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Environmental Policy
XVIVO is a medical device company developing, manufacturing and distributing clinically optimized solutions and systems for use in connection with organ transplantation and priming heart and lung machines. The purpose of XVIVO’s products is to minimize injury of organs ex vivo, extend the preservation time, increase the organ availability and transplantation success rate. XVIVO is committed to provide safe and sustainable products and to be compliant with applicable laws, regulations, and standards where environment plays an important role. We are also committed to minimize the environmental impact of all operations and of our products.
Energy
XVIVO facilities consist 70% of office space and workshops. Warehouses make up the remaining 30 %. Energy consumption mainly comes from heating and lighting of these facilities. We have incorporated energy efficiency measures into our facilities and are promoting efficient energy use.
Chemicals
At XVIVO we evaluate new materials and chemicals in the product development process to ensure that we satisfy directives and regulations such as REACH – Registration, Evaluation, Authorization and Restriction of Chemicals and Restriction of Hazardous Substances (RoHS). In our facilities we are maintaining chemical registers and all new chemicals are assessed related to among other environmental impact. According to XVIVO’s policy, potential hazardous chemicals shall be replaced with less hazardous alternatives.
Production
XVIVO has outsourced all production of commercial products. All suppliers are required to meet the demands in the XVIVO Code of Conduct for Suppliers where it is stated that the supplier shall have procedures in place to secure compliance with the requirements of applicable environmental legislation and regulations. Also, the supplier shall have knowledge of the environmental impacts of its operations, and shall continuously strive to reduce impacts and improve environmental performance in a systematic way. Improvements should cover reduction of energy and water use, emissions and waste as well as the reduction and/or substitution of hazardous chemicals.
Suppliers have suitable environmental management systems and some are certified with ISO 14001.
Packaging
XVIVO strives to reduce unnecessary packaging. For transportation some of the packaging is reused. When possible we use recyclable packaging such as cardboard. XVIVO complies with requirements on packaging for Medical Device products. The source, history and traceability of all materials, especially recycled materials, shall be known and controlled to ensure that the sterile barrier system consistently meet the requirements. With current commercial technologies, it is unlikely that anything other than virgin manufacturing waste will be used in recycled materials, due to insufficient controls to allow the safe use of other recycled material in sterile barrier systems.
Transportation
XVIVO outsources transportation and uses transportation suppliers with strong environmental policy such as UPS and DSV. XVIVO are also striving to use more sea freight instead of air. We are continuously optimizing freight in order to reduce the number of transportations.
Internal air travel has decreased and has largely been replaced by permanent video meetings. When possible we travel with train instead of plane.
Waste
XVIVO follows the Waste Electrical and Electronic Equipment (WEEE) directive and takes a producer responsibility for our machines . The machines have life times of 10 years and almost all components are recyclable. Our operations have some impact on the environment and climate. Primarily through the use of our disposable products. Due to strict sterility requirements, a pre-requisite for guaranteeing patient safety, the reuse of disposable items is prohibited, which WHO also clearly stipulates. Recycling of our disposable products is not either an option due to biological contamination.
Document reviewed and approved by CEO in May 2022.
This policy is reviewed on a regular basis to evaluate continued relevance and to monitor compliance.
