Equipment Standards: History, Litigation, and Advice

Abstract

Summary

The authors present a concise history of the development of national and international standards for surgical equipment. Standards-writing organizations, surgical and other specialty societies, universities, test houses, and the U.S. government have influenced this process, which is now manifested in complex interactions between national and international standards-writing organizations, and in CE (Conformité Europeene) marks being placed on surgical equipment in the United States and elsewhere. The history of litigation in standards development is also reviewed. Recommendations to maximize patient safety and to help ensure successful, cost-effective defense in litigation for surgeons who use equipment and may suffer its malfunctions are given. Overall, the complicated oversight of surgical equipment standards and the approval process appears to be contributing to the improving and outstanding results of U.S. surgery reported by the U.S. government.

NEW MARKS

Surgeons have lately been noticing CE (Conformité Europeene) marks on the equipment that they use. These marks show that the equipment has been type-tested and manufactured according to European standards, or to international or American standards that have later been been adopted as European standards. Council Directive 93/42/EEC of 14 June 1993, Concerning Medical Devices, ¹ provided that all such products used in the European Union (EU) bear the CE mark (Fig. 1) as of July 1, 1998. In addition, compliance with the EU’s Electromagnetic Compatibility Directive became mandatory as of Jan. 1, 1996. To receive a CE mark, medical equipment must comply with International Electrotechnical Commission (IEC) Standard 60601-1-2 on Electromagnetic Compatibility. ² Also, to use the CE mark on a product, a manufacturer must apply for approval to a designated organization known as a notified body. Some of the European national standards organizations serve as notified bodies, and four-digit numbers adjacent to the CE marks identify the approving organizations. Before June 1998, self-certification by a manufacturer was permissible for compliance with the Electromagnetic Compatibility directive. Therefore, if a CE mark appears with no identifying number, it signals that that device complies with the Electromagnetic Compatibility directive only and probably has not been approved by a notified body.

Figure 1. The form of the CE mark. If the marking is reduced or enlarged, it must be of the proportions shown and must have a vertical dimension of ≥5 mm. For small-scale devices, this minimum may be waived.

The CE mark now appears on the main label of a medical device, along with the company name, address, logo, serial number, and so forth (Fig. 2), or longitudinally on catheters, tubing, and similar products, and also in the manufacturer’s literature and instructions (Fig. 3).

Figure 2. The CE mark as it appears on the label of an oxygen concentrator. Note the part number, the standards with which it is in conformance, the four-digit number of the notified body (0050), and the name and address of the manufacturer. (Reprinted with permission of Nellcor-Puritan Bennett.)

Figure 3. The CE mark as it appears in the operator’s manual for oxygen concentrators. Note the four-digit number of the notified body (0050) and the references to EEC Directives. (Reprinted with permission of Nellcor-Puritan Bennett.)

Why do these marks show up in the United States? The prime reason is that it is more expensive for manufacturers to produce different versions for different markets. In general, mechanical device manufacturers deplore different national standards and welcome international standards that are universally accepted. But are any standards for medical and surgical devices universally accepted? In practice, yes, but with many caveats, and the history of their development and related litigation are important to understanding this vital area. Such understanding is vital to a surgeon being sued for the alleged misuse of almost any piece of equipment used on a patient.

HISTORY

Although the American Society for Testing and Materials (ASTM) and the Underwriters Laboratories were founded in the 19th century, and the IEC in 1906, medical equipment standardization really started as a result of the medical equipment incompatibilities that became apparent during World War II. The International Organization for Standardization (ISO) was founded in Geneva in 1948, and the American National Standards Institute (ANSI), founded in 1918, is the U.S. member body for both the ISO and the IEC. ³

The Joint Committee for the Study of Surgical Materials was established in 1952 under the aegis of the American College of Surgeons and the American Medical Association. ⁴ Dr. Joseph Barr, chairman of orthopedic surgery at the Massachusetts General Hospital and then president of the American Academy of Orthopedic Surgeons, was a strong proponent of standards activity and an instigator of the joint committee. In his 1952 presidential address, he recommended the formation of a nonprofit organization of physicians and manufacturers to address issues related to surgical implants. ⁵

In 1962, representatives of the American Academy of Orthopedic Surgeons, the American Orthopedic Association, the American College of Surgeons, and some existing ASTM committees, such as A-1 (steel), D-20 (plastics), and E-7 (nondestructive testing), the American Dental Association, the U.S. Armed Services, and representatives of numerous manufacturers and universities joined the newly established ASTM Committee F-4. ⁴ At present, Committee F-4 has four divisions: resources, orthopedic devices, medical/surgical devices, and tissue engineered medical products (Table 1). Committee F-4 has contributed >150 published standards and specifications for surgical materials and instruments, test methods, and practice and performance specifications ⁴ and has had much to do with the success of surgery in the United States. ^6,7 Each year these standards are incorporated into volume 13.01 of the Annual Book of ASTM Standards. ⁸ ISO Technical Committee 150 on Implants for Surgery was formed in 1972, ⁴ with orthopedic, cardiovascular, and neurosurgical subcommittees. The members of Committee F-4 also make up the U.S. Technical Advisory Group to ISO Technical Committee 150 on implants for surgery, prosthetics, and orthotics.

