Legal And Policy
- Code of Conduct
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- Legal and Policy - World
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Legal and Policy Statements
If you have questions or concerns about the statements within this section, or your interactions with this Web site, contact us here or at 800.567.BAXA (2292), or by writing:
9540 S Maroon Circle
Englewood, CO 80112
Attention: Marketing Department
DEHP STATEMENTBaxa Corporation develops and markets equipment and disposables designed to improve patient safety and reduce the opportunity for errors in medication preparation and administration. Our responsibility to our customers and their patients is to design and manufacture products that are constructed of materials that are approved for use in medical devices and provide the safest available technology that meets the need.
Many medical disposables are manufactured from plastic resins. Some of these resins contain components that can leach out of the finished device and, therefore, contaminate the solution that they come in contact with. In some cases, the best available material for device manufacture may contain trace amounts of these components. Baxa Corporation makes every effort to use raw materials and components that represent the safest solution for product performance and patient safety. For disposables used in the compounding and delivery of fluid medications, Baxa promotes the use of non-DEHP plastic resins wherever possible.
DEHP, or di (2-ethylhexyl) phthalate, is a plasticizer widely used in PVC medical devices to increase their flexibility. Depending on the temperature, fluid lipid content and the duration of contact with the plastic, DEHP can leach into the solution being prepared. In its publication assessing the relative safety of DEHP in medical devices, the FDA acknowledged, "Patients undergoing procedures such as IV therapy and IV administration of drugs, transfusion of blood products, hemodialysis, peritoneal dialysis, artificial ventilation, enteral and parenteral nutrition support, cardiopulmonary bypass and ECMO can be exposed to DEHP released from PVC medical devices."1
The FDA has determined that there is little or no risk posed by patient exposure to DEHP released during the infusion of crystalloid fluids (e.g., normal saline, D5W, Ringer's Lactate).2 While there are no data on adverse effects in humans, based on animal data the FDA recommends that precautions be taken to limit the exposure of the developing male to DEHP. Depending on the data used to derive the tolerable intake/dose ratio, neonates receiving TPN admixtures with lipid may be at increased risk of DEHP-mediated adverse effects.
Most of the Baxa Corporation devices used for multi-ingredient solution compounding are DEHP-free, however the 100 Series of ExactaMix® EVA Containers contains DEHP in its spike port tube. Baxa laboratory testing3 has determined that patients receiving a 3-in-1 (lipid-containing) TPN solution would not exceed the tolerable intake (TI) levels defined by the FDA4 if their weight were greater than 5.175 kg (11.385 lbs). Typical 2-in-1 solutions (no lipids) would potentially result in a clinically insignificant level of DEHP.
Divergent opinions exist regarding the risks of DEHP exposure continue. This is due in part to the lack of scientific evidence for observed effects from exposure and in part due to differences in the data interpretation. Certain medical procedures, where high volumes of fluids are infused over relatively short periods of time, can result in a greater risk of exposure to DEHP. In addition, because of their relative body mass, children undergoing these medical procedures receive a greater dose of DEHP, on a mg/kg basis, than adults. With regards to the potential exposure to DEHP and its relative risks, healthcare providers need to assess their patient populations, in the context of the therapy and its life-saving benefits, to determine the safest and most effective devices and an appropriate risk management strategy to address this issue.
- Baxa Corporation