The National Agency of Health Regulation, Control and Surveillance (Arcsa)registered 522 problems with medical devices in the country, in the last two years. Almost half of these were considered as “adverse events”, that is, they caused unintentional harm to the patient.
The International Consortium of Investigative Journalists (ICIJ) began on Sunday the publication of an investigation on the damages caused by medical device sand the lax controls around the world. The work was attended by journalists from 36 countries, including EL UNIVERSO.
Newspaper EL UNIVERSO requested the Arcsa the statistics of the problems registered with medical devices since 2012, but only delivered the information generated in2017 and 2018.
Implant regulation, the European advantage
In the classification of the Arcsa, in addition to the “adverse events”,there are the “adverse incidents”, which refer to potential damages.
The seare the figures. Adverse events: 46 serious and 188 not serious. Adverse incidents:24 serious and 194 not serious. Others: 70. In total: 522 problems. What was the cause and what devices are in question? They are questions without answers.
The general technical coordinator of Surveillance and Subsequent Control of Establishments and Products of the Arcsa, Patricia Zambrano Mora, argued that they cannot reveal more information due to the protection of personal data from medical records. EL UNIVERSO has insisted before the Arcsa, because it is not necessary to know the identity of the patients but only the details of the problems, but still does not receive an answer.
A data base that tracks defective medical devices globally
Nor does it receive alerts from the Arcsa about medical devices. Until yesterdayafternoon, on your website, in the medical devices section, there were twomedication alerts.
In addition, in a spreadsheet posted in another section of the portal, the Agency included an alert from the US FDA regulator on StrataMR valves and adjustable leads from Medtronic, another from Colombian regulator Invima on Novosyn surgical sutures and one issued by Arcsa itself on the Profigel tooth whitening, which did not have sanitary registry.
The Agency was created by executive decree on August 30, 2012. Four years later, it issued a regulation for medical devices. This regulation classifies these products into twelve types, defines four levels of risk and establishes there quirements to obtain the sanitary registration and the operating permit for producers and marketers.
The latest regulation dates from March 2017 and provides that a Techno surveillance Committee must operate in each hospital or clinic to treat problems and alerts related to medical devices and other types of products.
As the country does not produce sophisticated devices or quality tests of these devices, Maria Fernanda Matamoros, technical director of Sanitary Registry,said that the Arcsa tries to control the maximum before extending the sanitary registry, which is the only that allows the marketer to import and sell a product. And then the post-control is done, which corresponds to the Techno surveillance.
As here, in other countries of the region, the authorization of the European Unio nor the United States facilitates the local registration of a device. There areno exams of their own.
This newspaper also requested information from the National Customs Service of Ecuador (Senae) on seizures of medical devices, but has not yet received aresponse.
The Arcsa arranged that each medical device must have an identification card, to be able to trace it in case of any problem.
This card must contain the establishment where the implant is made, the identification of the patient, the date of the implant, the common denomination of the device, its commercial name, the name and address of the manufacturer,the name and address of the importer and the number of Sanitary Registry.
There must be three copies: one for the patient, another for the clinical history and another for the distributor. (I)