Controlled reprocessing still to come in the European Union?
A single-use device (‘SUD’) is designed to be used only once on a single patient during a single procedure. A SUD should not be used again, not even on the same patient, and is not intended to be reprocessed. Reprocessing means disinfecting, cleaning, sterilizing and packaging a used device in order to make it serviceable again. SUDs were developed in order to minimize infection and cross contamination. Today many of them are high-tech devices which enable procedures that otherwise would not be possible. Unfortunately, these delicate instruments and devices are often reprocessed and reused without sufficient control, thus endangering patient lives. On the other hand, regulated and safe SUD reprocessing may reduce healthcare costs, protect the environment and enhance patient safety. This requires clear, strict and unified regulation.
Currently there is no EU-wide legislation to control reprocessing of SUDs. Each member state has its own regulations. For example, Hungary, the Czech Republic and the Baltic States forbid reprocessing of SUDs. However, Germany has guidelines in place to regulate reprocessing to some extent. Other Member States have no specific legislation on this aspect (e.g.: Slovakia, Poland.) These discrepancies demonstrate the need for unified regulations to ensure the highest possible level of safety for patients and citizens in Europe as well as to minimize the risks for manufacturers of these devices.
But does the new Medical Devices Regulation (‘MDR’) meet these needs?
First of all, reprocessing medical devices will only be possible if Member States decide to allow the practice under national law. Thus, Member States will be able to “opt out” of reprocessing. Since national rules will apply, these might differ between Member States. Thus, despite the intent of the Commission, the rules for reprocessing will not be binding on all EU countries. From a regulatory perspective, it is probable that countries that prohibit reprocessing will uphold the status quo since this solution is more convenient. However, this will not prevent uncontrolled reprocessing in healthcare institutions, which poses significant risks to patient safety.
In order to ensure patient safety, according to the MDR, the reprocessor of a SUD will be considered the manufacturer of the reprocessed device, thus assuming the obligations of a manufacturer. It might need to be certified by a notified body and also has to place its name and address on the reprocessed device. This aims to ensure that reprocessed devices have the same level of safety as the initial SUD.
However, member states have the possibility to “opt in” to an exemption for healthcare institutions (and possibly also external reprocessors) not applying the general rules that apply to manufacturers if SUDs are processed and used only within a healthcare institution. This divergence from the MDR will only be permitted when a health institution or an external reprocessor complies with common specifications or national provisions and harmonised standards to be certified by a notified body. It is still unclear what the common specifications will be and it is also doubtful whether notified bodies will certify the reprocessing policies of health institutions.
Although the MDR is a step in the right direction, unfortunately it seems that even the MDR cannot establish a harmonized and unified regime to secure safe reprocessing of SUDs.
It is highly doubtful whether the new regulation will increase patient safety. Stopping uncontrolled reprocessing, which currently takes place in many EU countries, requires a harmonized and unified regulatory regime supervised by public authorities and controlled by notified bodies. However, the future opt-out regulation of the MDR that additionally provides special loopholes for hospitals does not affect discrepancies in current national regulations and even poses many unanswered questions for businesses and regulators.