These hbm values are useful to assess a higher body burden with metabolites of dehp. The department of environment and science acknowledges aboriginal peoples and torres strait islander peoples as the traditional owners and custodians of the land. Small bore immersion extension set with 14 tubing and 0. Di2ethylhexylphthalate dehp proposition 65 warnings.
Medical devices containing pvc with di2ethylhexylphthalate dehp have important clinical benefits. Flexible pvc polyvinyl chloride is produced by mixing a rigid pvc resin with a blend. Aggregate exposure to dehp from multiple medical devices. I understand you cannot put phthalate free but you should be able to put dehp free. Medical devices mds in polyvinyl chloride pvc are not a wellknown source of exposure to plasticizers, in particular during pregnancy. Agency for toxic substances and disease registrypublic health statement. Final opinion on the safety of medical devices containing dehp. Tonnes dehp year according to information retrieved from all the seven manufacturers of dehp in the eu, the total manufactured volume in 2007 was 341,000 tonnes.
The major use more than 95% is soft medical grade pvc in. Revision date indicates the date the msds or sds was last revised. In the dehp treated cows, dehp metabolite levels increased p dehp exposure days 2 and 4, followed by rapid clearance throughout the subsequent days of the experiment days 11, 19 and 24 to levels similar to those detected in the control group table 2. Di2ethylhexylphthalate dehp causes impaired adipocyte. Quality assurance statement pvc and dehpfree products. Immersion extension set 14 tubing, no clamp tubing a. Dehp, dep and dbp exposure analysis using urinary metabolites. Usfloors is committed to providing unique and sustainable floors that have minimal impact on the environment and do not introduce anything into the human environment that would cause adverse health effects. This suggests that measuring concentrations of free and conjugated forms will be. Figure 01 overall flow of dehp sent into circulation in eu society in 2007. Hospital will include a statement on its bidquote content certification form asking vendors if their product contains mercury. Di2ethylhexylphthalate and bisphenol a testing for health. Fda advises clinicians to use dehpfree products where available.
Renesas leadfree rohs compliant devices do not contain any of 9 substances known as hazardous substances cd, crvi, hg, pbb, pbde, dehp, bbp, dbp, dibp, whereas lead pb does not exceed 0. On september 1, 2008 health canada will be sending out a survey to all manufacturers of licensed class ii, iii and iv medical devices. This transition to phthalatefree plasticizers has prevented manufacturers. Dehp is listed in the worlds largest and most authoritative dictionary database of abbreviations and acronyms. Manufacturer indicates the medical device manufacturer. In addition, although plasticizerfree tubing can be used gravity infusion of lipid emulsions, the. Home news dehpfree and phthalatefree medical tubing grayline llc has introduced flexible, medical grade pvc tubing products that are either phthalatefree or dehpfree. After software installation, use basic fax settings from the hp utility. At this time health canada is not requesting that manufacturers submit test reports on dehp and bpa. Eco bear biohazard cleaningflickrdangers of phthalates and dehp. Dehp is listed in regulation ec no 12722008 as follows.
The smartsite needlefree valve helps to protect your staff from potential and harmful injuries. To set up after software installation, open the hp printer software doubleclick the icon with the printer name on the desktop, go to the fax tab, and then select fax setup wizard. Di 2ethylhexyl phthalate or dehp is a synthetic chemical belonging to a family known as phthalates, which is used to make plastics more. Thyroid hormones ths levels and transcriptional profiling of key genes related to. Prevention of medication errors with guardrails safety software. Dehp is the most commonly used phthalate based plasticizer in these applications.
The smartsite needle free valve helps to protect your staff from potential and harmful injuries. Classification and labelling of dehp according to annex vi, table 3. In europe, for example, dinp can no longer be used in toys and childcare items that can be put in the mouth even though the eu scientific risk assessment concluded that its use in toys does not pose. A plasticizer softener is typically added to increase the flexibility of the polymer. Renesas lead free rohs compliant devices do not contain any of 9 substances known as hazardous substances cd, crvi, hg, pbb, pbde, dehp, bbp, dbp, dibp, whereas lead pb does not exceed 0. Our dehppvcfree pledge has committed the hospital to. Viaflo containers are a nonpvc nondehp option that provides additional flexibility across your fluid therapy portfolio to help meet your patient needs.
