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New Guidance Issued on Phthalates in Medical Devices: Medical Engineering Technologies Ltd Leads the Way in Analytical Methods Screening

Jan 10, 2024
By Luminita Moraru MSc | MRSC | MBTS

Phthalates new guidance

Medical Engineering Technologies Ltd (MET), a leading provider for medical and combination device batch release and design validation testing, announces its commitment to adhering to the latest guidance on phthalates in medical devices. With the government extending acceptance of CE marked medical devices in Great Britain, MET is at the forefront of ensuring the safety and efficacy of its products through rigorous analytical methods screening. 

Phthalates, a group of chemicals commonly used to increase the flexibility of polyvinyl chloride (PVC) plastic, have been a topic of concern in the medical device industry. However, the latest guidance highlights the importance of maintaining a balance between clinical benefits and potential risks associated with these substances. 

MET's analytical methods screening, which includes comprehensive assessments of extractables and leachables, allows the company to ensure the safe use of medical devices containing phthalates. The screening process helps identify any issues related to the leaching of phthalates, such as Di (2-ethylhexyl) phthalate (DEHP), into solutions like blood or nutrition formulas. 

As stated by the Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR), medical devices containing plasticised PVC with DEHP can offer significant clinical benefits. The SCENIHR report emphasises the importance of considering the efficiency, toxicological profile, leaching properties, and potential alternatives when evaluating the use of DEHP in medical devices. MET fully supports these recommendations and encourages the industry to explore alternatives to DEHP where feasible. 

MET understands the regulatory landscape and complies with the Medical Device Regulations (SI 2002 No 618, as amended) (UK MDR 2002) and applicable EU regulations for CE marking. The company ensures that any potential risks associated with DEHP exposure are outweighed by the anticipated benefits to patients. MET remains committed to reducing or eliminating risk whenever possible, while recognizing that DEHP may still be essential in critical circumstances. 
"We are dedicated to upholding the highest standards of safety and efficacy in medical device manufacturing," said Luminita Moraru MSc | MRSC | MBTS, Analytical Chemistry Manager at MET. "Our analytical methods screening enables us to stay ahead of regulatory updates and ensure the safe use of medical devices containing phthalates. We encourage the industry to join us in adopting alternative materials and promoting patient well-being." 
MET's commitment to adhering to the latest guidance on phthalates in medical devices sets a new benchmark for the industry. By prioritizing patient safety and consistently seeking innovative solutions, MET remains at the forefront of medical engineering. 

About Medical Engineering Technologies Ltd (MET)

Medical Engineering Technologies (MET) is the destination for medical and combination device batch release and design validation testing. Clients from across the globe have found our laboratory services to be rapid, precise, and extremely effective. MET has successfully delivered testing to medical device and pharmaceutical companies in over 20 countries across Africa, Asia, Australasia, Europe, and the USA. We knowledgeably, reliably, and effectively deliver medical device and packaging validation, and are a world leading CRO for combination device and pre-filled syringe testing. 

If you have any questions, please contact sales@met.uk.com

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