Pharmacy & Therapeutics - June 2008 - (Page 359)

Evaluating and Standardizing Medical Devices materials designed to support cellular survival and engraftment.9 Joints and joint surfaces may eventually be regrown and replaced with biotech products instead of mechanical implants.2 Miniaturization and telemetry already make it possible for physicians to monitor patients remotely, and advances in health information systems promise to improve the integration of care delivery.1 prolonged survival, and improved quality of life for patients.15 All contributors should view themselves as strategic partners and work together for this common purpose. REFERENCES 1. Raab GG, Parr DH. From medical invention to clinical practice: The reimbursement challenge facing new device procedures and technology, Part 1: Issues in Medical Device Assessment. J Am Coll Radiol 2006;3:694–702. 2. Burns LR. Growth and innovation in medical devices: A conversation with Stryker Chairman John Brown. Health Aff 2007; 26(3):w436–w444. 3. White PF, Smith I. Impact of newer drugs and techniques on the quality of ambulatory anesthesia. J Clin Anesth 1993;5(Suppl 1):3S–13S. 4. Montgomery K, Schneller ES. Hospitals’ strategies for orchestrating selection of physician preference item. Milbank Q 2007; 85(2):307–335. 5. Trombetta B. Category captain management: A new approach for healthcare suppliers to partner with their hospital customers. J Hosp Marketing Publ Relations 2007;17(2):61–69. 6. Balu S, O’Connor P, Vogenberg FR. Contemporary issues affecting P&T committees, Part 1: The evolution. P&T 2004;29(11): 709–711. 7. Balu S, O’Connor P, Vogenberg FR. Contemporary issues affecting P&T committees, Part 2. Beyond managed care. P&T 2004; 29(12):780–783. 8. Feldman MD, Petersen AJ, Karliner LS, Tice JA. Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment. J Gen Intern Med 2007;23(Suppl 1):57–63. 9. Guezuraga RM, Steinbring DY. View from industry. Eur J Cardiothorac Surg 2004;26:19–24. 10. Keselman A, Tang X, Patel V, et al. Institutional decision-making for medical device purchasing: Evaluating patient safety. MedInfo 2004;11(Part 2):1357–1361. 11. Myers C, Burchill T. The short life of a medical device. Health Forum J 2002;45(5):34–38. 12. Goldenberg MM. Recent controversies in consumer lawsuits: When medical devices fail. P&T 2004;29(9):581–583. 13. Raab GG, Parr DH. From medical invention to clinical practice: The reimbursement challenge facing new device procedures and technology, Part 2: Coverage. J Am Coll Radiol 2006;3:772–777. 14. Raab GG, Parr DH. From medical invention to clinical practice: The reimbursement challenge facing new device procedures and technology, Part 3: Payment. J Am Coll Radiol 2006;3:842–850. 15. Baim DS, Donovan A, Smith JJ, et al. Medical device development: Managing conflicts of interest encountered by physicians. Catheter Cardiovasc Interv 2007;69:655–664. I Areas for Improvement in Medical Device Review and Procurement Without question, an alignment of manufacturer, hospital, practitioner, and patient interests will be necessary to improve the purchase and use of medical devices. The medical device industry invests heavily in new techniques and technology, research, product development, reimbursement, and patient access.9 Alignment of interests can occur through close working relationships with manufacturers that provide access to hospital executives and purchasing departments to educate them about the impact of technology investments on cost– benefit and improved patient outcomes.9 Better reimbursement mechanisms for new procedures or technologies may also emerge if doctors, hospitals, and manufacturers unite and lobby for them.9 Hospitals and practitioners can also take a leadership role in improving practices for monitoring and benchmarking clinical outcomes and disseminating the information necessary for evidence-based technology assessments.9 More sophisticated information systems are being developed that link products to cost, outcomes, and safety, but widespread adoption requires establishing standards for systematic data collection as well as specially trained staff members to conduct evidence-based studies that incorporate cost–benefit and cost-effectiveness analyses.4 With the availability of more postmarketing surveillance data, independent organizations can conduct technology assessments to identify the medical technologies that have pitfalls and those that are truly beneficial and safe.8 Such assessments will educate both health care professionals and patients, and they may also motivate researchers to address unanswered questions.8 An expanded, more informed understanding of new medical devices is expected to enhance health outcomes. Progress toward the establishment of a more standardized medical device review process is represented by the formation of the Association of Healthcare Value Analysis Professionals (AHVAP).4 The widespread use of VATs or other internal assessment committees may achieve the ideal goal of preserving quality and a diversity of options while controlling the costs of devices. In order to protect patient interests and to prevent undue emphasis on costs, it may also be desirable to designate a patient advocate to participate in the review process. Christine Maroulis noted, “Having a patient advocate would be a wonderful addition to these committees. I frequently meet with hospital committees, and I’ve rarely seen a patient advocate as a voting member of the committee. Ideally, the patient’s interests are prioritized in these decisions.” Collaboration between physicians, hospitals, industry, insurers, regulators, and patients has long been essential to the development of medical devices that have eased suffering, Vol. 33 No. 6 • June 2008 • P&T® 359

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - June 2008

Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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