dehp in medical devices

Requirements for labelling of medical devices containing phthalates BS EN 980:2008 Symbols for use in the labelling of medical devices Graphical symbols for use in the labelling of medical devices CD-ROM BS ISO 15223-2:2010 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Symbol development selection and validation BS EN 14375 Healthcare providers are encouraged by the FDA to avoid DEHP products where possible especially in perinatal and neonatal care 3 B Braun a supplier of DEHP-free IV solution containers and infusion devices in the United States provides clinicians and patients safer alternatives to DEHP-plasticized PVC intravenous medical products

DEHP in medical devices: HCWH (Health Care Without

The non-government organisation Health Care Without Harm (HCWH) known for its often aggressive campaigns has issued a press release stating that the European Parliament's Environment Public Health and Food Safety Committee has supported a ban in medical devices of the use of chemicals which can cause cancer mutation and reproductive problems in medical devices

DEHP is the most common phthalate plasticizer in medical devices such as intravenous tubing and bags IV catheters nasogastric tubes dialysis bags and tubing blood bags and transfusion tubing and air tubes DEHP makes these plastics softer and more flexible and was first introduced in the 1940s in blood bags For this reason concern has been expressed about leachates of DEHP transported

However DEHP is not chemically bound to PVC and migrates from medical devices with time and use The potential for DEHP to produce adverse effects in humans has been the subject of considerable discussion and debate in the scientific community In particular newborns in the new environment have to be considered at particularly increased risk because of their small body size and the multiple

The plasticizer di(2-ethylhexyl) phthalate (DEHP) has been widely used in the manufacture of polyvinyl chloride-containing products such as medical and consumer goods Humans can easily be exposed to it because DEHP is ubiquitous in the environment Recent research on the adverse effects of DEHP has focused on reproductive and developmental toxicity in rodents and/or humans

However DEHP is not chemically bound to PVC and migrates from medical devices with time and use The potential for DEHP to produce adverse effects in humans has been the subject of considerable discussion and debate in the scientific community In particular newborns in the new environment have to be considered at particularly increased risk because of their small body size and the multiple

Biomonitoring Summary

DEHP present in medical devices and parenteral delivery systems results in the diester rather than the monoester form being directly introduced into the blood After parenteral administration hydrolysis of DEHP most likely also occurs in the blood and subsequent metabolism is similar to that following ingestion (Koch et al 2005 a 2005 b 2005 c )

a new exemption for DEHP in plastic strain relief devices used to prevent damage to cable connections to MRI imaging coils (Pack 17) – Final Report Under the Framework Contract: Assistance to the Commission on technical socio-economic and cost-benefit assessments related to the implementation and further development of EU waste legislation European Commission RoHS Exemptions Evaluation

Medical devices (MDs) in polyvinyl chloride (PVC) are not a well-known source of exposure to plasticizers in particular during pregnancy Because of its toxicity the di-(2-ethylhexyl) phthalate (DEHP) has been replaced by other plasticizers such as di (isononyl)-cyclohexane-1 2-dicarboxilic acid (DINCH) tri-octyltrimellitate (TOTM) and di-(isononyl) phthalate (DiNP)

SCENIHR Opinion on the safety of medical devices containing DEHP or other plasticisers on neonates and other groups possible at risk 2008 10 RAC Background document to the Opinion on the Annex XV dossier proposing restrictions on four phthalates 2012 11 Technical briefing Phthalates and their alternatives: Health and Environmental concerns Lowell centre for sustainable production 2011

DEHP can leach out of plastic medical devices into solutions that come in contact with the plastic The amount of DEHP that will leach out depends on the temperature the lipid content of the liquid and the duration of contact with the plastic Seriously ill individuals often require more than one of these procedures thus exposing them to even higher levels of DEHP Exposure to DEHP has

Patients undergoing medical procedures such as intravascular therapy parenteral nutritional support blood transfusions hemodialysis cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO) can be exposed to di-(2-ethylhexyl)phthalate (DEHP) a compound used as a plasticizer in polyvinyl chloride (PVC) medical devices DEHP has been shown to produce a wide

DEHP (Di(2-ethylhexyl)-Phthalat) und andere Weichmacher sind Zusatzstoffe fr PVC die auch fr die Herstellung von Medizinprodukten verwendet werden Es ist bekannt dass Weichmacher aus PVC in die Umgebung migrieren knnen Durch die Fettlslichkeit von DEHP tragen DEHP-haltige Medizinprodukte insbesondere dann quantitativ zur DEHP-Aufnahme der Patientinnen und Patienten bei wenn sie mit

EuropeRegulatory Measures by Non-EU AuthoritiesBfArM (Germany) RecommendationsIn the last few years a number of government agencies and expert panels in Europe the US Canada and Japan have reviewed the safety of DEHP used to soften PVC medical devices Each of these agencies and expert panels has found that DEHP exposure from some medical procedures may pose a risk to patients'

Medical devices

Medical devices Certified Class I medical devices for diagnostic therapeutic contraceptive or monitoring use by healthcare professionals and other users Medical face masks Tested filter performance: medical face masks to protect against infectious germs and to reduce the risk of infection Latex free and type II masks according to EN 14683 More Withdrawal cannula - Spikes Safe and

safety of medical devices containing di(2-ethylhexyl) phthalate (DEHP) or alternative plasticizers for their polyvinylchloride (PVC) based components Even though most of the 2008 opinion remains valid new studies on DEHP activity and alternative agents are available Therefore the scientific information published from 2008 and onwards was reviewed and evaluated by SCENIHR The Opinion is

Context - Diethylhexyl-phthalate (DEHP) is a substance that is mainly used as an additive in plastics to make them more flexible Its widespread use in everyday and medical products has raised some concerns about its safety Does DEHP pose a risk to health or the environment? Bis(2-ethylhexyl) phthalate (DEHP) - US EPA No information is available on the acute effects of DEHP in humans via

Some medical devices and equipment including some types of blood and intravenous solution bags tubing for dialysis feeding tubes oxygen masks and surgical gloves California law prohibits the manufacture sale or distribution of children's toys and child care articles containing DEHP at levels greater than 0 1% US law has a similar prohibition How does exposure to DEHP occur? DEHP

Polyvinyl chloride (PVC) plastic is used in medical devices for critical applications such as enternal feeding wound drainage and airway ventilation However it is hard and brittle at room temperature To make it flexible it must be softened by a chemical additive called a "plasticizer " The most commonly used plasticizers today are phthalates DEHP (Di-(2-ethylhexyl) phthalate) also

Medical Devices containing DEHP Plasticised PVC This is to inform the public regarding medical devices made of polyvinylchloride (PVC) containing Di(2-ethylhexyl)phthalate (DEHP) Attachment Size advisory_medical_devices_20080603 pdf: 106 97 KB: Related Health Alerts Global recall of Althin A AF and AX series dialysers February 17 2015 Health Care Equipment February 17 2015 Health

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