MARC details
| 000 -LEADER |
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| fixed length control field |
03310nam a22004337a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
220511s20222022 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
0194-5998 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1177/01945998221085166 [doi] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
35290135 |
| 245 ## - TITLE STATEMENT |
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| Title |
Recalls of Moderate- and High-Risk Otolaryngologic Devices Approved by the US Food and Drug Administration, 2003-2019. |
| 251 ## - Source |
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| Source |
Otolaryngology - Head & Neck Surgery. :1945998221085166, 2022 Mar 15 |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Otolaryngol Head Neck Surg. :1945998221085166, 2022 Mar 15 |
| 253 ## - Journal Name |
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| Journal name |
Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Publication date |
2022 Mar 15 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
aheadofprint |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2022-05-11 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
CONCLUSION: Otolaryngologic devices approved by the FDA via the 510(k) pathway exhibit a higher number of recalls than the PMA pathway. Given the balance between regulation and facilitating innovation, postmarket surveillance and ongoing regulatory improvements are critical to ensure optimal safety of medical devices. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
METHODS: The FDA Ear, Nose, and Throat Devices Panel database was queried for 510(k) clearances and PMA approvals from 1976 to 2019. Device recalls from 2003 to 2019 were reviewed. Devices were then categorized by subspecialty, type, supporting evidence, and PMA supplement type. Logistic regression characterized the odds of recall for each device type and subspeciality. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
OBJECTIVE: The US Food and Drug Administration (FDA) regulates the marketing of medical devices based on the premarket approval (PMA) or 510(k) pathway. We investigated the relationship among the regulatory pathway of otolaryngologic devices, the number of recalls, and the recall characteristics. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
RESULTS: A total of 1061 (57.8%) 510(k) and 778 (42.3%) PMA device applications and modifications were approved. There were 120 (11.3%) recall events associated with 42 unique otolaryngologic devices cleared via the 510(k) pathway, as compared with 25 (3.2%) recall events for 5 unique PMA devices. 510(k) device approvals were more likely to be recalled than PMA device approvals (odds ratio, 3.67; 95% CI, 2.38-5.88; P < .0001). 510(k) surgical devices (odds ratio, 2.1; 95% CI, 1.1-4.4; P = .03) were more likely to be recalled than diagnostic devices. Devices designated for laryngology (70.0%) and general otolaryngology (25.0%) composed the majority of recalls. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
SETTING: Publicly available FDA databases. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
STUDY DESIGN: Retrospective cross-sectional analysis. |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
IN PROCESS -- NOT YET INDEXED |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Washington Hospital Center |
| 656 ## - INDEX TERM--OCCUPATION |
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| Department |
MedStar Georgetown University Hospital/MedStar Washington Hospital Center |
| 656 ## - INDEX TERM--OCCUPATION |
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| Department |
Otolaryngology |
| 656 ## - INDEX TERM--OCCUPATION |
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| Department |
Otolaryngology Residency |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Gao, William Z |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Parsa, Keon |
| 790 ## - Authors |
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| All authors |
Gao WZ, Parsa KM, Talati IA |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1177/01945998221085166">https://dx.doi.org/10.1177/01945998221085166</a> |
| Public note |
https://dx.doi.org/10.1177/01945998221085166 |
| 858 ## - ORCID |
|---|
| ORCID text |
Parsa, Keon M |
| Orcid |
<a href="https://orcid.org/0000-0001-9198-5121">https://orcid.org/0000-0001-9198-5121</a> |
| Name |
https://orcid.org/0000-0001-9198-5121 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
