Eucomed (Brussels, Belgium), the European medical technology industry association, has joined with several other associations to adopt the final text of a joint manifesto calling for European Union action to regulate all reprocessing of single-use medical devices (SUDs) by hospitals, reprocessors and original manufacturers. The action by the Patients' Association, the International Alliance of Patients' Organizations, the European Medical Association, the Standing Committee of European Doctors and the Standing Committee of Nurses of the EU is directed toward "protecting the health and safety of patients and healthcare workers in the European Union," according to a statement by Eucomed.

"With the increasing prevalence of hospital-acquired infections, antibiotic resistance, and life-threatening transmissible diseases such as hepatitis and variant Creutzfeld-Jakob disease [v-CJD], the invaluable role of single-use instruments in ensuring sterility and preventing cross infection is undisputed," Eucomed said. "However, many hospitals reuse single-use medical devices in the belief that this practice reduces healthcare budgets and benefits the environment."

The risk of cross-infection is real, the organization said, "because of the practical difficulty or impossibility of cleaning single-use devices. Recent studies show blood residues and dirt, as well as damage and physical alterations, on samples of reprocessed catheters, guidewires and biopsy forceps taken from hospital shelves. Eucomed said Finland, France, Italy, Germany, Portugal, Spain, Sweden and the UK "have introduced some specific legislative measures (and in some cases a total ban) against the reuse of single-use medical devices." But, it said, "the practice remains widespread."

The draft manifesto was launched by Eucomed and the Patients' Association during a hearing on the reuse of medical devices at the European Parliament in Brussels last April. The other organizations participated thereafter in a number of meetings to adapt the content of the draft manifesto to meet their specific concerns, Eucomed said, adding that the final text "has now been officially agreed by all." Eucomed said recently that it is now working on a second manifesto, this one calling for EU action to help protect healthcare workers against sharps injuries.

MDUFMA to be test of FDA timelines

The Medical Device User Fee and Modernization Act of 2002 (acryonymed to MDUFMA) is expected to provide a major test of the FDA's regulatory timelines, and an optimist will hope that it also serves to shake out some of the contradictory statements in the annual report from the Office of Device Evaluation for 2002. That report declares that the Center for Devices and Radiological Health is making faster decisions in terms of all decisions made. But such statements aren't likely to convince everyone in the medical technology sector, especially those seeking original premarket approvals. PMAs took longer in fiscal year 2002 than in 2001.

The seemingly contradictory statements are supported by figures and the particular regulatory situations they refer to in the Office of Device Evaluation's FY02 annual report released in December. The statistics illustrate the ongoing challenges facing the FDA and the need for rapid implementation of MDUFMA, according to the Advanced Medical Technology Association (AdvaMed; Washington). "Statistics show that FDA still is taking far too long to act on many of these important innovations," said AdvaMed in a statement responding to the report, which is essentially a grade card for the agency's performance. The organization took the opportunity to compare the data in the report to the performance goals established in the MDUFMA legislation. The FDA must take graduated steps toward 25% improvements in review times.

Total average review times for original PMAs within the Center for Devices and Radiological Health increased 41 days last year, up to 213 days as compared to FY01's 172 days. This increase occurred despite a reduction in the total number of PMA actions rendered by the agency, from 282 to 236. The 236 actions consisted of 46 filing decisions, 122 review determinations, and 68 approval/approvable/not approvable decisions. Of the 68 decisions, 41 were approved, 17 were approvable, and 10 not approvable, according to the data.

Total average review times at the 90th percentile of PMAs from first filing to final action was 404 days in 1999 (the most recent year with complete data), AdvaMed contended in its review of the new figures. "Under the user fee provisions of [MDUFMA], FDA will have to approve 90% of PMAs within 320 days by 2007," the association said. The more advanced medical technologies usually fall within the 90th percentile of PMAs, it added.

Average time for the FDA's review of original PMAs increased from 129 days in FY01 to 160 days in FY02, a figure not including the cumulative time that the agency calls "non-FDA" time. PMAs in inventory those either in active consideration or on hold dropped in FY02 from 85 to 65. Active PMAs at the end of FY02 were 34, compared to 46 in FY01. PMAs on hold decreased from 39 in FY01 to 31 in FY02.

