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Technology Preparedness Council Outlines Strategy

Originally Published MDDI December 2001


In October, AdvaMed announced the formation of an industry council that would help develop strategies "to ensure that America is prepared to respond to future acts of terrorism or other civilian disasters" (see November 2001 issue of Medical Device & Diagnostic Industry). Last month, the organization named six senior executives of medical technology companies to serve as the directors of the Medical Technology Preparedness Council.

The directors will include Richard A. Gonzalez, executive vice president, Medical Products, of Abbott Laboratories (Abbott Park, IL); Ronald K. Labrum, group president of Allegiance Corp. (McGaw Park, IL); Dennis N. Longstreet, group chairman of Johnson & Johnson (New Brunswick, NJ); Edward J. Ludwig, president and CEO of Becton Dickinson and Co. (Franklin Lakes, NJ); and Richard J. Meelia, president and CEO of Tyco Healthcare Group (Mansfield, MA). The council will be chaired by William H. Longfield, chairman and CEO of C.R. Bard Inc. (Murray Hill, NJ) and chairman of AdvaMed's current board of directors.

Susan Alpert has been selected as the medical adviser to AdvaMed's Medical Technology Preparedness Council.

AdvaMed also announced that former Office of Device Evaluation (ODE) Director Susan Alpert, PhD, MD, will serve as medical adviser to the council. Alpert, who became vice president of regulatory sciences at C.R. Bard after leaving ODE, says, "Medical technologies, such as rapid diagnostic tests. . . , are perfect examples of how makers of medical devices and diagnostics can help combat bioterrorism." The group notes that Alpert will be able to offer the council "dual perspectives of a physician and government official when tackling issues to improve the readiness of the nation's public health system."

The council's actions are being shaped in part by the findings of AdvaMed's recent survey of medical technology company executives. Respondents to the survey identified three areas of critical technology development, including diagnostic devices for biological and chemical agents, vaccine-delivery devices, and blood safety technologies. The council specifically "will work to accelerate the development and expedite FDA review of needed medical technologies to combat bioterrorism," according to AdvaMed.

AdvaMed submitted testimony on behalf of the council during a House Energy and Commerce Subcommittee on Oversight and Investigations hearing on November 1. The testimony outlined steps that the council believes will help speed availability of key technologies.

The council will call for a collaborative expedited review policy for medical technology. This will entail the need for clear FDA review paths, the group argues, citing combination products as a technology that faces added delays at FDA because such products must go through two FDA offices for premarket review. The council will urge FDA to establish "a separate office to ensure clear review paths and timely action on these technologies," according to AdvaMed.

A second key issue to be addressed by the council is the need for scientific expertise at the agency when dealing with the complex scientific issues that are likely to be presented by breakthrough countermeasures developed to fight bioterrorism. The council will also argue that FDA should receive adequate resources to ensure timely premarket review of technologies that could help meet needs resulting from terrorist attacks or other civilian disasters. AdvaMed suggests that an additional $1.5 million be made available for priority review and preapproval inspections for breakthrough medical technologies that provide countermeasures to bioterrorism, and that the agency be encouraged to use its existing authority to contract with outside experts.

Copyright ©2001 Medical Device & Diagnostic Industry

U.S. Presents Trade Proposal To Japan

Originally Published MDDI December 2001


Deputy U.S. Trade Representative Jon Huntsman Jr. presented wide-ranging reform recommendations to Japan that are intended to further deregulate the economy, bolster competition, and open markets in that country. The proposal was offered during an October meeting of trade ministers in Singapore.

The recommendations are being offered as part of a Regulatory Reform and Competition Policy Initiative that was launched in June under the U.S.-Japan Economic Partnership for Growth by President Bush and Prime Minister Koizumi.

Ambassador Huntsman says, "These reform proposals are intended to help clear away the thicket of regulations that have limited Japan's potential to return to economic growth. As the world's second-largest economy, Japan's recovery is crucial to the global system."

Recommendations included in the proposal are focused on several key sectors of industry, including medical devices and pharmaceuticals. In the medical device sector, specific recommendations have been made in the areas of healthcare system reform, medical device and pharmaceutical pricing and regulatory reform, acceptance of foreign clinical data, and nutritional supplement liberalization, according to the Office of the United States Trade Representative.

Copyright ©2001 Medical Device & Diagnostic Industry

New CEO Named by AMA

Originally Published MDDI December 2001


In November, the American Medical Association (AMA) selected Michael D. Maves, MD, MBA, as its new executive vice president and CEO. Maves will assume leadership of the group on January 15, 2002.

The new AMA CEO served as executive vice president of the American Academy of Otolaryngology—Head and Neck Surgery Inc. from 1994 to 1999. He also headed the Consumer Healthcare Products Association in Washington, DC.

