Brazilian Medtech Welcomes Parametric Release Sterilization Regime
Brazil has approved a long-awaited reform of its medical device sterilization protocols, with the adoption of a parametric release regime – a move which the industry has welcomed as “putting an end to a significant barrier” to local medical technology business.
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While AdvaMed has remained relatively quiet over the recent closures of ethylene oxide (EtO) sterilization facilities, the medical device industry advocacy group is taking on critics in Georgia, where two facilities have been paused to upgrade their operations to reduce EtO emissions. Critics – including the Atlanta Journal-Constitution’s editorial board – say the chemical is associated with increased risk for cancer for nearby residents, but AdvaMed and its supporters say there’s no evidence to back that up.
Regulators are reaching out to industry and the public-at-large for ideas that would help develop new sterilization methods that could reduce or replace the need for ethylene oxide used to treat difficult-to-clean medical devices. They are also looking for ways to reduce the risk and environmental impact of the sterilizing agent.
Italy must ensure that ongoing efforts to tackle the coronavirus crisis do not rely on single suppliers, the country's medtech industry body said after DiaSorin looked likely to be the sole winner of a major COVID-19 diagnostics tender.