This policy pertains to the use of critical and semi-critical medical devices that are designed for
single-use.
A critical medical device is a device that penetrates the skin or mucous membranes, has contact with
blood and or body fluids, or enters normally sterile cavities and therefore presents a high risk of
infection if the medical device is contaminated with any organisms, including bacterial spores.
Examples include but are not limited to the following: needles (including acupuncture needles),
lancets, syringes, suture removal kits, urinary catheters, biopsy forceps, infusion supplies and
devices such as catheters, needles, lines (e.g. IV administration tubing), solutions, and access ports.
A semi-critical medical device is a device that comes into contact with mucous membranes or nonintact
skin, but ordinarily does not penetrate them. Examples include but are not limited to the
following: trans-rectal probes, vaginal, nasal and rectal specula and respiratory therapy equipment
(e.g. oral endotracheal tubes, airway devices, and suction devices).
A non-critical medical device refers to devices that touch only intact skin but not mucous membranes,
or devices that do not directly touch the patient. Examples include but are not limited to the following:
electrocardiogram (ECG) electrode patches and disposable non-sterile procedure gloves. Non-critical
medical device use is beyond the scope of this policy.
