel
ensure equipment subject to periodic testing and maintenance
appoint operators where required and ensure they are adequately trained
maintain production records
what is it recommended that a CP(D) doesn’t do?
carry out all 3 quarterly tests and the (re)validation test on a particular piece of equipment in a calendar year
AE(D)
person assigned to the organisation to advise on decon procedures
responsible for reviewing and witnessing local HB documentation on validation
liases closely with others - the apt should be made known in writing to all interested parties
should provide professional and technical advice to the AP(D), CP(D), decon lead, users etc
AE(D) principal responsibilities
general and impartial advice on all matters concerned with decon and on programmes of validation and testing
audit reports on validation, revalidation and yearly tests submitted by the AP(D)
advise on periodic tests and maintenance
advise on appt of AP(D) and provide technical advice on purchasing and selection of equipment
sign off validation reports (that are carried out by the CP(D))
CP (pressure systems)
Pressure Systems Safety Regulations 2000
chartered engineer responsible for drawing up a written scheme of examination for the system e.g. porous load sterilisers SHTM 01 01 pt A
AP(D)
manages the governance of equipment
have technical knowledge and ensure that equipment is being tested and is fit for purpose
liase with AE(D)
similar to role of user but more of a technical nature
