User fees are just one area that may eventually increase costs for medical device manufacturers. Another area will be in medical device tracking under new rules issued last month by the FDA. But the rules are intended to be clearer, and many devices could be exempted from the tracking provision. The revisions were first proposed in the Feb. 8 Federal Register and the final rule appeared in the May 15 Federal Register. Besides revising outdated terminology and references, the new rules add patient confidentiality requirements and make other changes in the scope of section 519(e) of the FDA Modernization Act of 1997 (FDAMA), which the agency calls "substantive."

The FDA estimates that the costs to the industry associated with maintaining device tracking systems will increase from about $40 million in 1999 to $71 million in 2006. However, those manufacturers that currently track devices will not incur additional costs as a result of the rule changes, according to the agency.

One of those groups that will incur new costs, as the "distributor" of a medical device, will be hospitals. The agency used the examples of dura mater implants and abdominal aortic aneurysm stents to illustrate this principle. FDA estimates that hospitals will incur an average annual cost of $66,000 cumulatively to track these two devices, estimating $130 for each hospital per year, but only 10% of U.S. hospitals implanting about 22,000 units per year. The changes should not have a significant economic effect on most smaller hospitals, the agency concluded.

There is considerable good news in the new rule. The agency has more discretion in deciding which devices to track, and the revision eliminates the requirement to track all devices in some categories. And even if a device meets one of three criteria for tracking, it may not have to be tracked. The FDA will notify a manufacturer through an order that a device must be tracked.

Specifically, the revised language of section 519(e) of FDAMA reads: "The Food and Drug Administration may require a manufacturer to adopt a method of tracking a class II or class III device, if the device meets one of the following three criteria and FDA issues an order to the manufacturer: the failure of the device would be reasonably likely to have serious adverse health consequences; or the device is intended to be implanted in the human body for more than one year; or the device is a life-sustaining or life-supporting device used outside a device user facility."

As of a January 2000 guidance document, the FDA requires manufacturers to track the following implantable devices:

  • Temporomandibular joint prosthesis.
  • Glenoid fossa prosthesis.
  • Mandibular condyle prosthesis.
  • Implantable pacemaker pulse generator.
  • Cardiovascular permanent implantable pacemaker electrode.
  • Replacement heart valve (mechanical only).
  • Implantable cardioverter defibrillator.
  • Implanted cerebellar stimulator.
  • Implanted diaphragmatic/phrenic nerve stimulator.
  • Implantable infusion pumps.
  • Dura mater.
  • Abdominal aortic aneurysm stent grafts.

The FDA has issued orders to manufacturers who are required to track the following devices that are used outside a device user facility:

  • Breathing frequency monitors.
  • Continuous ventilators.
  • Ventricular bypass (assist) device.
  • DC-defibrillators and paddles.
  • Infusion pumps (electromechanical only).

The new rule also provides new definitions for two terms: "importer" and "permanently implant-able device." The new definition of "importer" is "the initial distributor of an imported device that is subject to a tracking order. Importer does not include anyone who only furthers the marketing, such as brokers, jobbers, or warehousers." The definition for permanently implantable device was revised to clarify a difference between permanent and temporary devices. The new definition reads: "Device intended to be implanted in the human body for more than one year means a device that is intended to be placed into a surgically or naturally formed cavity of the human body for more than one year to continuously assist, restore, or replace the function of an organ system or structure of the human body throughout the useful life of the device. The term does not include any device that is intended and used only for temporary purposes or that is intended for explanation in one year or less."

In terms of confidentiality, the new rules allows for patients to refuse to provide to manufactures their name, address, telephone number and Social Security number, which manufacturers were required to provide to the FDA. Patients now can either refuse to release this information or refuse permission of the manufacturer to release the information.

NSPF in office-surgery safety initiative

The National Patient Safety Foundation (NPSF; Chicago, Illinois) launched what it bills as a "consensus initiative" focused on improving patient safety in ambulatory surgery settings, specifically in an office setting. Called the "Ambulatory Surgery in the Office Setting Initiative," the new program responds to what the NPSF called an "increasing concern in the medical community, public health policy makers, and patient groups about how to ensure patient safety when surgery is performed in a physician's office environment. This is the third in a series of similar initiatives for the organization designed by the NPSF as a neutral forum in which medical specialties and professional organizations can come together to reach consensus on ways to ensure patient safety in ambulatory surgery."

