Decommissioning

When a device becomes obsolete or unusable, or is no longer needed by the health care facility, it enters the final stage of its life cycle: decommissioning.

Decommissioning is the process of disposing a device, or removing a device from its originally intended use in the health care facility to an alternative use.

Every health care facility or institution shall have standard operating procedures in place to decommission a device according to the Occupational Safety and Health Administration (OSHA) regulations or/and the World Health Organization (WHO) Decommissioning Medical Devices Technical guideline.

The seller / manufacturer of the device has no legal obligation on the device sold in the event that the health care facility or institution decides to activate the decommissioning process.

Overview

The structure and the specifications of this device as well as the materials used for manufacturing makes it easy to wipe and clean and therefore suitable to be used for various applications in hospitals and other medical environments, where procedures for frequent cleaning are specified.

However, normal use shall exclude biological contaminated environments, to prevent spreading of infections.

Therefore use of this device in such environments is at the exclusive risk of Customer. In case this device is used where potential biological contamination cannot be excluded.

Customer shall implement the decontamination process as defined in the latest edition of the ANSI/AAMI ST35 standard on each single failed Product that is returned for servicing, repair, reworking or failure investigation to Seller (or to the Authorized Service Provider). At least one adhesive yellow label shall be attached on the top site of the package of returned Product and accompanied by a declaration statement proving the Product has been successfully decontaminated.

Returned Products that are not provided with such external decontamination label, and/or whenever such declaration is missing, can be rejected by Seller (or by the Authorized Service Provider) and shipped back at Customer expenses.