Legislation in the EU Member States
The legal situation in the EU is extremely diverse. Basically, there are three groups of differing Member State regulations:
1) Regulated/accepted under high quality standards
In a growing number of Member States reprocessing is regulated or accepted if validated procedures or high quality standards are strictly adhered to by reprocessors (as in Germany). Other Member States are currently assessing the introduction of a comparable system.
2) Not recommended but performed without quality standards
Some Member States such as the United Kingdom do not recommend reprocessing. However, such Member States’ stance appears to be largely based on a lack of information about the latest technological achievements of the reprocessing sector, and on a lack of differentiation between controlled and uncontrolled reprocessing. EAMDR has launched a dialogue with these countries and some of them have already expressed the view, albeit informally, that they could consider reviewing their policy.
Latest studies show that a simple prohibition of reprocessing does not hinder an uncontrolled and illegal reprocessing in hospitals, which find themselves under economic pressures. A recent study from Spain shows that 85% of hospitals in Spain reprocess medical devices labelled as “single-use” – without implementing any of the legally required quality standards. An uncontrolled reprocessing in hospitals without mandatory quality standards poses significant risks to patient safety. Therefore, prohibition of reprocessing is not reasonable as it has not proven to favour safety. On the contrary: Prohibition of reprocessing of single-use devices leads to a grey market outside the regulatory regime supervised by public authorities. It puts patient safety at enormous risk.
3) No legislation but performed without quality standards
Many Member States have not regulated medical device reprocessing at all. Consequently, reprocessors cannot offer their services in these Member States. However, uncontrolled reprocessing is performed at large scale – again putting patient safety at risk.
The following table categorises the EU-Member States into these three categories: “Regulated/accepted under high quality standards”, “No legislation but performed without quality standards” and “Not recommended but performed without quality standards”:
A regulatory framework for reprocessing of medical devices and especially single-use devices helps to effectively stop uncontrolled, and therefore unsafe, reprocessing which currently takes place in many parts of the world.
The introduction of high quality standards and the enforcement of validated procedures is a better way of regulation. This can be seen in Germany where relevant regulation and control have both been implemented for several years. Denmark, Poland and the Netherlands have chosen the same path, having discovered the potential of the emerging reprocessing industry. In doing so, these countries have experienced higher safety for patients, enormous cost savings in their health care systems, as well as environmental benefits. Belgium, Finland and Austria are currently testing quality standards for reprocessing services.
An example of a country where reprocessing is prohibited:
Spain has no regulations regarding reprocessing and the government has considered that prohibition is the optimal way to solve the problem of non-validated re-sterilisation of single-use devices. However, a recent study has shown that, far from stamping out the practice, this approach may actually be encouraging it, as the prohibition makes it impossible to use safe, validated reprocessing services.
It appears that up to 80% of hospitals in the Madrid area are currently reprocessing at least some of their devices labelled “single-use”. There have been a few reported cases of contamination from this practice, and it can only be assumed that there are many more which are unreported or perhaps even unknown.
The introduction of high quality standards and the enforcement of validated procedures is a better way of regulation. This can be seen in Germany where relevant regulation and control have both been implemented for several years. Denmark, Poland and the Netherlands have chosen the same path, having discovered the potential of the emerging reprocessing industry. In doing so, these countries have experienced higher safety for patients, enormous cost savings in their health care systems, as well as environmental benefits. Belgium, Finland and Austria are currently testing quality standards for reprocessing services.
An example of a country where reprocessing is prohibited:
Spain has no regulations regarding reprocessing and the government has considered that prohibition is the optimal way to solve the problem of non-validated re-sterilisation of single-use devices. However, a recent study has shown that, far from stamping out the practice, this approach may actually be encouraging it, as the prohibition makes it impossible to use safe, validated reprocessing services.
It appears that up to 80% of hospitals in the Madrid area are currently reprocessing at least some of their devices labelled “single-use”. There have been a few reported cases of contamination from this practice, and it can only be assumed that there are many more which are unreported or perhaps even unknown.
Reaction to study which shows illegal and unsupervised reprocessing is widespread
across Madrid
El Mundo Sept. 17, 2006 (Spanish)
across Madrid
El Mundo Sept. 17, 2006 (Spanish)
- Case Study: In Spain prohibition has driven reprocessing underground with increased healthy risks for patients
- Reprocessing in Germany - legal Overview
- Reprocessing in Belgium - legal Overview
- Reprocessing in the Netherlands - legal Overview
- Sweden – legal overview
- Poland – reprocessing procedures officially validated (Polish)
