European Association for Medical Device Reprocessing


Safety through controlled, validated reprocessing

Recent research has shown that controlled, validated reprocessing even of of “single-use” devices does not create any additional risk to patient or user safety. Ever since the reform of the medical device laws in Germany to allow this reprocessing in 2001, over six million devices have been reprocessed without a single claim.

In Sweden, where a similar regulatory framework has been adopted, studies have also demonstrated the safety record of reprocessed equipment.

It is also becoming clear that far from ensuring patient safety, banning the reprocessing of anything labelled “single-use” may actually be putting the public at greater risk. Hospitals across Europe are working under increasing budgetary restraints, and if they are not allowed to make use of professional reprocessing services, they are not able simply to buy more new devices to compensate. Rather, they are in practice faced with a choice between reprocessing their devices illegally without any standards, accountability or controls, or else cutting costs from other areas of their services.

Conversely, the cost savings that validated reprocessing can provide offers hospitals and clinics a concrete, short-term way to greatly reduce the cost per treatment without any increased risk. This economic aspect gives them the ability to offer better healthcare services within budget. Firstly, if the cost of using a device is reduced thanks to its “reprocessability”, then these (sometimes life-saving) devices are more widely available to patients. Secondly, if a department or clinic is able to save up to 50% on the cost of some of their devices, these savings can translate into investment in other areas, such as imaging equipment or personnel. Although difficult to quantify precisely, these additional benefits to patients and healthcare providers should be taken into account when assessing the benefits of regulated reprocessing.