Re-processing and re-use of single-use medical equipment

There has, for some considerable time, been considerable interest in the re-processing for re-use of single-use medical equipment and devices. If reprocessing is undertaken with sufficient care to provide a safe and effective product that does not jeopardise the care of any patient this may reduce overall costs of care.

Much work has been done, in the UK and Europe and in N America, to refine the reprocessing of many equipment items, often supported by the manufacturer. Product liability is a particularly grey area but generally lies with the reprocessor and end-user, certainly not the original manufacturer.

In parallel to this extensive activity, many items are being salvaged after use and reprocessed for use in resource-poor regions. This provides healthcare opportunities where previously none had existed, saving lives that would otherwise be lost. The same standards apply; items must initially be processed to make safe, then reprocessed ready for re-use. This includes checks on quality and performance, and probably repackaging and sterilisation to the same standard as required for new goods. It is the ultimate reduce, reuse, recycle.

Now, there is a fly in the ointment. In a rather suspicious email circulated to all members of the Infection Prevention Society, a letter purporting to be from Bob McIntyre seeks to stop all of this. The letter can be seen here. Why it is not on Environment Agency headed paper and signed in a matter for some considerable concern, though just possibly it may be just the way in which IPS have chosen to pass it on. Strange also that those with questions about this are asked, in teh accompanying email (not shown here) to report to Sue Berry, using a private rather than professional email address. Does this have any official status or is it some private enterprise? We are right to be suspicious.

It has come to our attention that medical practices ( hospitals in particular) may be approached to export waste medical instruments (e.g. single use cardiac catheters) overseas for recycling or reuse. These practices may not be fully aware of the legislative controls that apply to this activity.

To assist medical practices in England and Wales we would highlight four key points that they should be aware of before exporting waste medical instruments for recycling or reuse.
*         Hazardous waste;
*         Disinfection at the medical practice;
*         Export; and
*         MHRA guidance on reuse of single use-devices

This is, at least in part, quite reasonable. Equipment and devices intended for re-use, whether initially intended for reuse or not, must always be reprocessed to the highest possible standard and proven safe to use. That is not an issue for McIntyre or the Environment Agency.

This bullying approach seems perhaps predictable and fully in character.  Though properly a matter for the Department of Health and MHRA, and then within the UK only, this off-record involvement of the Environment Agency or perhaps just one Environment Agency employee acting independently, offers only barriers and obstruction, not answers, opportunities or solutions.

What is the official status of this letter, if there is any? Is McIntyre overstepping the mark? Is Berry acting likewise? We should watch this matter with interest, and concern both for the welfare of those who might be treated using our previously used medical equipment items, but also for those in resource-poor countries who may now be deprived of their only chance for treatment.

In the meantime, we continue to support the work of InterCare and other charitable organisations that work so hard to collect and redistribute unwanted medical equipment items and drugs for those in need.


Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.