The European Commission and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR), an influential committee whose role it is to investigate safety risks in health products, has announced that it has launched a public consultation into whether bisphenol A is safe for use in medical devices.
Bisphenol A, more commonly known as BPA, is regularly used in the manufacture of plastics and epoxy resins. While it has been used in many consumer goods like water bottles, emerging research has raised concerns that its hormone-like effects might pose safety risks to humans.
EU officials have recently launched formal investigations into the use of the chemical, with the European Food Safety Authority (EFSA) launching an assessment process on 17 January 2014, and SCENIHR on 30 January 2014.
SCENIHR's public assessment is based on a preliminary opinion it put together on BPA in medical devices, in which it indicates that the current No Observed Adverse Effect Level (NOAEL) of 50 µg/kg per day may need to be lowered in light of evidence of ongoing biological effects at that exposure level.
For medical devices, SCENIHR said it had evaluated "several exposure scenarios," including:
- external short-term contact with a medical device
- short- and long-term contact with dental materials
- medium- and long-term contact with an implanted medical device
- long-term contact via hemodialyzers; and
- medium-term contact in intensive care units with various medical devices
SCENIHR speculated that because most exposure to devices is for a limited period of time, subjects would be exposed to lower overall exposure levels than they would through food products.
That being said, "There may exist some risk for adverse effects of BPA, when the BPA is directly available for systemic exposure … especially when neonates in intensive care units are concerned," SCENIHR wrote. The committee called this the "worst-case scenario."
Better Data Needed
The committee concluded that "better data on exposure would be beneficial for the refinements of this risk assessment," but that even preliminary data "raise some concern," especially in prematurely born infants.
Even then, "The benefit of medical devices has also to be considered," the committee wrote. "The survival of these premature infants often depends on the available of the same medical devices which result in a relatively high BPA exposure due to treatment."
"The possibility to replace BPA in these products should be considered against their efficiency in the treatment, as well as the toxicological profile of the alternative materials."
SCENIHR Preliminary Opinion