Compatibility and Safety Implications Associated with Interfacing Medical Devices in Neonatal Respiratory Care: A Case Example Using the Inhaled Nitric Oxide Delivery System

Anthony L DeWitt,1 Jaron Acker,2 Thomas A Larkin,3 Jim L Potenziano,4 Jeffrey M Schmidt5 1Penumbra Seminars, LLC, Auburn, AL, USA; 2Medical Device Marketing, Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA; 3Device Engineering R&D, Mallinckrodt Pharmaceuticals Ireland Ltd., Dublin, Ireland...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	DeWitt AL, Acker J, Larkin TA, Potenziano JL, Schmidt JM
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	patient safety equipment failure medical device legislation Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/0baad3c5310d4d9ca8ebb648def53b16
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:0baad3c5310d4d9ca8ebb648def53b16
record_format	dspace
spelling	oai:doaj.org-article:0baad3c5310d4d9ca8ebb648def53b162021-12-02T14:12:01ZCompatibility and Safety Implications Associated with Interfacing Medical Devices in Neonatal Respiratory Care: A Case Example Using the Inhaled Nitric Oxide Delivery System1179-1470https://doaj.org/article/0baad3c5310d4d9ca8ebb648def53b162021-02-01T00:00:00Zhttps://www.dovepress.com/compatibility-and-safety-implications-associated-with-interfacing-medi-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Anthony L DeWitt,1 Jaron Acker,2 Thomas A Larkin,3 Jim L Potenziano,4 Jeffrey M Schmidt5 1Penumbra Seminars, LLC, Auburn, AL, USA; 2Medical Device Marketing, Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA; 3Device Engineering R&D, Mallinckrodt Pharmaceuticals Ireland Ltd., Dublin, Ireland; 4Scientific Affairs, Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA; 5Device Development, Mallinckrodt Pharmaceuticals, Madison, WI, USACorrespondence: Anthony L DeWitt 2755 National Village Parkway, Opelika, AL, 36801, USATel +1 573 230-4220Email aldewitt@aldewitt.comAbstract: Over the past decade, international organizations have instituted strict regulations for the safe use of connected medical devices. The International Organization for Standardization and the Medical Device Single Audit Program instituted certifications to ensure that connected devices are compatible and operate within their proper clinical parameters. These efforts came about, in part, as a consequence of clinicians’ decisions to use nonstandard, modified, or improvised devices for purposes outside the original manufacturers’ approved parameters. Unapproved device modifications can be associated with increased risk of dosing errors, monitoring errors, tubing misconnections and serious or potentially fatal adverse events; furthermore, health care providers who implement unapproved device modifications may assume legal and financial liability should harm come to patients as a consequence of the modification. Using the inhaled nitric oxide delivery system as an example, the objective of this paper is to raise awareness of the potential dangers associated with unapproved modification and interfacing of therapeutic gas delivery systems and ventilators in the neonatal intensive care unit setting. The paper also highlights the rationale and necessity for rigorous validation processes that ensure that interfaced medical devices perform as intended in the clinical setting.Keywords: patient safety, equipment failure, medical device legislationDeWitt ALAcker JLarkin TAPotenziano JLSchmidt JMDove Medical Pressarticlepatient safetyequipment failuremedical device legislationMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 14, Pp 27-35 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	patient safety equipment failure medical device legislation Medical technology R855-855.5
spellingShingle	patient safety equipment failure medical device legislation Medical technology R855-855.5 DeWitt AL Acker J Larkin TA Potenziano JL Schmidt JM Compatibility and Safety Implications Associated with Interfacing Medical Devices in Neonatal Respiratory Care: A Case Example Using the Inhaled Nitric Oxide Delivery System
