Postmarketing surveillance of medical devices using medicare claims

Health Affairs

Volumn 24, Issue 4, 2005, Pages 928-937

  Malenka, David J ^a   Kaplan, Aaron V ^a   Sharp, Sandra M ^b   Wennberg, John E ^b  

^a DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^b DARTMOUTH MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG CARRIER;

AGED; APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; CHEMICALLY INDUCED DISORDER; COHORT ANALYSIS; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HUMAN; INSTRUMENTATION; INSURANCE; MEDICARE; METHODOLOGY; MORTALITY; POSTMARKETING SURVEILLANCE; RESTENOSIS; STANDARD; STENT; THROMBOSIS; TRANSLUMINAL CORONARY ANGIOPLASTY; UNITED STATES; UTILIZATION REVIEW;

AGED; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; COHORT STUDIES; CORONARY RESTENOSIS; DRUG CARRIERS; EQUIPMENT AND SUPPLIES; HUMANS; INSURANCE CLAIM REVIEW; MEDICARE; PRODUCT SURVEILLANCE, POSTMARKETING; STENTS; THROMBOSIS; UNITED STATES; UNITED STATES CENTERS FOR MEDICARE AND MEDICAID SERVICES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 23044431610     PISSN: 02782715     EISSN: None     Source Type: Journal    
DOI: 10.1377/hlthaff.24.4.928     Document Type: Article

References (12)

1. L.H. Monsein, "Primer on Medical Device Regulation, Part II: Regulation of Medical Devices by the U.S. Food and Drug Administration," Radiology 205, no. 1 (1997): 10-18;
2. and D.W. Feigal, S.N. Gardner, and M. McClellan, "Ensuring Safe and Effective Medical Devices," New England of Journal of Medicine 348, no. 3 (2003): 191-192.
3. As early as 1973, the U.S. Food and Drug Administration (FDA) requested voluntary reporting by health care professionals of device-related adverse events, a program that continues today as MedWatch. The Medical Device Regulation of 1984 (MDR, Federal Register 49, no. 36325, 14 September 1984) and the Safe Medical Devices Act of 1990 (P.L. 101-629) required the FDA to mandate universal reporting by facilities and distributors of serious adverse events associated with high-risk devices. The Medical Device Amendments of 1992 (P.L. 102-300) and the FDA Modernization Act of 1997 (P.L. 105-115) greatly modified these statutory requirements for postmarketing surveillance, repealing the mandate for such surveillance by distributors and requiring the FDA to develop a system for universal reporting among a representative subset of facilities. This has led to the formation of the Medical Product Surveillance Network (MedSun), which expects to be operating by 2005. As part of premarketing approval or Section 522 of the FDA Modernization Act of 1997, or both, the FDA still mandates postmarketing surveillance of high-risk devices when deemed appropriate. For a detailed description of the FDA's role in insuring the safety of medical devices, see T.P. Gross and L.G. Kessler, "Surveillance for Medical Devices," in Pharmacovigilance, ed. R.D. Mann and E.B. Andrews (Indianapolis: John Wiley and Sons, 2002), 411-422.
4. Task Force on Risk Management, Managing Risks from Medical Product Use: Creating a Risk Management Framework, Report to the FDA Commissioner (Rockville, Md.: U.S. Department of Health and Human Services, Food and Drug Administration, May 1999).
5. ICD-9-CM: International Classification of Diseases, Ninth Revision, Clinical Modification (Los Angeles: Practice Management Information Corporation, 1999).
6. American Medical Association, Current Procedural Terminology: CPT 2001 (Chicago: AMA Press, 2001).
7. Subacute thrombosis refers to the formation of a blood clot within the stent that inhibits the flow of blood through the stent and, if not removed, usually results in a myocardial infarction (MI). It is termed "subacute" because it occurs after the stent has been successfully deployed and the patient has left the catheterization laboratory. The risk of subacute thrombosis is increased if for technical reasons the stent is incompletely opposed to the vessel wall. It is also increased for a period of days to weeks following stent deployment while a layer of cells, which normally lines the inside of blood vessels and inhibits clot formation, slowly covers the newly placed stent. The presence of a subacute thrombosis can be documented only with the use of coronary angiography, which visualizes the total occlusion of the blood vessel at the site of the stent. However, it can be inferred when a patient who recently received a stent presents with typical symptoms, electrocardiographic changes, and laboratory findings of MI, most often prompting a cardiac catheterization confirming the thrombosis and a repeat PCI to reopen the vessel. A sudden death within thirty days of stent placement is usually attributed to MI from subacute thrombosis associated with a life-threatening arrhythmia. Based on studies in which all patients underwent cardiac catheterization thirty days after receiving a stent, it is known that there is a rare patient with subacute thrombosis who has minimal symptoms and does not have MI.
8. FDA, "FDA Public Health Web Notification: Information for Physicians on Sub-Acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER Coronary Stent," 29 October 2003, www.fda.gov/cdrh/safety/ cypher.html (18 April 2005).
9. We used exclusion criteria based on the Stent Anticoagulation Restenosis Trial Study (STARS). See M.B. Leon et al., "A Clinical Trial Comparing Three Antithrombotic-Drug Regimens after Coronary-Artery Stenting: Stent Anticoagulation Restenosis Study Investigators," New England Journal of Medicine 339, no. 23 (1998): 1665-1617.
10. The study starts on 1 February because a thirty-day period of observation is required to eliminate patients with a recent revascularization. It ends 30 November to ensure a full thirty days of observation for the last enrolled patient.
11. P.S. Romano et al., "A Comparison of Administrative versus Clinical Data: Coronary Artery Bypass Surgery as an Example, Ischemic Heart Disease Patient Outcomes Research Team," Journal of Clinical Epidemiology 47, no. 3 (1994): 249-260.
12. M. Beebe, "CPT Category III Codes Cover New, Emerging Technologies," Journal of the American Health Information Management Association 74, no. 9 (2003): 82-84, 86, 88.