Medical Device & Diagnostic Industry MagazineMDDI Article IndexOriginally Published May 2000BOTTOM LINEA barrage of new and proposed laws and regulations at both the federal and state levels will increasingly complicate the development and marketing of sharps in the United States.

May 1, 2000

8 Min Read
Sticking Point: Sharps Makers, Users Feel Pinch of Needlestick Prevention Initiatives

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published May 2000

BOTTOM LINE

A barrage of new and proposed laws and regulations at both the federal and state levels will increasingly complicate the development and marketing of sharps in the United States.

Efforts to protect healthcare workers from potentially fatal needlestick injuries have gained national attention in recent months. Federal and state legislators and regulators have been promoting initiatives designed to force hospitals and other healthcare providers to implement technologies to reduce needlesticks. At the federal level, both houses of Congress are considering legislation that would require the Occupational Safety and Health Administration (OSHA) to mandate the use of specific needlestick reduction technologies. OSHA has already issued a compliance directive interpreting the current Bloodborne Pathogens Standard (henceforth referred to as "the standard") as requiring the use of state-of-the-art needlestick prevention technologies by employees. At the state level, a growing number of states have proposed or already enacted legislation similar to the pending federal bills.

Manufacturers of sharps devices should be attuned to these federal and state initiatives, which could dramatically affect the ability of device makers to market existing and future products across the nation. Conceivably, companies may be forced to modify or discontinue selling devices that have already received market clearance from FDA, as customers seek to comply with newly enacted and proposed standards.

PROPOSED FEDERAL LEGISLATION

In the spring of 1999, the House and Senate introduced identical bills (HR 1899 and S 1140) that would direct OSHA to revise the standard to promote the use of needlestick prevention technologies. Most importantly to device manufacturers, the bills would require OSHA to amend the standard within one year to require employers to use needleless systems or sharps with engineered sharps injury protection (ESIP), except in limited circumstances. As currently drafted, the bills define needleless system as a device that does not use needles for

  • The withdrawal of body fluids after initial venous or arterial access is established.

  • The administration of medication or fluids.

  • Any other procedure involving the potential for an exposure incident.

The draft legislation also defines ESIP, as follows:

  • A physical attribute built into a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids that effectively reduces the risk of an exposure incident by a mechanism such as barrier creation, blunting, encapsulation, withdrawal, retraction, destruction, or other effective mechanisms.

  • A physical attribute built into any other type of needle device, or into a nonneedle sharp, that effectively reduces the risk of an exposure incident.

If the legislation is enacted in its current form, employers covered by the standard—and exempt employers who want to participate in the Medicare program—would be required to use needleless systems and sharps with ESIP at their work sites to prevent the spread of bloodborne pathogens. The requirement would not apply when the employer determines that such technologies do not promote employee safety, or interfere with patient safety or with the success of a medical procedure. Employers would also be exempt if such devices were not commercially available.

Although neither the House nor the Senate bill has made it out of committee, the bills have the strong backing of the Service Employees International Union, and both have a long list of cosponsors and some measure of bipartisan support.

STATE INITIATIVES

Several states—including California, Hawaii, Maryland, New Jersey, Tennessee, and Texas—have already enacted needlestick-prevention legislation. The legislatures in over a dozen more have introduced or enacted bills, many of which are similar to the legislation introduced in Congress. However, because each state is considering the issue independently, there is some inconsistency in how needlestick injuries are addressed across the country. For example, California, which has played a leadership role on the issue of reducing needlestick injuries, enacted a statute similar to the pending federal legislation, but also established four regulatory exceptions to the requirement that employers use needleless systems, needles with ESIP, and nonneedles. Under one of these exceptions, known as the "safety performance" clause, these safety-enhancing technologies do not need to be used "if the employer can demonstrate by means of objective product evaluation" that such technologies are "not more effective in preventing exposure incidents than the alternative used by the employer."