In late 1999, the NPSF initiated a new approach to reducing health care errors through consensus of diverse stakeholders. Using a collaborative action planning model designed to leverage the partnerships necessary for sustained, systemic improvement of patient safety, NPSF convened a group of 25 stakeholders in the pharmaceutical community to build consensus for systems change in the area of health care safety. This first consensus project, known as Pharmaceutical Safe Use, served as a model for a second, refined project, End-Stage Renal Disease Patient Safety, which was launched in May 2000.

"This is part of that series of agenda setting initiatives that the National Patient Safety Foundation has facilitated and sponsored," said Louis Diamond, NPSF's director of programs. He told The BBI Newsletter's sister publication, Medical Device Daily, that what his organization does is bring together the various stakeholders who have an interest in the particular topic that is on the table. "It's consumers, regulators, physicians, nurses, it's meant to be fully inclusionary," Diamond said.

Among those contributing financial support to this particular initiative are the Accreditation Association for Ambulatory Health Care (Skokie, Illinois), the American Medical Association (Chicago, Illinois), the Joint Commission on Accreditation of Healthcare Organizations (Oakbrook Terrace, Illinois), the American Academy of Dermatology (Schaumberg, Illinois), the American Academy of Orthopaedic Surgeons (Rosemont, Illinois), the American College of Surgeons (Chicago, Illinois) and the American Society of Anesthesiologists (Park Ridge, Illinois).

"Convening diverse stakeholders is an effective way of developing and implementing action for patient safety in ambulatory surgery," Diamond said. Generally, he noted that the agenda that is initially formed by these large and diverse groups is quite large. "But the system causes [the group] to land on a small number of agenda items that are of high priority and need to be done first."

According to the NSPF, the new initiative will provide a framework for action plans and ultimately an outline of applicable patient safety improvement solutions.

Diamond said that a lot of the focus has been on the hospital patient safety setting, and the whole outpatient setting had not been addressed. He noted that the ambulatory and hospital settings both have at least some regulatory oversight, "but there's absolutely nothing going on in the office setting, and its becoming more common and there's a trend going in that direction." He said some patients have died recently died following office surgery.

The ambulatory initiative group was to meet early this month, and the report generated from this will surface about six weeks later. The group will then focus on implementing the recommended changes.

The NPSF was founded in 1996 by the American Medical Association, CNA HealthPro, 3M (Minneapolis, Minnesota) and contributions from Schering-Plough (Kenilworth, New Jersey). It is an independent, nonprofit research and education organization. It was designed to bring health care practitioners, institutional providers, health product providers, health product manufacturers, researchers, legal advisors, patient/consumer advocates, regulators, and policy makers together to make health care safer for patients.

New standards sought for CT dosing

A panel of radiation safety experts meeting late last month recommended that the FDA hasten development of amended standards for use of X-ray computed tomography equipment. Furthermore, the panel, known as the Technical Electric Products Radiation Safety Standards Committee, suggested that the FDA, specifically the Center for Devices and Radiological Health (CDRH), should do a better job of distributing its web-based radiation educational materials to a more targeted audience.

The FDA is considering ways of modifying the radiation dose that patients are exposed to when they undergo a computed tomography (CT) exam, based on news about a year ago that high doses could cause cancer. The FDA has raised special concerns about CT dosing received by children, and activist groups have expressed concerns over future increasing rates of cancer from such dosing.

Stanley Stern, a health physicist with the FDA, told the agency-appointed panel that the government currently is preparing a concept paper — one of the early steps to creating new government regulation — that includes amendments to deal with the potentially dangerous radiation levels. "We're working to facilitate radiation dose reduction through consideration of amendments to the existing CT performance standard," he said. "Our motivation is the proposition that the current federal regulations covering CT, in place since the mid-1980s, have not kept pace with technological developments and with the need to assure the lowest dose for the best image quality practically achievable." And due to advancing technology and clinical practice, the scope of CT applications is increasing, Stern said. "CT is used in many different ways, from diagnosis, to cancer staging to treatment planning and, more recently, for real-time visualization during interventional operations."

