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”:
The actual Medical Device Directive 93/42/EWG does just partially adress the question of reprocessing of medical devices. Just liabilities for labeling and informations to be provides are defined (s. 93/42/EWG Annexe I section 13.3 f, 13.6 h).
The new EU regulation on medical devices tries to close these gaps. The amendments adopted by the European Parliament on 22 October 2013 plans the following regulations:
General principles on safe reprocessing:
1. Any natural or legal person, including health institutions as specified in Article 4(4), who wishes to reprocess a single-use device to make it suitable for further use within the Union, and who can provide scientific evidence that such a device could be safely reprocessed shall be considered to be the manufacturer of its reprocessed device and shall be held liable for its reprocessing activities. The natural or legal person shall ensure the traceability of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, with the exception of obligations linked to the conformity assessment procedure
2. Only reusable devices that have been placed on the Union market in accordance with this Regulation, or prior to [date of application of this Regulation] in accordance with Directive 90/385/EEC or Directive 93/42/EEC may be reprocessed
3. Unless they are placed on the list of single-use devices referred to in Article 15b, medical devices shall be considered as suitable for reprocessing and reusable devices in accordance with the provisions laid down in Article 15c, and providing the highest level of patient safety is guaranteed
4. A Member State may maintain or introduce national provisions prohibiting, within its territory, on grounds of protection of public health specific to that Member State the following:
(a) the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing
(b) the making available of reprocessed single-use devices
Member States shall notify the Commission and the other Member States of the national provisions and the grounds for introducing them. The Commission shall keep the information publicly available.
The process for generation of a list of not suitable reprocessable medical devices is described in article 15b:
List of single-use devices unsuitable for reprocessing:
1. In accordance with Article 15a(3), the Commission, after the mandatory consultation of the MDAC shall establish, by means of delegated acts, a list of medical devices or types of medical device which are unsuitable for reprocessing. The Commission shall regularly update that list, including by adding or removing items. A first list shall be established no later than six months before the date of entry into force of this Regulation
2. The decision to include or remove any device or type of device from the list shall be made in particular by taking into account:
3. The delegated acts referred to in paragraph 1 shall be adopted in accordance with Article 89
Also the reprocessing of multiple use medical devices is defined more precise including some requirements to the reprocessor.
Reprocessing of medical devices labelled as reusable:
1. Any natural or legal person, including health institutions as specified in Article 4(4), who reprocesses a device labelled as ‘reusable’ shall:
2. The Commission shall, by means of implementing acts, and in collaboration with the International Medical Devices Regulatory Forum and international standardisation bodies, define a clear set of high quality and safety standards for reprocessing of single use devices, including specific requirements for the manufacturers of reprocessed devices
3. In drawing up these quality and safety standards, the Commission shall notably include:
These standards shall be consistent with the latest scientific evidence and guarantee the highest level of quality and safety, in accordance with the severity of the condition, as reflected in European standards from the European standardisation organisations, where the latter take into account the provisions of relevant international standards, in particular those of ISO and IEC, or any other international technical standards able to guarantee, at the very least, a higher level of quality, safety and performance than ISO and IEC standards.
3. The natural or legal person referred to in paragraph 1 shall comply with EU standards referred to in paragraph 1 to ensure the quality of the reprocessing of medical devices labelled as ‘reusable’ and the safety of reprocessed devices
4. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, the Commission shall be empowered to adopt CTS, as referred to in Article 7(1)
The aim of the new regulation is to become a clear situation in the field of reprocessing of medical devices at all and to reduce the risks resulting from reprocessed medical devices. Also the trend leading to more single use devices should be stopped by giving some regulations for the declaration as “single use”. In consequence this would mean: If a medical device is not accepted as single use, the manufacturer has to develop validated procedures for reprocessing of this device.
It stays the question, if the regulation will be accepted by the European Council.
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 testing quality standards for reprocessing services.
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.