OSHA starts fact-finding talks on requiring use of safer needles

Supporters cite California needle initiatives in call for national action

Responding to calls for action from frontline health care workers and the U.S. Congress, the Occupational Safety and Health Administration (OSHA) has opened fact-finding discussions on whether needle safety devices should be required in the nation's clinical settings.

OSHA Secretary Charles Jeffress announced the landmark initiative Aug. 10, 1998, at the Frontline Health Care Workers conference in Washington, DC. The agency did not specifically require replacing conventional sharps with needle safety devices in its 1991 bloodborne pathogens standard, but health care worker safety advocates argue there is now enough efficacy data to warrant mandating some of the devices. Such devices can cost considerably more than conventional designs but include mechanisms to retract, shield, or blunt needles after medication has been administered or blood drawn.

After years of debate on the issue, Jeffress announced that OSHA will reopen the needle safety question by soliciting information and comment in a Federal Register notice, which was scheduled for publication sometime in August. Suggestions to the agency have included implementing an emergency temporary standard mandating use of needle safety designs, amending the bloodborne pathogen standard to require them, or rewriting compliance instructions to OSHA inspectors to emphasize their use in exposure control plans, he explained. OSHA is examining the alternatives and, as a first step, will gather information on current research and solicit recommendations from clinicians, Jeffress said.

"This month, we will be issuing in the Federal Register a formal Request for Information (RFI) on needlestick prevention," he told conference attendees. "That's a call for public comments and research results. Our RFI will include about a dozen questions on preventing needlesticks."

"Underlying all those specific queries is one basic question: What works? This is a chance for you to tell us. Which strategies are making a difference at your hospital, your nursing home, or your clinic?"

OSHA is aware that safer alternatives to standard syringes, intravenous equipment, and suture needles have been developed, Jeffress noted, but he cautioned against using deceptively simple solutions for the complex problem.

"Should the availability of newer technology make use of older equipment a violation of OSHA's bloodborne pathogens standard?" he said. "We need to bear in mind that what was considered 'safe' yesterday may not be considered 'safe' today. We also know that simply buying devices touted by manufacturers as 'safer' alternatives is not enough. Generally, safer devices result in fewer needlesticks. But not always. Needlestick prevention involves more than sifting through rival manufacturers claims and purchasing new syringes. One size does not fit all. There is no magic formula nor any absolute guarantee."

^{Members of Congress call for action}

Requests for OSHA action on the issue have come from both health care worker unions and the U.S. Congress. Spurred by an ongoing effort to implement needle safety regulations in their home state, a California delegation led by U.S. Rep. Pete Stark petitioned Jeffress in a July 17, 1998, letter to consider issuing new regulations requiring needle safety devices. Subsequently posted on Stark's Internet Web site, the letter also lists U.S. Rep. Henry Waxman and U.S. Sens. Barbara Boxer and Diane Feinstein.¹

"We urge OSHA to follow the example set by the state of California and issue regulations to require the use of safer needle technology," the letter states.

Those members of Congress emphasized that more than 800,000 needlesticks are reported in hospitals annually, and some 16,000 of those involve HIV exposures. They also cited the threat of infections from hepatitis B or C viruses from needlesticks and noted that the injuries are typically under-reported in health care settings.

Lead author of the OSHA letter was Stark, who last year introduced a bill in the U.S. House of Representatives that would withhold federal funding to hospitals that fail to evaluate and purchase needle safety devices designed to prevent bloodborne infections in health care workers. The "Health Care Worker Protection Act" (HR2754) calls for the U.S. Food and Drug Administration (FDA) - in consultation with an advisory council composed of representatives from consumer groups, frontline health care providers, industry, and technical experts - to establish safety standards for hypodermic devices that minimize the risk of occupational needlestick injuries. (See Hospital Infection Control, January 1998, pp. 10-11.) The bill generated some interest and has gone from 18 original co-sponsors to 78. It is not likely to be approved this year, however, but will be reintroduced in January 1999, according to staff sources in Stark's office. Meanwhile, legislative staff from approximately a dozen states have called Stark's office to seek information and express interest in introducing such legislation at the state level.

^{California debating law, Cal-OSHA reg}

California in particular is moving ahead with proposed needle safety legislation, and a regulatory initiative from its state OSHA program is already in its second draft. Sponsored by Assemblywoman Carole Migden, (D-San Francisco), assembly bill No. 1208 was originally introduced in February 1997 and was most recently revised June 30, 1998. As this issue went to press, staff sources in Migden's office were optimistic that the bill would be put to a vote of the state Legislature before the session adjourned Aug. 31.

As proposed, the bill would amend the state labor code to require that "needles with engineered stick protection shall be used for procedures involving the withdrawal of body fluids or accessing a vein or artery. . .[unless] the employer can show that the use of needles with engineered stick protection is medically contraindicated or that their use does not provide additional protection in the prevention of needle stick injuries to employees."

In light of the legislation, the California Occupational Safety and Health Administration (Cal-OSHA) began drafting similar regulation that would also require use of needle safety devices. State OSHA plans can make such amendments as long as they meet the intent of the federal OSHA regulation, but the federal agency must ultimately approve such changes, national OSHA spokeswoman Susan Fleming explained.

