Re: Advisory No. A16/03AS: Reprocessing of reusable medical devices in health service organisations

06/06/2016 at 3:23 pm #73173 Quote

Glenys Harrington

Participant

Author:
Glenys Harrington

Email:
infexion@ozemail.com.au

Organisation:
Infection Control Consultancy (ICC)

State:

Dear All,

Further to below Im concerned about the advisory in terms of patient safety.

Given that the advisory primarily relates to the sterility of instruments used for surgical and other invasive procedures I was surprised to see a lag time of up to 5 years (2021)to fully implementation of AS:4187:2014.

This seems like a very long lag time for such high risk instruments and equipment.

What do others think?

Kind regards

Glenys

Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
PO Box 5202
Middle Park
Victoria, 3206
Australia
M: +61 404 816 434
infexion@ozemail.com.au
ABN 47533508426

—–Original Message—–

Hi Roel,

Many thanks for the update and advice for ICPs.

I understand from some ICPs that sourcing the ISO standards as referenced in the AS:4187:2014 could be up to $10,000.

Are you saying that you can purchase specific sections of an ISO standard (i.e. the normative component of the compliance) rather than the whole standard and that this section includes specific details to enable auditing of a facility?

You mentioned independent organisation/s (comes with a price) that you can purchase audit tools from – can you provide the details and ill get some costings.

Many thanks in anticipation

Glenys

Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
PO Box 5202
Middle Park
Victoria, 3206
Australia
M: +61 404 816 434
infexion@ozemail.com.au
ABN 47533508426

—–Original Message—–

Hi All

In relation to questions posted below. I will try my best to answer. Otherwise I can be contacted on my work email. Happy to help. I am lucky that the facility I work with happened to have an ISO accreditation 3 weeks ago. My role have given me the option to comply with some of the requirements of the AS 4187:2014.

– have organisations been able to access/obtain all the standards that you are required to meet in AS:4187:2014 (i.e. AS and ISO standards)? – Answer: Yes at the facility I am currently employed and at a previous facility I worked with. Please be aware that you are only required to access parts of the relevant standards specifically referred to as a normative component of the compliance. I have known managers in areas where they have purchased what is required.

– what was the cost associated with obtaining these standards (i.e. ISO standards)?

– have organisations been able to develop an audit tool that include standards (i.e. ISO standards) that are referred to in AS4187:2014?

Roel Castillo

Sterilising Services Unit Manager

Macquarie University Hospital
3 Technology Place
Macquarie University, NSW 2109, Australia Locked Bag 2231, North Ryde BC, NSW 1670

T: +61 2 9812 3213 I M: +61 0 434 496 829
http://www.muh.org.au

Macquarie University Hospital is Australias first and only private hospital on a University campus. We are committed to delivering superior clinical outcomes and a positive patient experience through the best available care and technology.

—–Original Message—–

Dear All,

In relation to the ACSQHS advisory posted below Im interested to know the following:

– have organisations been able to access/obtain all the standards that you are required to meet in AS:4187:2014 (i.e. AS and ISO standards)?

– what was the cost associated with obtaining these standards (i.e. ISO standards)?

– have organisations been able to develop an audit tool that include standards (i.e. ISO standards) that are referred to in AS4187:2014?

Regards

Glenys

Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
PO Box 5202
Middle Park
Victoria, 3206
Australia
M: +61 404 816 434
infexion@ozemail.com.au
ABN 47533508426

—–Original Message—–

[Posted on behalf of Roel Castillo – Moderator]

Hi all

Please refer to link below. ACSQHS advisory in regards to compliance to the new AS:4187:2014:

https://apac01.safelinks.protection.outlook.com/?urlhttp%3a%2f%2fwww.safetyandquality.gov.au%2fpublications%2fadvisory-a1603-reprocessing-of-reusable-medical-devices-in-health-service-organisations%2f&data01%7c01%7cRoel.Castillo%40MUH.ORG.AU%7c6923ac5e4084400687e008d38db7d5be%7cde154fbf3b664e1a9f9f3f164fdc85e1%7c1&sdatavnzV3DmdelaFfK88P6Gy%2bJAvJKk4bmwFSDILFhyQJw8%3d

Regards

Roel Castillo

Sterilising Services Unit Manager

Macquarie University Hospital
3 Technology Place
Macquarie University, NSW 2109, Australia Locked Bag 2231, North Ryde BC, NSW 1670

T: +61 2 9812 3213 I M: +61 0 434 496 829
https://apac01.safelinks.protection.outlook.com/?urlwww.muh.org.au&data01%7c01%7cRoel.Castillo%40MUH.ORG.AU%7c6923ac5e4084400687e008d38db7d5be%7cde154fbf3b664e1a9f9f3f164fdc85e1%7c1&sdataesr%2fIJ9bpB384J6hVbIxAhqpFx5FW8JB7jXGieP9US4%3d

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