Article by Christina Hecker, MD, and Stefanie Brauer on Medtec Online on 23.06.2022
Reprocessing of medical instruments under sustainability aspects in outpatient practice
Not easy to implement, but possible - if manufacturers and users pull together
Disposable vs. reusable: reprocessing of medical instruments under sustainability aspects in outpatient practice
Not easy to implement, but possible - if manufacturers and users pull together
- The decision between reusable and disposable instruments is not only a question of climate protection and sustainability, but also a financial decision.
- To find answers to the ecological challenges of our time, we have to think outside the box and develop new (business) models.
- All reprocessing factors should be taken into account as early as the product development stage.
The use of disposable instruments in patient care is steadily increasing. Particularly in the area of plastics, it is evident that the demand for certain raw materials for the production of disposable medical products has doubled in the last 15 years (Statista, 2021). Estimates suggest that the trend will continue and that the quantity will even have tripled by 2025 (ibid.). The demand for materials for reusable medical products, such as metals, has increased only slightly over the same period. The trend can be seen both among doctors in private practice and in clinics. In order to run a climate-neutral and sustainable practice, the ecological impact of the medical products used must also be taken into account. But what does this mean and what possibilities are there in the area of reusable and disposable instruments?
Use of instruments in practice
In private practices, medical devices are needed for various procedures. This can range from small procedures such as the removal of a birthmark to larger outpatient procedures. The quantity and type of instruments used depend on the type of procedure, the speciality and, of course, the preferences of the person treating the patient. But what happens to the instruments used afterwards?
Currently, the following two scenarios are common:
- When disposable medical products are used, they are disposed of.
- When reusable medical products are used, they are reprocessed in practice.
Use of disposable products
Disposable medical products, e.g. made of medical stainless steel, are securely packaged and ultimately end up in household waste. The metallic components are filtered out and melted down in waste management, but not sorted by type. The high-quality medical stainless steel thus becomes a lower-quality product - classic downcycling. One cannot speak of a functioning cycle here.
Use of reusable products
With reusable medical products, there is one main way: the practice reprocesses them itself. At the same time, the effort required for reprocessing, for example with steam sterilisation in an autoclave, is complex and cost-intensive (acquisition costs, space, staff training, regularly required maintenance and validation of the equipment, etc.). In addition, the process itself must be fully documented and may only be carried out by trained personnel. Furthermore, the liability for any errors lies with the practice itself. Sharing resources by sterilising medical devices of different practices in the same building is also too risky due to liability and therefore not feasible. The use of disposable medical products is therefore obvious, but is not a satisfactory and future-proof solution from a sustainability point of view.
So, in order to reduce ecological impacts due to high waste generation from packaging and disposable instruments, it would be better to prefer reusable products and reprocess them - despite all the risks. Furthermore, many single-use products cannot meet all quality requirements. Another reason to give preference to reusable products.
The challenge of recycling from an ecological point of view
The type and effort of reprocessing depend on various factors, which are mainly listed in ISO 17664 and the recommendations of the Robert Koch Institute. On the one hand, the criticality of the product is assessed: from non-critical (products that come into contact with intact skin at most) to semi-critical (products that come into contact with mucous membranes and non-intact skin) to critical (products that penetrate sterile parts of the body). Furthermore, a distinction is made between classes A (without special requirements for reprocessing) and B (with special requirements for reprocessing). This results in the permitted procedures for reprocessing, e.g. whether manual or mechanical reprocessing is permitted.
Necessarily, the autoclaves must be in use as long as possible in order to be profitable for the practice and at the same time meet sustainability requirements. This also includes that the products are repairable and wear parts can be replaced easily and cost-effectively.
Design and materials
In addition, the effort required for reprocessing is crucially dependent on the medical device itself. Despite some efforts and progress in this regard, manufacturers are also still strongly challenged to develop medical devices in such a way that they can be reprocessed as easily as possible. The geometry should be chosen in such a way that all areas are as easily accessible as possible and, for example, cavities or edges and mechanics that are difficult to clean are avoided. At the same time, it is important to find the appropriate material to ensure as many reprocessing cycles as possible with consistent product quality. The choice of reprocessing method and the chemicals used should also be taken into account during product development.
Maintenance and repair
Sustainable practice management in this case depends on the willingness of manufacturers to cooperate, because without the interest in providing wear and spare parts - often over a long period of time - and developing products appropriately, meaningful use is not possible. Although the right to repair was passed by the EU Parliament, a proposal for a directive from the EU Commission is not expected until mid/end 2022. The trend towards more disposable products is understandable from a market economy perspective, which focuses on short-term profit maximisation and does not factor in the global follow-up costs, but it is completely contrary to a sensible response to the ecological challenges of our time.
External reprocessing
Another option to minimise both the effort and the risks in the practices and to reduce the ecological impact is to use external reprocessors. In practice, however, this is more complicated than expected:
- Financial: More instruments are needed to always have a sufficient number available. The service is on average about twice as expensive as doing the reprocessing yourself.
- Ecological: There are relatively few reprocessors, transport must also be taken into account in the balance.
However, if practices show greater interest in such a model, it is conceivable that a nationwide network of reprocessors will develop, so that external reprocessing can be a genuine ecological alternative that at the same time relieves the burden on practices - both in terms of personnel and liability risk.
If one thinks about the topic further, in the sense of a sharing economy, even more approaches are conceivable: It is important that the people who treat the patients receive the appropriate tools. But do they have to be their own? Couldn't a reprocessor maintain a pool of instruments from which the practices order the material they need - borrow it, so to speak - and return it after use? Particularly for rare procedures, there would be no need to keep special instruments in stock and surgical sets could be ordered to suit the respective planned procedures. This would minimise unnecessary reprocessing due to incorrectly assembled sets and save resources for reprocessing, packaging and transport.
Conclusion
In the field of reusable and disposable instruments, there is a lot of potential in terms of sustainable practice management. Manufacturers and users are both called upon to provide alternatives and to ask for them. The legal framework with regard to the right to repair is still being discussed in Brussels - it is currently unclear what requirements manufacturers will have to meet.
External links
https://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Aufb_MedProd/Aufb_MedProd_node.html
Normative references
https://www.beuth.de/de/norm/din-en-iso-17664-1/344664906
Sources and references
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