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Medical Errors: Leading Cause of Death or Urban Legend?

Originally Published MDDI November 2001

Medical errors do happen, but exaggerating the scope of the problem will impede efforts to address serious threats to the healthcare system.

Thanks in part to the prevalence of e-mail and spam, we've all encountered urban legends. Whether it's that Nigerian official who needs to store $100 million in your bank account for a few days or a friend who passes on a warning about an imminent postal-service plan to tax e-mail, there is no dearth of people ready and willing to propagate unlikely myths.

Somehow, despite their implausibility, these urban legends are passed around as truths by people too shocked to raise questions. In most cases, the implications are relatively harmless. But sometimes, the failure to critically examine assertions presented as facts can have serious consequences.

One pertinent example for the medical device industry is the widely quoted statistic that medical error kills 100,000 people every year. Based on a report by the Institute of Medicine (IOM) released in 1999—which actually cited estimates of between 44,000 and 98,000 deaths a year caused by medical errors—this claim received extensive coverage in the news media.

Much less attention was paid to a subsequent article, published in the Journal of the American Medical Association (JAMA) last July 25, which called into question the conclusions of the IOM report. According to authors Rodney Hayward and Timothy Hofer, the results of their study suggest that "these statistics are probably unreliable and have substantially different implications than have been implied in the media." Hayward has suggested that the number of deaths due to error is probably closer to between 5000 and 15,000 annually.

The core argument of the JAMA article was not to reject absolutely the IOM estimate. Rather, it was to caution against accepting it as a factual statistic. As the authors found, opinions among the doctors reviewing the records that were examined varied considerably about whether a particular error led to a death, and even on whether an event was in fact an error. Moreover, previous studies had not considered whether the patient would have died regardless of the error.

Unfortunately, the JAMA article appears to have had little moderating effect on the holding power of the IOM figure. The 100,000 number shows signs of having become another urban legend. More than a month after the JAMA article was published, for instance, a full-page ad published in The Wall Street Journal referred to the original estimate. "Medical error," said the ad, "ranks with cancer and highway accidents as a major killer in the United States."

This may be good ad copy, but it's misleading rhetoric. To take up this debatable estimate as accepted fact is to misidentify the enemy. Yes, medical error is a problem. But if society exaggerates its scope, precious resources may be diverted away from other serious threats to the healthcare system.

Obviously, medical errors do happen, and medical device malfunctions are sometimes contributing factors to such terrible mistakes. To the extent that the delivery of healthcare has been improved by the publicity over medical errors, it has been a good thing. But if too much emphasis is put on errors, it will end up hampering the efforts of the healthcare system and medical device companies to implement further improvements.

The healthcare system is far from perfect, but it is hardly a threat comparable to cancer. Let's not try to fix what isn't broken.

The Editors

Copyright ©2001 Medical Device & Diagnostic Industry

FDA Web Site Update

Originally Published MDDI November 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

This document, issued on October 5, 2001, supersedes both Guidance for Electrical Safety, Electromagnetic Compatibility, Mechanical Testing for Indwelling Blood Gas Analyzer Premarket Notification Submissions, issued June 28, 2000, and Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions, issued February 21, 2000. The document describes a means by which indwelling blood gas analyzers may comply with the requirement of special controls for Class II devices. Manufacturers attempting to establish that their device is substantially equivalent to a legally marketed indwelling blood gas analyzer device should demonstrate that the proposed device complies with either the specific recommendations of this guidance or some alternative control that provides equivalent assurances of safety and effectiveness.

Medical Device Reporting—Remedial Action Exemption; Guidance for Industry and FDA

Issued on September 26, 2001, this document supersedes MDR Guidance Document: Remedial Action Exemption E 1996001, dated July 30, 1996. The medical device reporting (MDR) regulation requires device manufacturers to report adverse events for products undergoing remedial action. This document offers guidance on requesting an exemption under 21 CFR 803.19 for reporting certain adverse events that involve device remedial action. FDA intends to grant this exemption to manufacturers when they provide information that indicates additional reports about a device that already has been the subject of a remedial action will not provide any significant new data.