New Jersey's statute, which was signed by Governor Christine Todd Whitman earlier this year, mandates the Commissioner of Health and Senior Services to require, by January 2001, that licensed healthcare facilities use only needles and other sharps devices with integrated safety features that have been cleared or approved for marketing by FDA. If there are no FDA-cleared or -approved products with integrated safety features that are commercially available for specific patient uses, facilities may continue to use appropriate needles and other sharps devices—including those with nonintegrated, add-on safety features—until products with integrated safety features are available. The legislation includes certain limited exceptions for situations in which the use of sharps with integrated safety features is inappropriate. Manufacturers of prefilled syringes have three years to meet the requirements of New Jersey's new legislation.

CURRENT ENFORCEMENT

Users of sharps devices are already being forced to pay close attention to the federal and state developments in this area. In a compliance directive issued last November, OSHA instructed its compliance officers to issue citations to any facility whose exposure-control plan does not reflect currently available engineering controls. The directive states that effective engineering controls include "safer medical devices," which are generally of two types: needleless systems and sharps with ESIP.

On the heels of the publication of the OSHA compliance directive, the National Institute for Occupational Safety and Health issued an alert strongly recommending that employers of healthcare workers (1) eliminate the use of needles when safe and effective alternatives exist and (2) implement the use of devices with safety features.

Reflecting OSHA's more-aggressive enforcement posture, federal and state inspectors already have cited several hospitals for failing to institute engineering controls. Last September, a hospital in Cincinnati, OH, was required to pay a fine and implement a plan to introduce newly developed needlestick prevention devices, following an OSHA complaint inspection. OSHA also cited a hospital in Denver, CO, last November for failing to use engineering controls such as needleless IV systems, blood suture needles, and self-sheathing needles. Similarly, last October, California's state Occupational Safety and Health Agency fined a medical center in Daly City for nine violations of the state's revised bloodborne-pathogens regulation. Cal/ OSHA cited the facility for continuing to use conventional needles for administering medications and gaining arterial and venous access.

IMPLICATIONS FOR DEVICE COMPANIES

Needlestick prevention initiatives can affect medical device and pharmaceutical companies in a number of potentially significant ways.

Declining Market. It is no longer enough to have an FDA clearance or an FDA approval for a sharps device. Sharps devices that have been successfully marketed in the past may lose their marketability if new or existing bloodborne-pathogen regulations are interpreted as barring the use of such products.

Conflicting State Requirements. Devices that may be used by healthcare employers in one state may not be permitted in other states. Those responsible for marketing devices will need to be able to understand the differing requirements that apply in each state, including what is required to meet various exemptions that might be applicable.

Constantly Evolving Requirements. By their very nature, state and federal standards will evolve over time, so that a technology that is acceptable today may not be acceptable tomorrow. For example, an employer now may be able to use a prefilled syringe that contains a unique drug therapy but does not have a built-in safety feature, because there is no commercially available alternative. However, once such a device does incorporate a safety feature, federal and state standards may prohibit the use of the first one.

Reengineering. Companies should consider the feasibility of redesigning existing products—or of developing new needleless systems or sharps with ESIP—to help them continue to meet their customers' needs. To minimize disruption to their business, manufacturers must factor in the time and cost of obtaining FDA clearance or approval of modified or new products.

Uncertain Outlook for New Technologies. New legislation in some states is unclear as to whether needlestick reduction technologies that are developed in the future will be permissible. This may restrict the development of more-advanced needleless systems or ESIP devices.

CONCLUSION

Rapidly evolving federal and state needlestick prevention initiatives may significantly restrict the ability of sharps manufacturers to continue marketing their FDA-cleared devices. The inconsistencies among these initiatives make it particularly difficult for companies to monitor and react to developments in this area. Yet, with the stakes so high, manufacturers should continue to pay close attention to these emerging regulations so that they are not faced with damaging consequences down the road.

Scott H. Reisch and Edward C. Wilson, Jr. are partners in the law firm of Hogan & Hartson LLP. Reisch's Denver-based practice emphasizes environmental and occupational health issues. Wilson's practice in Washington, DC, focuses primarily on the regulation of medical devices.


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