Pacemaker Cybersecurity
Notice bibliographique
Résumé
◼ security measures ◼ United States Food and Drug I n August of 2016, Muddy Waters Capital LLC released a short-sell report outlining potential cybersecurity vulnerabilities in several St Jude Medical (now Abbott) pacemaker models after demonstrations of a crash attack and a battery drain attack by vulnerability research firm MedSec. 1 The motivation behind the release of this report does not appear to have been focused on patient safety.Rather than inform Abbott or the US Food and Drug Administration directly, the information was released to the public sector. 2 This event was followed by a safety communication issued by the US Food and Drug Administration in January of 2017 describing the vulnerabilities and informing the public of a software patch.3 Shortly thereafter, the US Food and Drug Administration issued a warning letter to Abbott in April of 2017.In response to these events, Abbott released a firmware upgrade with enhanced cybersecurity.Installation of this firmware upgrade is noninvasive and takes a few minutes to complete.During the installation procedure, the pacemaker may temporarily change its pacing mode, leaving open the possibility that patients may become symptomatic during the upgrade.4 In addition, Abbott identified several other small risks associated with the upgrade, including a complete loss of function (0.003%), loss of device settings (0.023%), and failure of the update (0.161%) 2 (accessible at https://www.sjm.com/~/me-dia/galaxy/hcp/resources-reimbursement/technical-resources/product-adviseriesarchive/cybersecurity-pacemaker-firmware/pacemaker-firmware-update-doctorletter-aug2017-us.pdf).Changes to device settings are usually transient, however; complete loss of function may require urgent action (temporary pacing) and definitive solution with a battery replacement.Other less dramatic changes such as a transient shift to unipolar mode may not require specific action.On the basis of these risks, it has been recommended that these firmware upgrades be performed in a center with the ability to perform urgent temporary pacing.4 It is important to note that the adverse event rates reported by Abbott are based on estimates derived from other circumstances, and the true adverse events rate may not be known until after completion of many upgrades.Clinicians are responsible for identifying patients with devices who may be at risk and explaining the risks and benefits associated with the firmware upgrade.At our large tertiary care center with 5 electrophysiologists, 155 patients were identified with affected devices and offered the firmware upgrade between November 17, 2017, and February 13, 2018.This study was approved by the institutional review committee, and the subjects gave informed consent.Out of 155 patients seen in clinic, 6 (3.9%) elected to receive the firmware upgrade once the risks and benefits were fully explained in a systematic manner using recommendations devised by Abbott and endorsed by the Canadian Heart Rhythm Society.During the upgrade, 1 patient with a dual-chamber pacemaker (programmed in VVIR mode) exhibited a transient 3 second pause followed by a
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,016 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,001 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,004 | 0,002 |
| Communication savante | 0,005 | 0,002 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,037 | 0,028 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,021 | 0,006 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».