Cancer Drug and Biological Products—Clinical Data in Marketing Applications; Guidance for Industry

This document provides recommendations for sponsors on data collection for cancer clinical trials submitted to FDA to support marketing claims in new drug applications, biologics license applications, or supplemental applications for new indications. Collected data should be sufficient to evaluate the safety and effectiveness of the treatment but need not include other data. This guidance is also intended for private investigators, cooperative cancer groups, contract research organizations, and others designing and conducting studies that later can be used in a marketing application for an anticancer drug or biological product. Because of the complexity of clinical trials and different data that should be included in different situations, the precise data for each trial cannot be specified in a guidance document. This guidance provides general principles for data collection and submission.

Presentation to Central New York Healthcare Central Service Professionals

This September 11, 2001, presentation by Office of Compliance staff describes FDA's current regulatory policy regarding facilities that reprocess single-use devices (SUDs). It also summarizes the regulations that now apply to reprocessors of SUDs and provides information on where to get questions answered.

Changes in Enforcement of FDA's Requirements on Reprocessing of Single-Use Devices

This site includes a letter, dated September 25, 2001, to hospital administrators and risk managers. The letter outlines changes in FDA's policy on the reuse of single-use devices (SUDs) that will affect hospital SUD reprocessors. FDA has extended the deadline for active enforcement to August 14, 2002, for the following postmarket requirements: medical device reporting, tracking, corrections and removals, quality system, and labeling.

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Premarket Submission Review and Quality System Inspections under United States/European Community Mutual Recognition Agreement

FDA is seeking public comment on the proposed collection of information by the agency regarding third-party premarket submission reviews and quality system inspections under the United States/European Community mutual recognition agreement. Written or electronic comments on the collection of information must be submitted to the agency by December 4, 2001.

Updated Information for Clinical Investigators

This site has been recently updated by CBER. Information is provided on participation of females in clinical trials and gender analysis of data in biologic product applications, clinical trials and institutional review boards, good clinical practice in FDA-regulated trials, HHS human research protections, and Center for Drug Evaluation and Research information for clinical investigators.

Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance

This document describes FDA's recommendations for data and information to be provided in 510(k) premarket notifications for radioallergosorbent test (RAST) methods for allergen-specific immunoglobulin E (IgE) test systems. RAST testing measures specific allergen antibodies and may aid in the diagnosis of various pulmonary disorders. The document has been modified to include allergens for which few patient samples are available.

Copyright ©2001 Medical Device & Diagnostic Industry

Medical Alley Gears Up for Tighter Race

Originally Published MX November/December 2001

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Medical Alley Gears Up for Tighter Race

Minnesota has long been a hotbed of medtech activity, and the state’s economic development officials are not resting on their laurels. According to Department of Commerce figures, more than 65 new medical device manufacturers were established there between 1990 and 1998, an increase of 45%.

The shortage of skilled labor that plagues other regions in the country doesn’t seem to faze Medical Alley. In fact, according to Patricia Neuman, an official with the Minnesota State Department of Trade and Economic Development, her state has the fifth-highest per capita ranking for residents with at least a bachelor’s degree level of education. Nor is venture capital a problem, as the region has the highest intensity of venture capital investment per capita in the United States, adds Neuman.

However, the phrase per capita appears frequently in Medical Alley data, and it has a flip side in the game of comparisons. If having a cluster of similar

Covering New Ground

Originally Published MX November/December 2001

GOVERNMENTAL & LEGAL AFFAIRS

Covering New Ground

CMS is working to make Medicare’s national coverage process more understandable, predictable, timely, and inclusive.

