Herculean efforts and standardizing valve labeling

Abstract

Author has nothing to disclose with regard to commercial support. Author has nothing to disclose with regard to commercial support. The European Association for Cardio-Thoracic Surgery—The Society of Thoracic Surgeons—American Association for Thoracic Surgery Valve Labelling Task Force has set out a clear and compelling argument as to why there is a scientific need for standardized labeling of heart valves.1Durko A.P. Head S.J. Pibarot P. Atluri P. Bapat V. Cameron D.E. et al.EACTS–STS–AATS Valve Labelling Task ForceCharacteristics of surgical prosthetic heart valves and problems around labeling: a document from the European Association for Cardio-Thoracic Surgery (EACTS)—The Society of Thoracic Surgeons (STS)—American Association for Thoracic Surgery (AATS) valve labelling task force.J Thorac Cardiovasc Surg. 2019; 158: 1041-1054Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar From the surgeon's point of view, the failure to standardize the labeling of heart values would mean that values would continue to be evaluated in “apples to oranges” comparisons. On the other hand, valve manufactures would prefer the status quo labeling system because of its lack of market transparency, which leads to greater profits. The US Food and Drug Administration (FDA) controls the labeling of medical devices.2US Food and Drug Administration CFR—Code of Federal Regulations. Title 21—Food and Drugs—Chapter I–Food and Drug Administration, Department of Health and Human Services: Subchapter H–Medical Devices: Part 801—Labeling.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.1Google Scholar Briefly, these regulations state that manufacturers of medical devices must adhere to labeling requirements that have been approved by the FDA. A manufacturer who fails to comply with FDA's labeling requirements faces civil and criminal liability for misbranding. Conceptually, then, the easiest way to standing the labeling for heart valves is to lobby the FDA for such regulations. The bad news is that there is a vast difference between the capacity of cardiothoracic surgeons and the capacity of medical device manufacturers to lobby the FDA. In 2018, Medtronic spent $4.8 million on lobbying.3The Center for Responsive PoliticsClient profile: Medtronic Inc.https://www.opensecrets.org/lobby/clientsum.php?id=D000022110&year=2018Date accessed: October 5, 2019Google Scholar To match this figure, the country's approximately 4000 cardiothoracic surgeons would need to contribute approximately $1200 each to an appropriate political action committee. Importantly, this collection of $1200 contributions would only match what Medtronic alone spent on lobbying—allowing all the other medical device manufacturers' lobbying dollars to go unmatched. Dollars spent on lobbying by medical device manufacturers go a long way in exerting influence on the FDA. For example, FDA regulations require device manufactures to file publicly available MAUDE (Manufacturer and User Facility Device Experience) reports when a medical device is found to have “suspected device-associated deaths, serious injuries and malfunctions.”4US Food and Drug Administration MAUDE—Manufacturer and user facility device experience.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfmDate accessed: October 5, 2019Google Scholar And yet, despite its own regulations, since 2016, the FDA has allowed medical device manufacturers to conceal 1.1 million MAUDE events in a secrete database.5Jewett C. Hidden reports masked the scope of widespread harm from faulty heart device. Kaiser Health News.https://californiahealthline.org/news/hidden-reports-masked-the-scope-of-widespread-harm-from-faulty-heart-device/Date: May 21, 2019Date accessed: October 5, 2019Google Scholar Accordingly, if the FDA administrators are willing to aid and abet medical device manufacturers in the concealment of adverse events, it seems unlikely the FDA will promulgate regulations mandating uniform labeling requirements for heart valves. The Valve Labelling Task Force is to be commended for its herculean efforts to compile the literature on factors that affect heart valve performs. But an ever larger herculean effort will be required to standardize the labeling requirements for heart valves. Characteristics of surgical prosthetic heart valves and problems around labeling: A document from the European Association for Cardio-Thoracic Surgery (EACTS)—The Society of Thoracic Surgeons (STS)—American Association for Thoracic Surgery (AATS) Valve Labelling Task ForceThe Journal of Thoracic and Cardiovascular SurgeryVol. 158Issue 4PreviewIntraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labeling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). Full-Text PDF Open ArchiveReply: Focus: Diameters and gradients, not commerce or regulationsThe Journal of Thoracic and Cardiovascular SurgeryVol. 159Issue 4PreviewWe thank Dr McLean for conveying in his Letter to the Editor1 his thoughtful appreciation of the intensive efforts made by the EACTS–STS–AATS Valve Labelling Task Force. Indeed, these efforts included lengthy in-person meetings and animated and erudite discussions by expert participants from multiple specialty areas, as well as detailed, organized, shared writing assignments. The panel was truly multicontinental and multinational. Full-Text PDF