Dehp is a plasticizer which has been used in plastic products of everyday use for decades. To further investigate these effects, we used an immature rat model to examine the effects of di2 ethylhexyl phthalate dehp and flutamide flu on the male reproductive system. Dehp free pvc nasogastric tubes entriflextm and dobbhoff tm cbw enteral nutrition products covidien kendall. Dehp and bpa testing for health canada medical device licensing. Dehp exposure is known to cause adverse effects on the development of the male reproductive systems of laboratory animals. The bair hugger 241 fluid warming set enables you to use two warming modalities with one piece of equipment the bair hugger warming unit. Testing is available through intertek s global network of laboratories supporting. This public health statement is the summary chapter from the toxicological profile for di2 ethylhexyl phthalate dehp. Plastics are used throughout the medical device industry, and as you can imagine, so are plasticizers. Although more research is needed to develop alternatives to dehp that gives the same benefits of being soft and.
A shorter version, the toxfaqstm is also available. Phthalates in soft pvc products used in food production equipment and in other food contact materials on the danish. The effects of disturbance on hypothalamuspituitarythyroid. Grayline llc has introduced flexible, medical grade pvc tubing products that are either phthalatefree or dehpfree. The four phthalates are mainly used as insulation plasticizers, and are on the reach list of svhc substances of very high concern. Highlights after dehp intake, dehp and mehp in blood show oscillating time courses. The european commission asked the european food safety authority efsa in accordance with article 123 of regulation ec no 19352004, to update its opinions published in 2005 on certain phthalates di. Kinetics of di2ethylhexyl phthalate dehp and mono2. These include the nonuse of di2ethyl hexylphthalate dehp, butyl benzyl phthalate bbp, dibutyl phthalate dbp and diisobutyl phthalate dibp. The eu has restricted six phthalates bbp, dbp, dehp, didp diisodecyl. With a smooth, swabable surface designed to help clinicians disinfect every access point, our smartsite technology comes standard on our extensive line of iv sets and accessories that includes primary, gravity, secondary and extension sets. Prenatal and ancestral exposure to dehp significantly decreased gene expression of cell cycle regulators in the f1 and f3 generations.
How ever as was stated the statement below is concerning. Unplasticized pvc is hard and brittle at room temperature. In order to correctly assess the mean and high p95 exposure to the groupphthalates. Latex free, silicone free, dehp free, styrene free.
Dehp is still used in various types of plastic consumer products. Just slide the 241 set into a bair hugger warming unit hose and you instantly add fluid warming to the warming protocol. Phthalates, a family of industrial chemicals used to soften polyvinyl chloride pvc plastic and as solvents in cosmetics and other consumer products, can damage the liver, kidneys, lungs, and reproductive system. Using this test data, cirrus logic certifies that all ics currently available for sale or delivery are halogen free. Tonnes dehpyear according to information retrieved from all the seven manufacturers of dehp in the eu, the total manufactured volume in 2007 was 341,000 tonnes. We recognise their connection to land, sea and community, and pay our respects to elders past, present and emerging. Dehpfree phthalatefree pvc medical tubing grayline llc. Phthalates in soft pvc products used in food production. Dec 11, 2014 dehp is listed in regulation ec no 12722008 as follows. Intertek, a global leader in restricted materials compliance, provides di2ethylhexylphthalate dehp testing and bisphenol a bpa testing for the purposes of medical device licensing in canada. Msds sds are dated when they are originally issued and when any significant change has been made to the chemical compound or research has revealed a health or physical hazard different from what was originally stated.
Procedure product instructions for use documents ifus are available in electronic pdf formats. Aug 25, 2011 tion sets with dehp free andor pvc free sets could present a dual benefit, by preventing patient exposure to a known toxin while optimizing the clinical properties of. The three main examples of phthalates used as plasticizer in pvc are dinp, diisononyl phthalate, didp diisodecyl phthalate and dehp diethylhexyl phthalate, also known as dop dioctyl phthalate. In the dehptreated cows, dehpmetabolite levels increased p software is provided to you as is, and medtronic expressly disclaims any and all warranties with respect to the licensed software and your use thereof, including without limitation any implied warranties of merchantability, fitness for a particular purpose, title, and noninfringement. Furthermore, the cep panel decided to group dbp, bbp, dehp and dinp into a common assessment group and to allocate potency factors relative to dehp as the reference substance see section 4. Di 2ethylhexyl phthalate dehp is the type used the most in medical devices such as. Rohs 3 adds four additional restricted substances phthalates to the list of six. Kangaroo dehpfree enteral feeding pump sets with antifree. As such, usfloors vinyl flooring products, across all brands, are manufactured phthalatefree and contain no dopdehp additives. Halogen free statement cirrus logic works closely with our suppliers to gather 3rd party test data at the homogeneous material level. No leaching of phthalates into fluid pathway, avoiding therefore patient exposure to dehp plasticizer. Hard copy ifus are available freeofcharge to customers and will be provided within seven business days. Rohs stands for restriction of hazardous substances, and impacts the entire electronics industry and many electrical products as well.
