Anja Leetz, Executive Director of Health Care Without Harm Europe, discusses EFSA's Scientific Opinion on bisphenol A (BPA) and why concerns remain regarding exposure from medical devices.
Headlines this week proclaimed ‘No consumer health risk from bisphenol A exposure’, in response to the publication of the European Food Safety Authority (EFSA) Scientific Opinion on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs.
In the opinion, EFSA recommend that the Tolerable Daily Intake of this suspected endocrine disruptor be lowered from 50 micro g/kg body weight per day to 4 micro g/kg. They also state that BPA “poses no health risk to consumers of any age group (including unborn children, infants and adolescents) at current exposure levels”.
This headline grabbing statement alone can be misleading. It’s important to realise that EFSA have only investigated exposure from diet or from a combination of sources like diet, dust, cosmetics and thermal paper. Their focus is on foodstuffs. This does not mean that there are no health risks from BPA present elsewhere. It is important to point out that the CEF panel noted that there is “considerable uncertainty in the exposure estimate for the non-dietary sources.” In particular, the presence of BPA in medical devices is extremely concerning. In this instance, exposure can be prolonged, often lasting weeks, if not months or years.
Exposure from medical devices
If we take the example of premature babies in intensive care, these vulnerable infants are exposed to BPA in devices like feeding tubes and even incubators. HCWH Europe’s Factsheet on BPA in Medical Devices highlighted the extent of exposure citing studies that confirmed newborns receiving medical treatment using four or more devices, had a level of BPA in their urine that was three times higher than babies treated with fewer medical devices.
It is unacceptable that vulnerable and chronically ill patients are routinely exposed to BPA in an environment designed to heal them. This hazardous chemical has become virtually unavoidable in healthcare settings. A recent report by UBA, Germany’s main environmental protection agency, listed 20 uses of BPA in the medical and healthcare sector, including: blood oxygenators, cardiotomy reservoirs, dialysers, respirators, breastpumps, inhaler housings, IV connectors, single-use operating instruments, scalpel cases and countless other vital objects.
Safer alternatives to BPA
The good news is that safer alternatives are often available and already in use. Our members, like the Vienna Hospital Association and Stockholm County Council have BPA reduction policies, applying the precautionary principle in the interest of patient health. Later this year, HCWH Europe will add information on BPA-free products to its Safer Medical Devices Database. The site already contains information on phthalate-free alternatives provided by manufacturers. By adding BPA-free options, medical device procurers can make even more informed choices to protect our health.
In March 2014, HCWH Europe responded to the Public Consultation on the preliminary opinion on the safety of the use of bisphenol A in medical devices, launched by the European Commission (EC) and SCENIHR. EU Member States are currently debating the EC proposal for a new regulation on Medical Devices and evaluating the European Parliament’s amendment that foresees the phase out of EDCs like phthalates and BPA if safer alternatives exist.
HCWH Europe hopes that the European Parliament's amendment will be taken into consideration by the European Council as it stands in order to strengthen the protection of patients, despite scientific uncertainties. While legislation is still lagging behind, regions and hospitals across Europe are already addressing BPA concerns as shown in HCWH Europe’s leaflet.
– Anja Leetz, Executive Director of Health Care Without Harm Europe