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Vol. 4, no. 2, pp.15-17

Copyright © 2000, International Health Care Worker Safety Center



California's Transition to Safety Devices:

What will be the impact on device manufacturers?

 By Jane Perry, M.A.


In September 1998, with the passage of AB 1208, California became the first state in the nation to require health care institutions to use protected needle devices. As a result of the new legislation, which required the California OSHA (Cal/OSHA) Standards Board to develop a revised bloodborne pathogens standard, an emergency standard was issued on December 17, 1998. A revised emergency standard, containing only one substantive change, was issued on January 14, 1999: the start-up date for the provisions that were originally proposed to take effect on August 1, 1999 was changed to July 1, 1999.

The Standards Board is now conducting permanent rulemaking which will consider the revisions that were adopted in the emergency rule; a public hearing on the proposed revisions is being held on February 18, 1999. The purpose of both the emergency and proposed permanent revisions, according to Cal/OSHA, is to "increase protection from sharps injuries, which can transmit bloodborne pathogens in the workplace, by putting into place stronger requirements for employers to use needles and other sharps which are engineered to reduce the chances of inadvertent needlesticks or sharps injuries." (See the sidebar for a summary of the major revisions to the standard.)


California Hospitals Look for Guidance

How are hospitals in California responding to this major regulatory change, which has so many financial and practical implications? According to Len Welsh, special counsel for Cal/OSHA and co-chair of the Advisory Committee that oversaw the revisions to the standard, the overall response has been very favorable. "This rulemaking has generated tremendous positive interest. The sense I get from institutions is that they know it's a change whose time has come, and they're anxious to get going. In some cases they wish they'd gotten going sooner. There's been some anxiety about the rulemaking-how it will be interpreted, how it will be enforced. Many callers are seeking assurance that Cal/OSHA is not going to be knocking on their door next week. But overall the response has been positive; we really haven't gotten the negative feedback that we sometimes get with other regulations."

Linda Doyle, president of the coordinating council of the California chapter of the Association for Professionals in Infection Control, says the council "supports efforts to decrease and, where possible, prevent sharps injuries," but that the new regulations requiring the use of safety devices have raised some concerns. "It is impractical to assume that all organizations can incorporate safety products for all general practice. A requirement that directs 'if it is available, you must use it' may prevent an organization from fully implementing preventive measures for the highest-risk procedures. With limited finances, this spreads resources too thin, since not all procedures pose a risk of disease transmission." Doyle also emphasizes that safety products are not a substitute for employee education and training. "In fact, many safety products require more training and practice before the employee becomes proficient." And, she says, safety products are only one factor in preventing exposures. "Others include adequate staffing, the patient's condition (cooperative vs. combative), emergency vs. routine care, and the hours worked [by the healthcare worker], to mention a few. The employer must not consider safety products to be the only solution to safety problems."

To address concerns of health care professionals around the state who are responsible for ensuring that their institutions are compliant with the new standard, the California Healthcare Association (CHA) is sponsoring a series of workshops in March and April to help them through the process. Entitled "Implementing a Compliant Sharps-Injury Prevention Program-Meeting Cal/OSHA and AB 1208 Requirements," the seminar addresses topics such as developing an exposure prevention plan, evaluating safety products, and prioritizing safety device needs, and includes a hands-on demonstration of safety products by practitioners and users. More information about the seminar is available at (916) 552-7502.


Will Other States Follow California's Example?

An interesting question to follow over the next year is how other states will respond to California's action. Bill Borwegan of the Service Employees International Union (SEIU) says that the union has "launched a national effort to introduce as many needlestick bills at the state level as possible." Both Maryland and the state of Washington are expected to pass laws similar to California's within 90 days, and six other states have legislation pending. Some safety device manufacturers have expressed concern, however, about the possibility of having a confusing welter of state laws on safety devices, with a variety of requirements for such areas as labeling. Kevin Seifert, director of policy and business development for the Advance Protection Technologies group at Becton Dickinson (BD), says that while "device manufacturers seem to be supportive of either legislative or regulatory initiatives, most tend to favor regulation over legislation, because the regulatory community better understands the complexities of the health care environment." In general, he says, BD supports regulatory or legislative initiatives as long as they allow for good patient care, do not support just one kind of technology, and allow for development of new technologies.

Borwegan hopes that the SEIU's drive for state legislation will provide the impetus for national legislation that would give protection to health care workers in all states. The political climate may now be ripe for such an initiative; Borwegan believes that a federal bill can be put together that, unlike the Stark bill [see AEP 3:3, p. 26], will have bipartisan support. "If Pete Wilson, conservative as he is, can sign legislation protecting health care workers, we think there should be many Republican friends for a similar federal bill." Politically, Borwegan notes, "the momentum has definitely shifted; the amount of opposition to safety is almost undetectable at this point."

