Some medical devices may be used more than once and be reprocessed safely. This practice gives them a longer product life and use, as long as they provide effectiveness and functionality.

Medical devices that may be processed are those that allow repeated cleaning, disinfection or sterilization and that can be reused, given they comply with current regulations. This reprocessing should not be repeated indefinitely: there is a moment at which the quality of the product – in terms of its effectiveness and functionality – no longer corresponds to that required for its use.

For this reason, ANVISA opened Public Consultation 584, on December 20th, 2018, which was published in the Official Gazette on December 21st, 2018, in order to receive comments and suggestions from the general public regarding the text of the proposed resolution which deals with the categorizing of medical devices as single use or reusable. The Public Consultation will be open for 60 days, from January 8th to March 9th, 2019. Suggestions should be sent by electronic form in Portuguese.

Exceptionally, international contributions may be sent through letter to the following address: National Health Surveillance Agency (Ainte) – SIA, Section 5, Special Area 57, Brasília-DF, CEP 71.205-050.

In addition to this specific CP, another one has been open with two other connected themes: The first one (CP 585) is related to the requirements of good practices for the processing of products used in health care assistance. Anvisa’s goal with the proposal of a new RDC is to improve the management of risks associated with the processing of medical devices.

The second one (CP 586) deals with a Normative Instruction (IN) that establishes guidelines for quality assurance in health services and its main purpose is validation, monitoring and controlling the routine of sterilization processes and automated cleaning processes as well as disinfection in its services.

To contribute your opinion go to:
CP 585.
CP 586.

Font: Anvisa Website: http://portal.anvisa.gov.br