BPA in Medical Devices - is This a Concern? Carmel Pharma's PhaSeal Closed-System Drug Transfer Device (CSTD) Does Not Contain BPA.
Columbus, OH, January 14, 2011 --(PR.com)-- Bisphenol A (BPA) is a substance used to make common polycarbonate plastic. However, the growing global concern regarding the health effects of this substance has lead several countries and organizations to issue health warnings. BPA will be banned in the manufacture of baby bottles 2011 in the European Union[1], and in September 2010 Canada listed Bisphenol A as a ”toxic substance”.[2]
US Food and Drug Administration (FDA)
In cooperation with the National Toxicology Program, the FDA’s National Center for Toxicological Research is currently carrying out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA .(3)]
As these studies continue, the FDA is taking reasonable steps to reduce human exposure to BPA within the food supply chain.
In reference:
The 2008–2009 Annual Report of the President’s Cancer Panel declared: ”because of the long latency period of many cancers, the available evidence argues for a precautionary approach to these diverse chemicals, which include (...) Bisphenol A”.[4]
The 2010 review at Tufts University Medical School concluded that "Bisphenol A may increase cancer risk"[5], while another 2010 study found that "BPA may reduce sensitivity to chemotherapy treatment of specific tumors"[6].
Some in vitro studies have suggested that "BPA can promote the growth of neuroblastoma cells"[7], whilst another 2010 in vitro study has concluded that, "BPA potently promote invasion and metastasis of neuroblastoma cells through over expression of MMP-2 and MMP-9 as well as down regulation of TIMP2"[8].
Dan Pitulia, CEO of Carmel Pharma, the manufacturer of the closed-system drug transfer device* PhaSeal, states: "I want to make it clear that the PhaSeal system does not contain Bisphenol A. All our products are made of materials that are safe and BPA free. While our product is designed to protect health care workers from chemical contamination, we also of course take the patients health into consideration."
* National Institute for Occupational Safety and Health (NIOSH) defines a closed-system drug transfer device (CSTD) as a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug vapor concentrations outside the system. The International Society of Oncology Pharmacy Practioners (ISOPP) uses a similar definition, but includes the terms airtight and leakproof.
[1] John Dalli, Commissioner in charge of Health and Consumer Policy, the EU’s executive Commission in a statement.
[2] http://www.reuters.com/article/idUSTRE69D4MT20101014
[3] http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm197739.htm
[4] http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp08-09rpt/PCP_Report_08-09_508.pdf
[5] Soto, A. M.; Sonnenschein, C. (2010). ”Environmental causes of cancer: endocrine disruptors as carcinogens”. Nature Reviews Endocrinology.
[6] Lapensee, E. W. et.al. (2010). ”Bisphenol a and estradiol are equipotent in antagonizing cisplatin-induced cytotoxicity in breast cancer cells”. Cancer Letters 290
[7] Zhu, H.; Xiao, X.; Zheng, J.; Zheng, S.; Dong, K.; Yu, Y. (2009). ”Growth-promoting effect of bisphenol a on neuroblastoma in vitro and in vivo”. Journal of Pediatric Surgery 44 (4): 672–680.
[8] Zhu, H; et.al (2010). ”Environmental endocrine disruptors promote invasion and metastasis of SK-N-SH human neuroblastoma cells”. Oncology reports 23 (1): 129–39.
SW 902 2011-01
Contact: Cheryl Jacobs
Company Name: Carmel Pharma, Inc.
Email Address: cheryl.jacobs@carmelpharma.com
Web site address: www.phaseal.com
###
US Food and Drug Administration (FDA)
In cooperation with the National Toxicology Program, the FDA’s National Center for Toxicological Research is currently carrying out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA .(3)]
As these studies continue, the FDA is taking reasonable steps to reduce human exposure to BPA within the food supply chain.
In reference:
The 2008–2009 Annual Report of the President’s Cancer Panel declared: ”because of the long latency period of many cancers, the available evidence argues for a precautionary approach to these diverse chemicals, which include (...) Bisphenol A”.[4]
The 2010 review at Tufts University Medical School concluded that "Bisphenol A may increase cancer risk"[5], while another 2010 study found that "BPA may reduce sensitivity to chemotherapy treatment of specific tumors"[6].
Some in vitro studies have suggested that "BPA can promote the growth of neuroblastoma cells"[7], whilst another 2010 in vitro study has concluded that, "BPA potently promote invasion and metastasis of neuroblastoma cells through over expression of MMP-2 and MMP-9 as well as down regulation of TIMP2"[8].
Dan Pitulia, CEO of Carmel Pharma, the manufacturer of the closed-system drug transfer device* PhaSeal, states: "I want to make it clear that the PhaSeal system does not contain Bisphenol A. All our products are made of materials that are safe and BPA free. While our product is designed to protect health care workers from chemical contamination, we also of course take the patients health into consideration."
* National Institute for Occupational Safety and Health (NIOSH) defines a closed-system drug transfer device (CSTD) as a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug vapor concentrations outside the system. The International Society of Oncology Pharmacy Practioners (ISOPP) uses a similar definition, but includes the terms airtight and leakproof.
[1] John Dalli, Commissioner in charge of Health and Consumer Policy, the EU’s executive Commission in a statement.
[2] http://www.reuters.com/article/idUSTRE69D4MT20101014
[3] http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm197739.htm
[4] http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp08-09rpt/PCP_Report_08-09_508.pdf
[5] Soto, A. M.; Sonnenschein, C. (2010). ”Environmental causes of cancer: endocrine disruptors as carcinogens”. Nature Reviews Endocrinology.
[6] Lapensee, E. W. et.al. (2010). ”Bisphenol a and estradiol are equipotent in antagonizing cisplatin-induced cytotoxicity in breast cancer cells”. Cancer Letters 290
[7] Zhu, H.; Xiao, X.; Zheng, J.; Zheng, S.; Dong, K.; Yu, Y. (2009). ”Growth-promoting effect of bisphenol a on neuroblastoma in vitro and in vivo”. Journal of Pediatric Surgery 44 (4): 672–680.
[8] Zhu, H; et.al (2010). ”Environmental endocrine disruptors promote invasion and metastasis of SK-N-SH human neuroblastoma cells”. Oncology reports 23 (1): 129–39.
SW 902 2011-01
Contact: Cheryl Jacobs
Company Name: Carmel Pharma, Inc.
Email Address: cheryl.jacobs@carmelpharma.com
Web site address: www.phaseal.com
###
Contact
Carmel Pharma, Inc.
Cheryl Jacobs
614-318-2622
www.carmelpharma.com
Cheryl Jacobs
614-318-2622
www.carmelpharma.com
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