Single-use devices split business and medical camps

Date:24/07/03

By Karen Carstens

MAKERS of medical devices should stop stealing the limelight and let a subsidiary industry that refurbishes some of their products muscle in a little more on their act.

This is the mantra of the reprocessing industry, which runs high-tech businesses with specialized staff and machinery to make so-called single use devices (SUDs) - ranging from scalpels to heavy staplers used to stitch people up after an operation - reusable.

But Eucomed, the European Medical Technology Association, along with a coalition of doctors and nurses groups, begs to differ. It claims that the reuse of SUDs can affect their safety and performance, exposing both patients and hospital staff to unnecessary risk.

According to Eucomed, when a single-use device is reprocessed, it is not possible to guarantee that all blood, tissue and body residues have been removed, or that micro-organisms have been inactivated.

But Robert Schrödel refutes this. He runs a Berlin-based company specializing in the reprocessing of SUDs which has found that some 4,000 of about 50,000 of such devices now on the market can be safely reprocessed using high-tech methods.

Moreover, he said, new laws recently introduced in Germany making it easier for such reprocessing to take place could be used as a model for an EU-wide law.

Schrödel said he plans to establish an association representing the interests of the SUDs reprocessing industry in Brussels, adding that certain SUDs are reprocessed in the US after getting the green light from the Food and Drug Administration (FDA).

"But there is no central approval from a notified body like the FDA (in Europe), he said. "This needs to change."