Adding device identifiers to claims forms—a key step to advance medical device safety

Kadakia, Kushal T; Dhruva, Sanket S.; Ross, Joseph S.; Krumholz, Harlan M.

doi:10.1136/bmj.p82

Cited by 7 publications

(6 citation statements)

References 3 publications

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“…24 Integration of UDIs into electronic health records and claims forms would improve the accuracy of attributing safety events to medical devices. 25 , 26 This would enable the inclusion of more comprehensive and accurate information about injuries and deaths in recall notices so patients and healthcare professionals could better understand the risk of recalled devices, especially as the majority of recall notices recommended clinicians evaluate risk and offer education with respect to the recalled devices. Furthermore, patient instructions were not included in most recall notices of devices that involved patient use.…”

Section: Discussionmentioning

confidence: 99%

Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study

Mooghali¹,

Ross²,

Kadakia³

et al. 2023

MDER

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Background Medical device recalls are initiated in response to safety concerns. Class I (highest severity) recalls imply a reasonable likelihood of serious adverse events or death associated with device use. Recalled devices must be identified, assessed, and corrected or removed, upon which a recall can be terminated. Objective To characterize Class I medical device recalls and corresponding recalled devices. Methods This was a cross-sectional study of Class I recalls posted on the Food and Drug Administration’s annual log from January 1, 2018 to June 30, 2022 for moderate-risk and high-risk medical devices. Devices were categorized by therapeutic use, need for implantation, and life-sustaining designation; recalls were categorized by reason, status, and time elapsed. Results There were 189 unique Class I medical device recalls, including 151 (79.9%) for moderate-risk and 34 (18.0%) for high-risk devices. Sixty-five (34.4%) recalls were for cardiovascular devices, 36 (19.0%) for implanted devices, and 37 (19.6%) for life-sustaining devices. The median number of device units recalled in the US per recall notice was 4620 (interquartile range [IQR], 578–42,591), with 11 (5.8%) recalls associated with more than 1 million device units. Overall, 125 (66.1%) devices had multiple recalls, with a median of 4 (IQR, 3–11) recalls issued per recalled device. As of September 15, 2022, 50 (26.5%) recalls were terminated, with a median of 24 (IQR, 17.3–30.8) months elapsed between recall initiation and termination. Recalls were terminated more commonly among devices recalled once compared to those recalled multiple times (36.2% vs 19.2%; p=0.02) and for recalls that recommended discontinuing further use of affected devices compared to those that recommended device assessment and/or education of affected population (31.8% vs 18.2%; p=0.04). Conclusion High-severity medical device recalls are common and affect millions of device units annually in the US. Recall termination takes a significant amount of time, putting patients at risk for serious safety concerns.

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Section: Discussionmentioning

confidence: 99%

Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study

Mooghali¹,

Ross²,

Kadakia³

et al. 2023

MDER

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show abstract

“…Integrating unique device identifiers into claims data and electronic health records could permit the FDA to better identify patients using faulty devices. For Medicare to include unique device identifiers on claims forms, such a policy must first be endorsed by the National Committee on Vital and Health Statistics, which next meets in December 2022 …”

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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“…Fortunately, there is a proposal to include the device identifier portion of the UDI on claims forms. 7 If this is ultimately adopted as a requirement by the United States' largest payor, the Centers for Medicare & Medicaid Services, health systems would need to integrate this information into electronic health records so that they could transmit the device identifier to receive payment. This process would entail linking each medical device to a patient and, therefore, would enable tracking clinical outcomes associated with medical devices in both electronic health records and claims data.…”

Section: + Related Articlementioning

confidence: 99%

“…Fortunately, there is a proposal to include the device identifier portion of the UDI on claims forms . If this is ultimately adopted as a requirement by the United States’ largest payor, the Centers for Medicare & Medicaid Services, health systems would need to integrate this information into electronic health records so that they could transmit the device identifier to receive payment.…”

mentioning

confidence: 99%

Medical Device Modifications Through Premarket Approval Supplements—Ensuring Patient Safety

Caughron

Dhruva

2023

JAMA Netw Open

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Adding device identifiers to claims forms—a key step to advance medical device safety

Cited by 7 publications

References 3 publications

Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study

Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study

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

Medical Device Modifications Through Premarket Approval Supplements—Ensuring Patient Safety

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