Standards Development

Scope

(Please see ISO/IEC Directives, Part 1, Annex C, Clause C.4.3)

This document considers and identifies the risks associated with allowing a patient to use their personal ME equipment within a professional healthcare facility and provides guidance on the tests and inspections needed for the responsible organization to be able assess and control those risks. 

Often times patients require the use of their personal ME equipment (e.g., sleep apnoea therapy breathing equipment, ventilatory support ME equipment, ventilators, infusion pumps, peritoneal equipment, sphygmomanometers, glucometers, stimulators, etc.) when admitted into a professional healthcare facility. The use of the personal ME equipment can be unrelated to the purpose of the professional healthcare facility admittance but is nonetheless necessary to allow the patient to manage their health while admitted.

The intent of this document is to provide guidance to ensure that the personal ME equipment is safe to use for the patient, professional healthcare facility and environment.

Purpose

(Please see ISO/IEC Directives, Part 1, Annex C and additional guidance on justification statements in the brochure Guidance on New Work)

Some healthcare organizations prohibit patients from bring with them and using their personal medical equipment. Patients can need access to such equipment that allows the patient to manage their health while admitted. In many cases that equipment is unrelated to the purpose of the professional healthcare facility admittance.

For example, a patient’s ventilator needed to manage their respiratory inadequacy, sleep apnoea therapy equipment for restful sleep or glucometer or infusion pump needed to manage their diabetes.