| Newsletter | Vol. 4, No. 2 May 1996 |
Largely motivated by the fiscal realities of recent times, reuse of manufacturer-designated "single-use only" medical devices in hospitals and healthcare facilities appears to be a growing practice. In most cases, the decision to reuse medical devices is one which is undertaken responsibly, having the utmost regard for patient safety and quality care. Nevertheless, many institutions engaged in this practice (including TTH) do not currently have a formalized reuse protocol which outlines the processes for evaluation, approval and quality control surrounding reuse. In the absence of such a formalized protocol, care providers and healthcare institutions expose themselves to liability claims in the event that there is a mishap which can in some causal way be traced back to the decision to reuse a medical device designated by the manufacturer to be for single use only.
Several recent events in the community, including the local epidemic of Hepatitis B associated with the reuse of needle electrodes, serve as useful reminders to care providers and healthcare institutions of the potential liability which arises when reuse activities are undertaken without formal and rigorous evaluation. The practice of reuse is not a practice that should be implemented in a casual way.
A recent Canadian Hospital Association publication entitled "The Reuse of Single-Use Medical Devices: Guidelines for Healthcare Facilities" deals directly with this subject. The guidelines mandate a formal evaluation process on a device by device basis, which considers clinical effectiveness, patient safety, cost-effectiveness and environmental impact.
It is important that each reuse proposal be approached in a consistent and thorough manner. At TTH, the Infection Control Unit, assisted by the Hospital's General Counsel and a multi-disciplinary working group, has drafted a policy on Reuse, which will be reviewed and finalized over the next few months.
The draft policy contemplates the creation of a Reuse Task Force, which will report to the Medical Advisory Committee. The mandate for this Task Force will be to create an inventory of "single-use items" approved for reuse at the Hospital, as well as to consider proposals for adding items to the inventory. In addition, the Task Force will monitor and evaluate our reuse practices on an ongoing basis.
Provided the hospital has documented evidence of the safety of reuse, and is satisfied on reasonable grounds that reuse will not result in a materially increased risk to patients, then patients, care providers, healthcare institutions and our ever-shrinking health budget will be protected.
Guest Writer: Bella Martin,
General Counsel and Director,
Medical/Legal Affairs
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