John Whyte

Over the past two years, the U.S. Medicare program has revised its methods for deciding whether or not to cover a medical device, procedure, or service. The Centers for Medicare and Medicaid Services (CMS, formerly the Health Care Financing Administration; Baltimore) has implemented the changes in an attempt to make the program more understandable, predictable, timely, and inclusive. This article describes some of the recent changes and discusses the effects they may have on business planning for medtech manufacturers.

The Social Security Act grants the secretary of Health and Human Services, acting through CMS, the authority to determine what medical devices, procedures, and services are covered under the Medicare program. However, the act also restricts all Medicare coverage and payments to those services that have been found “reasonable

NIBIB Web Site Launched

Originally Published MDDI November 2001

NEWS & ANALYSIS

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), the newest of the NIH research institutes, was mandated by legislation that was signed into law in December 2000. According to the NIBIB, its mission is "to improve health by promoting fundamental discoveries, design and development, and translation and assessment of technological capabilities in biomedical imaging and bioengineering enabled by relevant areas of the physical, engineering, and computational sciences."

An NIBIB Web site can now be found at http://www.nibib.nih.gov/. The site provides information on NIBIB's structure and operations, and on activities related to biomedical imaging and bioengineering in general. Among the topics addressed on the Web site are biomedical imaging and bioengineering activities, articles describing breaking news and events realted to imaging and bioengineering, links to NIBIB research and training opportunities and NIH extramural grant information, and items of general interest to the biomedical research community—including reports, news articles, and links to other Web sites.

In addition, the Web site for the NIH Bioengineering Consortium (BECON), which contains information on BECON activities and funding opportunities, has been made part of the NIBIB Web site. The BECON consists of representatives of all NIH research institutes and centers as well as other federal agencies. Its site is intended to serve as a focus for bioengineering activities at the NIH.

Copyright ©2001 Pharmaceutical & Medical Packaging News

Epoxy material for small electronic packages.

A specialty material suited for small optoelectronic-package designs is available from Rogers Corp. (Rogers, CT; 860/774-9605). The white epoxy molding material is formulated to endure high solder temperatures while retaining the necessary optical, electrical, and mechanical properties. Reflecton epoxy meets the demand for dense packaging and components by reflecting "good" light and keeping out unwanted light, thus enabling thinner package designs. By balancing high reflectivity with opacity, Reflecton makes it possible for design engineers to eliminate the traditional extra epoxy layer and to create more-efficient components. The epoxy displays good IR solder-reflow capabilities; it is moisture resistant and provides lot-to-lot quality and consistency.

Hot Spots: 10 Sites for the Medtech Executive’s Itinerary

Originally Published MX November/December 2001

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Hot Spots: 10 Sites for the Medtech Executive’s Itinerary

Communities throughout the country are wooing medtech companies. Here are 10 of the most notable.

Cliff Henke

Medical technology has always been one of the star attractions of economic development agencies throughout the world, and those in the United States have not been immune to its luster. As the world appeared to be already dipping into recession well before the outrages of September 11, such agencies are stepping up their efforts to lure companies in this sector.

However, medtech companies and their investors can be hard to convince. The complexity of the industry and its finances means that regional development agencies have to work doubly hard to offer medtech executives just what their companies are looking for.

According to Daniel Wood, a partner with the venture capital (VC) firm IngleWood Ventures (San Diego), "Location is still very important. Virtual companies can’t offer the

Ensuring Blood Supplies in Uncertain Times

Originally Published MDDI November 2001

NEWS & ANALYSIS

Ensuring Blood Supplies in Uncertain Times

In the aftermath of the attacks on New York City and the Pentagon, an unprecedented number of Americans donated whole blood to help meet the needs of victims and rescuers alike. A few weeks later, radio personality Paul Harvey suggested inaccurately that millions of units would be "dumped" because of the donated blood's short shelf life of 42 days.

Listeners began calling the American Red Cross (ARC) to see if they had waited in long lines to donate blood that would be dumped. Callers were assured that the ARC has been freezing blood for 30 years. Harvey broadcast a clarification of his comments on a subsequent program.

