A new study published in BMJ Surgery, Interventions & Health Technologies
finds that registries for high-risk implantable medical devices often contain enough to identify outlier safety or effectiveness issues, but in some cases do not capture data that could identify other functional or quality issues.
According to the authors, registries and coordinated registry networks (CRNs) “offer a promising alternative or adjunct” to preapproval data collection and postapproval studies for answering questions about the safety or effectiveness of a device that are unanswered at the time of marketing approval.
The authors also suggest that data linkages between registries and other sources of health care information such as insurance claims, electronic health records or data from health apps and wearable devices could enable better long-term follow-up.
But tracking patient reported outcomes (PROs) via registries remains a challenge as registries and other sources of healthcare information “do not currently capture such outcomes,” the authors note.
The study looked at registries for four types of medical devices: total hip replacement (THR), total knee replacement (TKR), endovascular aneurysm repair (EVAR) and surgical mesh implanted for pelvic organ prolapse (POP).
“Our analyses suggest that registries to not need to follow unrealistically large cohorts to identify outlier performance of types of devices,” the authors write, noting that “most registries either contain sufficient numbers of patients already or are expected to” in the future.
However, the authors point out that while major registries for hip and knee replacements see records of more than 1 million total joint replacements each year, they “lack robust capture of functional and quality measures,” such as the Harris hip score (HHS) or quality of life (QoL).
In comparison, the authors say the US Vascular Quality Initiative (VQI)’s registry has data for over 32,000 abdominal aortic aneurysm (AAA) repairs and “adequately captures key performance measures.”
The authors also point out that it is not entirely clear whether current registries are large enough for identifying issues with specific device brands.
Linking registries to other data sources, such as insurance claims, as the US Food and Drug Administration (FDA) is proposing to do under the National Evaluation System for Health Technology (NEST), would address obstacles to long-term surveillance and follow-up.
But the authors note that such linkages are “better suited for clinically measured safety or effectiveness outcomes … than for patient-reported outcomes (e.g., QoL) which requires direct data collection.”