Rates of Adoption and Outcomes After Firmware Updates for Food and Drug Administration Cybersecurity Safety Advisories (bibtex)
by Saxon, Leslie A., Varma, Niraj, Epstein, Laurence M., Ganz, Leonard I. and Epstein, Andrew E.
Abstract:
In response to Food and Drug Administration (FDA) Cybersecurity Safety Advisories affecting over 1 500 000 patients implanted globally with pacemakers (490 209 US patients) and implantable cardioverter-defibrillators (ICDs; 357 647 US patients) and related equipment, Abbott released 2 cybersecurity firmware updates between August 2017 and April 2018 for impacted pacemakers and ICDs.1,2 We previously reported on firmware update rates, complications, and predictors of upgrades in a subset of affected US patients with pacemakers.3 Firmware update adoption, requiring a clinic visit, was low, as were complications. Subsequently, in 2018 to 2019, FDA cybersecurity advisories have also impacted over 16 000 programmers and 600 000 ICDs manufactured by Medtronic and mitigations for those have also been FDA approved.
Reference:
Rates of Adoption and Outcomes After Firmware Updates for Food and Drug Administration Cybersecurity Safety Advisories (Saxon, Leslie A., Varma, Niraj, Epstein, Laurence M., Ganz, Leonard I. and Epstein, Andrew E.), In Circulation: Arrhythmia and Electrophysiology, volume 13, 2020.
Bibtex Entry:
@article{saxon_rates_2020,
	title = {Rates of {Adoption} and {Outcomes} {After} {Firmware} {Updates} for {Food} and {Drug} {Administration} {Cybersecurity} {Safety} {Advisories}},
	volume = {13},
	issn = {1941-3149, 1941-3084},
	url = {https://www.ahajournals.org/doi/10.1161/CIRCEP.120.008364},
	doi = {10.1161/CIRCEP.120.008364},
	abstract = {In response to Food and Drug Administration (FDA) Cybersecurity Safety Advisories affecting over 1 500 000 patients implanted globally with pacemakers (490 209 US patients) and implantable cardioverter-defibrillators (ICDs; 357 647 US patients) and related equipment, Abbott released 2 cybersecurity firmware updates between August 2017 and April 2018 for impacted pacemakers and ICDs.1,2 We previously reported on firmware update rates, complications, and predictors of upgrades in a subset of affected US patients with pacemakers.3 Firmware update adoption, requiring a clinic visit, was low, as were complications. Subsequently, in 2018 to 2019, FDA cybersecurity advisories have also impacted over 16 000 programmers and 600 000 ICDs manufactured by Medtronic and mitigations for those have also been FDA approved.},
	number = {8},
	journal = {Circulation: Arrhythmia and Electrophysiology},
	author = {Saxon, Leslie A. and Varma, Niraj and Epstein, Laurence M. and Ganz, Leonard I. and Epstein, Andrew E.},
	month = aug,
	year = {2020},
	keywords = {CBC}
}
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