He said one possible amendment to the current radiation-safety performance standard would require "particular technical features for CT equipment." Stern added that "The initial focus is on technically feasible features that would reduce patient dose — dose-index standardization, display and recording, automatic exposure control and X-ray field size. Were these features implemented on all CT systems, the projected collective dose savings in the U.S. would be approximately 193,000 person-sievert yearly."

John Sandrik, a panel member and imaging physicist with GE Medical Systems (Waukesha, Wisconsin), said the FDA needs to consider how to balance the lowest dose for the best image quality. "You're talking about low-dose to no-dose, but we have to see at which dose the imaging becomes unusable." In terms of requiring CT users to retrofit equipment, other panel members asked whether the FDA had that authority. Despite questions, the panel voted 10-2 in favor of requiring users of older CTs to update or retrofit equipment.

To get a better handle on how CT equipment impacts public health, Stern said CDRH provided technical direction on a survey of 263 CT facilities in 39 states (between April 2000 and July 2001), conducted through the Nationwide Evaluation of X-Ray Trends program and administered by the Conference of Radiation Control Program Directors. The survey, which is expected to be complete next year, looked at doses and workloads of the CT facilities.

Citing preliminary data, Stern said approximately 58 million CT exams are conducted annually, including 79% which comprise scanning in six anatomical regions or combinations of regions: brain, abdomen-pelvis, chest, abdomen, chest-abdomen-pelvis, and pelvis alone. About 29% of all CT units in the U.S. can do multi-slice spiral scanning.

The FDA web site (www.fda.gov) posted a CT screening page providing information about concerns related to CT, radiation risks, radiation quantities and units, plus the regulatory status of CTs. The agency has said that it hopes to complete its concept paper (an internal requirement) by the end of the year and expects decision-making and follow-up with the committee next year.

CMS adds breast biopsy coverage

The Centers for Medicare & Medicaid Services (CMS; Washington) said it will extend national coverage of percutaneous image-guided breast biopsy for palpable lesions as an alternative to needle localization and open excisional biopsy for women. The coverage decision was requested by Ethicon Endo-Surgery (Cincinnati, Ohio), a division of Johnson & Johnson (New Brunswick, New Jersey).

Benefit categories for the treatment will be: 1861(s)(1) — physician services; 1861(b) — inpatient hospital services; 1832(a)(2)(F)(i) — ambulatory surgery center. The decision memorandum will be posted by CMS no later than June 14.

Image guidance technology is more accurate in diagnosing breast masses than using palpation, or feeling by hand. Image guidance helps determine where to insert a biopsy needle for lesions that are difficult to find by hand, according to Sean Tunis, MD, director of CMS's coverage and analysis group.

Report charts Europe's biotech lag

A new report commissioned by the European Union (Brussels, Belgium) appears to confirm the weaknesses of the European biotechnology sector compared to the aggressive growth of that sector in the U.S. European biotechnology's lag in pace behind the U.S. has systemic causes, rather than simply being the result of specific market or institutional failures, the report suggests. Those systemic issues include the need for a coordinated strategy, which has so far been absent in the region.

The report, by Alfonso Gambardella and a team at the University of Siena (Siena, Italy), underlines key disadvantages of the European environment. Comparatively little U.S. research is done in Europe, it points out, and the European research system in the life sciences and in biotechnology is "still too fragmented," due to regulatory, entrepreneurial, fiscal and financial factors, as well as inadequacies in cutting-edge scientific research. Additionally, it finds European firms still too small and too specialized in specific niches and unable to make efficient use of collaborative research networks. The report suggests that increased funding is only a part of the solution, and that more pluralism in funding sources, lower dependence on closed national systems and higher integration of research with teaching, clinical research and medical practice should become priorities for a European research biotech policy.

The report says European companies have tended to collaborate more with U.S. biotechnology firms than European firms. Even in the absence of other institutional barriers to entrepreneurial ventures, start-ups in Europe might have been crowded out by the large number of U.S.-based firms anxious to trade non-U.S. marketing rights for capital, it says.

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