he issues surrounding patient and health care worker (HCW) safety have a long history and came into clearer focus in the early days of the HIV epidemic in the mid-1980s. We will not review these, but the general concerns led to recommendations for “universal precautions” by the Centers for Disease Control and Prevention and the development of blood-borne pathogen (BBP) standards by the Occupational Safety and Health Administration (OSHA) in December 1991. As safety devices, more specifically, safer intravenous (I.V.) catheters, came on the market in greater numbers and variety, there was an increasing focus on occupational health with the goal of decreasing needlestick injuries. In November 2000, President Bill Clinton signed the Needlestick Safety and Prevention Act that required OSHA to revise the BBP standards to be in conformance with the Needlestick Safety and Prevention Act. This legislation became effective in April 2001 and put even greater emphasis on the use of safer equipment and techniques.

Many anesthesiologists have expressed concern that the “safer equipment” is more difficult to use and may compromise patient safety. This concern has focused primarily on I.V. catheters, although they are only a small part of the safety equipment and other changes in practice that have occurred over the last 15 years or more. Great strides have indeed been made in the area of occupational safety for HCWs. Some, if not all, of the manufacturers have involved HCWs in developing equipment and making decisions on its manufacture. Certainly a number of the members of the Task Force on Infection Control and the Committee on Occupational Health were consulted over time by Johnson & Johnson (catheters now produced by Medex). The technical, manufacturing and economic challenges in designing the new safety catheters were never easy.

Despite these efforts to improve the safety of I.V. catheters and address the needs of anesthesiologists over a number of years, legitimate concerns remain on the part of many ASA members for whom I.V. access is at the center of patient care and well-being. Further, in many hospitals, anesthesiologists are the I.V. access “providers of last resort.” The equipment we have must suit the task at hand, be it I.V. access, arterial access or more invasive central monitoring. As more safety equipment becomes available, there has been a professional and, to some extent, legal push to limit or stop, in effect, the use of “nonsafety” equipment.

Many anesthesiologists wish to have several catheter types available, feeling that there are unique tasks or more difficult I.V. access needs for which the traditional or nonsafety catheters are more satisfactory and in the patient’s best interest. Occupational health concerns, however, have led some hospitals to remove these catheters entirely from their institutions. There is no legal requirement to do this. The compromise in other institutions is to use “safer catheters” for all but the more difficult cases or unique situations but to keep both types available to anesthesiologists. The removal of nonsafety catheters by some institutions brought the following question up at the 2003 Annual Meeting: “Will nonsafety catheters continue to be manufactured?”

In late October 2003, Committee on Occupational Health member Arnold J. Berry, M.D., contacted Medex directly. The response at that time was that it would continue to produce these catheters in the foreseeable future. The Task Force on Infection Control has followed this issue for some years both nationally and at the state level, particularly in California where guidelines and rules became the model for OSHA’s later needlestick regulations. The use of “nonsafety” I.V. equipment remains legal and appropriate and, in our view, necessary in some clinical situations.

ASA Annual Meeting, October 2004
During the 2004 Annual Meeting, an informal meeting was held to broadly discuss the use of safety I.V. catheters and the continued production of “nonsafety” I.V. catheters (traditional I.V. catheters). Samuel C. Hughes, M.D., Chair of the Task Force on Infection Control, led the meeting along with Donald E. Martin, M.D., Chair of the Committee on Equipment and Facilities. Task force members and members of Dr. Martin’s committee were present as was Randall M. Clark, M.D., representing the ASA Committee on Pediatric Anesthesia.

Dr. Martin had communicated with Medex, which manufactures Optiva, Jelco and Cathlon lines of I.V. catheters, and Becton Dickinson, which manufactures the Angiocath line, so that representatives of the two largest manufacturers of I.V. access equipment in the United States were present. Both ASA groups have been considering I.V. access equipment from either an occupational health viewpoint or the more technical equipment aspects. The meeting was spurred by the concern that the traditional I.V. catheters might no longer be produced by these companies.

