Anatomical Concepts, Inc. Addresses Risks Associated with Use of PVC-based Plastics in Medical Devices, which can Pose Risks to Both Medical Professionals and Patients

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The company reveals how a class of thermoplastics have been initiated into the orthotic landscape with little regard for the imminent danger it presents to both the health care professional and the patients themselves.

Anatomical Concepts, Inc.

Anatomical Concepts, Inc.

"Hospitals and medical facilities should seriously consider reviewing their policies to prohibit the use of medical products containing PVC-based plastics in the interest of health and safety." - William A. DeToro, CPO, LPO, President, Anatomical Concepts

Anatomical Concepts, Inc. (http://www.anatomicalconceptsinc.com), designer and manufacturer of industry-leading medical devices, custom-fit and custom-fabricated orthoses for both upper and lower extremities, released a formal statement, “Risks associated with the use of PVC-based plastics in Orthotics,” which can be downloaded from the Anatomical Concepts, Inc. website in its entirety at http://www.anatomicalconceptsinc.com/use-of-pvc-based-plastics.

The application of thermoplastics in the orthotics industry has proliferated over the last 30 years, making it the predominant material used today in both custom and off-the-shelf orthotic systems. The physical properties afforded by thermoplastics make it the natural choice when designing support systems that require structural integrity, light weight, dynamic responses and most of all adjustability. Many of the polymer based plastics possess these desirable traits and selection is predicated on the ultimate goals of the orthotic design.

However, research shows that there exists a class of thermoplastics that has been initiated into the orthotic landscape with little regard for the imminent danger it presents to both the health care professional and the patients themselves. A primary example is Kydex® plastic. Kydex® plastic is used for many prefabricated lower extremity and spinal orthotic systems due to its relative low cost, availability and workability, but with potential risk. Kydex® is principally composed of polyvinyl chloride (known as PVC) (1) which is the main structural material in many orthotic systems on the market today. This has occurred despite volumes of compelling evidence classifying PVC as a carcinogen and, at nonspecific levels of exposure, a severe irritant to the viscera of the eyes, nasal passages and lungs. The compound Dioxin (2), a well-known harmful carcinogen, is formed during the manufacturing of PVC and also when PVC items are re-exposed to heat or flame. This Dioxin is then released into the environment exposing those in contact to substantial health risks (3).

There is no question that Kydex® is a reputable product with a proven track record in many applications worldwide. Kydex® and other PVC-based plastics can be used safely in many products, however, it is Anatomical Concept’s position, based on publicly-available, sound evidence, that when used in certain medical devices and adjusted with the use of heat, this material can be harmful.

William A. DeToro, CPO, LPO, president of Anatomical Concepts, said, “Awareness of this serious issue has already been raised by some hospitals. We’re concerned that the use of PVC-based plastics and latex is proliferating in medical devices because of their low cost, and with little regard to medical professionals working with the devices, nearby coworkers, and patients. Anatomical Concepts does not use PVC-based plastics, nor Kydex®, nor latex in any of our products for these reasons. Hospitals and medical facilities should seriously consider reviewing their policies to prohibit the use of medical products containing PVC-based plastics in the interest of heath and safety.”

Studies have demonstrated that heating PVC based products will indeed expose the health care professional, their patient and environment to those aforementioned carcinogens and its most hazardous gaseous state.

The complete article may be downloaded in PDF format from the Anatomical Concepts, Inc. Website at http://www.anatomicalconceptsinc.com/use-of-pvc-based-plastics.

Citations
(1) kydex.com/Uploads/Files/Kydex/Resources/KYDEX_MSDS_101_KYDEXSheet.pdf
(2) noharm.org/global/issues/toxins/pvc_phthalates/dioxin.php
(3) mindfully.org/Plastic/PVC-Primary-Contributor-Dioxin.htm

Additional Resources
fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm228418.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=pvc%20medical%20devices&utm_content=2 and medassets.com/ResourceCenter/Environmental-Resources/Pages/PVCandDEHP.aspx
machinedesign.com/article/materials-controversy-brewing-over-pvc-in-toys-0424 and healthychild.org/blog/comments/big_news_apha_calls_for_a_phase_out_of_pvc/
chej.org/wp-content/uploads/Documents/PVC/healthcare_institutions_reducing_pvc.pdf
en.wikipedia.org/wiki/Polyvinyl_chloride
who.int/mediacentre/factsheets/fs281/en/
noharm.org/global/issues/toxins/pvc_phthalates/alternatives.php
noharm.org/global/issues/toxins/pvc_phthalates/action.php
noharm.org/global/issues/toxins/pvc_phthalates/resources.php#studies
noharm.org/all_regions/issues/toxins/pvc_phthalates/
ronsimonlaw.com/vinyl.html?gclid=COSSpM_11pACFQ9THgodO31oPQ
wisegeek.com/what-is-polyvinyl-chloride.htm
ejnet.org/plastics/pvc/
chron.com/default/article/EPA-sets-new-rules-for-emissions-from-PVC-3324417.php
mindfully.org/Plastic/BPTF-PVC-Resolution.htm
epa.gov/ttn/atw/hlthef/vinylchl.html
chej.org/wp-content/uploads/Documents/PVC/bad_news_comes_in_threes.pdf
sustainablehospitals.org/HTMLSrc/IP_PVC.html
ehp03.niehs.nih.gov/article/fetchArticle.action?articleURI=info%3Adoi%2F10.1289%2Fehp.7617107

About Anatomical Concepts Inc. USA
Since 1990, Anatomical Concepts has developed industry-leading medical devices, custom-fit and custom-fabricated orthoses for both upper and lower extremities. Anatomical Concepts Inc. is the manufacturer and distributor of the V-Vas™ Knee Orthosis (KO) and Knee Ankle Foot Orthosis (KAFO). It is a team of practitioners, designers, and manufacturers utilizing advanced technology to develop superior products that not only deliver effective outcomes, but present ease-of-use for the medical professional. The company is the original concept developer of the PRAFO® Orthosis, its patented design for the orthotic management of the ankle foot that minimizes undesired contact with the boney prominences of the ankle or foot.

Anatomical Concepts is headquartered in Poland, OH, and provides medical devices, services, and consulting both nationally and internationally. The company's innovative product line has inspired the procurement of over seventeen US product patents and/or trademarks. Providing solutions for medical professionals and helping to improve patient outcomes is still the driving force behind the corporation. Anatomical Concepts, Inc. products are FDA registered and also carry the CE marking. All products, including the ELLIOTT™, are designed, manufactured, and trademarked by Anatomical Concepts, Inc.

To learn more about Anatomical Concepts’ range of products, learning resources, and events, please visit http://www.anatomicalconceptsinc.com or call (800) 837-3888.

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