The National Health Surveillance Agency (Anvisa) provides guidance on prevention and mitigation measures for Monkeypox in hospitals, clinics and other health services that provide care to suspected and confirmed cases of the disease.

The document brings together preventive and infection control measures in these environments and stresses the importance of health services developing contingency plans based on the guidelines of the Situation Room created by the Ministry of Health.

Main points

  • That a minimum distance of 1 meter be maintained between patients’ beds. The recommendation takes into consideration the risk of transmission by droplets from the infected person.
  • Infected patients should remain in isolation until the “crusts” of the lesions disappear.
  • If possible, the accommodation of the suspected or confirmed case should be done, preferably in a private room with a closed door and well ventilated (air conditioning that ensures adequate exhaustion or open windows).
  • Another recommendation is the suspension of visitors and companions to reduce the access of people to the infected. For specific situations foreseen by law, such as children, the elderly, people with special needs, among others, the exchange of companions should be avoided in order to minimize the risk of transmission.
  • For screening areas of suspected cases, physical barriers must be installed.
  • Patients who develop a rash should be isolated or self-isolated, according to the guidelines of the Ministry of Health, and evaluated as a suspected case and a sample should be collected for laboratory analysis.

Handling of patients

Cleaning and waste treatment: There are no specific sanitizing products for this type of virus. Therefore, it is recommended that the traditional routine be maintained, using products approved by Anvisa. The residues must be treated as risk group 3 (high individual risk and moderate risk for the community) and packed in appropriate red bags.

When touching patients, as well as products and surfaces used by them, the healthcare professional should wear PPE (personal protective equipment) appropriate to the procedure. Whenever assistance is provided at a distance of less than 1 meter or when entering the infected patient’s room, an apron, gloves, surgical mask, and goggles or face shield must be worn.

Other ANVISA actions: Vaccines and Drugs

Other ANVISA actions: Vaccines and Drugs

Anvisa has not received an application for authorization for a vaccine or medication against smallpox or monkeypox.

The registration application and the submission of data and information to support the application should be initiated by the pharmaceutical laboratory.

For the eventual need to import products Anvisa has regulation that deals with the import of medicines and vaccines without registration in Brazil, the resolution RDC 203/2017.

Thus, it is possible to authorize the import, on an exceptional basis, of products subject to sanitary surveillance in situations of public health emergency, if it becomes necessary.

Are there tests for smallpox diagnosis?

To date, there is no regularized commercial product for monkeypox virus diagnostic purposes.

Nor has the Agency received any application for registration of a product for this purpose.

Currently, laboratory diagnosis of the virus can be made by molecular assays using validated two-step protocols. This is possible thanks to the release of the virus’ genetic sequencing, which allows laboratories to develop their own identification methodologies. These in-house methodologies are known as in-house testing.

Sanitary control for travelers' entry: Ports and Airports

Anvisa reiterates that the resolutions RDC 584/2021 and RDC 456/2020, which establish sanitary control measures in ports and airports, respectively, due to human infection by the new coronavirus (SARS-CoV-2), are in force.

Considering that the transmission of the SARS-CoV-2 virus occurs mainly through droplets from the respiratory tract, the measures related to the use of masks, respiratory etiquette, physical distancing, and sanitization of surfaces currently already provided for in the regulations act synergistically to reduce the risk of dissemination of both viruses.

For maritime vessels arriving in the country, it is already mandatory to present the sanitary documents foreseen in Anvisa’s regulations. The documentation enables the sanitary control of vessels, regardless of the disease in question.

Moreover, as of the Covid-19 pandemic, it is now mandatory that the ship presents the On Board Medical Book, containing the records of health occurrences on board for the last 30 (thirty) days from the moment of the request for authorization to operate in Brazilian ports.

Monkey Pox

About the Monkey Pox: Specific guidelines on prevention measures for Monkeypox in ports, airports and borders are detailed in Technical Note 60/2022.

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