Table 1. ASTM F-4 Subcommittees

In 1976, another professor of surgery at Harvard, Dwight Harken, was instrumental in founding the Association for the Advancement of Medical Instrumentation, which also writes standards for medical equipment and publishes many useful manuals on medical equipment, such as their annual Medical Equipment Management Manual: How to Comply with the JCAHO Regulations. ⁹ Another more controversial action of Dwight Harken was his lobbying and congressional testimony, which had much to do with the drafting and subsequent passage of the Medical Device Amendments of 1976 (Pub. L 94-295), which amended the 1938 Federal Food, Drug and Cosmetic Act (52 U.S. Stat.1040, 1938), thereby giving the Food & Drug Administration (FDA) jurisdiction over medical and surgical devices and charging it with promulgating mandatory performance standards. ¹⁰

Despite a call for such standards in the Federal Register, ¹¹ the increase in funding to undertake such work was not voted in subsequent budgets. Naturally, the U.S. standards-writing bodies were opposed to this requirement for federally written, mandated standards; possibly more importantly, the U.S. Department of Defense also was adamantly opposed. Being responsible for medical and surgical equipment within NATO and being strongly represented on both U.S. and international standards-writing bodies, the Pentagon and its allies persuaded the Office of Management and Budget to issue Circular A-119 in 1982 urging “Federal Participation in the Development and Use of Voluntary Consensus Standards.” Circular A-119 was revised and strengthened in 1993. ¹²

In 1995, the Technology Transfer Improvements Act (PL 104-113) codified the policies of A-119 and directed federal agencies to “use technical standards that are developed or adopted by voluntary consensus bodies.” ¹² The act does give federal agencies discretion to use other standards where use of voluntary consensus standards would be unlawful or impractical, but then the head of the agency must justify the action to the Office of Management and Budget through the National Institute of Standards and Technology.

Also in 1995, President Clinton signed an agreement with the European Economic Community (now the EU). ¹³ The preparatory document for this agreement stated that, “the European Union and the U.S. should aim to develop and adopt common and open standards wherever possible based on international product standards such as those of the International Organization for Standardization and the International Electrotechnical Commission where appropriate and supported by industry.” ¹⁴ In addition, there was a call for “full and complete mutual recognition agreements” for medical and surgical devices and many other high technology products, by the start of 1997. After delays in mid-1997, the EU and the United States finally agreed to the “Agreement on Mutual Recognition Between the United States of America and the European Community,” ¹⁵ which covers telecommunications equipment, electromagnetic compatibility, electrical safety, pharmaceutical good manufacturing practice, and medical and surgical devices. The FDA and its European counterparts are now allowed to exchange inspection reports for facilities producing medical devices and pharmaceuticals. Under a pilot program, medical device evaluation reports are exchanged between relevant government agencies and approved test houses. The various regulatory authorities will use these evaluation reports to determine whether the products of a manufacturer meet the importing countries’ standards and qualify for CE marks.

Since 1991, the Vienna Agreement between the ISO and the European Commission on Standardization (CEN) has provided for technical cooperation through mutual representation at meetings, parallel balloting of draft standards, and standardized procedures for the adoption of ISO standards as European standards. Guidelines for implementation of the Vienna Agreement were finalized in 1996. ¹⁶ The procedural steps for parallel voting in ISO and CEN are carefully defined. A list of types of ISO standards documents is given in Table 2.

Table 2. Forms of International Standards Documents

The FDA Modernization and Accountability Act of 1997 amends the federal Food, Drug and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biologic products and for other purposes. ¹⁷

A key provision of this legislation (Section 204) is expansion of the use of performance standards for medical equipment. This act authorizes the FDA to recognize, whether in whole or in part, the standards for medical devices developed by national and international standards-writing organizations, simply by publication of such standards in the Federal Register. Equipment manufacturers are then permitted to declare conformity with recognized standards to meet the review requirements of the FDA. The manufacturer must maintain data in support of conformity with nationally or internationally recognized standards, which the FDA may request. This feature of the FDA Modernization Act will both encourage standards development and expedite the review and approval process for new medical devices.

