Mandatory use of safety devices just around the regulatory corner
California OSHA leads the way in drafting legislation
Needlestick injuries to health care workers have been the focus of plenty of attention over the past several years, particularly from manufacturers who have introduced a steady stream of safety devices into the market. Until now, the choice has been yours regarding whether you implement the use of such devices, which often cost more than standard cannulas and tube sets. However, the choice may soon be out of your hands.
Leading the way is the San Francisco-based California Occupational Safety and Health Administration (Cal OSHA), which is working on the second draft of a regulation that would require the use of safety devices by all California health care providers, including home care.
"We have an advisory committee, and we're putting language down to amend the second draft of the regulation and we're sending it out for comment," John Howard, director of Cal OSHA, told Home Infusion Therapy Management.
Requiring the use of safety devices, rather than simply providing language that strongly suggests their use, is an important leap for health care. Howard says the time has come for such a requirement.
"The purpose is to satisfy the regulatory community both from the labor side as well as the employer side," he says. "Labor has brought to our attention that there are various reports of efficacy of so-called safer devices."
With manufacturer studies showing the safety benefits of such devices, Howard says the current draft has a clear bottom line.
"Our view is, those [safety] devices must be used from a regulatory standpoint unless you can show that patient care would be compromised, that they are not available, or certain other things," he notes. "When we issue a regulation, you must comply or show a good reason why not."
The intention is for the regulation to take effect as soon as possible.
"We would like to prepare this regulatory package for adoption as soon as we have comments in from people and feel we have a good proposal, but we'd like to do this soon," says Howard.
The second draft recently forwarded for comment to industry and regulatory representatives includes several interesting requirements. Health care providers will be required to have:
· an exposure control plan designed to eliminate or minimize employee exposure;
· a sharps injury log that records each exposure incident involving a sharp within 14 days of the incident (the log must contain the following information: date and time of exposure incident, type and brand of sharp involved, frequency of use of the type and brand of sharp involved, and a detailed description of the exposure incident);
· an exposure determination list that will include a list of all job classifications in which all employees have occupational exposure, as well as a list of job classifications in which some employees have occupational exposure;
· methods of compliance.
The draft also specifically requires that needleless systems will be used for withdrawal of body fluids, administration of medication or fluids, and any other procedure that involves the potential for an exposure incident for which a needleless system is available.
Engineered protection required
Cal OSHA doesn't stop there, though. In an effort to make the regulation as all-encompassing as possible, the second draft includes the following statement:
"If sharps other than needle devices are used, or if objects that can become sharps are used, these devices and objects shall include engineered sharps injury protection."
Needles with engineered sharps injury protection will be used for withdrawal of body fluids, accessing a vein or artery, administration of medication or fluids, and any other procedure that involves the potential for an exposure incident for which a needleless system is available.
The only exceptions are if the physician or dentist determines that any such device will jeopardize the delivery of patient care, if such a system is not available, if the device is not more effective in preventing exposure incidents, or if reliable information regarding the efficacy of the device is not available and the employer is actively seeking such information.
With such widespread changes looming, providers could be in for a massive overhaul of most of the products they use in delivering care. But some consider the change worth the cost.
"It's a good move," says Gary Dangerfield, PharmD, pharmacy manager for Central Coast IV Services in Monterey, CA. "It is far more costly, but if you can prevent one person from being infected it's worth the cost. I wish the manufacturers would reduce the pricing on those systems. I'm sure they're more expensive to manufacture as well, so it's a difficult situation."
Federal OSHA not far behind
While California appears to be blazing the trail, federal OSHA is hot on its heels, according to OSHA spokeswoman Susan Fleming. She told HITM that Charles N. Jeffress, assistant secretary of labor for occupational safety and health, told attendants at the recent Frontline Healthcare Workers Safety Conference in Washington, DC, that health care worker safety is a priority.
"Specifically, we're focusing on needlesticks, and with good reason," he said, pointing to alarming statistics compiled by OSHA. In particular, Jeffress noted that nearly one out of seven healthcare workers suffers a needlestick injury each year, and that needlesticks account for up to 80% of the accidental exposures to blood.
However, it's not clear in what direction OSHA will head, as it appears to be in a fact-finding mode right now.
"The first step is gathering information, and that's what we plan to do," said Jeffress. "We plan to issue in the Federal Register a formal Request for Information on needlestick prevention, which will call for public comments and research results."
OSHA already has received numerous suggestions, all of which it is examining, such as:
· implementing an emergency temporary standard mandating safer devices;
· reopening the bloodborne standard;
· rewriting instructions to inspectors;
· emphasizing engineering controls;
· looking at exposure control plans.
However, Jeffress did point out that OSHA believes that "the key to preventing needlesticks lies in a comprehensive strategy" that includes a four-step approach:
1) Evaluate the problem at your specific facility.
2) Involve employees in selecting safer devices.
3) Train employees to use new equipment effectively and safely.
4) Evaluate the results and make changes accordingly.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content