Re-use of medical devices not uniformly regulated in the EU: Romania prohibits it, Germany permits it, France only approves donation to other countries/ The situation in other countries/ Cardiologist: „Few devices are purchased, they run out quickly/ Sometimes we don’t know what decisions to make because of the chaos in the laws”

Romanian legislation explicitly prohibits the reuse of disposable medical devices and materials, a class that includes implantable devices that were allegedly taken from corpses to be fitted to heart patients by doctors in Brasov and Iasi, the Health Ministry said on Saturday at the request of G4Media.

However, cardiologists consulted by G4Media explain, some disposable medical devices, such as pacemakers or defibrillators in the cardio segment, can be reused after sterilisation according to the instructions that come with the devices. For example, Germany is among the countries that reuse medical devices, and France does not allow reuse on its territory, but allows donation to other countries.

At European level, Regulation (EU) 2017/745 (MDR) allows the reprocessing of single-use devices only if national legislation permits it. In other words, the procedure for reusing already used devices is not regulated in a uniform way, but each Member State imposes its own law. In Romania, the procedure has only recently been regulated (GEO 46/June 2021) and states in Article 4 that „the reprocessing of single-use devices” is „prohibited”, but also „the use of reprocessed devices”. In other words, the Romanian state completely prohibits the re-use of medical devices considered disposable, including those of cardiac patients that could be re-used after sterilisation according to the manufacturer’s instructions.

A list made available by the European Commission, which is updated in real time, shows that, alongside Romania, the other EU and European Economic Area countries that completely ban the re-use of medical devices are Austria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Italy, Latvia, Lithuania, Malta, Norway and Slovakia.

On the other hand, countries that allow the re-use of medical devices are Germany, Belgium, Croatia, Ireland, Sweden and the Netherlands.

Which medical devices the EU considers unsuitable for re-use

According to the European Commission Implementing Regulation of 19 August 2020, examples of single-use medical devices that may be considered unsuitable for reuse include:

• radiation emitting devices;
• devices used for the administration of cytostatic or radiopharmaceutical drugs;
• devices incorporating medicinal substances;
• devices intended for use in invasive procedures on the central nervous system;
• devices presenting a risk of transmitting spongiform encephalopathies;
• implantable devices;
• devices which have resulted in serious incidents after reprocessing and where the cause of the incident is related to reprocessing or where it cannot be excluded that reprocessing is the cause;
• devices with batteries that cannot be replaced or are at risk of malfunction after reprocessing;
• devices with an internal data storage unit necessary for the use of the device and which cannot be replaced or which presents a risk of malfunction after reprocessing;
• devices with cutting or scraping blades, drills or components that wear out, are no longer suitable after first use and cannot be changed or sharpened before the next medical procedure.

According to the European Commission, EU countries are obliged to notify the institution of national laws on reprocessing of single-use devices introduced by Article 17(3) of the MDR. EU countries that allow reprocessing of single-use devices may maintain or introduce national rules stricter than those laid down in the MDR. These national rules must be notified to the Commission.

At international level, according to a European Commission report, different situations may arise in the procedure for the use or re-use of medical devices.

For example, in the US, before medical devices can be reprocessed and reused, a third party or a hospital commissioning the reprocessing must comply with the same requirements that apply to original equipment manufacturers, including filing pre-market notification or approval documents, registering reprocessing firms and listing all products, filing adverse event reports, tracking devices whose malfunction may have serious consequences, correcting or removing unsafe devices from the market, and meeting manufacturing and labelling requirements.

Canada does not regulate the re-use of single-use medical devices, as the current laws and regulations do not give the government health agency (Health Canada) any powers to do so. Some provinces have banned the reuse of critical single-use devices and other provinces have mandated that hospitals must use a licensed reprocessor.

In Australia, a public or private institution that reprocesses a medical device originally intended for single use only becomes the manufacturer of the reprocessed device and, as such, is required to apply the appropriate conformity assessment procedure for that product.

In Japan, the requirements for single-use devices are that the label must state „single use” and the instructions for use must state that „re-use is prohibited”.

Cardiologist Eleonora Gima, primary care physician in Constanta: „Few devices are bought, they run out quickly/ Sometimes we don’t know what decisions to make because of the chaos in the laws”

Cardiologist Eleonora Gima, a primary care physician in Constanta, told G4Media that Romania is facing major problems in supplying hospitals with medical devices, at least in the cardio segment. Doctors are often faced with having to make decisions to keep patients alive, but at the same time they have to comply with the legislation in force, which is often chaotic, incomplete or contradictory.

• „Legislative chaos puts doctors in a situation where in critical cases they don’t know how to react and what decisions to take, and lawyers don’t know what to do. Nobody knows how to tell you what to do. Our only solution is to start reading the law ourselves, to learn how to defend ourselves,” explains Gima.
  The doctor also points out that a certain number of devices are being bought in the country, but this is small compared to demand:

„The stock for the first quarter runs out soon, there are always backlogs from one month to the next. This is taking a lot of time in hospital because you can’t send the patient home because you are putting their life at risk. And when you draw the line, you end up more expensive than if you bought more machines.”
Eleonora Gima believes that, on the one hand, it is ethical to reuse medical devices when the devices are not enough and the patients are in danger of dying because reuse means saving their lives. On the other hand, the doctor believes that only in underdeveloped countries is it possible that the devices needed for life-or-death interventions are not enough for everyone who needs them.

• „Recovering implantable electronic cardiovascular devices at autopsy may increase the number that can be reused and distributed for humanitarian purposes, and it is even a matter of ethics not to leave such a device that keeps sending pulses into an inert body. It is also ethical to save a person’s life, even if the device has already been used,” says primary cardiologist Eleonora Gima.

Context

Prosecutors allege that doctor Dan Tesloianu, from the Sfântul Spiridon hospital in Iasi, who was detained on Friday night, implanted 238 devices extracted from dead persons or whose source is unknown between 2017 and August 2022. Prosecutors also allege that a large number of these interventions „were not necessary”, having been carried out either following „fictitious diagnoses” or through the prior recommendation of drugs causing reactions likely to lead to specific symptoms. G4Media sources said it would be the drug Neoton. A total of six doctors and four patients are targeted in the case, according to a statement issued by the Prosecutor’s Office of the High Court of Cassation and Justice (PÎCCJ) on Saturday.

Also in this case, prosecutors are prosecuting five other individuals (including the suspect mentioned above), who are doctors at the hospital in Iasi, for the offence of taking bribes, as well as four other individuals, who are patients, for the offence of giving bribes. For one of the medical suspects, the prosecutor ordered a preventive measure of 60 days of judicial supervision, with the obligation to stop practising as a doctor.

The five medical suspects allegedly received various amounts of money as bribes for their work in the course of providing specialist consultations to patients. As regards the four suspected patients, it was found that they had offered the doctors various sums of money by way of bribes for the services received.

The scandal of medical devices moved from corpses onto heart patients by doctors in Brasov and Iasi has hit the international press. Several publications and news agencies have reported on the corruption scandal in Romania, including Reuters, The Guardian, Independent and Jerusalem Post. Details of the reactions in the international press here.

The scandal of medical devices transferred from corpses to cardiac patients by doctors in Brasov and Iasi has hit the international press. Several publications and news agencies have reported on the corruption scandal in Romania, including Reuters, The Guardian, Independent and Jerusalem Post.

Translated by Ovidiu Harfas