37Reusable articles must be sterilised

37 Reusable articles must be sterilised

37 Reusable articles must be sterilised

(1) All reusable articles used to penetrate a person’s skin for skin penetration procedures must be sterilised at the premises or off-site.

(2) If reusable articles are sterilised at the premises—

(a) an autoclave must be used, and

(b) there must be at least 1 person present at the time the autoclave is used who is adequately trained in the operation of the autoclave, and

(c) the sterilisation must be carried out in accordance with AS 5369:2023, and

(d) the autoclave must be calibrated at least every 12 months in accordance with AS 5369:2023.

(3) If reusable articles are sterilised at the premises, the occupier of the premises must make, and keep for at least 12 months, a record of—

(a) the time and date when each article was sterilised, and

(b) the length of time the article was autoclaved and the temperature and pressure levels of the autoclave.

(4) If reusable articles are sterilised off-site, the occupier of the premises must—

(a) make, and keep for at least 12 months, a record of the date on which each article was sent off-site for sterilisation and the contact details of the person who sterilised the article, and

(b) keep, for at least 12 months, a copy of the report on the sterilisation by the person who sterilised the article.

(5) In this section—

AS 5369:2023 means AS 5369:2023, Reprocessing of reusable medical devices and other devices in health and non-health related facilities.

autoclave means a bench top autoclave that uses steam under pressure.

s 37: Am 2025 (624), Sch 1[3] [4].