Screw bank references of interest!

[Anonymous]

Thanks all for coming back with your thoughts
We do seem to need some national action

Some references from our manager of CSD!

Hi John

Just reiterating that In Europe the revised Medical Device Regulation to which Suppliers must comply with by May 2020 to receive the CE mark, require suppliers to provide information in their IFU’s that clearly states if an RMD can be reprocessed or if it is intended for one sterilisation only. Implant IFU’s now state that due to the construction and design they cannot be reprocessed. The last attachment above is a photo of a Medatis Vertex Screw Bank Set and the IFU. This bank has been reprocessed at JHH many times due to surgeon’s preferences and yet the IFU clearly states under Warnings and Precautions that the screws are not designed to be reprocessed as there is risk of HAI’s . Health Care Facilities in Germany will not accept unsterile implants of any description , with the remainder of countries in Europe and America following suit.

Sue Ison| Manager Sterilising Department GNS
Level 1 John Hunter Hospital
Lookout Road, New Lambton, NSW 2300
Tel (02) 4921 3131 Sue.Ison@health.nsw.gov.au

[cid:image001.png@01D5CBAB.0465BC40]

This message is intended for the addressee named and may contain confidential information. If you are not the intended recipient, please delete it and notify the sender.

Views expressed in this message are those of the individual sender, and are not necessarily the views of NSW Health or any of its entities.

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.

Replies to this message will be directed back to the list. To create a new message send an email to acipclist@acipc.org.au

To send a message to the list administrator send an email to admin@acipc.org.au

You can unsubscribe manually from this list by sending ‘signoff acipclist’ (without the quotes) to listserv@aicalist.org.au

[Author]

Posts