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.

The outcomes of a bundled payment system

Evaluation of Medicare’s Bundled Payments Initiative for Medical Conditions

The measurement of episodes of care is a precondition for understanding the cost-effectiveness of health care. Unfortunately there are few experiences on this issue. The largest demonstration in US, The Medicare Budled Payment for Care Improvement Initiative started in 2013 and finished in 2017. The NEJM publishes an article that evaluates the outcomes of such experience.

In summary, hospital participation in five common medical bundles under BPCI, as compared with nonparticipation, was not associated with changes from baseline in total Medicare payments per episode, case complexity, length of stay, emergency department use, hospital readmission, or mortality.

If this is so, it is necessary to understand the reasons behind such failure. The article provides some of them. My guess is that the episodes were not holistic in the scope of services (not including post-acute care i.e.) and were constrained to several episodes. Unless a holistic approach is taken into account (all episodes and all services), incentives will not be working in the appropriate way, the cost-effective one. Excellent article and research effort that explains an unexpected and unfavourable result, no bias of publication. Good example.

Maya Fadeeva