Heart of Health Policy

Updates on Health Policy News Affecting Practice.

JACC Leadership Page: Helping ACC Members Deliver Higher-Quality Care

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In a recent Leadership Page published in the Journal of the American College of Cardiology (JACC), ACC President C. Michael Valentine, MD, FACC, discusses the ACC’s efforts to deliver high-quality care to patients. These efforts include appropriate use criteria, NCDR registries and formal principles to guide members and payers.

In the last five years, the College has moved to focusing on development of resources as well as national quality campaigns and initiatives. Looking forward, the goal is to create a suite of tools to help members drive quality improvement in their practices. “The ACC’s new vision calls for the creation of a world where innovation and knowledge optimize cardiovascular care and outcomes,” Valentine writes. “Our core values, in part, call for us to hold ourselves and our profession to the highest standards of evidence and knowledge; constructively challenge the status quo through innovation; and promote a culture of continuous improvement and lifelong learning. We are no longer just a knowledge organization, but a place where individual and institutional members can find the resources and tools to drive higher quality.”

Click here to read the full piece.

Are You Prepared to Address Cybersecurity Vulnerabilities in CIEDs?

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A new statement released at the Heart Rhythm Society’s 39th Annual Scientific Sessions last month outlines communication recommendations to assist health care professionals in understanding and preparing for potential cybersecurity vulnerabilities of cardiovascular implantable electronic devices (CIEDs).

The statement is the result of a 2017 Heart Rhythm Society Leadership Summit on Cybersecurity Vulnerabilities: Communications Strategies for Clinicians and Patients. It highlights several factors, including the “interconnectedness of the health care environment” and the “common persistence of outdated and unsupported software” that make CIEDs particularly vulnerable to exploitation. Given these factors, patients with CIEDs can feel particularly vulnerable and are turning to their health care professionals for guidance. Read More >>>

The authors highlight the importance of educating patients prior to CIED implant, and in advance of an announcement of a specific vulnerability or threat, so that they understand the systems in place to quickly assess and respond to potential vulnerabilities and are less likely to fall prey to those seeking to exploit patient fears.

The statement recommends that experts from manufacturers and federal agencies, such as the U.S. Food and Drug Administration (FDA), be the first line of defense in assessing a threat. From there, if vulnerability is validated, they suggest that health care professionals can then serve a critical role in assisting patients to interpret the significance of a cybersecurity vulnerability, the relative risks and benefits of continuing to receive therapy from the potentially affected device and deciding if they will pursue a mitigation strategy.

Five topics of discussion between the health care professional and patient should include:

  • Potential consequences if the vulnerability is exploited
  • Strategies to mitigate the risks
  • Technical challenges to exploit the vulnerability
  • Long-term solutions to eliminate the threat
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  • Benefits provided by the CIED compared with the risk if the vulnerability is exploited

“Medical societies and health care professionals are important resources not only to our patients, but to manufacturers and the FDA,” said Mary Norine Walsh, MD, MACC, immediate past ACC president and an author on the statement. “We are on the front lines of care and can help to ensure communications are consistent, accurate and effective.”

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Class I Recall for HeartMate 3 Left Ventricular Assist System

The U.S. Food and Drug Administration recently issued a Class I Recall for the HeartMate 3 Left Ventricular Assist System due to a malfunction that may lead to graft occlusion.

The potential defect in the device’s outflow graft assembly may cause the graft to reduce or stop pump flow, setting off a low flow alarm. Reduced pump flow can lead to serious adverse events including blood clots or death. Recalled products were distributed from Sept. 2, 2014, to present, totaling 4,878 recalled products nationwide. Affected devices include model numbers 106524US, 106524 and 10652INT.

Class I Recall: CARDIOSAVE Hybrid IABP

Maquet Datascope Corp. has issued a Class I recall for the CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.

In case of an interruption in therapy, Maquet Datascope Corp. instructs users to transfer the patient to an alternative IABP. If an alternative IABP is unavailable, manually inflate the IABP with air or helium and immediately aspirate. Affected customers will be contacted by Maquet Datascope Corp. to schedule on-site service of the IABP. Health care professionals and patients are encouraged to report adverse events related to the use of this product.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support

Keywords: ACC Publications, Cardiology Interventions, Health Policy, Quality Improvement, Leadership, United States Food and Drug Administration, Medical Device Recalls, Intra-Aortic Balloon Pumping, Societies, Medical, Thrombosis, Registries, Computer Security, Equipment Failure, Risk Assessment

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