In recent hours, the National Institute for Drug and Food Surveillance (Invima) issued a new alert: surgical, dental and orthodontic instruments are being marketed that have a suspended health record.
The alert was issued after identifying, during the recertification audit to the company Instrumentos Dentales de Colombia S.A.S., that the health registry 2016DM-0015291 was suspended, however, the product was still being marketed.
The products that Invima ordered to be recalled are manufactured and imported by Daddy D Pro, Instrumentos Dentales De Colombia S.A.S. - Indecol S.A.S., Productora Y Comercializadora Odontológica New Stetic S.A, Aldental S.A, Pardentales Ltda. Medical Marketer, International S.A.S, Dentimed Sao Joao S.A.S, La Muela S.A.S, Casa Dental Eduardo Daza Ltda., Ortho Professional Dental Ltda.
According to Invima, these surgical instruments are used by dentists to perform basic maneuvers, bend or cut wires, to position and remove orthodontic accessories, and for general dental procedures or surgical procedures.
Invima announced a series of measures to be taken by the community at large, the Health Service Providing Institutions (IPS) and tenured establishments, distributors and marketers.
For the community at large, Invima suggests that if you are using the product, contact the importer, distributor or marketer to clarify whether there are any specific recommendations for the use of the product.
The entity invited citizens to verify the health registration of the product on its website.
With regard to IPS, Invima also recommended that they contact the distributor or marketer to specify the actions to be taken. In addition to reporting any adverse events associated with the use of the products referenced to the Invima National Technovigilance Program.
Invima also provided that titular establishments, distributors and marketers must trace the product concerned and initiate the action plan provided by the manufacturer.
Finally, Invima requests that the institutional Tecnovigilance programs carry out an active search for the detection of adverse events or incidents involving the referenced medical device and notifying the Institute.
It is worth remembering that on April 20, Invima ordered the preventive withdrawal of a batch of condoms from the Today brand. According to the entity, some of the condoms showed a “non-compliant” result in a hole screening test by the entity's Office of Laboratories and Quality Control.
“We report that lot 2106572316 yielded a non-compliant result according to a hole detection test,” Invima explained in a statement. The entity issued the alert taking into account that the use of condoms could lead to the occurrence of “adverse events on users”.
Invima measures and recommendations
For the community at large, the entity recommended that those using the referenced condoms should contact the importer, distributor or marketer to clarify whether there are any specific recommendations for using condoms. They also made the invitation to verify if the product has the Invima health registry. This can be consulted through the entity's website.
Invima noted that departmental, district and municipal health secretariats should carry out inspection, surveillance and control activities in establishments within their competence, “where they can potentially use or market the referenced product and take appropriate sanitary measures.” In case of finding a condom involved in the lot, it is necessary to inform the entity.
Health Service Providing Institutions (IPS) and health professionals were asked to check whether they have the product referenced. In this case, they should contact the importer, distributor or marketer, to specify the actions to be taken. “Report any adverse events associated with the use of the referenced medical device to the Invima National Technovigilance Program,” he added.
“To the titular establishments, distributors and marketers, carry out the traceability of the product concerned and initiate the action plan provided by the manufacturer”, read the Invima statement. They also asked them to implement and implement the factory action plan and to report incidents and adverse events.
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