Maves was a member of the initial AMA Resource-Based Relative Value Scale Update Committee and has testified before Congress, the Centers for Medicare & Medicaid Services (CMS), and FDA. In addition, he is a consultant to the clinical center at the National Institutes of Health. He currently co-chairs the medical/surgical panel of the CMS Medicare Coverage Advisory Committee.

Copyright ©2001 Medical Device & Diagnostic Industry

Global Healthcare Exchange and HealthNexis to Merge

Originally Published MDDI December 2001


Global Healthcare Exchange LLC (GHX; Westminster, CO) and HealthNexis LLC (Minneapolis) will combine their operations into a single Internet-based exchange, according to the organizations. Supplier members of both organizations will be connected to GHX's 70 integrated delivery networks (IDNs), which currently represent approximately 600 hospitals. The combined entity will operate as Global Healthcare Exchange LLC and will be headquartered in Westminster, Colorado. The merger announcement follows recent GHX alliances with Neoforma Inc. and AmeriNet Inc. Says GHX president Mike Mahoney, "Connectivity, participation, and cooperation among all members of the supply chain is critical for e-commerce to reach its full potential. HealthNexis and its membership of leading healthcare companies provide considerable e-commerce technology solutions and supply chain expertise. This combination reinforces GHX's commitment to building an open and neutral healthcare exchange to drive supply chain savings."

Copyright ©2001 Medical Device & Diagnostic Industry

Use of Alternative Care Sites for Patient Recovery Driving Increased Demand for Ambulatory Infusion Pumps

Originally Published MDDI December 2001


The total market for infusion pumps—including large-volume, syringe infusion, enteral feeding, pain, and ambulatory infusion pumps—reached $463.4 million in 2000 and is projected to jump to $606.5 million by 2007, according to a new analysis by Frost & Sullivan (San Jose, CA). The projected increase is being driven by growing demand for ambulatory drug delivery systems as more patients spend their recovery in alternative facilities and become more mobile.

According to the U.S. Infusion Pump Markets report, this shift toward alternative care is driving new business strategies. "Some companies are placing free infusion pumps with hospitals and making money through the disposables that go with them," says Frost & Sullivan research analyst Dipti Malaviya. He explains that participants hope to attract the attention of healthcare purchasers by bundling pumps with intravenous solutions and other disposables, then selling these products at discounted prices. While this is an effective strategy for big companies with broad product lines, more-focused firms will find it difficult to compete, according to Frost & Sullivan. "Companies that manufacture only infusion pumps are at a distinct disadvantage," Malaviya adds. "Fostering alliances with larger enterprises would enable smaller businesses to also offer lower-priced, packaged solutions."

The report emphasizes, however, that all market participants must focus research and development on products that provide accurate dosing. "New technology that eliminates human error and ensures accuracy in dosage and flow-rate calculation would provide a significant competitive edge," says Malaviya.

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) issued a warning to hospitals in November 2000 concerning the improper use of infusion pumps. The major concerns identified by the JCAHO included human errors that might lead to incorrect dosage, wrong medication, or the free-flow of medicine into patients. Frost & Sullivan suggests that to address these concerns, infusion pump manufacturers must devote substantial resources to product innovation. Developing new applications that ensure greater accuracy are also expected to help generate sales.

Copyright ©2001 Medical Device & Diagnostic Industry

Are Device Manufacturers Ready to Comply with 21 CFR Part 11 Requirements?

Originally Published MDDI December 2001


Are Device Manufacturers Ready to Comply with 21 CFR Part 11 Requirements?

Figure 1. Economic impact of Part 11 compliance. (Click to enlarge.)

Companies and organizations required to comply with 21 CFR Part 11, FDA's rule governing electronic signatures and records, are finding the task "ambiguous," according to a recent poll conducted by NuGenesis Technologies Corp. (Westborough, MA). Thirty-eight percent of the respondents admitted they do not fully understand the implications of Part 11 as it affects their companies.

Responses also indicate that efforts to achieve compliance measures are lagging. While 75% of the respondents claimed they have begun putting Part 11 measures in place, only 11% said they were fully Part 11 compliant in at least some areas.

As the figures below illustrate, the majority of involved parties believe that achieving Part 11 compliance will have a substantial economic impact on their business (Figure 1). The respondents' most significant point of anxiety involving Part 11 stems from the potential impact of the regulation on their company's legacy systems. Twenty-four percent of the respondents cited legacy system changes as their greatest concern regarding the regulation, with data archival and retrieval listed next, at 19% (Figure 2).

Figure 2. Greatest concern regarding Part 11 compliance. (Click to enlarge.)

Perhaps the more interesting finding of the poll came when respondents were asked what the most significant factor would be in helping them achieve compliance. The highest percentage of respondents (22%) cited their vendor's technology improvements—not their own company's internal changes—as the most important tool for achieving compliance.

