Selecting Safety Blood-Draw Devices Causes Controversy
By Michael Garvin, MH
At is evident that hospitals are embracing the use of safety devices. Laboratory professionals, nurses and phlebotomists have converted to safety blood-draws sets in a record rate in the last year. Injuries occurring during a blood specimen collection activity have declined. Yet there are two major issues that have arisen recently regarding how hospitals protect staff members that collect blood specimens.
Both controversies involve the Occupational Safety and Health Administration (OSHA). The first issue focuses on misinformation that OSHA is indicating a preference for one safety-engineered design over another. This impression is simply not true. The language in the final rule of the Bloodborne Pathogen Standard is very clear that OSHA cannot express a preference for a safety-engineered design. That activity would be out of the agency's regulatory authority and would open it up to free-trade infringement litigation. The second issue involves the long-standing discussion concerning blood-draw set hubs that are allowed to be reused under the Bloodborne Pathogen Standard. The consensus is that blood-draw hubs cannot be used more than once. Hospitals are encouraged to convert to single-use blood-draw hubs.
Can OSHA Say What Safety Device Design is Safe?
In a recent OSHA inspection in a California hospital, the facility was cited even though the hospital was using certain safety devices. It was determined that there had not been a consistent and effective education and training program established to ensure healthcare workers (HCWs) were using the safety devices properly. A discussion developed in the industry as to whether or not OSHA can dictate what kind of safety device a hospital should use. It is clear that OSHA cannot do so.
Of the various engineering safety models, the hinged cover, the retractable and the sheathing style, is there one design that is safer than the other? Can OSHA dictate what safety style to use? The focus of the final rule of the Bloodborne Pathogen Standard indicates that hospitals are to identify safety devices and then conduct clinical trials so that staff can use the various devices to determine which of them may reduce the number of sharps injuries. The standard says nothing about OSHA playing a role in determining which device should be used by a hospital; that is up to the judgment of the hospital staff and administration. OSHA cannot say that retractable designs are better than hinged designs. If it were to make that claim, it would have to produce evidence that the retractable design is inherently safer than the hinged design. The evidence is simply not there.
The majority of hospitals that have a safety blood-draw set use the hinged devices. There are three manufacturers of the hinged blood draw devices: Becton Dickinson, SIMS Portex and ReTrac Medical. The designs vary slightly but all three rely on the hinged cover to provide a safety component for the blood-draw device. The International Center of Health Care Workers Safety maintains data on the effect that different types of safety devices have on needlestick injuries. Its database indicates sharps injuries that occur during blood specimen collection activities have declined by 66 percent during the past three years. If anything, that data provides evidence that hinged cover blood-draw devices, which are used predominantly in the blood-draw safety devices, are very effective at decreasing needlestick injuries. Given this information, OSHA would be ill advised to fine a hospital for using hinged cover safety blood-draw devices. OSHA will be in violation of its authority under the final rule of the Bloodborne Pathogen Standard. OSHA also would violate the Fair Trade Act by negatively impacting the business activities of those companies that manufacture and sell these types of devices.
"We are not directing our compliance officers to cite facilities using any kind of safer device," says Amber Hogan, an industrial hygienist with the U.S. Department of Labor. "OSHA is not in the business of telling employers what is best for them. If they choose a hinged device based on employee feedback and implement them where appropriate, they are in compliance with our standard. The case in CalOSHA was unique and does not represent federal OSHA or compliance in federal states. If, however, a safer device were chosen based not on employee feedback but arbitrary corporate decision, and it was continuing to generate needlesticks, we may issue a citation based on the hazard present, but it would not be simply because of the device they have chosen. The performance-oriented nature of the standard allows employers and employees to pick devices that best serve their needs, hinged, sheathing, blunting, whatever they determine is best."
Single-use vs. Multi-use Blood-Draw Holders
For years, laboratory professionals have debated the merits of single-use vs. multi-use blood-draw holders. The discussion revolves around convenience, safety and cost. Multi-use advocates argue that if a phlebotomist's technique is good, rarely is there any visual blood contamination on the holder. If there were, that holder would be replaced. Single-use advocates argue there is no reason to run the risk of missing a contaminated holder, and that each blood-draw activity requires a separate holder. OSHA has indicated that it does not want to see blood-draw hubs being reused. The language in the final rule of the Bloodborne Pathogen Standard favors single-use blood-draw holders. A number of laboratories are in the process of changing to single-use holders.
The change impacts hospitals financially and logistically. Phlebotomists often carry a needle-disposal container on the blood-draw tray. The needle is deposited in that container after each blood-draw activity. The holder is used again with the next patient. If a hospital does convert to the single-use holder, this causes a problem for the phlebotomist. In most hospitals, each treatment and patient room has a sharps-disposal container so the phlebotomist can place the needle and holder into the container. This will fill the containers faster so the housekeeping department should be informed of the likely impact on its supply budget. Another way some facilities are dealing with the conversion from multi-use to single-use holders is to have the phlebotomist carry a needle-disposal container on the blood-draw tray. The new containers have a "detach" slot where the needle can be wedged and twisted off to drop into the container. The new containers work with safety blood-draw sets from manufacturers such as Becton Dickinson, SIMS Portex and ReTrac Medical. The holder can then be placed in the regular trash since it does not meet the criteria of infectious waste. The definition of infectious waste established by OSHA says that waste is considered potentially infectious if it releases blood or body fluids if compressed, or will allow flaking if the blood or body fluids have dried. Neither would be the case with blood-draw hubs simply because the materials from which they are made will not absorb or hold blood or body fluids.
The healthcare industry is doing an admirable job at reducing sharps injuries. The manufacturers of sharps have delivered effective products to the industry, hospital managers have been successful in evaluating the new safety devices and healthcare facilities are buying safety devices in record numbers. Most importantly, the number of sharps injuries is declining, so the system is working. OSHA would be ill-advised to fix something that is already working. The agency has no role to play in determining which safety devices produce the highest level of safety; this will be determined by the hospital safety and infection control professionals who evaluate and buy the best safety products for their staff.
Michael Garvin, MHA, is a safety consultant for the University of Iowa Hospitals and Clinics.
Needlestick Safety Act Seminar Series Announced
Mike Garvin, a frequent contributor to Infection Control Today magazine, is involved in a national seminar tour discussing the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard and the Needlestick Safety Act. The seminar addresses the major regulatory issues such as selection of safety devices as well as the recent controversy over reusable blood-draw hubs. The session reviews more than 70 medical safety devices. The seminar will be presented in the following cities during June and July: Boston, New York, Atlanta, Orlando, Fla., Houston, Omaha, Neb., Denver, Detroit, Seattle and Los Angeles.
For more details on dates, contact Garvin at [email protected] or call (319) 626-7324.