Recentemente, Anvisa, the Brazilian Health Regulatory Agency, has enacted a nationwide ban on the production, importation, sale, and use of mercury-based thermometers and sphygmomanometers (blood pressure monitors) in healthcare services. This significant resolution was officially published on Tuesday, the 24th, in the national government gazette.
The devices affected by this resolution contain a transparent column of mercury and are primarily used for measuring body temperature and blood pressure for diagnostic purposes. However, the prohibition does not extend to mercury products intended for research, instrumentation calibration, or as reference standards.
Furthermore, the resolution outlines that any mercury thermometers and sphygmomanometers removed from circulation must adhere to the Good Practices for Waste Management in Health Services established by Anvisa in 2018.
Failure to comply with this new regulation is classified as a sanitary infraction and may result in civil, administrative, and criminal liabilities.
In a 2022 public meeting, Anvisa’s board approved this regulatory initiative, responding to a demand from the Minamata Convention, established in Japan in 2013, which Brazil is committed to. The convention aimed to reduce global mercury use by 2020.
While the heavy metal does not pose a direct threat to users of thermometers or blood pressure monitors, it becomes a hazardous toxic agent when improperly disposed of in the environment. Anvisa emphasizes that safe alternatives to mercury-based devices are already available in the market.
“Digital thermometers and sphygmomanometers are widely used health products in Brazil and provide the same clinical indications as their mercury counterparts. These devices undergo mandatory precision evaluations by the Brazilian Conformity Assessment System and are environmentally friendly,” Anvisa affirmed.