The poll received 325 responses from various fields, including scientists, managers, consultants, and regulatory compliance officers. The respondents represent pharmaceutical, biotechnology, and contract research organizations.

Copyright ©2001 Medical Device & Diagnostic Industry

Survey of Disposable-Device Reuse in Canadian Hospitals Provokes Mixed Response

Originally Published MDDI December 2001

Survey results indicating that up to half of Canadian healthcare institutions engage in reuse of single-use devices have sparked responses in both Canada and the United States. Health Canada, the federal department responsible for medical device regulation, sent the survey of reuse to 741 Canadian acute-care health institutions containing more than 80 beds.

The questionnaire presented a list of disposable medical devices and asked respondents to indicate which ones their respective institutions reused. Other survey questions asked respondents about existing device reuse procedures, committees, and guidelines. Among the disposable devices identified on the survey were electromyography needles, cardiac electrophysiology catheters, gastrointestinal snares, and hot gastrointestinal biopsy forceps.

Of the 422 infection-control professionals and CEOs who returned the questionnaires, only 43 (10%) indicated they had a specific reuse committee in place in their facilities. According to the survey summary, "many" disposable devices are reused more than 20 times in Canadian healthcare institutions before being discarded, and "there are no written reuse protocols [in place] for the majority of the cited single-use devices."

Medical Devices Canada (MEDEC), Canada's trade association for the medical device industry, is citing these findings to support its condemnation of reuse. In a press release dated August 24, 2001, MEDEC expressed support for Health Canada's investigation into the reuse of disposable devices; the release restates MEDEC's position that reuse "could pose serious risks to the safety of patients."

Among those taking the opposite view are Dan Vukelich, deputy executive director of the Association for Medical Device Reprocessors (AMDR) in the United States, and Pamela Furman, AMDR's executive director. In response to Health Canada's survey results, Furman and Vukelich argue that the reprocessing and reuse of disposable devices is generally safe, so long as those doing the reprocessing are "adamant" about selecting devices for reuse. "There are test methods used by reprocessors that allow them to determine if a device originally marked for single use is amenable [to reprocessing]," Vukelich says. Speaking for the third-party reprocessors represented by AMDR, he says that of all the devices marked for single use, only a very small percentage of those tested meet criteria for reprocessing. "We think validation is critical," he adds.

Kevin Murray, MEDEC's vice president of regulatory affairs, responded to AMDR's comments in an e-mail to MD&DI: "If AMDR has evidence of safe reprocessing of single-use devices, we would be interested to see it," he said. "And if some devices are not suitable for reuse, then it follows that very rigid criteria must be established to justify reprocessing the remaining types of devices. This 'criteria' should be no less than what industry would be required to provide to government regulators."

Copyright ©2001 Medical Device & Diagnostic Industry

AdvaMed Offers Praise as CMS Moves to Avert Outpatient Payment Cut for Technology

Originally Published MDDI December 2001

A final rule issued by the Centers for Medicare & Medicaid Services (CMS) regarding outpatient prospective payment "represents a significant step forward in protecting Medicare patients' access to innovative medical technologies, drugs, and biologics in the outpatient setting," according to AdvaMed.

Considered to be a major policy shift, the action by CMS effectively avoids deep cuts in temporary "pass-through" payments for new medical technologies by moving 75% of technology costs into the base outpatient payment bundles and by applying pass-through cuts only to the remaining costs. As a result, the net payment cuts for medical technology will be far lower than the 80.7% pass-through cut that would have been made, according to AdvaMed.

Says AdvaMed President Pamela G. Bailey, "This final rule offers real hope to the patients, physicians, and hospitals across the country who have raised concern that Medicare's proposed cuts would force patients into the more costly and less convenient inpatient setting." Bailey adds that, "to make these solutions a reality, CMS and Congress must continue moving in the new direction they have taken today."

AdvaMed believes that it is critically important for CMS to ensure adequate reimbursement for new technologies as it shifts pass-through payments into the base outpatient payment categories.

Bailey also indicates that AdvaMed is pleased that CMS has voiced its support for legislation to allow the agency to use funds from the outpatient "outlier" pool to further reduce payment cuts. "We are hopeful Congress will enact this change soon to support full patient access to advanced outpatient care," she says. Bailey adds, "Congress' goal in creating the pass-through program was to ensure that CMS moves to an outpatient program that provides adequate reimbursement for the innovative medical technologies that patients need."

Copyright ©2001 Medical Device & Diagnostic Industry

European Meetings Address Advanced Technology and SUD Reuse Issues

Originally Published MDDI December 2001

During a press conference during this year's MEDICA meeting in Düsseldorf, the German Medical Technology Association (BVMed) urged greater recognition of advanced medical devices. Said Volker Wagner, BVMed deputy chairman, "Innovative medical technologies must be more strongly promoted and appreciated in the German healthcare system." Volker argued that Germany needs a more aggressive and innovation-oriented environment to encourage the development of new treatment therapies and medical technologies.

