Sticky business with tube holder

Reducing sharps injuries

April 2003
Cover Story

Karen Southwick

Clinical laboratory groups are up in arms over a recent directive that
prohibits the reuse of holders for contaminated needles, even when they are designed for multiple use.

Blood tube holders, as the containers are known, can be single-use or multiple-use. OSHA issued a clarification letter last year saying that its bloodborne pathogens standard requires blood tube holders to be discarded immediately into a sharps container once the needle’s safety device has been activated—basically restricting them to single-use.

“Removing contaminated needles and reusing blood tube holders can expose workers to multiple hazards,” OSHA administrator John Henshaw said in a June 12, 2002 statement. “We want to make it very clear that this practice is prohibited.”

Amber Hogan, senior industrial hygienist with OSHA, says the agency gets calls daily on the issue. “It’s an Achilles’ heel,” she says. “When tube holders started becoming reusable, people were trying to remove needles, and exposures occur from the back end of the needles,” which weren’t designed to have safety devices. Injuries can also occur when the sharps container is overfilled. “Until the technology gets better, we decided to prohibit removal of the needle from the tube holder,” she says.

After the prohibition letter was issued in June, OSHA issued complaints against Laboratory Corp. of America and Quest Diagnostics for failing to comply. Faced with intense opposition, OSHA dropped the citations early this year but says that its policy, for now, remains intact. “We are still evaluating our position on the issue,” a spokesman says.

LabCorp and Quest, backed by the American Clinical Laboratory Association, are vehemently fighting the federal government’s directive. The Clinical Laboratory Management Association and the American Association of Bioanalysts have joined the effort. AAB leaders recently met with OSHA representatives to discuss their concerns. “Some adjustment needs to be made,” says Bob Waters, Washington counsel for the AAB.

“OSHA’s position makes it difficult to compromise on this issue,” says David King, senior vice president and general counsel for LabCorp. King says LabCorp is fully compliant with the bloodborne pathogens standard for reusable blood tubes and that OSHA’s position “is legally and factually erroneous.”

Quest was more cautious in its public response. “We’re reviewing our policy internally and awaiting any further clarification from OSHA on the subject,” says Quest spokesman Gary Samuels.

ACLA has prepared a 13-page white paper countering OSHA’s position. “There’s absolutely no data to indicate a problem here,” says JoAnne Glisson, ACLA vice president of government relations. “There are millions of [blood] draws and virtually no evidence of injuries. This is like regulation of some imaginary problem.”

Worker safety advocates say that while few injuries have been traced directly to reusable blood tube holders, the threat is real. One research organization that tracks needlestick injuries, the University of Virginia’s International Health Care Worker Safety Center, reported that in late 1999 a nurse who was required to reuse blood tube holders was stuck with the back end of a used needle she was removing from a holder. Consequently, she was infected with hepatitis C.

“That case demonstrates a clear risk of bloodborne pathogen transmission when health care workers are stuck by the back end of phlebotomy needles,” says Jane Perry, director of communications for the safety center. “If we have heard about one case of infection, there are likely to be others.” The risk of infection would be substantially less if the workers didn’t have to remove the needles from the holders, she adds.

The Service Employees International Union, which represents more than 700,000 health care workers, agrees with Perry. “We don’t think blood tube holders should be reused,” says Bill Borwegen, SEIU occupational health and safety director. Withdrawing a needle from the holder “requires additional manipulation that seems to be contrary to OSHA standards.”

Besides, Borwegen says, one woman has already been infected with hepatitis C as a result of using the multiple-use holders. “How many more cases do you need before people spend a couple of pennies to change to single-use?” he asks.

The CAP’s position
The CAP has taken a more measured stance than the clinical laboratory groups. Thomas Merrick, MD, chair of the CAP Safety Committee, says he checked with his hospital, Presbyterian-St. Luke’s Medical Center, Denver, and several others regarding the disposal of single-use holders, “and no one seemed to think it was a big deal.”

Dr. Merrick, medical director of the microbiology laboratory at Presbyterian-St. Luke’s, says his lab has already moved to single-use holders and so have many others. (OSHA’s Hogan confirms that the problem with reusables occurs primarily at large reference labs, not hospital-based facilities.)

