Considerations for Developing a Reuse Protocol
November 1, 1999
Considerations for Developing a Reuse Protocol
I. Establishment of feasibility
Collaborate with the device manufacturer to ensure that the single-use device can be safely reused. Questions should include:
• What materials are used in the construction of the device?
• Can the device be effectively processed?
• At which point should the product be discarded because of material or function degradation?
• How can the number of reuses be controlled?
• What are the manufacturers specifications to ensure that the device will perform as designed each time it is used?
II. Development of reprocessing procedures
The following phases of reprocessing must be considered:
• care and handling of the device after use;
• transportation to a reprocessing center;
• cleaning;
• inspection;
• performance testing;
• appropriate marking or labeling;
• packaging;
• preparation for sterilization;
• method of sterilization;
• aeration;
• storage;
• delivery to user.
III. Development of quality assurance program
• A well-designed program that ensures the final product consistently meets a predetermined standard.
• An emphasis on risk prevention.
• Step-by-step reprocessing procedures that contain measurable results.
• Established outcome standards.
• Appropriate indicators for weighing quality, including sample sizes, inspection points, acceptable compliance rates, corrective actions, and documentation requirements.
Source: Adapted from Reichert M. Reuse of single-use devices. Nurs Clin North Am 1993; 28:697-709.
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