Volker added, "We urge all decision-makers in the field of healthcare to recognize the significance of medical devices and to take adequate account of them in the forthcoming discussion about future policy. First steps have already been taken. The involvement of the medical devices industry in the 'Round Table' of the German health minister reflects the appreciation of medical technology as an independent industry."

The issue of single-use device (SUD) reprocessing was addressed during a recent BVMed conference. During the meeting, a representative of the German Federal Ministry of Health, Hans-Georg Will, urged a stronger stance on the issue of device reprocessing. Will said the reprocessing of single-use medical devices in hospitals must be monitored in a much stronger way by the authorities.

"If increased surveillance of third-party or hospital reprocessors shows that they are unable to reprocess medical devices according to the legal requirements, further legal bans will have to be considered," said Will. According to BVMed, current data do not warrant prohibiting reprocessing of single-use devices in general. The organization notes that reprocessing of medical devices is subject to a validation procedure to lower the potential risk to patients and users.

Copyright ©2001 Medical Device & Diagnostic Industry

FDA Web Site Update

Originally Published MDDI December 2001


A monthly review of new and notable additions to FDA's Web site.

Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA

Originally issued October 5, 2001, this document supersedes the June 28, 2000, Guidance for Electrical Safety, Electromagnetic Compatibility, Mechanical Testing for Indwelling Blood Gas Analyzer Premarket Notification Submissions, and February 21, 2000, Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions. The document describes a means by which indwelling blood gas analyzers may comply with the requirement of special controls for class II devices. The guidance has been developed as a special control to support a change in classification from class III to class II, and identifies material required for a 510(k) premarket notification application.

Proceedings of the ACR/FDA Workshop on Fluoroscopy

This site provides an out-of-print document that includes presentations from an American College of Radiology (ACR)/FDA workshop, Strategies for Improvement in Performance, Radiation Safety, and Control, which was held October 16–17, 1992.

IDE Memorandum #D01-1; Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices

This memorandum provides written procedures for handling inquiries regarding the need for an investigational device exemptions (IDE) application for research involving medical devices.

FDA Public Health Notification: Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients

This notification emphasizes the importance of keeping radiation doses as low as reasonably achievable during CT procedures, particularly during treatment of pediatric and small adult patients. Such patients may sometimes receive more radiation than needed to obtain diagnostic images. The document emphasizes the importance of adjusting CT scanner parameters appropriately for each individual's weight and size, and for the anatomic region being scanned.

Special Controls Guidance Documents to Reduce Regulatory Burden

CDRH recently developed a special controls guidance document to reduce the regulatory burden associated with obtaining marketing authorization for indwelling blood gas analyzers, and to serve as a possible template for special controls guidance documents for other device types. The site provides a link to indwelling blood gas analyzer documents.

Guidance for FDA Staff: The Leveraging Handbook

Described as a resource for effective collaborations, this guidance to FDA staff represents the agency's current thinking on the topic. Leveraging consists of partnerships, cooperative agreements, or similar collaborative arrangements entered into by FDA and another organization.

Reuse of Single-Use Devices: FDA's Regulatory Requirements for Third-Party and Hospital Reprocessors

This was a presentation by Lily Ng, of FDA's Office of Surveillance and Biometrics at CDRH, at the Regulatory Affairs Professional Society 2001 Annual Conference in Baltimore, MD, in November. The main points of the presentation included development of FDA's policy, principles underlying the policy, a list of regulatory requirements and important dates, premarket submissions received to date, and key issues FDA has encountered in the process.

Annual Comprehensive List of Guidance Documents at FDA

This site provides FDA's annual comprehensive list of all guidance documents currently in use at the agency.

Science at Work in CDRH: A Report on the Role of Science in the Regulatory Process

This is a final report by the CDRH External Review Subcommittee on its assessment of "whether the needed scientific expertise is available currently, whether it is effectively used, and a determination of the scientific expertise needed for the future." The review of the individual FDA Centers by subcommittees of the science board began three years ago with the Center for Biologics Evaluation and Research and more recently included the Center for Food Safety and Nutrition.

NIH Human Embryonic Stem Cell Registry

This site provides an overview of CBER's current regulatory strategy for human tissue. A link is also provided to the National Institutes of Health (NIH) embryonic stem cell registry.

Medical Devices; Exemptions From Premarket Notification; Class II Devices, Final Rule

FDA issued this final rule in response to a petition requesting an exemption for the F-Spoon fluoroscopic compression device. The final rule exempts the device from premarket notification requirements. The manual compression device allows a radiologist to press on the abdomen during a fluoroscopic procedure without exposing his or her hand to the x-ray beam.

Copyright ©2001 Medical Device & Diagnostic Industry