With California Legislation, Safety Market Given a Boost

The California legislation is having far-reaching implications for the safety device market. Tom Sutton, executive vice president of Bio-Plexus, Inc., says there has been a "rapid shift in the market climate." Until now, Sutton says, many companies have taken a "wait and see" attitude regarding the fate of conventional needles; however, the passage of the California legislation provides a "very strong signal that conventional unprotected needles are going to be obsolete," and that protected needles will be the industry standard in the near future.

Sutton uses the marketing concept of "product lifecycle" to describe the current needle market. "In marketing terms, products have an introductory phase, a growth stage, a mature stage when growth levels off, and a decline stage. The conventional needle market has been in the 'mature' stage for a long time. However, with the rapid shift to safety needles signaled by the California legislation, standard needles are now in the declining stage and the needle business is up for grabs, based on who has the best, most user-friendly safety designs with the best manufacturing efficiency. Needles have effectively become a new product category."

Kevin Seifert adds that "this new legislation provides an opportunity for companies to either enter into the safety market or maximize their current safety offering. For companies like ours and others that have been focused on safety for a decade, this is an opportunity to scale up manufacturing so that volume and cost can be addressed." Will the increased market demand for safety devices in California put a strain on product availability? "I believe it shouldn't, and we have made a financial commitment to make product available if additional state or federal legislation is passed," Seifert responds. "All manufacturers have to keep a close eye on what's occurring in other states and at the federal level because it usually takes between one to two years to create new manufacturing lines."

When it comes to the current crop of safety devices, Seifert thinks today's technologies represent a significant advance over the first generations of safety devices. "Yet over the next decade, as in any emerging technology market, we can only imagine what technologies will be available to protect health care workers. Because of regulatory activity like California's, and possibly regulations from other states and the federal government, the opportunity for growth in the safety product market has arrived. We can expect to see more and better products in the future. The best is yet to come." ?



Q&A: Len Welsh, Cal/OSHA Special Counsel, Answers Questions About California's Revised Bloodborne Pathogens Standard

Q: What are the penalties associated with non-compliance?

A. The penalties are no different than any other Cal/OSHA violation; the amendments won't change the penalties. We go by a classification scheme to determine whether a violation is serious or not; usually a bloodborne pathogens violation is considered serious because of the potential to cause a life-threatening disease. Then a formula is used to calculate the penalty, similar to federal OSHA. The penalties are usually in the neighborhood of $800 to $5,000.

Q. What will the schedule of inspections be?

A. Right now we don't have programmed inspections for [the health care] sector; we largely respond to complaints. That works well for the health care industry, which tends to have better informed workers than other industries, so they aren't afraid to call when there's a problem. It's possible in the future that we may have programmed inspections for health care; the closest thing we have to that now is something called the "high hazard" program. If an employer has a rate of workers' comp claims that is well above average then they get flagged in our system and we investigate. Any organization could appear on that radar, including hospitals, and we've had a few of them from time to time.

Q. Will hospitals have to submit a compliance plan to Cal/OSHA or a list of safety devices being used?

A. No. They will have to develop, for internal use, a sharps injury log, and retool their exposure control plans. Reporting is burdensome for industry and for government. There are a few industries where it is required, such as requiring permits for certain kinds of construction projects because of the high rate of accidents.

Q. How do the regulations mesh with workers' compensation?

A. There is some overlap in general between OSHA and workers' comp, but there's nothing about the amendments that would change the existing relationship. In our system in California, if we believe a violation has caused a serious injury we can classify it as an "accident-related" violation; if we prevail with that kind of citation, it can have implications for the workers' comp case, if there is one. There is a kind of workers' comp claim called "serious and willful," and if there's a serious Cal/OSHA violation that results in injury then that's pretty much an automatic "serious and willful" workers' comp claim, with a higher recovery for the claimant.

Q. What about exception #4 to the general requirement to use devices with engineered sharps injury protection-"lack of sufficient information to determine whether a new device on the market will effectively reduce the chances of a sharps injury." Has it been determined what constitutes "sufficient information"?

A. You put your finger on a very significant issue. The bind we're in there is that there's evidence that some safety devices don't, in fact, work. Kaiser did a study that showed that two devices on the market actually made things worse. So the Advisory Committee felt-and these exceptions were hammered out in the committee meetings where all sectors were represented-that it wouldn't be a good idea to require the use of a device about which we know nothing, other than it's claim to be a "safety" or "anti-stick" device.

Once you acknowledge that there needs to be some critical mass of information before making a decision to use a device, you have to confront that issue-how much is enough information? The exception language gets across the concept, but how that is going to work out in terms of actual compliance remains to be seen. However, with these exception clauses the burden of proof will be on the employer: if an employer wants to take advantage of an exception, then it will be up to the employer to demonstrate that the exception applies. ??