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

Authors DeWitt AL, Acker J, Larkin TA, Potenziano JL, Schmidt JM

Received 19 June 2020

Accepted for publication 19 January 2021

Published 17 February 2021 Volume 2021:14 Pages 27—35

DOI https://doi.org/10.2147/MDER.S268477

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Scott Fraser


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, USA

Correspondence: Anthony L DeWitt 2755 National Village Parkway, Opelika, AL, 36801, USA
Tel +1 573 230-4220
Email aldewitt@aldewitt.com

Abstract: 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

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