LITIGATION AGAINST STANDARDS-WRITING BODIES AND COMMITTEE MEMBERS FOR SURGICAL EQUIPMENT

Because both the ISO and the IEC have long-established codes of conduct and vote is by national delegation, standards-related litigation has not occurred at the international level. Moreover, because both organizations are based in Geneva, Swiss law has jurisdiction. Verbal threat of litigation has occurred over individual U.S. expert representation to the ISO’s Technical Committee 121 on Anaesthetic and Respiratory Equipment. On explanation that representation was based on nomination by ANSI based on a vote of the relevant United States Technical Advisory Group, the threat was withdrawn. Incidentally, the individual national vote is cast by the leader of the national delegation, with each participating country having a single, equal vote. This system works surprisingly well because the interests of the patient seem to be considered paramount.

At the national level, in the United States in the nonmedical area there has been successful litigation over egregious misconduct in writing industrial standards. ^18,19 In the area of surgical equipment, allegations as to the causes of electrosurgery unit burns led to the verbal threat of litigation. ²⁰ These were later withdrawn with the intervention of legal counsel.

National standards activity in the area of anesthetic and respiratory equipment was transferred by committee vote in 1983 from ANSI to ASTM because the committee believed the legal protection provided committee members would thereby become more inclusive. Verbal threats, at least in the United States, are generally made to the chairman of the relevant committee and are best countered by the chairman’s verbally contacting the firm’s chief executive officer. Chief executive officers of surgical equipment firms are aware that user and general interest voting members of standards-writing committees are, by ATSM rules, required to outnumber the producer members.

Litigation against members of the operating team when equipment is alleged to have malfunctioned does not generally come to trial; out-of-court settlement is more common. Surgeons, however, should know which equipment they are “dispensing” and whether it meets current standards, both national and international. Standards, when adopted, almost universally apply to equipment manufactured after their effective date. Juries and judges are swayed to the side of the defense by the use of equipment that has been certified to the relevant standard. Ideally, the equipment will have met both national and international standards. There should be agreement as to who is responsible for what equipment in the operating room. The surgeon who is allocated responsibility for an anesthesia workstation should know that current standards contain approximately 50 pages of requirements. ^21,22

But what of equipment such as infusion pumps? Sometimes they infuse substances that are being dispensed by the surgeon, and sometimes by the anesthesiologist. Sometimes their performance is monitored by electronic information transferred by a standard medical information bus to a multiparameter patient monitor, and sometimes to an anesthesia workstation. Before a potentially adverse incident occurs, does the surgeon or anesthesiologist have guidelines for reaction to an alleged mishap and knowledge of the state of the equipment? What do they know of monitoring information transfer? If equipment performance data are available, both legal defense and settlement are more likely to be successful and less costly, because equipment failure is relatively rare. ²³ At least in the United States, up-to-date operating room equipment is cost-effective.

NEED FOR SURGEONS

That surgeons and anesthesiologists should be attentive to the standards-writing process is illustrated by the fact that the first proposed international standards on endoscopic bronchoscopes made no provision for an adequate patient airway. At that time, no surgeon or anesthesiologist was a member of the ISO Technical Committee 172 on Optics and Optical Instruments writing group.

A false alarm sounds every 12 minutes on average in a U.S. operating room. ^24,25 With more input from surgeons into national and international standards for operating room alarms, the cacophony caused by multiple alarms designed for solo use, rather than as harmonious system components, might be more effectively tempered. ²⁶ The three international standards on operating room alarms, International Standards 9703-1, -2, and -3, produced by ISO Technical Committee 121, were the result of work by anesthesiologists and intensive care specialists, with only one surgeon participating.

LITIGATION AND THE SURGEON

Suggestions follow as to what should be done when operating room equipment malfunctions. If a patient or other person is injured or might have been seriously injured, as specified in the Safe Medical Devices Act of 1990, ²⁷ the FDA must be notified within 10 working days, as well as the manufacturer (if it is known). The appropriate state and institutional authorities must be informed as well. It is the legal responsibility of the surgeon and anesthesiologist to ensure that this is done promptly and accurately (Table 3).

Table 3. Suggested Actions After Injury Associated With Equipment Malfunction

Caveat Chirurgus!

The hospital, its bioengineering department, the equipment supplier, the maintenance service, and the manufacturer all have divergent interests in the events and the evidence. The patient’s malpractice attorney may be well versed in exploiting differences and lacunae in information. The surgeon’s actions are most easily defensible in court if every piece of malfunctioning equipment that leads to an FDA-reportable error is immediately sequestered and then expeditiously examined by a qualified, independent professional prepared to testify as an expert witness (see Table 3). If the equipment malfunctions during surgery and if no completely satisfactory replacement equipment is promptly available and the patient is not thereby endangered, the operation should be terminated. If the surgeon or his or her deputy tries to make ad hoc repairs, the defense in a medical malpractice action is compromised. If the defective equipment is examined before the expert’s arrival, except by noninvasive, nonmanipulative photography, the waters are muddied. Photographs should be timed and corroborated (see Table 3). Defense attorneys and insurers also complain that surgeons and anesthesiologists under cross-examination claim to be better versed in their equipment than is really the case.

