ABSTRACT
Sustainability of a medical device has not yet become a major issue in public discussions compared to other topics with impact to material performance, clinical application, production economy and environmental pollution. Due to their unique properties, polymers (plastics) allow for multiple, flexible applications in medical device technology. Polymers are part of the majority of disposable and single use medical device and contribute with 3% to the worldwide production of plastics. The global medical polymer market size was valued 19.9 billion US-$ in 2022 and its value projection for 2023 is expected to reach 43.03 billion US-$ Here, a wider concept of related sustainability is introduced for medical devices and their polymer components. A close look on medical device specification reveals that additional properties are required to provide sustainability, such as biodegradability, quality by device design (QbD), as well as an inbuild performance service for patients, healthcare professionals and healthcare providers. The increasing global numbers for chronic and non-communicable diseases require a huge demand for single use medical devices. A careful look at polymer specification and its performance properties is needed, including possible chemical modifications and degradation processes during waste disposal. Bioengineers in charge of design and production of medical devices will only be successful when they apply a holistic and interdisciplinary approach to medical device sustainability.
ABSTRACT
Sustainability of a product or device is currently primarily related to its environmental footprint. Here, a wider concept of sustainability is introduced for medical devices and their components in healthcare provision. Such devices sustain healthcare and patient wellbeing due to their quality specifications for material composition, product design and performance. The term quality must be intended in the most comprehensive term, including purity and biocompatibility of materials, device reliability, limited number of recalls and reduced risks as well as acceptability for patients. A close look on medical device specification shows, however, that additional parameters, such as societal, demographic and economic factors also determine medical device sustainability. The medical device life cycle, from design phase, production process to clinical application and the final disposal, also determines its impact. Recommendations for healthcare operators and managers will complete the hypothesis of this paper, that a thoroughly outlined device choice and operation together with a careful waste management of spent medical devices and their components positively affects medical device sustainability. As an example, the limited quantity of wastes and the reduced risks for adverse reaction have a positive impact on both the environmental pollution and on the costs sustained by the healthcare organisations and by the community. These factors determine both, the success of healthcare manoeuvres and the related environmental footprint.
ABSTRACT
This paper describes the historical journey that led to the adoption of on-line hemodiafiltration (HDF) as a standard therapy for the patients in the Fresenius Medical Care (FME) NephroCare dialysis network. In 1998, FME faced the tremendous challenge of consolidating a series of heterogeneous clinics under one umbrella. In 2002, the European Best Practice Guidelines (EBPG) for hemodialysis (HD) were published by the European Renal Association which FME promptly adopted within its clinic network. On the basis of this document, the strategic decision was taken to apply high-flux, biocompatible membranes throughout the entire network. To cope with the effective implementation of this step, the clinics' technical infrastructure was updated. The widespread application of high-flux therapy, together with the implementation of the required infrastructure, especially concerning water quality, opened the way to the extensive use of on-line HDF. To fully realize this ambitious goal, two further technological steps were targeted and successfully reached: introduction of the Fresenius 5008 dialysis equipment and an even stricter control of the water quality. The combined pressure from the educational activities, which brought about a preliminary cultural change, and the creation of a target based on the percentage of treatments by this technique resulted in an increasing implementation of this modality by the individual clinics. After 2004, on-line HDF continuously increased its share among the dialysis techniques prescribed in the network and currently more than 50% of patients are on this modality.
