Changes to obligation concerning labelling of medical devices containing phthalates
London, 21 April 2010
The obligation concerning labelling of medical devices containing phthalates became Law on 21 March 2010, consequently all products Placed on the Market and Put into Service (ie, supplied from 21 March 2010) must comply otherwise it is an Offence. The restrictions concern devices or parts (components or constituents thereof) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances.
Phthalates are animal carcinogens reported to cause foetal death, malformation, and reproductive toxicity in laboratory animals. Phthalates are plasticisers produced in high volume that are commonly-added to polyvinyl chloride (PVC) products to impart flexibility and durability. Human exposure is extensive though poorly defined.
“Given the situation, it would be advisable for manufacturers to take some actions in order to prevent potential risks for the company and users of the devices in question,” explains Haroon Atchia, co-founder and CEO of Quality First International. “Manufacturers should list all products that could contain phthalates (typically anything plastic, elastomeric, etc, not metals), draft suitable improvements to labels and other Information supplied with the product, improve all CE Technical documentation, improve hazard evaluations, including risk management reports, FMEAs, etc, solicit appropriate declarations from vendors concerning formulation of materials, etc, and formulate appropriate expert biological safety assessment applied to devices in question.”
Phthalates have not been shown to be acutely toxic. Chronic toxicity has been studied only in laboratory animals, although a few occupational studies in humans suggested some excess risk of adverse health effects with chronic exposure. No short or long-term follow-up studies have evaluated possible phthalate toxicity in medically-exposed infants.
Relevance of animal toxicology data requires careful examination of relevance to human exposure since human toxicity remains poorly-studied.
Although toxicity profiles and potency are known to vary by specific phthalate, the extent of such toxicities and their relevance to humans remains incompletely characterised and controversial. Nevertheless, analysis of prevailing information on phthalates by various observers representing scientific panels, advocacy groups, and industry groups express different conclusions about hazards of such substances. The quality and relevancy of data on toxicity in humans remains controversial because extrapolation of risk to humans originates from animal data demonstrating differing inter-species toxicity, route of exposure, and age at exposure and because of persistent uncertainties in human exposure data.
About Quality First International (QFI)
Quality First International (QFI) is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting-edge, minimally invasive and cardiovascular products and implants. QFI can help to examine the biological safety risks of phthalates in a medical device, explore relevant intolerance and toxicity aspects and formulate the required documentation to support continued Placement of product on the market.
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