Procedures and devices for the removal, containment and disposal of scalpel blades
AS 3825-2020 pdf download.Procedures and devices for the removal, containment and disposal of scalpel blades from scalpel handles.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document:
NOTE Documents br informative purposes are listed in the Bibliography.
AS 4031, Non-reusable containers for the collection of sharp medical items used in health care areas
AS/NZS 4261, Reusable containers for the collection of sharp items used in human and animal medical
applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
chamber
that part of the scalpel blade removal device which fully encloses the scalpel blade after its removal
3.2
container
receptacle intended for the collection and containment of scalpel blade removal devices
3.3
containment
complete enclosure of the scalpel blade within a chamber of the scalpel blade removal device following removal
3.4
loaded
physical state wherein a scalpel blade is attached to a scalpel handle, ready for use
3.5
may
indicates the existence of an option
3.6
removal
separation of the scalpel blade from the scalpel handle prior to containment
3.7
resheathing-type removal action
physical action whereby the user or other person holds a loaded scalpel handle with one hand and attempts to remove the scalpel blade with a device held in the other hand
3.8
scalpel blade
device which has a sharpened edge or edges designed for cutting, and which can be loaded onto a scalpel handle
3.9
scalpel blade removal device
any device designed for the safe removal and containment of a scalpel blade from a loaded scalpel handle
3.9.1
active scalpel blade removal device
scalpel blade removal device in which removal is manually performed by the user
3.9.2
multiple-use scalpel blade removal device
device consisting of one chamber which is designed to contain more than one blade
Note I to entry: A multi-use device can typically accommodate in the order of 100 or more blades.
3.9.3
passive scalpel blade removal device
scalpel blade removal device in which removal is automatically performed with no extra action being required by the user
3.9.4
single-use scalpel blade removal device
device consisting of one or more chambers, each chamber designed to contain a single blade
310
scalpel blade removal procedure
any procedure or series of procedures designed to separate a scalpel blade from a loaded scalpel handle
3.11
scalpel handle
handle, or other device of similar function, designed for holding a scalpel blade during use
3.12
shall
indicates that a statement is mandatory
3.13
should
indicates a recommendation
4 Design requirements for scalpel blade removal devices
(ii) a visual cue;
(c) allow for the safe containment of the scalpel blade immediately after the scalpel blade is removed, (test in accordance with Appendix A);
(d) ensure that the scalpel blade remains completely contained within the device after removal (test In accordance with Appendix B);
(e) be such that during use the loaded scalpel handle is not directed towards the user’s body; and
(1) if a single-use device, allow for accurate count of the contained scalpel blades.
The design of the scalpel blade removal device should also —
(I) permit the removal of the scalpel blade —
(A) with minimum droplet dispersal;
(B) without breakage or flip-back of the blade, and
(C) without damage to the scalpel blade handle;
(ii) not require excessive force to remove the scalpel blade;
(iii) if a single-use device, be capable of being sterilized, where claimed by the manufacturer; and
(iv) if a multiple-use device, allow for ease of cleaning of the external surfaces.
NOTE 2 Appendix C may be useful for reporting purposes.
5 Procedures for the removal of scalpel blades
5.1 Location of scalpel blade removal device
The scalpel blade removal device shall be situated as close as possible to the point of use.
5.2 Type of scalpel blade removal device
Where a scalpel blade removal device is loaded onto a reusable handle, removal of the scalpel blade from the handle shall be done with a passive scalpel blade removal device in preference to an active scalpel blade removal device.
5.3 Removal by hand
Scalpel blades shall not be removed by hand (see Figure 11.AS 3825-2020 pdf download.