There was a broad-ranging discussion of many issues related to the manufacture of I.V. catheters. The representatives of Medex said they would continue, at least in the short term, to manufacture the traditional catheters. Becton Dickinson seemed more firm in their commitment to continue manufacturing these catheters. Both firms were interested in a discussion of the situations in which members felt the nonsafety catheters were vital, including arterial line placement, many pediatric cases (particularly in children less than three years), pediatric caudal anesthesia, some emergency room work, central line placement, transtracheal use and some regional anesthetic techniques. The issue of the most difficult I.V. placement cases or emergency use came up repeatedly. The concern for the pediatric patient has been expressed directly to the Food and Drug Administration last year in a letter by 2004 ASA President Roger W. Litwiller, M.D.

On the other side of the fence, there were several ASA members present who felt that the newest catheters available were much improved and that the real issue was training and experience. Another issue raised by some ASA members was the essential “monopoly” of the large manufacturers: would the “better mouse trap,” or most technically advanced catheters, realistically get to the marketplace given the control and bargaining power of the larger firms? Such concerns, however, were beyond the scope of this meeting.

From the manufacturers’ viewpoint, the interesting ethical question was, “Is it ethical or moral to continue to produce a catheter that may harm a health care worker?” In answer ASA members stressed the much larger issue of patient safety and their needs. How many patients’ lives might be lost, for example, in emergency settings if quick, effective I.V. access was not gained? The consensus of most ASA members present was that the nonsafety catheters do have a role in good patient care in unique situations. While the newer safety catheters can be used in most routine settings and general I.V. access situations, there will remain a role for traditional I.V. catheters. We felt that the manufacturers heard this message and that production will continue.

Future Considerations
On the organizational front, the 2004 House of Delegates passed Resolution No. 2 (Intravenous Catheters), which was presented from the director of the Washington State Society of Anesthesiologists to encourage continued production of traditional I.V. catheters. A similar resolution had been passed by the American Medical Association (AMA) in June 2004 at the request of ASA. This resolution calls upon AMA to contact catheter manufacturers to urge continued production of traditional I.V. catheters. ASA must continue to make it clear that such continued production is a patient safety issue. From the very beginning of needlestick safety concerns, patients’ needs have been stressed as well as those of HCWs. While great changes have been made that have improved HCW safety (needleless systems, for example, and “standard precautions”), we must not overlook the patient.

At a local, practical level, anesthesiologists, be they individuals, groups or corporations, must work closely with their hospitals or places of practice. We must be involved in equipment selection and purchasing. OSHA actually requires that “frontline” HCWs be involved in the selection of equipment. We must be as vigilant in this area as we are in our clinical work. We must insist that our patients’ needs are met and their safety is kept in mind so that the task at hand can be effectively accomplished.

The future also must include our close cooperation with the manufacturers of equipment. The Committee of Equipment and Facilities, under Dr. Martin, had a lengthy list of suggestions and questions for the manufacturers at the above-mentioned meeting. The manufacturers present were quite interested in this feedback, and the Committee on Equipment and Facilities will continue to communicate its thoughts to the research and design divisions of all manufacturers who participate in discussion. It is through this communication between manufacturers and frontline HCWs that advances will be made toward better safety I.V. catheters that will be as easy to use and will maintain a high or higher success rate and more clinical reliability than traditional catheters.

The members of the Task Force on Infection Control and the Committee on Equipment and Facilities wish to continue to support the use and development of effective safety-type catheters as well as syringes and any other reasonable equipment and techniques that lessen the hazard of blood-borne pathogens to HCWs. Such support is important to all ASA members and our many co-workers. At this time, though, we feel that the continued availability of traditional I.V. catheters for unique uses and clinical situations is vital until we all agree that new safety catheters meet all of the special clinical needs of anesthesiologists as effectively as traditional catheters.

As noted by OSHA, “[T]he revised Exposure Control Plan requirements make clear that employees must implement the safer medical devices that are appropriate, commercially available and effective. No one medical device is appropriate in all circumstances of use.” The definition of “appropriate” includes “… a safer medical device, includes only devices whose use … will not jeopardize patient or employee safety or be medically contraindicated.”

We need to continue to meet our patients’ needs as well as to protect ourselves and co-workers from needlestick injuries.

Samuel C. Hughes, M.D., is Professor of Anesthesia, San Francisco General Hospital, University of California-San Francisco, San Francisco, California.

Donald E. Martin, M.D., is Professor of Anesthesiology and Associate Chair for Academic and Professional Development, Pennsylvania State University College of Medicine, Hershey, Pennsylvania.