Release of Human Tissue and Explanted Medical Devices Policy
MP 0129/20 - Release of Human Tissue and Explanted Medical Devices Policy (pdf 182KB)
Applicable to: Health Service Providers
Description: This Policy sets out the minimum requirements for responding to requests for the release of human tissue or an implantable medical device that has been removed (explanted) from an individual’s body. Human tissue in the context of this Policy includes a human fetus or placenta. Accordingly, in all cases, reference to human tissue includes a human fetus or placenta unless stated otherwise.
This Policy is in accordance with the Environmental Protection Act 1986 and Environmental Protection (Controlled Waste) Regulations 2004 which regulate clinical waste; and the Therapeutic Goods Act 1989 (Cth) which regulates medical devices supplied in Australia. Neither State nor Commonwealth legislation explicitly authorises or prohibits the release of human tissue or explanted medical devices to a requestor.
This Policy is a mandatory requirement for Health Service Providers under the Public Health Policy Framework pursuant to section 26(2)(c) of the Health Services Act 2016.
This Policy supersedes OD 0398/12 Release of Human Tissue and Explanted Medical Devices.
The Policy does not relate to actions concerning tissue or organs intended for donation, or teeth, hair and nails.
Date of effect: 28 January 2020
Policy Framework
Public Health
Patient Information Sheet and Consent Form - Authorisation and Release of Human Tissue (DOC 76KB)
Patient Information Sheet and Consent Form - Authorisation and Release of Human Tissue (pdf 140KB)
Patient Information Sheet and Consent Form - Authorisation and Release of a Human Fetus or Placenta (DOC 75KB)
Patient Information Sheet and Consent Form - Authorisation and Release of a Human Fetus or Placenta (pdf 142KB)
Patient Information Sheet and Consent Form - Authorisation and Release of an Explanted Medical Device (DOC 74KB)
Patient Information Sheet and Consent Form - Authorisation and Release of an Explanted Medical Device (pdf 141KB)
Guideline for the Release of Human Tissue (pdf 84KB)
Guideline for the Release of a Human Fetus or Placenta (pdf 40KB)
Guideline for the Release of an Explanted Medical Device (pdf 97KB)