ENVIRONMENTAL PRODUCT DECLARATION for the LoFric Hydro-Kit catheter system. Verified by: DNV (Det Norske Veritas Certification AB)

Transcription

1 ENVIRONMENTAL PRODUCT DECLARATION for the LoFric Hydro-Kit catheter system Verified by: DNV (Det Norske Veritas Certification AB)

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3 Introduction Several conditions affect your body's ability to keep urine in the bladder and to empty the bladder. The most common causes for problems in controlling your bladder are illness, injury and ageing. Common medical diagnoses associated with these conditions are incontinence, retention and neurologic bladder dysfunction. Not being able to empty the bladder in a natural way is of course a problem. The patient needs to find the best solution possible. Not only from a medical point of view but also for their own comfort, treatment security, availability, practical handling etc. Many patients have found LoFric catheters to be their solution for all these aspects and as a result of this they have experienced an improved quality of life. Another very important aspect of all products is the environmental performance. Almost all human activities have some degree of environmental impact. We can all contribute to some extent to reduce this impact by choosing a product with a low environmental impact. This environmental declaration shows a standardized environmental profile for the LoFric Hydro-Kit TM catheter system. A responsible business supporting sustainable development We have a clear vision for a sustainable business including a financial-, social- and environmental dimension. To realize the vision we focus on areas like patient safety, work conditions for employees and environmental aspects of our business and products. Our Code of Conduct set up a framework for all our activities, suppliers included. We are certified by ISO for Environmental Management System since 2001.

4 The LoFric product and technology The method of emptying the bladder using a catheter has been used for thousands of years. Before LoFric catheters were introduced in the early 1980 s, only plastic catheters without coating were available. Lubricant gels were applied to the catheter's surface but these didn't sufficiently reduce friction and the gel tended to disappear from the surface of the catheter when it was inserted, causing trauma on removal. Additionally gel made the procedure messy. A great step forward was taken when the hydrophilic LoFric catheter was introduced. The latest technology consists of a catheter made of a polyolefin-based elastomer, POBE, with Urotonic TM Surface Technology. The expression hydrophilic refers to the ability to attract water. The surface of LoFric consists of polyvinylpyrrolidone (PVP) and salt (NaCl). When immersed in water, PVP attracts water to the surface of the catheter, creating an outer layer mainly consisting of water, which greatly reduces friction. PVP is a harmless and nonallergenic substance which has been used in pharmaceuticals, and medical devices and in the cosmetics industry since the 1930 s (H. Folttmann, Drug Delivery Technology, June 2008, Vol 8, No 6). Today PVP is one of the medical product industry's most studied and well-documented substances. What makes LoFric unique compared to other hydrophilic catheters is that, thanks to the added salt, its surface is ideally adapted to the environment in the urethra. This gives LoFric its unrivalled capacity to retain water throughout catheterization. Once the PVP surface has attracted water, the salt binds the water and prevents it from disappearing during catheterization. The outer layer makes LoFric slide easily - both in and out - reducing friction by up to 95 % (J. Carlsten, IMSOP, Stoke Mandeville Hospital, 1987). Thanks to this unique outer layer, catheterization with LoFric is easy to perform, safe and proven kind to the body, even after long-term use. The LoFric catheter with Urotonic TM Surface Technology is a very well-documented catheter that gives a significantly reduced risk of complications, both in short-term and long-term use ( com/professionals/lofric-proven-better-for-you/ documentation). Water PVP + salt Raw catheter

5 The catheters are then packed in different types of functional packaging to further improve patient functionality. The primary packaging closest to the catheter can be a plain container for the urinary catheter for convenient usage at home or in hospital, or it can be a more complex multi-functional packaging including for example a urine bag to be used away from home. In this way, the comprehensive LoFric assortment gives a very good overall function for the patient. LoFric Hydro-Kit is an all-in-one catheter system including the catheter with sterile water and an integrated urine collection bag. Wheelchair users find it particularly convenient, and its collection bag also makes it ideal for bedridden patients in need of post-op bladder emptying. LoFric Hydro-Kit offers the freedom and reassurance to catheterize safely wherever the user is, whenever needed, whether toilet facilities are available or not. The catheters and their primary packaging are sterilized to obtain an optimal patient safety. The packaging keeps the water from the catheter until activation. Catheters with primary packaging are packed directly into product cartons and further into larger transport boxes. These boxes are transported on pallets with plastic covers to obtain a protection during transport. Due to our environmental concern, we try, as far as possible, to reduce the amount of packaging materials, while maintaining product and patient safety. Plant and process T he manufacturing of LoFric urinary catheters is located at a high-tech manufacturing unit in Mölndal, Sweden. In the manufacturing process, the catheter tube is first extruded into the desired shape and size. Many different sizes are produced to fit all patient needs. The catheter tube is then attached to a connector whose function is to create a good connection to the urinary drainage system. The catheter then undergoes a coating process to create a hydrophilic surface coating, thereby giving the patient as comfortable a catheterization as possible. This coating process gives LoFric catheters a unique and patient-friendly function. The Functional and Declared Unit The function of a urinary catheter is to empty the bladder for a patient who cannot empty the bladder in a normal way. The patient s condition determines the time that the artificial emptying needs to continue. The functional unit has been chosen to be one catheter system, CH 12, 40 cm.

