CAJICA, Colombia – The COVID-19 pandemic has exposed the weaknesses of Mexico’s techno-vigilance system, along with a chronic lack of reporting of inventories and adverse effects related to medical devices in use. These weaknesses were exposed during previous pandemics but the country’s antiquated tracking and reporting system has not changed.
“When H1N1 hit Mexico more than a decade ago, the government requested all hospitals report the availability of critical devices to face the epidemic. When health care organizations sent their inventory information, the government had the impossible task of analyzing data expressed in multiple formats (.doc, .xls, etc.) in a short period of time,” Luis Fernandez, CEO at Tecnología en Ingeniería Clínica SAPI (TINC), from Hermosillo, Mexico, told BioWorld. “Surprisingly 10 years after, when the COVID-19 pandemic hit the country, the same problem emerged.”
In Mexico and other countries in Latin America, most health care institutions rely on simple spreadsheets to manage med-tech inventories.
“When a clinical engineering department relies on spreadsheets for asset and service management, in addition to not having a nationally uniform asset nomenclature to effectively manage their medical equipment units, one of the main problems for techno-vigilance strategies emerges, which is data analysis,” Fernandez said.
Managing inventories on simple spreadsheets opens the door to typos, brand names of devices tracked incorrectly, incorrect classifications due to different denominations for the same device and a lack of standardization for follow-ups – like the ones required by the Mexican government to understand the availability of ventilators in 2020 when the COVID pandemic hit the country.
“This causes stakeholders to procure unnecessary equipment and allocate resources without considering the real and current situation regarding necessary equipment for the pandemic,” said Fernandez.
Back in the days of H1N1, the Mexican government ended up buying equipment that it didn't need and “the lesson was not learnt,” Fernandez said.
Without clear inventories of availability of ventilators in 2020, the Mexican government encouraged the public and private sectors to design, develop and manufacture as many of the devices as possible. The development and manufacture of domestic ventilators was one of the first steps many governments in Latin America took to fight COVID-19 as patients started flooding intensive care units.
“In Mexico, over 30 project initiatives emerged to produce ventilators,” recalled Fernandez. “While this was a great intention, building a medical device is not just building another machine, these devices will be used on patients and also represent a huge risk if not built according to what regulations and the industry establishes.”
Most of the dozens of ventilator projects that emerged in Mexico over the past year and tracked by COFEPRIS, the country's health care surveillance agency, led to the production of machines that were medically useless, said Fernandez.
One exception was the VSZ-2-20 ventilator developed through a public-private partnership and approved through an emergency pathway. More than 200 units were produced and many were distributed to eight Caribbean nations.
“We had the opportunity to save lives in our hands. That was our motive for doing it, and there was no time to waste,” said Salvador Almaguer, food service operations director at Femsa Torrey, a company from Nuevo Leon, involved in the development of the device along with other companies such as GSE Biomedical, from Hermosillo.
Aware of the pitfalls identified a decade earlier, Fernandez and his team developed the post-market surveillance strategy for the VSZ-2-20 project.
“We donated a license of our TINC CMMS software so that the appointed third-party service provider could capture service, customer support and user training activities, which will give us the data to conduct an analysis over the next 24 months to assess the performance of those devices,” he said.
However, Fernandez noted that the VSZ-2-20 techno-vigilance model is almost unique one in the country.
“This is a case of success, however and very unfortunately, it is one of the few made to assess medical devices in the field,” he said. “Many more efforts need to be made to analyze the operational, risk and financial feasibility of medical devices in Mexico.”
An investigation in 2018, led by the journalistic organization Ojo Publico and coordinated by The International Consortium of Investigative Journalists called ´The Implant Files,´ found that since 2000, only two medical devices were removed from the Mexican market by COFEPRIS for safety concerns.
“In Mexico, [COFEPRIS] hides information about failures with medical devices. Patients cannot know if implants accumulate complaints in other nations or if they have been discontinued due to being related to the deaths or injuries of other users,” said the journalists.
Data from COFEPRIS showed 2,254 adverse events related to medical devices were reported to the health care system between 2014 and May 2018, but none since then.
For his part, Fernandez explained that hospitals in the country see little value in reporting adverse effects.
“Hospitals are not reporting because they believe that they will be sanctioned, or in some cases, that it is useless information, when it is the opposite: techno-vigilance helps us to understand root causes of malfunctions, preventing adverse events from happening again,” he said.
“Directors from both public and private institutions keep ignoring the real value of clinical engineering for their institutions,” said Fernandez. “If we survive this pandemic, we are at the perfect place in time to change the course of events by enhancing medical equipment management and assessment strategies.”