Standard Guide for Designing Reusable Medical Devices for Cleanability

Importancia y uso:

4.1 Reusable medical devices have a range of cleanability. The equipment, effort, and time expended for cleaning devices should be feasible in the intended setting. For that reason, it is essential that cleanability be considered during the design phase.

4.2 The next section highlights features that either have a tendency to retain debris and/or make removing contamination difficult. Individually, the criteria listed in this document may not render a device difficult to clean. Furthermore, it is the manufacturer’s responsibility to consider feasibility and ease of cleaning the device in the clinical environment when designing their device. Although it may not be feasible to remove or modify all of the problematic design features from a device, device manufacturers should be aware of challenging designs for cleaning and take appropriate action for minimizing the impact of these features on cleaning. For example, disassembly may be necessary to thoroughly clean a device, or it may be determined that a device cannot be adequately cleaned, in which case that device would be designated single-use only. In addition, manufacturers should consider the compatibility of their device design with subsequent sterilization or disinfection.

Subcomité:

F04.15

Referida por:

E3106-22

Volúmen:

13.02

Número ICS:

11.040.01 (Medical equipment in general)

Palabras clave:

cleanability; medical devices; reuse;