Prenatal and ancestral exposure to di2ethylhexyl phthalate. Sample list of pvcdehpfree products in health care. Dehp belongs to a family of chemicals called phthalates, which are added to some plastics to make them flexible. Because of its toxicity, the di2ethylhexyl phthalate dehp has been replaced by other plasticizers such as di isononylcyclohexane1,2dicarboxilic acid dinch, trioctyltrimellitate totm and diisononyl phthalate dinp. Phthalates or phthalate esters, are esters of phthalic anhydride. Dehp deregulates adipokine levels and impairs fatty acid. Symbol glossary definitions symbol standard reference standard title symbol title explanatory text en 980, clause 5. In this survey the manufacturer will only be asked to check a box as to whether their devices contain. Dehp statement cl101495 latex free statement cl101848 consumable storage conditions cl102426. Studies in mice and murine cell culture models identified dehp as an endocrine disruptor that may also. Bis2ethylhexyl phthalate is an organic compound with the formula c6h4 2. It is one in a series of public health statements about hazardous substances and their health effects.
This statement implies that biochemical evidence itself should not serve as the basis for a loael. Public health statement di2ethylhexylphthalate dehp. Influence of lipid type on bis 2ethylhexylphthalate dehp. Limits, mhazard factors class and category codes hazard statement codes. A softener for polyvinyl chloride pvc, a plastic polymer used in a wide array of products. Memorandum of understanding between the united states. Flexible pvc polyvinyl chloride is produced by mixing a rigid pvc resin with a blend of plasticizers, stabilizers, fillers and pigments. Doserelated blood levels of dehp are 50 times higher in humans than in rats.
Doserelated blood levels of free mehp are 2 times higher in humans than in rats. Some shower curtains, furniture and automobile upholstery, garden hoses, floor tiles, and coverings on wires and cables. Carryover effects of acute dehp exposure on ovarian function. Exposure of hospitalised pregnant women to plasticizers. Elimination of dehp and its metabolites is short with halflives of 4. Tubing has check valve and rotating luer but no clamp. In this study, zebrafish danio rerio embryos were exposed to different concentrations of dehp 0, 40, 100, 200, 400.
Sick infants treated in the nicu have high exposure levels to the reproductive toxicant dehp. Hard copy ifus are available free ofcharge to customers and will be provided within seven business days. We previously demonstrated that the androgenic and antiandrogenic effects of endocrine disruptors eds alter reproductive function and exert distinct effects on developing male reproductive organs. Di2ethylhexyl phthalate dehp has the potential to disrupt the thyroid endocrine system, but the underlying mechanism is unknown. Dehp is the plasticizer for most pvc medical devices. Viaflo containers are not made with natural rubber latex and are available in 250 ml, 500 ml and 1l sizes. Any business that sells applicable electrical or electronic products, equipment, subassemblies, cables, components, or spare parts directly to. Dec 02, 2015 di2 ethylhexyl phthalate dehp causes impaired adipocyte function and alters serum metabolites kloting nora, 1 nico hesselbarth, 2 martin gericke, 3 anne kunath, 4 ronald biemann, 5 rima chakaroun, 2 joanna kosacka, 2 peter kovacs, 1 matthias kern, 2 michael stumvoll, 1, 2 bernd fischer, 6 ulrike rollekampczyk, 7 ralph feltens. The original rohs, also known as directive 200295ec, originated in the european union in 2002 and restricts the use of six hazardous materials found in electrical and electronic products. Phthalates are also frequently used in soft plastic fishing lures, caulk, paint. Please contact cantel customer service at 8003283345 to request your hard copy if required. Home news dehp free and phthalate free medical tubing grayline llc has introduced flexible, medical grade pvc tubing products that are either phthalate free or dehp free.
Rohs 3 eu directive 2015863 adds category 11 catchall products and adds four new restricted substances all phthalates. Sep 26, 2009 we previously demonstrated that the androgenic and antiandrogenic effects of endocrine disruptors eds alter reproductive function and exert distinct effects on developing male reproductive organs. Kangaroo dehp free pump set, ml, 30ca buy the covidien medical supply kangaroo dehp free pump set, ml, 30ca online at discount prices, from totaldiabetessupplycom. Di 2ethylhexyl phthalate dehp, is a compound largely used in plasticizing polyvinyl chloride resin pvc products worldwide. For detailed information, please contact your sales representative. Studies in mice and murine cell culture models identified dehp as.