Equipment software errors occur with equal frequency at any time in the life of the equipment (as opposed to non-software errors, which are more likely to occur at the beginning and end of useful life). It is a bold surgeon who wishes to qualify himself or herself as an expert in the national and international standards on the testing of software in medical equipment.

Another caveat concerns descriptions of equipment failure on the Internet. Such communications are routinely monitored by regulators and litigators. One recent Internet description of an anesthesia ventilator stoppage, with no patient injury, thought to be the result of a software error, led to many repercussions not intended by the originator of the communication.

Failures of operating room mains electrical supply almost invariably lead to the auxiliary generator’s restoring power within the National Fire Protection Association-specified time of 10 seconds, ²⁸ but the frequency of the newly generated alternating current may fall outside the range of operating frequencies specified as acceptable in national and international standards. In such cases of equipment malfunctions in the operating room, the surgeon should see that these incidents are reported to the FDA and the equipment manufacturer. Currently, U.S. national standards generally require more battery backup than European standards.

Surgeons who use lasers in the operating room can be led to disaster if other members of the operating room team misdirect or overprescribe oxygen. National and international standards have been published on the safe use of lasers in an oxygen-rich environment, ^29,30 and in 1997 a new ASTM subcommittee, F-29.08 on Operating Room Fire Safety, was created. Despite media coverage, however, personnel besides surgeons and anesthesiologists may not be fully aware of the extreme flammability of operating room drapes, which despite the efforts of the American College of Surgeons and the ASTM have yet to be the subject of a meaningful standard.

The reuse of equipment intended for single use in the operating room is contrary to equipment standards. In the event of the malfunction of such equipment, the manufacturer is almost certainly not liable in law, and the surgeon or anesthesiologist may face difficult litigation. Single-use equipment is not generally designed to survive the vagaries of standard hospital sterilization techniques. ³¹

Mandatory FDA equipment recalls occur. Legally, it is not the responsibility of the FDA to see that the equipment is returned but rather that of the user and the manufacturer; on occasion, however, the manufacturer is defunct or defective in completing the recall. A recall is generally a major economic disaster for a manufacturer. In the past, takeovers or mergers of medical equipment firms have sometimes been bedeviled by unanticipated equipment recalls of the newly acquired company’s products.

Not surprisingly, the Securities and Exchange Commission is conversant with medical and surgical equipment standards procedures. Surgeons who have insider knowledge must not trade or divulge the knowledge except as required by law.

INTERNATIONAL ASPECTS

The director of the U.S. National Institute of Standards and Technology, after confirmation by the Senate, stated that, “While many U.S. developed standards are used internationally, worldwide pressure is increasing to move towards standards developed and promulgated at the international level.” ³² He continued, “There are many American Society for Testing and Materials standards that are in worldwide use that are not International Organization for Standardization/International Electrotechnical Commission standards. The suggestion that only ISO/IEC are international standards is neat and convenient, but it’s wrong.” ³³

Why does this matter? In the agreement between the EU and the United States on medical and surgical equipment, the two sides have agreed that European organizations can test goods to American standards on behalf of American authorities. Sometimes the American and international standards are identical, but if they are not, extra expense results from testing for certification and in manufacturing.

Occasionally, patients transported across the Atlantic are put at risk by anomalies between American and international standards, the most notorious anomaly being the color of the oxygen cylinder. Despite these problems in the international standardization of medical and surgical equipment, the annual trade surplus produced by the U.S. medical device industry exceeds $4 billion. International demand for U.S. medical and surgical devices is expected to increase to about $18 billion by the year 2000. ³⁴

SUMMARY

Surgeons have played a most important role in the usefulness to society of voluntary consensus equipment standards. Dwight Harken claimed, in the preamble to one of his historical films, that the first step in his astoundingly successful series of World War II intracardiac operations was that he himself standardized all the surgical and anesthetic equipment. ³⁵ The more retiring Joe Barr was attempting to further his pioneering work in disc surgery. ³⁶ Each encouraged his trainees and colleagues to participate on equipment standardization committees. It may be best, however, if surgeons and other physicians who do so forego invitations to be expert witnesses in medical malpractice actions involving equipment malfunction. Problems of operating room equipment malfunction are often complex, with simultaneous or cascading faults. Complex testimony, even if in favor of the defendants, can often be misrepresented. The reputation of the surgeon in standards development is then tarnished, impeding the constructive consensus process of standards development.

Surgeons should know what equipment they want and need. If surgeons are not present at the relevant meetings, the standard may be written for economy and not performance. A surgeon is the best guarantor that the patient’s interest is uppermost in the choice of equipment needs for surgery.