Congressional bill could mandate safety devices

Too early to forecast bill’s full impact

With the necessity to cut costs down to a bare minimum, many organizations have put off the implementation of more expensive safety canulas and hollow-bore needles. However, the federal government may be on the verge of requiring certain health care providers to use such devices.

HR 2754, introduced by Rep. Pete Stark (D-CA) prior to the Con-gressional holiday recess, would require hospitals and hospital-owned care providers to use only hollow-bore needle devices that minimize the risk of needlestick injury to health care workers. The bill, called the Health Care Worker Protection Act of 1997, would require the use of approved and safe hollow-bore needle products as a condition of participation in the Medicare program.

The Food and Drug Administration, in consultation with an advisory council composed of consumer groups, health care workers, industry representatives, and technical experts, would compile a list of devices deemed safe. To enhance compliance, the bill provides $5 million for education and training. The FDA and the advisory council will decide how the bill would be enforced, while the Secretary of Health and Human Services will decide how the $5 million will be disseminated for training and education.

While the language of the bill addresses hospitals, Medicare-certified home infusion providers may fall under the jurisdiction of the bill, which was recently referred to the Commerce and Ways & Means Committees.

"It includes only hospitals because Mr. Stark wanted to start off with that first, and others will probably be added later on," notes a Stark aide, who also noted that some home care agencies would be affected by the bill if passed as is because hospital-owned agencies are included in the term "hospital."

With the early support of the bill, wider application seems likely. The Health Care Worker Protection Act of 1997 has 24 original co-sponsors, with bipartisan support.

Lynda Arnold, RN, an activist for needlestick prevention through her International Healthcare Worker Safety Center (IHWSC), says the move is a step in the right direction.

"We had some input, and others did as well in the drafting of the bill," says Arnold. "Our organization’s commitment to the bill is to publicize the effort on our Web page and encourage people to write in to their members of Congress."

The IHWSC has already begun efforts targeting members of the Ways & Means Committee. Arnold adds that the bipartisan support the bill has already received is crucial.

"We worked very hard to make sure that would happen," she says, adding that even those members of Congress who weren’t willing to be an original cosponsor are likely to support the bill.

"Some initially did not want to be original co-sponsors, but they all indicated that they would support the bill once it was introduced," she says. "I haven’t run into anyone who has said, ‘No, this is not something we are interested in looking at. There hasn’t been any type of derailment activity."

What’s the downside?

There’s only one readily apparent downside to such legislation, says Tim Redmon, the director of regulatory affairs for the National Home Infusion Association in Alexandria, VA.

"From a safety standpoint, this could be a real plus, but what is the difference in cost?" he asks. "If there is a big difference, then you will have to worry about your expenses."

According to Stark’s office, safety devices cost anywhere from several cents to a dollar or so more per device. However, there will likely be savings over the long haul.

"The direct cost to treat a needlestick injury can average $2,800 even if there is no infection," according to the aide. "If infection occurs, it will cost more than $500,000."

That figure is from a strictly clinical sense and does not include other costs such as insurance and possible legal ramifications. For example, a specialist in internal medicine who tested positive for the AIDS virus after suffering a needlestick has sued Yale University for punitive damages, plus court costs and attorney’s fees. The woman, who nine years ago was a 25-year old intern at Yale-New Haven Hospital, was asked to insert a line into an AIDS patient’s artery. She punctured her glove and thumb with the contaminated needle and tested positive for AIDS six weeks later. The lawsuit recently went to court.

While the risk of acquiring AIDS through a needlestick is low, it’s clear the danger exists. A study published recently in The New England Journal of Medicine notes that "the average risk of human immunodeficiency virus (HIV) infection after percutaneous exposure to HIV-infected blood is 0.3%, but the factors that influence this risk are not well understood."1

It also points out that certain factors can actually increase the likelihood of infection, such as being exposed to large quantities of blood.

What’s available?

It’s interesting that one manufacturer of safety devices, while heartily supporting any legislation that would create safer work environments for health care workers, says such legislation needs to be refined.

"I want to be very clear that we agree with the Congressman that safety is absolutely paramount and that this should definitely be pursued," says John McKeegan, a spokesman for Arlington, TX-based Johnson & Johnson Medical. "We just don’t think that the type of safety devices they are talking about are available on all the various types of catheters and vascular access products that are out there and necessary for the market."


1. Cardo D, Culver D, Ciesielski Carol, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. N Engl J Med 1997; 337:1,485-1,490.