Reuse of single-use devices

Historically, the vast majority of medical devices were designed to be reusable. Their design, shape and size, as well as the construction materials used (glass, metal and rubber) lent themselves to relatively straightforward cleaning and sterilization. However, as public awareness grew of the risk of transmission of serious blood-borne diseases such as hepatitis and HIV, the need for single-use medical devices to reduce the risk of infection became established.

The development of these single-use devices, which did not have to withstand the rigours of reprocessing, such as steam sterilization and exposure to chemical cleaning, offered opportunities to use different materials and more complex designs. Since many of these devices were impossible to clean or sterilize effectively, they were labelled for ‘single-use’.

In 1993, the European Union’s Medical Devices Directive made a clear distinction between those medical devices which were intended by the manufacturer to be reused and those intended only for single-use. Manufacturers now had to label their products accordingly. In the case of reusable devices, this meant including instructions on how to prepare for reuse and any restrictions on the number of times it may be recycled. Those devices intended for single-use needed to have this clearly indicated on the label.

Despite this, an industry has grown up to refurbish, repackage and reuse single-use devices. This is usually carried out by or on behalf of institutions such as hospitals in an attempt to save money. Yet there is no evidence that reprocessing actually does save money; in fact, studies have shown that - in the case of single-use angiography catheters - a reprocessed device is actually more expensive than the cost of a new device to deliver equivalent levels of safety and quality.

Furthermore, the reprocessing of single-use devices causes considerable concerns around safety and ethics. From a safety perspective, the stress of reprocessing is not factored into the design tolerance of a single-use device. Exposure to the chemicals used for cleaning, and the high temperatures and pressure of autoclaving can induce physical changes to the materials. The result can be sudden mechanical failure or device malfunction. Yet the reprocessor is not required to validate the clinical usage in the same way as the original manufacturer. Nor is there any design or clinical safety data to support multiple use. From an ethical perspective, it is doubtful whether patients, given the choice, would decide upon a reprocessed device.

At the moment, there is no EU-wide law to prevent reprocessing of single-use devices; each country has its own regulations. In France, the re-use of single-use devices is illegal; in the UK, health authorities have issued guidance which warns of the potential risks and consequences when re-using a single-use device. Meanwhile, Germany has guidelines in place to regulate reprocessing to a certain extent, although it makes no legal distinction between single-use and multiple-use devices. These disparities highlight a clear need for legal measures to secure the highest level of safety for single-use medical devices, especially in the light of the proposed cross-border directive. Eucomed encourages the European Commission to propose suitable legal measures that will ensure the highest possible level of safety for patients and citizens in Europe.