Dr. Merrick says the Safety Committee will consider the issue at its annual meeting in May and decide whether to address it in the CAPinspection checklist. “We do think it’s our responsibility to have things in the checklist that are OSHA requirements,” he says.

The CAP’s manual on how to perform phlebotomy draws has already been updated to reflect OSHA’s position, reports Frederick Kiechle, MD, PhD, editor of the publication. The 10th edition of So You’re Going to Collect a Blood Specimen: An Introduction to Phlebotomy, issued this year, recommends that blood tube holders not be reused, citing the OSHA directive. “We published the 10th edition because of the OSHA ruling,” Dr. Kiechle says. “We changed all the language to be consistent with OSHA and spell out that the reusable holder is a no-no.”

Dr. Kiechle, chair of clinical pathology at William Beaumont Hospital, Royal Oak, Mich., and medical director of an affiliated clinical lab, says Beaumont has stopped reusing blood tube holders. “While the data [on injuries] is a little weak, I can understand OSHA’s position,” he says. “It’s somewhat extreme and will certainly increase the cost of doing phlebotomy, but sometimes you have to take an extreme position to get people to focus on the risk. You want to prevent the real cost, which is a needlestick injury that causes disease.”

Clinical lab arguments
The clinical lab industry asserts that OSHA’s position will have financial and safety implications. LabCorp’s King says that while single-use holders cost less than multiple-use holders, the latter can serve 70 to 100 times. “Of course we would never jeopardize employee safety to save money, but here we have no evidence that reusable holders are any less safe than single-use. And you’re looking at twice the cost,” he says. Furthermore, there’s more hazardous waste to be disposed of, because single-use devices are discarded immediately, and an increased risk of exposure for workers handling the waste.

“OSHA has not clearly defined what it considers the risk associated with multiple-use holders,” King says. “We have looked at this issue very closely, and we don’t see evidence of back-end sticks due to the use of the reusable holders.” The anecdotal evidence cited for back-end sticks can be attributed to poor workplace practices, he says, not to the reuse of needle holders. “In our experience, the risk of going to the single-use holders is just as great.”

LabCorp, he says, is continuing to use the multiple-use devices, which it buys from Becton, Dickinson andCo., and has no intention of switching. Besides that, he adds, “we keep a large number of these multiple-use devices at LabCorp and often supply needles to many of our accounts [such as physician offices] to do their draws, so we’re still supplying reusables.”

ACLA’s white paper details a number of objections to the OSHA action:

• First, reusable blood tube holders conserve space and allow mobile phlebotomists to carry one or two holders rather than several. “Requiring the phlebotomist to carry single-use holders negates these benefits and instead requires frequent trips to restock supplies, increases the amount of waste, and heightens the risk of an accident because of the larger volume of supplies and sharps containers that are required,” the white paper says. “Use of the single-use holder creates up to 10 times as much waste as use of the multiple-use holder because the single-use holder and the needle must be disposed of instead of simply the safety-shielded needle.”
  
• Second, the Food and Drug Administration has approved the reusable holders. “It is difficult to believe that FDA, the government’s expert on the safety and effectiveness of medical devices, would have cleared this device if it had concerns about whether the product could safely be reused in accordance with the labeled instructions,” ACLA says.
  
• Third, OSHA’s directive is based on an interpretation of the bloodborne pathogens standard, which says that “contaminated needles and other contaminated sharps shall not be bent, recapped, or removed unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure.”
  
  According to ACLA, many clinical laboratories have evaluated single-use and multiple-use devices and decided that the latter would serve them better. OSHA’s own regulation requires employees to evaluate safety devices, the association points out. “Many clinical laboratories have decided that no alternatives to removal [by using the release mechanism on the holder] exist based on a number of factors, including product supply, waste production, employee preference, and cost,” ACLA says.
  
• Fourth, ACLA points out that a large clinical lab may perform more than 50 million specimen draws per year. If all of them switched to single-use holders, “the manufacturer would not be able to supply the volume of holders necessary to fulfill the laboratories’ needs. A recent inquiry to a leading manufacturer of single-use holders revealed that these devices are four weeks back-ordered. Thus, it is presently not possible for clinical laboratories to employ only the single-use holders, because manufacturers would be unable to supply them, even if there was some reason to believe such a product switch was necessary.” ACLA sums up, “This fact alone should be sufficient to justify the use of multiple-use holders.”
  
