How bad health regulation leads to unsafety medical devices in Europe

Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Unión and United States: cohort study

The topic sould be at the top of health policy agenda (at least as it is in this blog). New evidence confirms the additional safety risks of european bad regulation.

In the European Union, medical devices are approved by private notified bodies if they meet performance criteria and are likely to be safe, but notified bodies generally do not require evidence of effectiveness for most devices. Many high risk devices are approved faster in the EU than in the United States, where the Food and Drug Administration usually requires prospective clinical trials of such devices.

And the results are in BMJ:

The unadjusted rate of safety alerts and recalls for devices approved first in the EU was 27% (62/232) compared with 14% (11/77) for devices approved first in the US. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval 1.4 to 6.2) for devices approved first in the EU.

This means exactly 2.9-fold greater rate of safety alerts and recalls and a 4.6-fold greater rate of recalls than devices approved first in the US  (and if you look at the confidence intervals you'll get more worried).  How can we trust the european regulator?. For decades, European Union has leaved its citizens with less safety protection than is required for medical devices. A perfectly designed absurdity to disseminate risk for european citizens that the new proposed regulation is unable to correct.

PS. If you wnat to understand the differences between EU and US regulation, read this NEJM article or Milbank one..

Algorithms: the underpinning of black box medicine?

 Algorithms as medical devices

The rapid growth of digital devices, software and technologies means that the medical device sector is changing. Many small and independent manufacturers are encountering medical device regulation for the first time. At the same time, responsive and effective regulation of digital devices requires sound understanding of the underlying new technologies and concepts.

Algorithms as medical devices describes how digital health is covered by existing medical device regulation and outlines three critical areas: 

The challenges that the digital health sector may pose for regulators and developers

How digital devices can be regulated as medical devices under UK/EU and US law

The specific problems that machine learning could pose to medical device regulation

 Meanwhile the market for black box medicine is growing, unless any regulator leaves their continous vacation.

TTIP and health

The Transatlantic Trade and Investment Partnership (TTIP) Towards an EU-US trade deal
EU position paper on medical devices
EU position on pharmaceutical products

Up to now the negotiation about the TTIP has avoided health care and has focused on pharmaceuticals and medical devices. This is the latest summary:

Round 9
Pharmaceuticals
The progress of the task force in charge of assessing the equivalence of EU and US Good Manufacturing Practices (GMP) systems was reviewed. Audits of Member States GMP inspectorates observed by US FDA took place and will continue during 2015. The EU will audit the US inspectoratate in September 2015. Other areas such as biosimilars, generics and international cooperation were discussed. The EU welcomed the first authorisation of a biosimilar by FDA. EU committed to submit a proposal for cooperation on generics ahead of next round. 

Medical devices
The EU presented its position paper on medical devices recently published in the web site. The US asked clarifications on the mutual recognition of quality management system audits concept (one of the objectives detailed in the paper) and its relation with the international Medical Devices Single Audit Programme (MDSAP). The EU noted that while it is committed to MDSAP work, a legal basis needs to be established for it to be able to accept audit reports carried out by US inspectors (TTIP could serve as such legal basis). Both sides took stock of progress on the two other TTIP priorities (Unique Device Identifier -UDI and Regulated Product Submission - RPS). Next steps were agreed for each topic.

On May 27th, a meeting in Brussels will be held with all stakeholders. Position papers on both issues are available. The assesment of the whole implications of this Treaty is still pending. A general approach is available in the paper by LSE scholars. The key documents and position papers are here.
A summary of the current regulation is here. As far as there is only limited information I will avoid any opinion about it by now.

PS. Alberto Alemanno paper on TTIP

The paucity of public information about medical devices

The need for transparency of clinical evidence for medical devices in Europe

Last year EU approved a new law for assessing safety and efficacy of medical devices. Unfortunately, it comes late and it is not enough to solve current situation of lack of information on evidence. An article in Lancet explains precisely what should be done to increase the transparency of information on medical devices.All the details in this list:

 A small task force of regulators and invited stakeholders has recommended what information should be included in the summaries of safety and clinical performance and which components of the Eudamed database need to be open to public access. Those recommendations are now under revision. The European Commission has been delegated authority to translate them into further legislation, but it has indicated that it does not consider that to be a priority. Any member of the public or any organisation with an interest in these issues should therefore make representations now to the European Commission. The medical device regulations will take effect from 2020.

The time is now.