Medical Device Tracking—How It Is and How It Should Be

Kinard, Madris; McGiffert, Lisa

doi:10.1001/jamainternmed.2020.7797

Cited by 10 publications

(14 citation statements)

References 2 publications

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“… 23 UDI use by health systems in management of recalled devices supports accuracy and efficiency to remove these devices and find patients that are affected. 5 , 24 , 25 As a result of the COVID-19 pandemic and supply disruptions impacting patient care, UDI adoption has been recommended to strengthen the health care supply chain. 26…”

Section: Discussionmentioning

confidence: 99%

Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers

Wilson¹,

Tcheng²,

Graham³

et al. 2022

MDER

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Background The requirement for medical device manufacturers to label their devices with a unique device identifier (UDI) was formalized by the 2013 US Food and Drug Administration Unique Device Identification System Rule. However, parallel regulatory requirement for US health systems to use UDIs, particularly the electronic documentation of UDIs during patient care is lacking. Despite the lack of regulation, some health systems have implemented and are using UDIs. To assess the current state, we studied representative health system UDI implementation experiences, including barriers and the strategies to overcome them, and identified next steps to advance UDI adoption. Methods Semi-structured interviews were performed with health system personnel involved in UDI implementation in their cardiac catheterization labs or operating rooms. Interviews were transcribed and analyzed using the framework methodology of Ritchie and Spencer. An expert panel evaluated findings and informed barriers, strategies, and next steps. Results Twenty-four interviews at ten health systems were performed. Identified barriers were internal (lack of organizational support, information technology gaps, clinical resistance) and external (information technology vendor resistance, limitations in manufacturer support, gaps in reference data, lack of an overall UDI system). Identified strategies included relationship building, education, engagement, and communication. Next steps to advance UDI adoption focus on education, research, support, and policy. Conclusions and Implications Delineation of UDI implementation barriers and strategies provides guidance and support for health systems to adopt the UDI standard and electronically document UDIs during clinical care. Next steps illuminate critical areas for attention to advance UDI adoption and achieve a comprehensive UDI system in health care to strengthen patient care and safety.

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Section: Discussionmentioning

confidence: 99%

Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers

Wilson¹,

Tcheng²,

Graham³

et al. 2022

MDER

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show abstract

“…9 UDI use in recall management adds accuracy, efficiency and effectiveness, supporting patient safety and quality of care. 10,11 Documented UDIs also have important downstream uses that support patient safety. UDIs in adverse event reports provide precise identification of devices, more complete and accurate records of device performance and the relative frequency of adverse events, all critical to support decision-making about devices that may not be performing well.…”

Section: Introductionmentioning

confidence: 99%

“… 9 UDI use in recall management adds accuracy, efficiency and effectiveness, supporting patient safety and quality of care. 10 , 11 …”

Section: Introductionmentioning

confidence: 99%

Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care

Wilson¹,

Tcheng²,

Graham³

et al. 2021

MDER

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Background:The US Food and Drug Administration's Unique Device Identification System Rule of 2013 mandated manufacturers to assign unique device identifiers (UDIs) to their medical devices. Most high-risk (Class III), moderate-risk (Class II) and implantable devices now have UDIs. To achieve the necessary next step for a comprehensive UDIenabled system for patient safety, UDIs must be electronically documented during patient care, a process not routinely done. The purpose of this research was to study the implementation experiences of diverse health systems in order to develop a roadmap for UDI implementation at the point of care. Methods: Semi-structured interviews were conducted with personnel at health systems that had implemented UDI for implantable devices in their cardiac catheterization labs or operating rooms. Interviews were audio-recorded, transcribed, and analyzed using the framework methodology of Ritchie and Spencer. Data interpretation involved development of a conceptual model and detailed recommendations for UDI implementation. An expert panel evaluated and provided input on the roadmap. Results: Twenty-four interviews at ten health systems were conducted by phone. Participants described implementation steps, factors and barriers impacting implementation. Findings populated a UDI implementation roadmap, that includes Foundational Themes, Key Components, Key Steps, UDI Use, and Outcomes. Conclusions and Implications:The UDI implementation roadmap provides a framework for health systems to address the necessary steps and multilevel factors that underpin UDI implementation at the point of care. It is intended to guide and advance routine electronic documentation of UDIs for devices used during clinical care, the critical next step for a comprehensive UDI-enabled system to enhance medical device safety and effectiveness for patients.

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“…This failure occurred because Philips, as has been the case for other manufacturers of moderate-risk devices, does not track individual devices using product registries or identifier systems. 19 Philips instead relied on durable medical equipment vendors to notify patients about the recall. 11 However, these contractors may not maintain long-term relationships or records of patients.…”

Section: Recommendations For Systemic Reformmentioning

confidence: 99%

The Philips Respironics Recall of Ventilators and Positive Airway Pressure Machines—Breakdowns in Medical Device Surveillance

2023

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Philips Respironics (Philips) initiated one of the largest medical device recalls in history, affecting more than 10 million devices in the United States and 15 million devices worldwide. 1 Philips recalled 14 models of ventilators and positive airway pressure machines (both bilevel positive airway pressure [BPAP] and continuous positive airway pressure [CPAP] machines) using polyester-based polyurethane (PE-PUR) sound abatement foam owing to concerns that foam degradation could harm patients through inhalation of toxic particles and emissions. The US Food and Drug Administration (FDA) categorized this recall as Class I (the most severe designation), indicating reasonable probability that device use could cause serious adverse health consequences or death.In April 2022, Philips received a subpoena from the US Department of Justice for information on events leading to the recall, and as of July 2022, the company was in discussions "regarding the terms of a proposed consent decree to resolve the identified issues." 2 In August 2022, the FDA reported that it had received more than 69 000 reports of adverse eventsincluding cancer, pneumonia, and chest pain-and 168 reports of death linked to the recalled devices. 1 This ongoing public health crisis highlights the need for reforms to medical device regulation in the US to better protect patients.

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Medical Device Tracking—How It Is and How It Should Be

Cited by 10 publications

References 2 publications

Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers

Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers

Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care

The Philips Respironics Recall of Ventilators and Positive Airway Pressure Machines—Breakdowns in Medical Device Surveillance

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