SUPROMED: Reprocessing and Reuse of Single Use Medical Devices in the Light of Sustainable Development Criteria - Implementation in Austria
Medical devices - don't dump it, reuse it
Motivation & Project objectives
In the health care sector, the conservation of natural resources and waste prevention in general has a low priority.
This fact can be seen in the case of medical devices. There is a strong increase in consumption especially for single-use devices (SUD) which are increasingly displacing multiple-use medical devices. If this development continues, multiple-use medical devices and related reprocessing systems will soon be completely squeezed out of the market.
On the other hand there is sufficient positive scientific evidence and practical experience that demonstrate the ecological and economical potential of reprocessing technologies in various industrial sectors. However to change the system, these arguments and the proof of the technological and organizational feasibility do not seem to be strong enough.
In our study we analyzed the requirements and potentials of a system change for medical devices from a resource intensive supply chain towards a more sustainable value creation chain (=extension of the life-cycle of medical devices through reprocessing). This question is also one of the key topics within the subprogram "Factory of Tomorrow".
The experience in other European countries, the United States and Australia demonstrate the feasibility of a high quality and safe reprocessing of single-use devices (SUD). In Austria, the authority interprets the relevant law as prohibiting the reprocessing of single-use devices. Thus significant potential for ecological and economical savings remains unused.
It seems that not only the question of SUD reprocessing itself is the main problem but rather the whole system of introduction, usage and disposal of medical devices - no matter whether single or multiple-use. Thus precise and uniform regulations and more information for all stakeholders (legislator, producer, retailer, user / hospitals and patients) are strongly needed.
A major objective of this project was to analyze why reprocessing of SUDs is not currently undertaken in Austria, as well as to identify appropriate possible solutions and map out a strategy to facilitate reprocessing in a safe way.
In the first phase of the project, we analyzed the status quo of SUD reprocessing by compiling a comprehensive literature research and evaluated the results in light of our research questions. This work was supported by our professional network in Europe and the US.
A stakeholder dialogue was designed for the second phase of the project to identify those essential aspects and expectations and to further review the results. We included as stakeholders those individuals who play an important role in the reprocessing and reuse of SUDs and would play an important role should reprocessing be implemented in Austria.
About 40 persons were individually interviewed and invited to give their impressions about risk and opportunities and possible overall system changes. Interviews were then evaluated on qualitative basis and condensed using our research questions and hypotheses.
Based on the results of the research, analysis and the interviews, we compiled a preliminary report about the ecological, economical and social potential and the implications thereof for the reprocessing of medical devices, including implementation strategies that would encourage a change of system.
In order to verify our results once more, we invited a smaller group of key experts for a roundtable meeting. Within this meeting, we reviewed the central aspects for reprocessing and reusing SUDs and outlined options for a system change especially in light of the Austrian situation.
Based on the analysis and the results of the stakeholder-dialogue we outlined a system design for reprocessing of medical devices in Austria including options for future action and a system change for the involved actors.
The Austrian medical device market is valued at over €730 million per year with a positive growth trend. Besides the growing medical demand, another reason is the ever increasing number of disposable single-use devices (SUD) which are dumped after use. SUDs are also responsible for the growing piles of hospital waste. Every year Austrian hospitals produce more than 100 millon kilograms of waste.
However this waste production is not unavoidable. Historically, many items in the hospitals were and some still are reusable and were and can be cleaned, disinfected, sterilised - in other words reprocessed - and reused. Many disposable items that are labeled by the original equipment manufacturer (OEM) as single-use only can also be reprocessed between two and twelve times
In Austria reprocessing of single-use devices is illegal. This in contrast to other countries including Germany and the United States. There reprocessing of SUDs is legal under certain constraints for hospitals and third party reprocessors.
It is the manufacturer's decision whether a medical device is declared single-use or multiple-use. And there is no need to justify it. This decision directly affects whether reprocessing is allowed in Austria or not.
From a manufacturers point of view single-use labelling is clearly advantageous: larger volumes, higher margins, and no liabilities for reprocessing.
Reprocessing is safe. In order to cover up the obvious economic benefits, patients safety is often used as an excuse. Single-use is safe. Reprocessing is not. Of course there are sometimes cases where reprocessed devices do not perform to quality standards. But this applies for new and designated reusable items alike. Clinical evidence supports that there is no increased risk for patient's safety using SUDs if validated cleaning, testing and sterilization procedures are carefully followed.
Reprocessing helps the environment. In Austria the ban on reprocessing SUDs is in contradiction to the political objectives for sustainability.. Significant ecological potentials to save resources, minimize waste and emissions are left idle. On average the reuse of reprocessed SUDs saves 80% of waste, while the overall recource savings are significantly higher.
Reprocessing saves money. Reprocessing of SUDs could approximately save 60 to 100 million Euros in Austria. However, until now this economic potential does not seem to be sufficient to establish a reprocessing system for SUDs.
Reprocessing is feasible. The experience in other countries such as Germany and the United States demonstrate the feasibility of a high quality reprocessing system that guarantees patients safety. This will help to improve existing systems for reprocessing of reusable devices, which are currently sometimes suboptimal in healthcare facilities. What is really missing is a clear commitment of the Austrian legislator and the executing authorities for reprocessing of SUDs.
In the near future we will not see a uniform regulation on a European level. Thus a national approach is required if we are to quickly capitalize on the ecologic and economic benefits. Most elements of an appropriate high level reprocessing system are well tried and tested in other contexts. In Austria we have the chance to swiftly build a safe and high quality reprocessing system for appropriate medical devices.
Mag. Michaela Truppe
Project or cooperation partner
- ARECon GmbH
Mag. Monika Himpelmann, DI Stefan Melnitzky
Obere Donaustrasse 71, 1020 Wien
- Institut für Umweltmedizin und Krankenhaushygiene, Universitätsklinikum Freiburg
DI (FH) Martin Scherrer
Hugstetter Straße 55