Cause for Concern: Reuse of Single-Use Medical Devices

A medical device labeled for single use is licensed by Health Canada on the basis that it is to be used only once during a single procedure and then disposed of after use. Single-use devices are not designed for reuse and it is strictly against the original equipment manufacturer’s instructions. Among the devices being reused by Canadian hospitals are electrophysiology catheters used to diagnose heart arrhythmias, harmonic scalpels used to dissect tissue and seal blood vessels, burrs and blades used to remove tissue and cut through bone.

Health Canada has stated that the reuse of single-use devices carries with it the obvious risk of cross-patient infection as well as an increased probability that a device could malfunction due to the adverse effects of reprocessing on materials or delicate components.

A decision to reuse a single-use device therefore raises serious concerns about patient safety and legitimate legal and ethical questions about a duty to inform. Hospitals are potentially liable to patients that suffer an adverse event from a reprocessed single-use device.

There are no regulations in Canada for the reprocessing of single-use devices.

Provinces and Health Authorities have been free to develop their own policies and guidelines related to reprocessing single-use devices with an increasing trend towards hospitals using a third-party reprocessing company rather than reprocessing the devices in-house. (read more)

There are no third-party reprocessing companies based in Canada. Third-party reprocessing companies based in the United States are reprocessing medical devices without having to provide Health Canada with any safety, efficacy or quality data for the devices they are shipping back for use in Canadian hospitals.

Of particular concern is the reprocessing of critical single-use medical devices that penetrate the skin or sterile tissue. The reprocessing of these devices poses the highest risk for potential adverse clinical reactions (e.g. infection, embolism, toxicity). Only aggressive cleaning methods, not compatible with commonly used device materials, can ensure complete inactivation of prions that cause a number of diseases including Creutzfeldt-Jakob disease (CJD).
 

Reporting a Medical Device Problem to Health Canada

Reporting of medical device problems is mandatory for medical device manufacturers and importers according to Canada’s Medical Devices Regulations but not for third-party reprocessing companies.

A voluntary problem report can be made to Health Canada by anyone purchasing, using or maintaining a medical device.

If the problem being reported is related to a reprocessed single-use device, that information can be included in the Problem Description section of the Health Canada form.

     How to Submit a Problem to Health Canada
     Form to Report a Problem to Health Canada
 

Case for Canadian Regulations for Reprocessing Single-Use Medical Devices

Health Canada has concluded that Canadian Medical Device Regulations don’t apply to the use of a device after its sale and therefore they don’t have the authority to regulate the reprocessing of single-use devices by hospitals or third party reprocessors. (read more)
 

Policies in Canada for Reprocessing Single-Use Medical Devices

In the absence of federal regulations, Provinces and Health Authorities have adopted different policies and guidelines related to the reuse of single-use medical devices. (read more)

Reporting a Trade Complaint to Health Canada

Section 44 of Canada’s Medical Device Regulations specifically states that no person shall import or sell a medical device unless the person holds an establishment licence (MDEL). (MEDEC members login to read more)