Reducing umbilical catheter migration rates by using a novel securement device.

OBJECTIVE: This study evaluates the effectiveness of a novel device, LifeBubble, in reducing umbilical cord catheter (UC) migration and associated complications in neonates. STUDY DESIGN: A retrospective review was performed at Oregon Health & Science University's NICU (2019-2021) to compare standard adhesive securement with LifeBubble. The primary outcomes were UC migration, discontinuation due to malposition, and CLABSI incidence. Differences between groups were statistically analyzed and logistic regression used to adjust for potential confounders. RESULTS: Among 118 neonates (57 LifeBubble, 61 adhesive), LifeBubble significantly reduced migration of any UC > 1 vertebral body (12.3% vs. 55.7%), including UVC migration (5.3% vs. 39.3%) and UAC migration (7.0% vs 23.0%), as well as UVC discontinuation due to malposition (5.6% vs 37.7%). The number needed to treat (NNT) to prevent one instance of UVC discontinuation is 4. CONCLUSION: LifeBubble effectively reduces UC migration and premature discontinuation, indicating its potential to enhance neonatal care and safety.

Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies.

Importance: A wide variety of novel medical diagnostics and devices are determined safe and effective by the US Food and Drug Administration (FDA) each year, but to our knowledge the literature lacks evidence documenting how long it takes to establish new Medicare coverage for these technologies. Objective: To measure time from FDA authorization to at least nominal Medicare coverage for technologies requiring a new reimbursement pathway. Design, Setting, and Participants: In this cross-sectional study, public databases were used to associate each technology to billing codes, determine the effective date of each code and Medicare coverage decisions, and stratify by the maturity of the Medicare coverage. At least nominal coverage was defined as achievement of explicit coverage milestones through a national coverage determination, local coverage determinations by Medicare administrative contractors, or by implicit coverage aligned to a new billing code. Characterization by product type (acute treatment, chronic or ongoing treatment, diagnostic assay, and diagnostic device), manufacturer size, and evidence level were assessed for association with coverage achievement. The study included new product applications authorized by the FDA through the premarket approval pathway, the de novo pathway, or with breakthrough designation in the 510(k) pathway from January 1, 2016, to December 31, 2019. Data analysis took place between May 1, 2022, and December 31, 2022. Main Outcome Measurement: Time from FDA authorization to the first coverage milestone. Results: Among 281 identified technologies in the total sample, 64 (23%) were deemed novel technologies based on the absence of coverage determinations and/or the use of temporary or miscellaneous billing codes. Twenty-eight of 64 technologies (44%) successfully achieved explicit or implicit coverage following FDA authorization. The median time to at least nominal coverage for the analysis cohort was 5.7 years (90% CI, 4.4-NA years). Analysis of time-to-coverage data highlighted company size (log-rank P<.001) and product type (log-rank P = .01) as significant covariates associated with coverage achievement. No association was observed for technologies with level 1 evidence at FDA authorization and subsequent coverage milestone achievement (log-rank P = .40). Conclusions and Relevance: In this cross-sectional study of 64 novel technologies, only 28 (44%) achieved coverage milestones over the study timeline. The several-year period observed to establish at least nominal coverage suggests existing coverage processes may affect timely reimbursement of new technologies.