Highlights 5th Latin American Conference of ISPOR – Medical Devices – RedETSA

Highlights 5th Latin American Conference of ISPOR – Medical Devices

Another highlight of the 5th Latin American Conference of the International Society for Pharmaeconomics and Outcomes Research (ISPOR) were medical devices and their implications on decision making.
According to its definition, the term medical device means any instrument, machine, software, biomedical equipment, whether used alone or in conjunction with other components and accessories that enable their full activity. These, in turn, must not present substitutive nature of the healthcare professional role, but to ensure better quality of care and promote value care.
An important aspect with regard to the devices is the characteristic of accelerated refresh cycle and renewal of technologies, through the process of paradigm shift in health, which promotes an economic impact due to the products becoming obsolete or not optimized to the target audience. In addition to making challenging the rapid incorporation of these at the same rate they are created.
Compared with pharmaceuticals, medical devices have greater adherence to treatment, however, the operator skill and different learning curves related to the process may jeopardize the expected results, thus presenting significant variability. Not only this factor hinders its assessment on studies, but also the small size of the population to be employed technology and the difficulty of being able to have a control group and masked.
Because of these limitations, most regulatory agencies bases the record of the devices according to their risk category:

Class I (low risk): technology subject to generic control, since it doesn’t display potential for patient injury.
Class IIa (moderate risk): device subject to special control at the manufacturing stage to demonstrate their effectiveness and safety.
Class IIb (high risk): device subject to special control in the design and manufacture to demonstrate their effectiveness and safety.
Class III (very high risk): technology subject to special control in all their development processes, as it possess the potential to evolve with injury to the patient.
Despite this alternative, the economic analysis is vulnerable to bias, given the lower quality of the information and the fact that sensitivity analyzes are more complex to interpret, reflecting a lower robustness. In addition to the lack of a consensus for a standard value for the discount rate as is done with the drugs.
European study conducted by Reinhard Busse et al tried to contemplate these challenges in order to create a new taxonomic model of medical devices, minimizing barriers while groups those in relation to their risk and based on the different selection criteria and prioritization in the health technologies assessment. The data was obtained from reports that had the highest possible quality and experience and through interviews in 16 different European institutions.
Coupled with the previously described classification it was then included the classes IV (implantable devices, such as cochlear) and V (in-vitro diagnostic methods).
It was identified that the devices in low-risk categories have less importance in the aspects of safety and economy. Implants, in turn, were noted as more relevant in the social, ethical and legal areas.
Despite the findings shown, it still lacks more evidence, with robust data to assess more accurately the impact of the medical devices and how to develop an effective assessment, contributing to the decision making process.
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