Pacemakers, neuro-stimulators and coronary stents placed on the market, and implanted in tens of thousands of patients, but without certification of compliance. But it gets worse: with false certifications, issued by the Higher Institute of Health, but in reality nonexistent, given that in the laboratories of the institution the machines were dilapidated, dated and practically unusable.
The devices that ended up in the sights of the Guardia di Finanza – we read in Il Messaggero – are in all 33,193: they were purchased by hospitals throughout Italy between 2010 and 2014. The damage calculated by the Fiamme Gialle for the public coffers is millionaire and to pay could be the four heads of the ISS Technology and Health department who should have dealt with the authorizations: the Court of Auditors of Lazio sued them, asking them to compensate the Authority and the Ministry of Health with 3,054. 714 euros.
The deed was notified to Velio Macellari, from July 2007 to December 2012 director of the Te.Sa. department, Mauro Grigioni, at the time delegate of the department director, Giuseppe D’Avenio, in those years responsible for the product line the coronary and peripheral stent type, together with Carla Daniele.
The investigations, conducted by the regional deputy prosecutor Massimiliano Minerva, revealed the issuance of certificates of conformity – irregular – for 43 models of “active implantable medical devices”, of the pacemaker and neuro-stimulator type, and also for 37 models of coronary stents. In the case of stents, even the documentation would have been produced only later and when the audits of the Finance Department were already in progress.
The investigations, according to the prosecution, also demonstrated the non-existence of test reports, the failure to carry out laboratory tests – at least as regards the pacemakers – and, above all, the impossibility of carrying them out due to “the state of obsolescence and non-functioning of most of the machinery “present,” the investigators noted in a statement.
Carrying out the checks was practically impossible: broken sensors, missing instrumentation, stopped machines. For the investigators, therefore, it is unthinkable that the perpetrators did not know that the tests of the devices had never been carried out.
In the proceedings – he always writes The messenger – it is specified that Macellari would have signed 33 certificates relating to pacemaker and neuro-stimulator models, then placed on the market by the thousands, and would also have approved 20 stent models. In all cases, according to the indictment, he would have certified the existence of compliance reports that had never been compiled.
According to the magistrates, Grigioni and Daniele, despite being aware of the – very bad – state of the laboratory machinery and knowing that the product line managers had renounced the task, since it was impossible to carry out the tests, they would not have taken the measures necessary to prevent the issuance of certificates. One of the attestors also said he was pressured to sign compliance reports in the absence of the required requirements.
D’Avenio, on the other hand, on the orders of the new department director – now deceased – would have compiled and printed posthumous compliance reports relating to the stent models under investigation. In 2014, during a search, the financiers had in fact found on his computer a file for the creation of documents, while in his office there were reports relating to certificates issued four years earlier.
CARLA DANIELE
The attestation of compliance of the products with the essential requirements of efficacy and safety is a necessary data for marketing and, therefore, for use by public health facilities. Since the documentation in question, according to the prosecutor, did not exist, the alleged damage concerns both the missed hours of work of the department heads and the price paid by the National Health Service for the purchase of the devices.
The actual cost was € 29,577,677. But the magistrates decided to challenge the four defendants for 10% of the total damage.