The ARC explains that blood donated after September 11 was frozen if not immediately needed. The organization adds that it is working with FDA to improve freezing and thawing techniques that could improve blood services. The ARC also says it is assessing new technology to create an inventory of frozen blood that can be stored in a number of sites around the country and tapped in an emergency.

As part of this effort, the organization recently contracted with Haemonetics Corp. (Braintree, MA) to use the firm's latest blood freezing technology to expand its frozen blood storage capability. Like currently available techniques, Haemonetics' ACP 215 cell processing system allows red blood cells to be frozen for as long as 10 years and to thaw cells as needed. Previous technologies, however, required thawed blood to be used within 24 hours after thawing or be discarded. The company explains that by automating the blood freezing process in a closed-circuit disposable system that eliminates exposure to air or bacterial contaminants, the shelf life of thawed blood can be extended to 14 days.

Using a closed-circuit system, the ACP 215 cell processing device aids supply management by extending the shelf life of thawed blood to 14 days.

Prior to freezing, glycerol is added to the blood bag through sterile, plastic tubing to protect the cells from damage. The blood is then placed in a freezer for long-term storage. After defrosting the blood, the device pumps a cleansing agent into the bag to remove the glycerol, making the blood safe for transfusion to a patient.

James L. Peterson, Haemonetics' president and CEO explains that, "The enormously generous outpouring of donors created blood inventory levels that could be leveraged to maximize frozen blood programs." He believes that the firm's technology will enable blood collection and storage facilities to ensure adequate levels of blood availability. The concept of freezing blood supplies is particularly important in preserving units of rare blood types, collected at times of surplus, to keep in reserve for use during shortages.

The frozen blood market is estimated to be relatively small at present, representing a minor portion of all blood transfused in the United States. Haemonetics speculates that frozen blood programs have been limited by the short shelf life of thawed blood. The company notes, however, that the United States has experienced significant localized blood shortages in recent years as a result of either increased demand or decreased supplies. Such shortages emphasize the importance of developing methods for managing frozen blood inventories.

The company believes that within a few years this new generation of laboratory processing equipment and disposables will also be used for pathogen inactivation of red blood cells. The firm is collaborating with V.I. Technologies Inc. (Watertown, MA) to develop pathogen inactivation methods that can increase the safety of red cell units transfused to patients.

Copyright ©2001 Medical Device & Diagnostic Industry

Thermoplastic Polymer Chosen for Packaging

Clear copolyester material used in a dental-tool box. The Swiss company Bien-Air SA has selected Eastar copolyester as its new dental-package material. Eastar is manufactured by Eastman Chemical Co. (Kingsport, TN; 423/229-1424); it will be used to create the dental kit's housing, lid, and several separation inserts and clips. The material, a thermoplastic polymer, displays clarity, chemical resistance, and mechanical strength. Bien-Air reportedly chose the material for its attractive product-display properties, its high flexibility, its dimensional stability, and its stress-crack resistance. Eastar copolyester can also be recycled. Additionally, the material complies with biocompatibility requirements set forth by FDA and ISO.

Budgeting and Contracting for Patient Recruitment

Originally Published MX November/December 2001

ADVERTISING, DISTRIBUTION, & SALES

Budgeting and Contracting for Patient Recruitment

Once all decisions regarding the recruitment tactics to be implemented have been made, the clinical trial sponsor has in hand the most important information necessary as a basis for determining an appropriate recruitment budget. The investment in tactics—in marketing the trial to patients—may very well be the most significant expense in that budget. This is especially true for campaigns that rely heavily on paid television advertising, a notoriously expensive tactic.

In the highly competitive and rapidly growing field of clinical trials, creating a patient recruitment budget and considering contracting options is becoming increasingly important. Clinicians, administrators, sponsors, and others involved in clinical trials must think strategically in deciding when, where, how, and why to budget and contract for patient recruitment.2 The following areas of growth and change in the budgeting and contracting process need to be considered when planning a new study.