• Fifth, “although added cost should never be the determining factor in safety decisions, it is certainly an appropriate consideration. Here, using only single-use devices [if they were available] would increase the cost of doing business approximately fivefold because laboratories would have to purchase so many more holders,” ACLA says. (LabCorp estimates a twofold increase, excluding waste disposal.)
  
• Finally, “ACLA believes there is no legal basis for OSHA’s policy statements, nor is there any evidence suggesting why OSHA believes the removal of a needle from a holder according to the manufacturer’s instructions is creating a hazard that must be addressed over and above what employers have already done to reduce or eliminate needlestick injuries.” The association suggests that if OSHA wants to make changes, it should do so with a formal regulatory process, “with opportunity for notice and comment.”

After OSHA issued the letter last year, the CLMA was swamped with calls from concerned members “asking for intervention on their behalf, citing the increased cost to laboratories and increased biohazardous waste,” says CLMA spokesperson Kathy Ayres. Consequently, the CLMA, ACLA, Quest, and LabCorp met with OSHA’s Hogan in the fall, but that meeting “resulted in little progress,” Ayres says.

The pressure on OSHA escalated in January when ACLA, Quest, and LabCorp met with OSHA’s Richard Fairfax, director of compliance programs and the official who signed the letter of clarification. Also present was the deputy assistant secretary of labor, representing the Department of Labor, which oversees OSHA.

“It’s going to be OSHA’s decision what to do about this directive,” says LabCorp’s King. “We see no reason to change our practices, given OSHA’s explanation of the reasons for its current policy.”

Dueling manufacturers
One manufacturer that’s watching the controversy closely is Keene, NH-based Portex, which makes single-use holders. Portex sponsored a study, “Safety Evaluation of Reusable Blood Collection Tube Holders,” that evaluated holders made by BD (Vacutainer and Pronto), Kendall (AutoDrop), and Bio-Plexus (Drop-It).

Performed by Steven Weinstein, a health and safety consultant in Sudbury, Mass., and Robert Shannon, a hospital epidemiologist at Boston VA Hospital, the study concluded that “handling holders that have been contaminated with blood may pose cutaneous bloodborne exposure risks to the phlebotomist and should not be used to collect blood from multiple patients.” The study also found that even new needles attached to reused holders can become contaminated, theoretically posing a risk of nosocomial infection to the patient and phlebotomist.

“We state whenever we discuss the results of this study that it was not undertaken to prove one holder less safe or inferior to another,” says Brenda Beauchamp, director of marketing for Portex, “but was undertaken to show the risks involved with reusable holders in general.” Portex “has always made single-use holders,” she adds. “Our philosophy is that the safety is in the holder.”

The OSHA directive, Beauchamp says, “lends credence to what we’ve been trying to tell people for 15 years.” Sales for Portex’s Venipuncture safety device are 30 percent ahead of last year, she says, “and we are projecting continued growth. We believe this is a direct result of the fact that our product fully complies with the OSHA directive.”

Beauchamp concedes that a multiple-use device will always beat a single-use device on upfront costs. However, “it’s all in the perspective of how you define costs.” Echoing the worker safety advocates, she notes that the cost of treating an employee infected by a needlestick could be greater than any savings on holders.

At the urging of customers, Portex in February began selling blood collection needles along with its single-use holder-based safety device. Previously, customers typically purchased BD blood collection needles separately to use with Portex tube holders. “BD offers the whole system, and there’s all kinds of bundling that goes on,” Beauchamp says. “We realized that people want options. They want to be able to go to Portex and get an equivalent product.” So Portex contracted with a private-label manufacturer to supply the needles, which its national sales representatives and distributors are now selling along with Portex’s holder-based safety devices.

Franklin Lakes, NJ-based BD, which has by far the largest market share for reusables, is shifting resources to make more single-use holders, says Krista Thompson, vice president and general manager, who oversees blood collection equipment.

“You don’t just flip a switch and change the market in a day,” she says. Customers have supplies they must use up, and workers must be trained in new devices.

