US House votes to kill medical device tax
Editor's Note A bill that would repeal the medical device tax cleared the House of Representatives on July 24 in a 283-132 vote. the July 24 The Hill reports. The tax provided part of the funding for the Affordable Care Act. Rep Erik Paulsen (R-Minn), the bill sponsor, says the…
Study: Medical device tax hurts investment in R&D
Editor's Note: This study from Iowa State University shows companies have cut funding for research and development (R&D) in response to the medical device tax imposed by the Affordable Care Act. Since 2013, the 2.3% excise tax has significantly reduced: R&D investment by $34 million Sales revenue by $188 million…
FDA delays UDI compliance dates for class I, unclassified devices
Editor's Note The Food and Drug Administration (FDA) on January 12 announced a delay in enforcement of unique device identification (UDI) requirements for class I and unclassified devices until September 24, 2020. The FDA also will not enforce direct mark requirements for these devices until September 24, 2022. The guidance…
EHR vendor linked to MU performance of hospitals
Editor's Note A study in the Journal of the American Medical Informatics Association found that some electronic health record (EHR) vendors consistently outperform others, the November 27 Becker’s Hospital Review reports. Epic had the highest performance on five of six meaningful use (MU) stage 2 criteria, including view, download, and…
ECRI Institute's new SERVICEguide helps reduce costs of outsourced services
Editor's Note SERVICEguide is the ECRI Institute’s new membership-based advisory service that helps hospitals maintain and manage their outsourced services. SERVICEguide includes an interactive assessment dashboard with spend analytics that reveal the highest potential areas for savings. Recently, for example, ECRI Institute helped a large healthcare system save more than…
Report predicts growth of spinal implant market
Editor's Note A Market Research Future report predicts the global market for spinal implants will reach $14 billion by 2011 because of an increasing prevalence of spinal injuries and disorders and an aging population, according to the July 5 Becker’s Spine Review. The costliness of spinal implants and unfavorable reimbursement…
FDA, device manufacturers make deal on user fees
Editor's Note The Food and Drug Administration and medical device manufacturers have made a deal on user fees companies pay to have the FDA review their products, the August 23 Mass Device reports. The Medical Device User Fee & Modernization Act IV will allow the FDA to collect nearly $1…
FDA issues draft UDI guidance
Editor's Note The Food and Drug Administration (FDA) on July 26 issued a draft Unique Device Identification (UDI) guideline that requires most medical device labels and packages to bear a UDI in easily readable plain-text and automatic identification and data capture technology forms. UDIs must be issued under a system…
Olympus told US executives not to issue warning on infections from tainted scopes
Editor's Note Despite “superbug” outbreaks and alerts issued in Europe, Japanese device manufacturer Olympus Corp told US executives in early 2013 not to issue a broad warning to American hospitals about potentially deadly infections from tainted duodenoscopes, the July 24 Los Angeles Times reports. At the time, Olympus was aware…
CMS, FDA advocate for UDI use in insurance billing
Editor's Note The Centers for Medicare & Medicaid Services (CMS) and Food and Drug Administration (FDA) are recommending using unique device identifiers (UDIs) in universal health insurance claims forms to improve value-based reimbursement for medical devices and postmarket surveillance, the July 14 Modern Healthcare reports. Proponents say UDIs could help…
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- Death, hospital readmission less likely for women treated by female doctors
- FDA announces class 1 recalls for infusion pumps, anesthesia workstation
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