The national Association for Professionals in Infection Control and Epidemiology (APIC) in Washington, DC, submitted comments on the first draft of the regulation, reminding Cal-OSHA in comments by APIC president Fran Slater, RN, MBA, CIC, that "regulating the use of certain types of devices, without due regard to the unique needs of individual health care departments, may very well prove to be detrimental, rather than beneficial." (See APIC comments, p. 132.)

Rather than legislative or regulatory mandates, it is better to let professionals in clinical epidemiology identify trends and problems in their own facilities and propose interventions that may include needle safety devices, adds Patrick Joseph, MD, president of California Infection Control Consultants in San Ramon, CA. There is a dearth of efficacy data on many of the designs, he notes, and it is not uncommon in the medical literature for "negative" research findings to go unpublished.

"I am against a mandate that you must use [this device], but I would have much more positive feelings toward a mandate that devices evaluated," Joseph says. "In California, more so than other places, we have a limited amount of health care dollars. We need to do everything that is necessary for our employees, but we need to avoid putting tens of thousands of dollars into something that is unlikely to be helpful."

The California Healthcare Association, which represents hospitals and other clinical settings, has also argued that the mandates would put the onus of expensive research initiatives on hospitals by requiring them to evaluate and determine the most effective needle safety devices. The association notes that such research should be conducted nationally by qualified researchers rather than individual hospitals.

"The problem is that just because a device has a so-called safety feature doesn't necessarily mean its safe," says Roger Richter, senior vice president of professional services at the association. "It has to go through efficacy testing. What is unfortunate is that a lot of people are under the misunderstanding that as long as there is a safety device it is safer. We have hospitals who switched to so-called safety devices and actually increased the number of needlesticks."

^{Specific exemptions sought}

In general, the association is more opposed to the state legislation than the proposed Cal-OSHA reg, but is seeking more specific exemptions for hospitals in that regulation. The proposed state regulation appears to allow more leeway for health care facilities to comply than the proposed state law. For example, the Cal-OSHA draft states that needle safety devices would be required unless they are "not reasonably available to the employer." (See related story, p. 131.)

The health care association argued in comments to Cal-OSHA for a more detailed exemption clause, noting that needleless systems or needles with engineered needlestick protection should not be required if the employer can document through injury records that fewer than 10% of documented injuries per year would have been prevented by the devices (i.e., more than 90% of documented injuries would not have been prevented by the use of either a needleless system or a needle with engineered needlestick prevention).

Such opposition to the legislative and regulatory proposals drew withering criticism in an editorial in the San Francisco Chronicle, which noted that, "A grindingly slow bureaucracy, a knee-jerk reaction by employers against anything that costs more money, and greedy manufacturers have so far prevented health care workers from getting the simple but safe syringes and catheters that could protect them.

Speedy approval in the Senate and Assembly and Governor Wilson's signature on Migden's bill would put California on the map as a state that cares about the health and safety of the honorable workers whose lives are devoted to caring for the sick and dying."³

In addition, Stark discounted arguments that the devices cost too much or have been insufficiently studied in a statement submitted in favor of the Cal-OSHA regulation in his home state. He said the cost of the devices are justified when all the cost factors of exposure follow-up, worker anguish, and liability are included. He cited the liability aspect in particular, noting that health care workers are bringing suits for the mental anguish of needlesticks and recalling the $12.2 million jury verdict last year against Yale Univer sity when a resident contracted HIV after a needlestick. (See HIC, February 1998, pp. 17-20.)

"I don't know how many safety devices $12 million buys, but I'm pretty sure Yale wishes it had gone needle-safe before this happened," Stark stated. ". . . The California hospital association is wrong to oppose this regulation, and the Cal-OSHA Standards Board would be wrong to delay any implementation of this proposed regulation based on that opposition."

Likewise, sources of efficacy data on needlestick prevention and safety devices include the Centers for Disease Control and Prevention (CDC), Stark noted. Indeed, a 1997 CDC study found that three needle safety devices reduced percutaneous injuries by a range of 23% to 76% during phlebotomies.⁴ But when facing similar calls for a specific recommendation in its 1998 revision of infection control guidelines for health care workers, the CDC cited the study but did not specifically recommend the devices.⁵

The CDC concluded in its guidelines that "only a few studies evaluating a limited number of safety devices have demonstrated a reduction in percutaneous injuries among health care workers. This document will not address the use of safety devices as the public health service is assessing the need for further guidance on selection, implementation, and evaluation of such devices in health care settings."

^References

1. Text of letter to OSHA Secretary Jeffress to urge the protection of health care workers. (http://www.house.gov/ stark/documents.oshajeffress.html)

2. State of California Division of Occupational Safety and Health. Department of Industrial Relations. Draft 2: Proposed Changes in Title 8 California Code of Regulations, Section 5193, Bloodborne Pathogens. San Francisco; 1998.

3. California could prevent deadly needle sticks. San Francisco Chronicle July 12, 1998:8.

4. Centers for Disease Control and Prevention. Evaluation of Safety Devices for Preventing Percutaneous Injuries Among Health Care Workers During Phlebotomy Procedures - Minneapolis-St. Paul, New York City, and San Francisco, 1993-1995. MMWR 1997; 46:21-25.

5. Centers for Disease Control and Prevention. Hospital Infection Control Practices Advisory Committee. Guideline for Infection Control in Healthcare Personnel. Infect Control Hosp Epi 1998; 19:407-463.