She says many, but not all, customers are switching to single-use holders. (As indicated, LabCorp, for one, continues to use reusables.) “Our position is, we make customers aware of what OSHA says and allow them to make the decision,” Thompson says. “Our policy is not to dictate medical practice.”

BD recognizes that “different clinical settings have different requirements, and one size doesn’t fit all,” she adds. “The data don’t support a strong need for total single-use across all settings.” By BD’s calculation, a complete shift to single-use holders would generate about 10 million additional pounds of waste each year.

One hospital buyer, who asked not to be identified, says BD customers are stuck because the manufacturer is back-ordered several weeks on disposable holders. “Most hospitals are converting to disposables, but right now they’re buying reusables and disposing of them because they have no other choice,” the buyer says.

Thompson says BD’s backlog on single-use holders was cleared by the end of March.

OSHA, right or wrong
Other organizations and experts in needle safety say OSHA’s position is justified, including the National Institute for Occupational Safety and Health, part of the Centers for Disease Control and Prevention. “NIOSH applauds this effort to protect the nation’s health care workers from needlestick injuries ... and decrease their risk of infection from hepatitis C, HIV, and other bloodborne pathogens,” says a statement from Kathleen M. Rest, deputy director of NIOSH.

Cal-OSHA, California’s counterpart to OSHA, determined years ago that reusing blood tube holders could present a danger, says Len Welsh, special counsel for the state agency. California law on needlestick injuries was a model for the OSHA standard.

“We have a very smart compliance officer who read the [state bloodborne pathogens] standard and said reusables were in violation,” Welsh says. Consequently, Cal-OSHA cited units of two major health care organizations in the state, Catholic Healthcare West (in 1999) and Kaiser Permanente (in 2001), for using the multiple-use holders. Both were fined and have complied, Welsh says. Since then, many institutions in California have moved to single-use holders.

In response to CAP TODAY’s query, Perry ran a report on phlebotomy needle injuries from the International Health Care Worker Safety Center’s EPINet sharps injuries database, a computerized program that has since 1993 allowed the safety center to collect data on needlestick injuries from hospitals using the program. In 2000 and 2001, 146 injuries were reported (from 26 facilities in 2000 and 58 in 2001). Eight percent of these injuries were from the back end of the needle. Health care workers described these injuries in the text fields provided on the EPINet form. Examples: “Disconnected [phlebotomy] needle from [holder], stuck self with covered end that pierces blood tube.” “While disposing of needle in sharps container, stuck by . . . rubber end of [phlebotomy] needle that had not gone down into sharps container.”

Says Perry, “Our position at the safety center is that we do not recommend reusing the blood tube holder at all because it exposes the back end of the needle, which is a potential hazard.” Safety phlebotomy needles, she notes, are designed to provide protection for the front end needle only.

ECRI, a nonprofit agency in Plymouth Meeting, Pa., that evaluates health care technology, has maintained for years that reusing blood tube holders presents an unacceptable risk, says Raylene Ballard, senior project officer. “Technically, this should have stopped back in 1991 when the original bloodborne pathogens standard was issued,” she says, “but OSHA and hospitals had many other higher priority things to concentrate on.”

Other experts point out that when OSHA acts, the industry is compelled to follow. “I don’t take a position on whether this OSHA directive is right or wrong,” says Dennis Ernst, director of the Center for Phlebotomy Education, Ramsey, Ind., although “I think it’s well intended.” But regardless of what anyone thinks, “this is what OSHA says, and there’s no argument.”

Ernst believes the lab groups’ resistance is predicated on cost. “Clearly money is at the bottom of it,” he says. “It’s going to be more expensive to comply.” However, Ernst adds, “OSHA doesn’t care about cost—the workers’ health and safety is paramount.”

Sheila Dunn, president and CEO of Quality America, Asheville, NC, advises physician practices on OSHA compliance. “Just do it” is her motto: “You can’t afford not to do it and have an OSHA inspector come in there and risk a fine.” However, she concedes, “I haven’t seen any complaints against doctors’ offices” for reusing blood tube holders. In many cases, physician offices receive their equipment from their provider of clinical laboratory services.

Doctors aren’t swayed by dollars, Dunn says, but by data. “Nobody likes the OSHA directive because there’s not enough data to show a reasonable risk. We all know that it’s possible [to get a needlestick injury from reusing a holder], but is it a reasonable risk that needs to be regulated?”

