The FDA is proposing to implement the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The proposed rules further strengthen the agency's mandate to protect the public health and provide safety and effectiveness information about devices, the agency says in its proposal document.

The act provides the FDA with the authority to require a manufacturer to conduct PS of a class II or class III device if: 1) Failure of the device would be reasonably likely to have serious adverse health consequences; 2) the device is intended to be implanted in the human body for more than one year, or 3) the device is intended to be life-sustaining or life-supporting and is used outside a device user facility, such as a physician's office. "We will be looking primarily at how a device is marketed, not how it is used," said Laura Alonge, biologist and principal author of the proposal document. "We are not out to 'get' anybody; our goal is to make the path to market as smooth as possible while assuring the long-term safety of a product," Alonge told The BBI Newsletter.

The authority to require PS studies was granted by Congress through the Safe Medical Devices Act of 1990 (SMDA) and further refined through FDAMA. Section 522 of SMDA gives the agency the flexible authority to order manufacturers to collect data about unforeseen adverse events and other information to "protect the public health." The power granted in section 522 would enable the agency to monitor the earliest experience with a device once it has been distributed in the general population under actual-use conditions. "The data the manufacturers give us is collected under ideal conditions," Alonge said. "What we are interested in learning is how a device functions in normal everyday use." The FDA also will monitor and enforce compliance with section 522. If a manufacturer fails to comply with section 522, the device subject to the order may be considered misbranded. In addition, the agency has set a presumptive limit of three years on studies, and it has set up what it terms "broad discretion to implement postmarket surveillance on a case-by-case basis."

The obvious concern to industry is the price tag for these new studies, since individual companies will be expected to foot the bill for their studies. The report says that most studies will require either secondary data (50%) or literature searches (40%). About 10% of companies will have to provide costly primary data, according to the proposal report. "That number is probably on the high side," Alonge said. "We are not really interested in more primary data, since it is more easily skewed. In most cases we will probably stop at the case controls and take a retrospective look at patients' records."

Using as a model a company with annual revenue of $9.8 million – and compelled to provide primary data over a three-year period for its postmarket surveillance – the new surveillance rules could cost that company 3.7% of its annual revenue on PS actions. Even secondary data would tap 1.7% of the hypothetical company's revenue, according to the agency's estimates. While this would seem to have greatest impact on less heavily capitalized firms – small and developmental companies – Alonge said most of the complaints have come thus far from larger companies.

The agency said it expects to conduct about 30 surveillance orders a year, looking at four categories of devices: diagnostic substances, surgical and medical instruments, dental equipment, and supplies and ophthalmic goods. "These categories will probably be a lot more specialized than the proposal indicates," Alonge noted. "It is highly unlikely that we would be looking at devices to be implanted over a year that don't have a PMA."

Alonge said she felt that device companies should not be alarmed by this new enforcement. "What we hope to achieve are improvements in labeling, user training and life-saving adjustments to the patient population for a given device." The comment period on the proposal extends to Nov. 27.

DeParle resigns as HCFA head

Nancy-Ann DeParle, administrator of the Health Care Financing Administration (HCFA; Baltimore, Maryland) for the past three years, has resigned to become a fellow at Harvard University's (Cambridge, Massachusetts) Kennedy School of Government, to focus on health policy programs. "There is no right time to leave the gratifying and important work we have shared," DeParle said in a statement released by the agency, "so leaving is very hard."

Before becoming HCFA administrator, DeParle oversaw budget and policy matters for federal health programs in the Office of Management and Budget. She was President Bill Clinton's second appointment to the post, succeeding Bruce Vladeck when he accepted a professorship at Mount Sinai School of Medicine (New York). Health and Human Services Secretary Donna Shalala said DeParle "has done an extraordinary job at the helm of HCFA. She's a first-class professional."

The medical device industry trade association AdVaMed (Washington) also praised DeParle for her efforts to reduce delays in access to medical technology during her tenure. "The association and its members appreciate Ms. DeParle's close collaboration with the industry and other stakeholders to address this issue," the group said in a statement. "Working together, we have reached important goals, such as creation of a new Medicare coverage advisory committee and a formal, open process for making coverage decisions. Ms. DeParle also moved to implement changes expeditiously to the hospital outpatient prospective payment system to assure patient access to new medical technologies."

Deputy administrator Michael Hash will run the agency through January, when a new administrator is likely to be named.

Rhode Island passes blood filtration rule

Rhode Island has become the first state to implement a universal leukoreduction (ULR) blood filtration policy, and the Rhode Island Blood Center (Providence, Rhode Island), which collects about 68,000 units of blood each year, says it is leukoreducing all of its blood collections. Donor white blood cells can cause reactions in the patient at transfusion and can transmit disease and predispose recipients to infection, with longer and more expensive hospital stays and diminished patient outcomes the result.

While there is no national mandate to filter all blood products in the U.S., the FDA's Blood Products Advisory Committee (BPAC) has recommended that all donor blood be filtered to remove white cells. In 1998, BPAC said that "the benefit-to-risk ratio associated with leukoreduction is sufficiently great to justify routine leukoreduction of all non-leukocyte transfusion blood components."

Since that recommendation, leukocyte reduction has increased in the U.S. from about 16% to nearly 50%, according to Eric Krasnoff, chairman and CEO of Pall (East Hills, New York), which makes blood filtration systems used by the center.

At least 22 other countries also are moving to filter all of their donor blood using leukocyte reduction technology, according to Pall. Many of them have mandated routine blood filtration of all blood components as a matter of public policy. Pall recently reported that it has been awarded a $6 million contract by the German Red Cross Transfusion Center, Lower Saxony, the second-largest blood center in Germany and one of the first in the country to implement total filtration voluntarily.

AHRQ reports on 10 'most expensive'

The highest average charge for a hospital stay – $68,000 for 24.6 days – is for respiratory distress in infants, according to a new report from the Department of Health and Human Services' Agency for Healthcare Research and Quality (Rockville, Maryland). The new report comes from a recently issued fact book that takes a look at key statistics for U.S. hospitalization during 1997. Overall, according to the report, U.S. hospital charges for the 10 most expensive conditions ranged from $34,000 to the high of $68,000. After infant respiratory distress, the next four most expensive hospital stays were for spinal cord injury ($53,000 cost; 15.9 days); prematurity and low birth weight ($50,000; 21.7 days); heart valve disorders ($48,000; 9.1 days); and leukemias ($44,000; 13.5 days). These five conditions, however, made up only 1% of hospitalization costs.

The figures for the study are exclusive of physician and other professional fees, rehabilitation costs or expenses for follow-up and home health services, according to AHRQ, and represent what these hospitals charged, not what they were paid.

Among other details in the new report:

The average charge for a hospital stay is $11,000 (for five days).

Heart attack, hardening of the arteries and congestive heart failure are among the top 10 conditions treated in hospitals for the 45 and older age groups.

The average age of a hospitalized patient in the U.S. in 1997 was 47, while the lengthiest stays were for the 18-44 and 65-79 age groups.

High blood pressure is the most common co-morbidity increasing the length and expense of a hospital stay.

Government, via Medicare and Medicaid, pays for about 54% of all hospital stays.

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