6 Life Cycle Assessment (LCA) Study and System Boundaries This environmental product declaration is based on a full LCA model of the production, use and disposal of the urinary catheters. The model and thus also the environmental performance results covers the entire life cycle for use of the specific urinary catheter. This includes extraction of raw materials, material production, catheter and packaging production, use of the catheter and waste handling of all materials. Transports and external energy production are also included in the model and allocated to each process. The environmental performance results are thus a good overall measure of the environmental aspects for the use of the specific catheter. To achieve a structured overview of the environmental performance, the results from the life cycle assessment have been divided in three different process areas which represent upstream, core and downstream processes. These process areas are defined as follows: Upstream processes Upstream processes include mainly the raw material extraction and production of materials used in the product. These are mainly plastics and other materials used in catheters and packaging materials. This process group also includes some production of prefabricated materials such as catheter tubing. Materials for the sterilization process are also included in this group. General LCA data has been used for the production of the different materials. Core processes Production processes taking place at the production facility in Mölndal, Sweden. Processes included here are preparation of the raw catheter, the hydrophilic coating process, packaging processes and sterilization. The LCA study covers the entire plant for urinary catheter production including operation of the buildings etc. Waste handling from the production is also included here. Primary data from the plant has been used in the LCA model. Data from year 2010 were used. Downstream processes Processes taking place after the product has left the production facility in Mölndal. This group thus includes transport to a typical customer, 1400 km from Mölndal to central Europe, product use at a typical customer, waste management for the catheter, and packaging materials and finally energy recovery from the waste handling processes. The energy recovery is given as an additional information in table 2. Incineration of the waste has been assumed, except for carton board that is material recycled to 80 % and where the remaining part is incinerated. A standard transport from the customer to the incineration plant of 50 km truck transport has been used. Energy from the incineration is assumed to be recovered in a district heating network where the heat is replacing fuel oil combustion.

7 Environmental performance The environmental performance gives a measure of a product with respect to different environmental impact categories. These environmental impact categories represent use of recources (energy resources and material resources), potential environmental impacts (Global Warming Potential, Ozone Depletion Potential, Eutrophication Potential, Acidification Potential and Photochemical Ozone Creation Potential and Waste (hazardous and other wastes)). The overall environmental performance results are presented in Table 1 per functional unit. The data are calculated with the LCA model developed in a research project. All calculations and data processing have been performed by IVL (Swedish Environmental Research Institute). The results are presented for the upstream, core and downstream part of the life cycle system. The effect of the avoided processes i.e., in this case, using the combustion heat from incineration of the wastes to replace fuel oil in a district heating system is shown separately as additional information in Table 2. A specification of the resource use has also been made to enable a better assessment of the different resource types. The specification is shown in Table 3. The different impact categories are described and the results are commented below.

8 Primary energy resources This impact category shows the depletion of energy resources calculated as original energy resources from the earth. The resource use has been divided into non-renewable (mainly fossil fuels and uranium) and renewable (mainly hydro power, biomass fuels and wind power) resources. The overall system is using 34 % renewable energy resources. However, in the core processes, the share of renewable energy is 94 %. The crude oil that is used to form the plastic materials in both catheters and in packaging material has been calculated as an energy resource use in spite of the fact that the energy is not released but still remains as an inherent energy resource in the material. This inherent energy is however released in the incineration of the material. Crude oil is also a fuel that is accounted to be replaced by other types of heat generation. For this reason, the avoided crude oil use can be subtracted from the primary energy use of the system. Primary material resources This impact category shows the depletion of material resources calculated as original material resources from the earth. The resource use has been divided into non-renewable and renewable material resources. The overall system is using 97 % renewable material resources. However, as shown in Table 3, 97 % of the renewable material resources emanate from water use. No production is localized to areas with water shortages. Global Warming Potential (GWP 100) GWP is a relative measure of how much heat (as IR radiation) a greenhouse gas can absorb in the atmosphere over a certain time, in this case 100 years. The heat absorption is measured relative to carbon dioxide. Important greenhouse gases are CO 2, CH 4 and N 2 O. GWP gives a measure of the greenhouse effect from a product or a process. In this case, the contribution from upstream, core and downstream processes are relatively equal, Table 1. The total emission is 160 g CO 2 eq./catheter. A significant amount of GWP can be avoided by using the heat from incineration of the waste. Ozone Depletion Potential (ODP) Some emittants, e.g. freons, are transported to the upper layer of the atmosphere where they react with ozone and in this way reduce the ozone layer which protects the earth from UV radiation that would otherwise be harmful to plants, animals and humans. ODP is a measure of this depletion effect. The contribution to ODP is small. The major sources are emissions of chlorinated solvents and various emissions from energy production such as nuclear power production. Eutrophication Potential (EP) Eutrophication is an enrichment of different nutrients in a biosphere. Eutrophication damages occur mainly in aquatic systems such as lakes or coastal areas but can also occur in terrestrial areas. Eutrophication is caused by different emissions such as air pollutants, waste waters and fertilization in agriculture. The Eutrophication Potential is equally distributed between upstream, core and downstream processes. The main source of Eutrophication Potential is the emission of NO X.