Safety improves
Despite the tempest over reusable blood tube holders, compliance with a 2001 OSHA regulation mandating use of safer devices, with front-line workers doing the evaluating, appears to be growing.

Ernst, who serves as a consultant to the laboratory industry on blood collection issues, says roughly 90 percent of the institutions he is in contact with use safety needles. The majority are also keeping expanded logs of sharps injuries and having workers evaluate the devices, he says, although they may not realize that they must now re-evaluate existing devices and new technology annually.

“Most facilities are probably in their first year after selecting devices, so they have not yet reviewed their exposure plan,” he says. “That review must take into account new technology. If an OSHA inspector knows of a new device and it’s not included in the evaluation, the facility is out of compliance.”

Winged blood collection sets are a safety improvement Ernst has seen recently. “There are at least seven safety butterfly needles out there, and you couldn’t say that 18 months ago,” he says. The next generation of safety needles will be passive devices where “the safety is built in. The worker doesn’t have to take additional steps to activate it.”

Dunn, of Quality America, who works primarily with physician offices, says more than half have switched from traditional to safety needles. She gauges that based on regional conferences she speaks at across the country, where she asks for a show of hands on compliance.

Compliance varies by region. In states where enforcement has been stiffer, like California, “there’s probably 75 percent compliance,” Dunn says. She adds that hospitals and reference labs made the switch more quickly than physicians, who usually wait for input from their local hospital before changing equipment.

BD, which sells its products to hospitals, clinical labs, and physician offices, confirms that doctors’ offices have not adopted new products as quickly. “The physician market is a little bit slower to convert because they don’t feel it’s very likely that they will be inspected by OSHA,” says Wendy Gallart, senior marketing manager for BD. But she points out that if they are, “it’s their responsibility to have safety devices, not their hospital or lab provider.”

BD promotes safety by supporting the EPINet sharps injury surveillance program, which it markets as a resource for health care users. “We offer it free to anyone interested in using the program,” says Gallart, including providing the software.

EPINet statistics show that percutaneous injury rates for nurses declined from 19.5 injuries per 100 occupied beds in 1993 to 9.6 per 100 occupied beds in 2001, a decrease of 51 percent. As hospitals shifted to safety devices, injuries stemming from conventional (nonsafety) devices dropped even more dramatically, from 18.75 per 100 occupied beds in 1993 to 7.3 in 2001, a decline of 61 percent.

OSHA’s Hogan says that because of publicity over needlestick injuries, the bloodborne pathogens arena “has become the No. 1 issue for this agency” based on phone calls and e-mails. In response, OSHA has stepped up inspections slightly. Critics, however, say the agency should do more. Hogan notes that the number of cited violations has risen, due partly to a higher volume of complaints and inspections.

In the fiscal year ending Sept. 30, 2002, OSHA performed 159 inspections of hospitals and found 25 serious violations on needlestick issues, compared with 144 inspections the previous year that found eight serious violations, and 158 inspections in fiscal 2000 that found seven serious violations. For doctors’ offices, clinics, and labs, it performed 73 inspections in fiscal 2002, with 17 serious violations; 61 inspections in fiscal 2001, with 10 serious violations; and 47 inspections in fiscal 2000, with one serious violation.

But safety advocates say that’s a small number of inspections relative to the overall number of health care institutions. OSHA has the right regulations on its books; “it’s the enforcement that needs to be fixed,” says Brad Poulos, executive director for the National Alliance for Primary Prevention of Sharps Injuries. NAPPSI members include users, such as physician and nursing organizations, and vendors of safety devices. “In terms of compliance, the number of inspections by OSHA seems rather low,” Poulos adds.

Says Borwegen, of the Service Employees International Union: “OSHA doesn’t have enough inspectors, so it’s hard to gauge the real level of compliance. Hopefully the word is getting out.”

One problem Borwegen has seen concerns group purchasing organizations, which may limit buying options. “We would hope that they just don’t buy the cheapest alternative,” Borwegen says. “We would urge people to look at information available from sources like ECRI, and if they’re buying through a GPO, to make sure it has a broad range of devices.”

Karen Southwick is a writer in San Francisco.