Another highlight of the 5th Latin American Conference of the International Society for Pharmacology and Outcomes Research (ISPOR) was medical devices and their implications for decision-making.
By 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 its full activity. These, in turn, should not be a substitute for the role of the health professional, but should ensure a better quality of care and promote the value of care.
An important aspect regarding devices is the characteristic of the accelerated renewal cycle and the renewal of technologies, through the process of paradigm change in health, which promotes an economic impact due to products becoming obsolete or not optimized for the target audience. In addition to making the rapid incorporation of these at the same rate as they are created challenging.
Compared to pharmaceuticals, medical devices have a higher adherence to treatment, however, the operator's skill and the different learning curves related to the process can jeopardize the expected results, thus presenting significant variability. Not only this factor makes their evaluation in studies difficult, but also the small size of the population to be used in the technology and the difficulty of being able to have a control and masked group.
Because of these limitations, most regulatory agencies base device registration according to their risk category:
Class I (low risk): technology subject to generic control, as it does not show potential for patient injury.
Class IIa (moderate risk): device subject to special control during the manufacturing phase to demonstrate its efficacy and safety.
Class IIb (high risk): device subject to special control in design and manufacturing to demonstrate its effectiveness and safety.
Class III (very high risk): technology subject to special control in all its development processes, since it has the potential to evolve with injuries to the patient.
Despite this alternative, economic analysis is vulnerable to bias, given the lower quality of information and the fact that sensitivity analyses are more complex to interpret, reflecting less robustness. In addition, there is a lack of consensus on a standard value for the discount rate as is done for medicines.
A European study by Reinhard Busse et al attempted to address these challenges by creating a new taxonomic model for medical devices, minimising barriers while grouping them according to their risk and based on different selection and prioritisation criteria in health technology assessment. Data were obtained from reports that had the highest possible quality and experience and through interviews at 16 different European institutions.
Along with the classification described above, classes IV (implantable devices, such as the cochlear) and V (in vitro diagnostic methods) were included.
Devices in low-risk categories were found to be less important in terms of safety and economics. Implants, in turn, were found to be more relevant in terms of social, ethical and legal aspects.
Despite the conclusions presented, there is still a lack of further evidence, with solid data to more accurately assess the impact of medical devices and how to develop an effective assessment, contributing to the decision-making process.
More news related to the V Latin American ISPOR Conference:
Multi-criteria decision analysis (MCDA)