device safety

Pathway map development for medical device event reporting in operating theatres: a human factors approach to improving the existing system
Arkeliana Tase, Massimo Micocci, Peter Buckle, Melody Ni, George Hanna

BMJ Surgery, Interventions, & Health Technologies Mar 2023, 5 (1) e000155; DOI: 10.1136/bmjsit-2022-000155
Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative
Maryam Mooghali, Vinay K Rathi, Kushal T Kadakia, Joseph S Ross, Sanket S Dhruva

BMJ Surgery, Interventions, & Health Technologies Sep 2023, 5 (1) e000186; DOI: 10.1136/bmjsit-2023-000186
Endovascular versus open repair in patients with abdominal aortic aneurysm: a claims-based data analysis in Japan
Yuki Kimura, Hiroshi Ohtsu, Naohiro Yonemoto, Nobuyoshi Azuma, Kazuhiro Sase

BMJ Surgery, Interventions, & Health Technologies Jul 2022, 4 (1) e000131; DOI: 10.1136/bmjsit-2022-000131
Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks
Art Sedrakyan, Danica Marinac-Dabic, Bruce Campbell, Suvekshya Aryal, Courtney E Baird, Philip Goodney, Jack L Cronenwett, Adam W Beck, Elizabeth W Paxton, Jim Hu, Ralph Brindis, Kevin Baskin, Terrie Cowley, Jeffery Levy, David S Liebeskind, Benjamin K Poulose, Charles R Rardin, Frederic S Resnic, James Tcheng, Benjamin Fisher, Charles Viviano, Vincent Devlin, Murray Sheldon, Jens Eldrup-Jorgensen, Jesse A Berlin, Joseph Drozda, Michael E Matheny, Sanket S Dhruva, Timothy Feeney, Kristi Mitchell, Gregory Pappas

BMJ Surgery, Interventions, & Health Technologies Nov 2022, 4 (Suppl 1) e000123; DOI: 10.1136/bmjsit-2021-000123
IDEAL as a guide to designing clinical device studies consistent with the new European Medical Device Regulation
Camilla Fleetcroft, Peter McCulloch, Bruce Campbell

BMJ Surgery, Interventions, & Health Technologies Mar 2021, 3 (1) e000066; DOI: 10.1136/bmjsit-2020-000066
How to tie dangerous surgical knots: easily. Can we avoid this?
Eric Drabble, Sofia Spanopoulou, Eleni Sioka, Ellie Politaki, Ismini Paraskeva, Effrosyni Palla, Lauren Stockley, Dimitris Zacharoulis

BMJ Surgery, Interventions, & Health Technologies Jul 2021, 3 (1) e000091; DOI: 10.1136/bmjsit-2021-000091
How much is enough? Finding the minimum annual surgical volume threshold for total knee replacement
Per-Henrik Randsborg, Amanda C Chen

BMJ Surgery, Interventions, & Health Technologies Oct 2021, 3 (1) e000092; DOI: 10.1136/bmjsit-2021-000092
‘Rise of the Machines’: Human Factors and training for robotic-assisted surgery
Fiona Kerray, Steven Yule

BMJ Surgery, Interventions, & Health Technologies Oct 2021, 3 (1) e000100; DOI: 10.1136/bmjsit-2021-000100
How real-world evidence can really deliver: a case study of data source development and use
Joseph Drozda, Angelique Zeringue, Benjamin Dummitt, Byron Yount, Frederic Resnic

BMJ Surgery, Interventions, & Health Technologies Mar 2020, 2 (1) e000024; DOI: 10.1136/bmjsit-2019-000024
Evaluation of reoperations for removal of bioabsorbable plates and screws based on adverse events reports from PMDA, Japan
Tomoko Kobayashi, Nobuhiro Handa, Kazuhisa Koike, Shuichi Mochizuki, I Kaku, Shinichi Takae

BMJ Surgery, Interventions, & Health Technologies May 2020, 2 (1) e000033; DOI: 10.1136/bmjsit-2020-000033

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