description	Anthony L DeWitt,1 Jaron Acker,2 Thomas A Larkin,3 Jim L Potenziano,4 Jeffrey M Schmidt5 1Penumbra Seminars, LLC, Auburn, AL, USA; 2Medical Device Marketing, Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA; 3Device Engineering R&D, Mallinckrodt Pharmaceuticals Ireland Ltd., Dublin, Ireland; 4Scientific Affairs, Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA; 5Device Development, Mallinckrodt Pharmaceuticals, Madison, WI, USACorrespondence: Anthony L DeWitt 2755 National Village Parkway, Opelika, AL, 36801, USATel +1 573 230-4220Email aldewitt@aldewitt.comAbstract: Over the past decade, international organizations have instituted strict regulations for the safe use of connected medical devices. The International Organization for Standardization and the Medical Device Single Audit Program instituted certifications to ensure that connected devices are compatible and operate within their proper clinical parameters. These efforts came about, in part, as a consequence of clinicians’ decisions to use nonstandard, modified, or improvised devices for purposes outside the original manufacturers’ approved parameters. Unapproved device modifications can be associated with increased risk of dosing errors, monitoring errors, tubing misconnections and serious or potentially fatal adverse events; furthermore, health care providers who implement unapproved device modifications may assume legal and financial liability should harm come to patients as a consequence of the modification. Using the inhaled nitric oxide delivery system as an example, the objective of this paper is to raise awareness of the potential dangers associated with unapproved modification and interfacing of therapeutic gas delivery systems and ventilators in the neonatal intensive care unit setting. The paper also highlights the rationale and necessity for rigorous validation processes that ensure that interfaced medical devices perform as intended in the clinical setting.Keywords: patient safety, equipment failure, medical device legislation
format	article
author	DeWitt AL Acker J Larkin TA Potenziano JL Schmidt JM
author_facet	DeWitt AL Acker J Larkin TA Potenziano JL Schmidt JM
author_sort	DeWitt AL
title	Compatibility and Safety Implications Associated with Interfacing Medical Devices in Neonatal Respiratory Care: A Case Example Using the Inhaled Nitric Oxide Delivery System
title_short	Compatibility and Safety Implications Associated with Interfacing Medical Devices in Neonatal Respiratory Care: A Case Example Using the Inhaled Nitric Oxide Delivery System
title_full	Compatibility and Safety Implications Associated with Interfacing Medical Devices in Neonatal Respiratory Care: A Case Example Using the Inhaled Nitric Oxide Delivery System
title_fullStr	Compatibility and Safety Implications Associated with Interfacing Medical Devices in Neonatal Respiratory Care: A Case Example Using the Inhaled Nitric Oxide Delivery System
title_full_unstemmed	Compatibility and Safety Implications Associated with Interfacing Medical Devices in Neonatal Respiratory Care: A Case Example Using the Inhaled Nitric Oxide Delivery System
title_sort	compatibility and safety implications associated with interfacing medical devices in neonatal respiratory care: a case example using the inhaled nitric oxide delivery system
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/0baad3c5310d4d9ca8ebb648def53b16
work_keys_str_mv	AT dewittal compatibilityandsafetyimplicationsassociatedwithinterfacingmedicaldevicesinneonatalrespiratorycareacaseexampleusingtheinhalednitricoxidedeliverysystem AT ackerj compatibilityandsafetyimplicationsassociatedwithinterfacingmedicaldevicesinneonatalrespiratorycareacaseexampleusingtheinhalednitricoxidedeliverysystem AT larkinta compatibilityandsafetyimplicationsassociatedwithinterfacingmedicaldevicesinneonatalrespiratorycareacaseexampleusingtheinhalednitricoxidedeliverysystem AT potenzianojl compatibilityandsafetyimplicationsassociatedwithinterfacingmedicaldevicesinneonatalrespiratorycareacaseexampleusingtheinhalednitricoxidedeliverysystem AT schmidtjm compatibilityandsafetyimplicationsassociatedwithinterfacingmedicaldevicesinneonatalrespiratorycareacaseexampleusingtheinhalednitricoxidedeliverysystem
_version_	1718391827288031232

Compatibility and Safety Implications Associated with Interfacing Medical Devices in Neonatal Respiratory Care: A Case Example Using the Inhaled Nitric Oxide Delivery System

Ejemplares similares