Establishing a Process to Assess and Approve Investigational Medical Devices

Abstract

Healthcare Technology Management (HTM) has proposed a process to assess and approve medical devices that are to be used for research within the Vancouver Coastal Health Authority (VCHA). The process is intending to help researchers who require access to VCHA facilities such as the operating rooms for clinical trials.

Before such access is granted by the administration, researchers must show that the necessary approvals and authorizations are in place for a medical device, and establish that the device is safe to use. It is not always clear to the researchers how to go about this, resulting in unnecessary delays and unexpected costs. The demands on the researchers became more onerous in 2007 with a communication from the BC Ministry of Health requiring that all provincial Health Authorities conform to recently published provincial guidelines for the cleaning, disinfection, and sterilization of medical devices.

In response to these difficulties, one researcher made a number of recommendations, including the formation of an in-house committee to assess and approve the use of investigational medical devices. The committee would comprise representatives from Biomedical Engineering (HTM), Risk Management, Infection Control, the Operating Rooms, and the Sterile Supply Department. HTM has developed a process based on these recommendations and put it forward to the stakeholders in VCHA for consideration.