Medical device to secure disconnection (distal end of the tubing) in oncology
The current secured medical device used for Mitomycin-C intra-vesical instillations protects nurses for syringe connection, without maintaining a closed system (distal end of the tubing) when disconnecting. Security actions are considered for:
- 5-FU diffusers disconnection (home hospitalization)
- Mitomycin-C intra-vesical instillation (day hospitalization).
Material and Methods
Decision-making process for a secured medical device follows three steps:
- Analysis of secured medical devices available on the French market,
- Selection (technical and economic criteria ; additional services),
- Negotiation with the medical provider affording diffusers for home hospitalization patients.
Medical device implementation (hospital, liberal nurses) has required followings:
- Pharmacy technicians and nurses training,
- Production an adjustment (critical points identified),
- Users’ satisfaction assessment.
QIMO® (male, female, prime) devices (VYGON laboratory) were introduced in June 2017. Medical providers affording diffusers bears costs related to female QIMO® as part of the care for patients with disconnection in home hospitalization.
VYGON laboratory has trained hospital and liberal health professionals, n>30 (after training course validation by a pharmacist). Lengthening of the purge time of the diffuser tubing (>10 minutes) has required to modify the preparation process and to use QIMO® prime (pre-purge syringes according to VYGON datasheet) (final purge time: 2 minutes).
To date, 203 diffusers (disconnection during home hospitalization, private hospital) and 176 Mitomycin-C instillation syringes have been dispensed. No adverse event due to practices change has been reported. Nurses’ satisfaction is noted: easy acquisition of specific gestures, best staff protection, no cytotoxic projection when disconnecting, no contamination of the patient’s environment at home. Additional cost of these devices is low (<3€/unit), 0,001% of the operating cost of the chemotherapy preparation unit.
Medical devices QIMO® secure identified critical steps of cancer chemotherapy administration, without organizational or technical trouble regarding to cancer chemotherapy preparation or administration. Because of a low budgetary impact, we plan to expand this use to all medical devices with cytotoxic risk to disconnection.