Selecting Safety Blood-Draw Devices Causes Controversy

May 1, 2002

Selecting Safety Blood-Draw Devices Causes Controversy

By Michael Garvin, MH

Atis evident that hospitals are embracing the use of safety devices. Laboratoryprofessionals, nurses and phlebotomists have converted to safety blood-drawssets in a record rate in the last year. Injuries occurring during a bloodspecimen collection activity have declined. Yet there are two major issues thathave arisen recently regarding how hospitals protect staff members that collectblood specimens.

Both controversies involve the Occupational Safety and Health Administration(OSHA). The first issue focuses on misinformation that OSHA is indicating apreference for one safety-engineered design over another. This impression issimply not true. The language in the final rule of the Bloodborne PathogenStandard is very clear that OSHA cannot express a preference for asafety-engineered design. That activity would be out of the agency's regulatoryauthority and would open it up to free-trade infringement litigation. The secondissue involves the long-standing discussion concerning blood-draw set hubs thatare allowed to be reused under the Bloodborne Pathogen Standard. The consensusis that blood-draw hubs cannot be used more than once. Hospitals are encouragedto convert to single-use blood-draw hubs.

Can OSHA Say What Safety Device Design is Safe?

Ina recent OSHA inspection in a California hospital, the facility was cited eventhough the hospital was using certain safety devices. It was determined thatthere had not been a consistent and effective education and training programestablished to ensure healthcare workers (HCWs) were using the safety devicesproperly. A discussion developed in the industry as to whether or not OSHA candictate what kind of safety device a hospital should use. It is clear that OSHAcannot do so.

Of the various engineering safety models, the hinged cover, the retractableand the sheathing style, is there one design that is safer than the other? CanOSHA dictate what safety style to use? The focus of the final rule of theBloodborne Pathogen Standard indicates that hospitals are to identify safetydevices and then conduct clinical trials so that staff can use the variousdevices to determine which of them may reduce the number of sharps injuries. Thestandard says nothing about OSHA playing a role in determining which deviceshould be used by a hospital; that is up to the judgment of the hospital staffand administration. OSHA cannot say that retractable designs are better thanhinged designs. If it were to make that claim, it would have to produce evidencethat the retractable design is inherently safer than the hinged design. Theevidence is simply not there.

The majority of hospitals that have a safety blood-draw set use the hingeddevices. There are three manufacturers of the hinged blood draw devices: BectonDickinson, SIMS Portex and ReTrac Medical. The designs vary slightly but allthree rely on the hinged cover to provide a safety component for the blood-drawdevice. The International Center of Health Care Workers Safety maintains data onthe effect that different types of safety devices have on needlestick injuries.Its database indicates sharps injuries that occur during blood specimencollection 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 veryeffective at decreasing needlestick injuries. Given this information, OSHA wouldbe ill advised to fine a hospital for using hinged cover safety blood-drawdevices. OSHA will be in violation of its authority under the final rule of theBloodborne Pathogen Standard. OSHA also would violate the Fair Trade Act bynegatively impacting the business activities of those companies that manufactureand sell these types of devices.

"We are not directing our compliance officers to cite facilitiesusing any kind of safer device," says Amber Hogan, an industrial hygienistwith the U.S. Department of Labor. "OSHA is not in the business of tellingemployers what is best for them. If they choose a hinged device based onemployee feedback and implement them where appropriate, they are in compliancewith our standard. The case in CalOSHA was unique and does not represent federalOSHA or compliance in federal states. If, however, a safer device were chosenbased not on employee feedback but arbitrary corporate decision, and it wascontinuing to generate needlesticks, we may issue a citation based on the hazardpresent, but it would not be simply because of the device they have chosen. Theperformance-oriented nature of the standard allows employers and employees topick devices that best serve their needs, hinged, sheathing, blunting, whateverthey 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, safetyand 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 torun the risk of missing a contaminated holder, and that each blood-draw activityrequires a separate holder. OSHA has indicated that it does not want to seeblood-draw hubs being reused. The language in the final rule of the BloodbornePathogen Standard favors single-use blood-draw holders. A number of laboratoriesare in the process of changing to single-use holders.

The change impacts hospitals financially and logistically. Phlebotomistsoften carry a needle-disposal container on the blood-draw tray. The needle isdeposited in that container after each blood-draw activity. The holder is usedagain with the next patient. If a hospital does convert to the single-useholder, this causes a problem for the phlebotomist. In most hospitals, eachtreatment and patient room has a sharps-disposal container so the phlebotomistcan place the needle and holder into the container. This will fill thecontainers faster so the housekeeping department should be informed of thelikely impact on its supply budget. Another way some facilities are dealing withthe conversion from multi-use to single-use holders is to have the phlebotomistcarry a needle-disposal container on the blood-draw tray. The new containershave a "detach" slot where the needle can be wedged and twisted off todrop into the container. The new containers work with safety blood-draw setsfrom manufacturers such as Becton Dickinson, SIMS Portex and ReTrac Medical. Theholder can then be placed in the regular trash since it does not meet thecriteria of infectious waste. The definition of infectious waste established byOSHA says that waste is considered potentially infectious if it releases bloodor body fluids if compressed, or will allow flaking if the blood or body fluidshave dried. Neither would be the case with blood-draw hubs simply because thematerials from which they are made will not absorb or hold blood or body fluids.

Conclusion

The healthcare industry is doing an admirable job at reducing sharpsinjuries. The manufacturers of sharps have delivered effective products to theindustry, hospital managers have been successful in evaluating the new safetydevices and healthcare facilities are buying safety devices in record numbers.Most importantly, the number of sharps injuries is declining, so the system isworking. OSHA would be ill-advised to fix something that is already working. Theagency has no role to play in determining which safety devices produce thehighest level of safety; this will be determined by the hospital safety andinfection control professionals who evaluate and buy the best safety productsfor their staff.

Michael Garvin, MHA, is a safety consultant for the University of IowaHospitals 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 mgarvin@southslope.net or call (319) 626-7324.

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