9 Acidification Potential (AP) AP is a measure of the potential acidification that a product or process can cause. The acidification is caused by emissions of acidifying substances such as SO 2 and NO X. Acidification can cause damage to the natural ecosystem and agricultural products as well as to other materials and products in the society. In this case, the main source of Acidification Potential is the emission of SO 2 and NO X. The emissions are 0.65 g SO 2 eq./ catheter. A significant amount of AP can be avoided by using the heat from incineration of the waste. Photochemical Ozone Creation Potential (POCP) When NO X and hydrocarbons are exposed to sunlight a number of complex reactions take place and photochemical oxidants are formed. The most important oxidant is often ozone (O 3 ). Ozone can damage vegetation and materials and is toxic to humans in high concentrations. In this case, POCP is generated by many different substances in many different production processes. The overall emission of POCP is 0.11 g ethene eq./catheter. Also in this case, a significant amount of POCP can be avoided by using the heat from incineration of the waste. Wastes Wastes are usually difficult to evaluate and can include several uncertainties, especially concerning type of waste and waste handling from upstream processes. The wastes from the system have been divided into hazardous and other wastes. Hazardous wastes include, in this case, also regulated chemicals and radioactive wastes from nuclear power production.

10 Table 1 Environmental performance for the LoFric Hydro-Kit catheter system shown per functional unit* Use of resources Energy resources non renewable Energy resources renewable Material resources non renewable Material resources renewable Potential environmental impacts Global Warming Potential (GWP 100) Unit Total Upstream processes per F.U.* Core processes Downstream processes MJ MJ kg kg kg CO 2 eq. 1.6E E E E-02 Ozone Depletion Potential (ODP) kg CFC11 eq. 1.0E E E-06 0 Table 2 Additional information Avoided processes Total # E E E-06 Table 3 Specification of the most significant recources Resources Energy resources non renewable (MJ) Energy resources renewable (MJ) Material resources non renewable (kg) Material resources renewable (kg) per F.U. Natural gas: 42% Crude oil: 40% Coal: 9 % Nuclear: 8 % Peat: 2 % Hydro power: 77 % Biomass fuel: 22 % Wind power: 1 % Stone and sand: 36 % Clay mineral: 35 % Soil and till: 21 % Bauxite AlO(OH): 3 % Fe: 2 % Other: 3 % Freshwater: 70 % Water unspecified: 26 % Wood: 1 % Other: 3 % Eutrophication Potential (EP) kg PO 4 eq. 1.5E E E E E E-04 Avoided processes per F.U. Acidification Potential (AP) kg SO 2 eq. 6.5E E E E-04 Photochemical Ozone Creation Potential (POCP) kg ethene eq. 1.1E E E E E E E E-05 Energy resources Crude oil gain: -43 % non renewable + (MJ) + Avoided energy resources are related to total energy use Other indicators Waste, hazardous kg 3.1E E E E-04 Waste, other kg 2.1E E E E E-02 *One *One catheter catheter system CH 12, CH 40 12, cm. 40 cm. excl. avoided processes # incl. avoided processes

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12 VERIFIED BY DNV CERIFICATION Promoting sustainable forest management See for more information on this document and for background material. Calculations and data processing have been performed by IVL (Swedish Environmental Research Institute). Valid until Contact information Independent verifi cation of the declaration and data, according to ISO 14021: Det Norske Veritas Certification AB Hemvärnsgatan 9 SE Solna, Sweden. Wellspect HealthCare, Aminogatan 1, P.O. Box 14, SE Mölndal, Sweden. Phone: Wellspect HealthCare, a DENTSPLY International Company. All rights reserved GBX-1212