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Single Patient Use

Single Patient Use refers to a use classification for medical device accessories. The item is intended for multiple applications on the same patient, e.g. within a 24-hour period for PLASMO®HEAL PRO, but must not be used for the treatment of another patient. This classification differs from single-use items and reusable accessories. For healthcare facilities using for example PLASMO®HEAL PRO, this classification specifies the interval after which the corresponding accessory must be discarded.

Distinction: Single Patient Use, Single-Use Items, and Reusable Accessories.

Three use categories must be distinguished in clinical practice.

Single-use items: Intended for exactly one application, followed by disposal. Reuse is not permitted, even for the same patient.
Single Patient Use: Intended for multiple applications on the same patient within a defined period. It must not be used for other patients.
Reusable accessories: Can be used for multiple patients following appropriate reprocessing; the number of reprocessing cycles is limited and must be documented by the manufacturer.

A single-use item provides protection through immediate disposal after each application. A Single Patient Use item allows multiple applications but restricts this use to one specific patient. It differs from reusable accessories in that reprocessing for use across different patients is not intended.

Person in medical protective clothing sorting accessory items on a tray — The correct classification of accessories according to their use category is an integral part of clinical hygiene standards.

Replacement Intervals for PLASMO®HEAL PRO.

PLASMO®HEAL PRO has three accessories with different use classifications. The information is based on the manufacturer's documentation.

Applicator. Single Patient Use. The applicator is strictly assigned to one patient. The permitted period of use is a maximum of 24 hours per patient. It must be disposed of after completion of treatment or when this period has elapsed. Use on another patient is not permitted.

Applicator Tubing. Reusable Accessory. Wipe Disinfection. The tubing is designed for use across multiple patients. Its service life is 300 applications or one year, whichever criterion is reached first. The middle LED on the device indicates when Service I is due. Scheduled replacement is performed using Service Kit REF 3015, which includes the tubing as well as seals and a filter mat. In addition, wipe disinfection must be performed before each patient application.

Water Reservoir. Reusable Accessory. Thermally Reprocessable. The water reservoir is rinsed in accordance with the instructions for use. Alternatively, it may be reprocessed in a washer-disinfector (WD). The manufacturer's specifications are: an A₀ value of >3,000, a maximum temperature of 100 °C, and a minimum exposure time of 3 minutes at atmospheric pressure. The maximum number of reprocessing cycles is limited to 30.

Nurse documenting accessory use and patient assignment in a patient record — The replacement intervals for the applicator and tubing are documented on a patient-specific basis in the hygiene plan.

Significance for Cross-Contamination and Hygiene Planning.

Compliance with the Single Patient Use requirement constitutes a manufacturer-defined hygiene barrier. If the applicator is used across different patients, this barrier is eliminated, and the infection safety assumed in the manufacturer's documentation can no longer be ensured. This is particularly relevant in care settings with an increased risk of infection, such as patients with chronically colonized wounds.

For hygiene planning in hospitals or healthcare facilities, this means that applicator use is documented on a patient-specific basis, while the replacement intervals for the tubing and water reservoir are incorporated into the hygiene plan.