Overall, the agency reported making strides in decision-making efficiency, according to the ODE report. The average total elapsed time from filing to final action showed a decrease from 265 days to 209 days. And the median elapsed time to a decision (defined as the time the agency takes to review half of the submissions) decreased from 234 days in FY01 to 180 days in FY02. "This means that all of the statistics of the PMA receipt cohort for FY02 indicate that we are making decisions faster," the report says.

Manufacturers seeking PMA supplements experienced slightly longer waiting times in 2002, with an average total review time increase from 97 days in FY01 to 105 days. But the agency had no active or overdue PMA supplements at the end of the fiscal year, unlike the previous four years, it noted. The agency averaged 14 more days to reach a decision for PMA supplements in FY02, the report states.

Review times for 510(k)s also increased, according to the report. Total review time from receipt to final action reached a four-year high of 164 days in 2001 for submissions in the 90th percentile. Data for 2002 is not yet available, the report says. A total of 4,320 original 510(k)s were received in 2002, as well as 1,780 supplements (whereby receipt of written responses at the FDA restarts the 90-day review clock). The average review time for FDA review of 510(k)s in FY02 was 79 days: an increase from 75 days in FY01. The median review time was 71 days in FY02.

Similar to PMA submissions, the agency made improvements in the amount of 510(k)s in inventory at year-end. There were 1,272 510(k)s under active review and 337 of those were on hold at the end of FY02. "Most important, for the seventh consecutive fiscal year, there were no 510(k)s active and overdue at the end of the reporting period," the report says.

The FDA notes in the report that it lost employees and encountered an increased workload in 2002. The office ended FY02 with 354 employees and lost 23 full-time staff, including 13 scientific reviewers, eight medical officers and two clerical staff. ODE added 27 new staff, but the total includes 10 non-paid student interns and contractors. The rest of the total includes 10 scientific reviewers, two medical officers and five clerical staff. AdvaMed said it "is concerned that, as in 2001, ODE saw a net loss in scientific and medical personnel last year. As FDA implements [MDUFMA], it will be important for it to make the greatest use possible of external sources of scientific expertise in the review process."

Canadian report: 'No' to privatizing

Reaction has been mixed to a new Canadian report calling for reinvigoration of that country's publicly funded healthcare system. The long-awaited "Romanow Report on the Future of Health Care in Canada" calls on the federal government to inject $15 billion dollars into healthcare over the next three years and to increase its annual contribution by $6.5 billion in 2005-2006. A national home care program, improved access to medical care in rural areas and reduced waiting times for diagnostic services top the list of healthcare services in desperate need of added funding, according to the report.

The Romanow report's most striking feature is its staunch opposition to any fundamental change to the underpinnings of the Canadian Medicare program. Like the U.S. healthcare system, Canadian healthcare has been under severe pressure from changing healthcare needs and rising costs over the past two decades. But while Canada provides its citizens with universal healthcare coverage, many patients must wait from six months to a year to be treated for all but the most serious medical conditions. In Canada this is viewed by some as reason enough to return to privatized healthcare.

The former premier of Saskatchewan, Roy Romanow, was having none of this, however, when he released his report late last year. "I am convinced the Medicare house needs remodeling, not demolishing," he said. And he is just as adamant that the Canadian government not be bullied into more privatized healthcare because of complaints that publicly funded healthcare is less efficient than private systems like those in the U.S. "The single payer/publicly funded system is demonstrably the most efficient financially and demonstrably the most effective in terms of health outcomes," Romanow said.

Not everyone agrees with that assessment, least of all Canada's 10 provincial and two territorial governments. Provincial healthcare costs have ballooned over the past 10 years, representing anywhere from 25% to 40% of annual budgets. Meantime, many provinces, including Romanow's home province when he was its premier, have centralized their hospital systems in an effort to streamline healthcare delivery and to contain costs.

The premier of Canada's most conservative province, Alberta, views such measures as mostly tinkering. "Reorganize and revamp the whole delivery system," says Ralph Klein. Klein's government has repeatedly challenged the Canada Health Act, the federal document that determines how the provinces will deliver health services, by allowing some private clinics to bill for services normally covered by Medicare. Klein's reaction to Romanow's report? "We think it's an intrusion into our constitutional authority over the delivery of healthcare."

Sindi Hawkins, British Columbia's minister of health planning, welcomes Romanow's recommendations that Ottawa spend billions more on healthcare but, like Klein, he balks at being told by Ottawa how to spend it.