Traceability of reusable medical devices (RMDs) AS4187 2.4.3.1

[Anonymous]

Good morning “Brains Trust”

I am seeking clarification around my interpretation of some wording in AS/NZS 4187:2014

Under 2.4.3 Identification and traceability of product

There are 3 NOTES; number 1 states ” in certain circumstances, traceability of an RMD to an individual patient might be required (e.g. those used on high risk tissues)

I am seeking clarification on the term “high risk tissues”

* Is this referring to High-infectivity or medium-infectivity tissues associated with CJD risk?
* Or more broad, as in the DEFINITIONS 1.5.18 the Critical medical device NOTE: a critical medical device contaminated with microorganisms confers a high risk of transmission of infectious agents.
* There is no specific definition for high risk tissues (that I could find).

I might be reading too much into it. Any clarification would be appreciated.

Kind regards

Mandy Davidson
RN; GCert Inf Pre & Cont; MPHTM; Cert III Sterilisation; Cert IV TAE; Immunisation cred; CICP-A
Clinical Nurse Consultant – 4187 compliance & PPE Stores
Infection Prevention & Control

[cid:image009.png@01D72F90.998A6920]
T
07 4433 1873 | 0402 987 432
E
Mandy.Davidson@health.qld.gov.au
W
http://www.health.qld.gov.au/townsville

Townsville Hospital and Health Service
100 Angus Smith Drive, Douglas, QLD 4814
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[Andrew Ellis]

Hi Mandy,

I think that your interpretation re CJD is correct, as the example given in the Note about “high risk tissues” is meant to relate to “individual patient use”. It’s reasonable to take that use to mean something other than normal use of a RMD on one patient between reprocessing (which would go without saying). Traceability of semi-critical and critical RMDs is already well covered throughout the Standard within the normative clauses too, so it would be an odd thing to tack on just as an extra reference to the definition of critical devices.

The Standard itself excludes specific requirements for CJD from its scope, per clause 1.2(b) so perhaps this was an acknowledgement that HSOs may wish to consider such risks, without going so far as to advise explicitly.

Regards,

Andrew Ellis
Sterilising and Reusable Medical Device Reprocessing State Coordinator
Infection Control Service | Communicable Disease Control Branch
Health Regulation & Protection
Department for Health and Wellbeing | Government of South Australia
Level 13 | 25 Grenfell Street | Adelaide SA 5000
HCW infection prevention: http://www.sahealth.sa.gov.au/infectionprevention
General public: http://www.sahealth.sa.gov.au/hospitalinfections

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Good morning “Brains Trust”

I am seeking clarification around my interpretation of some wording in AS/NZS 4187:2014

Under 2.4.3 Identification and traceability of product

There are 3 NOTES; number 1 states ” in certain circumstances, traceability of an RMD to an individual patient might be required (e.g. those used on high risk tissues)

I am seeking clarification on the term “high risk tissues”

* Is this referring to High-infectivity or medium-infectivity tissues associated with CJD risk?
* Or more broad, as in the DEFINITIONS 1.5.18 the Critical medical device NOTE: a critical medical device contaminated with microorganisms confers a high risk of transmission of infectious agents.
* There is no specific definition for high risk tissues (that I could find).

I might be reading too much into it. Any clarification would be appreciated.

Kind regards

Mandy Davidson

RN; GCert Inf Pre & Cont; MPHTM; Cert III Sterilisation; Cert IV TAE; Immunisation cred; CICP-A

Clinical Nurse Consultant – 4187 compliance & PPE Stores

Infection Prevention & Control

[cid:image009.png@01D72F90.998A6920]

T

07 4433 1873 | 0402 987 432

E

Mandy.Davidson@health.qld.gov.au

W

http://www.health.qld.gov.au/townsville

Townsville Hospital and Health Service

100 Angus Smith Drive, Douglas, QLD 4814

[Facebook-Icon] [Twitter-Icon] [Linkedin-Icon]

Townsville Hospital and Health Service acknowledges the Traditional Owners of the land, and pays respect to Elders past, present and future.

**********************************************************************************

Queensland Health carries out monitoring, scanning and blocking of emails and attachments sent from or to addresses within Queensland Health for the purposes of operating, protecting, maintaining and ensuring appropriate use of its computer network.

**********************************************************************************
MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.

The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.

Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.

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MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.

The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.

Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.

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