At hospitals across the country, millions of medical instruments that come in contact with blood and other bodily fluids labeled "for single-use" are being used more than once. While alarming at first, this reality may or may not be cause for concern. Providing quality health services at an affordable price is the essential, overarching goal of healthcare. Involved parties must strike the appropriate balance by exploring available options, protecting the sick and minimizing material and financial waste.

As debate on medical equipment reuse continues, it is essential that hospitals and other health settings follow cleaning and sterilization guidelines set forth by government health agencies, such as the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC).

Regulating Single-Use Devices

In October 1999, the FDA issued a letter stating that it "has been unable to find clear evidence of adverse patient outcomes associated with the reuse of a single use device [SUD] from any source." This year, the FDA wrote, "Despite a lack of clear data that directly link injuries to reuse, FDA has concluded that the practice of reprocessing SUDs merits increased regulatory oversight. We are concerned because we do not have enough information to be certain that SUDs are being reprocessed properly."

This concern may be warranted, as there is increasing evidence that the reuse of certain medical equipment can create a risk to patients. For example, according to an infection control practitioner from Baltimore's Johns Hopkins Hospital, a Colorado case in which reused cardiac catheters became contaminated with bacterial toxins resulted in the death of a patient. And from devices that have been FDA approved for reuse, a number of tuberculosis and hepatitis C outbreaks have occurred.

It is extremely difficult to prove whether or not a reprocessed device has caused disease. While the reuse of SUDs has been linked to occasional medical problems, the FDA acknowledges these misfortunes are isolated incidents given the tens of millions of SUDs that have been reused over the years.

On many devices, the "single-use" label is an arbitrary designation. Device manufacturers, not the FDA, choose when to label a device as single-use. In the wake of increased disease awareness, many devices that were previously marketed as reusable are now labeled as "single-use only" regardless of durability and cleaning ease.

Why Equipment Is Reused

Despite the uncertainties surrounding safety, reusing SUDs is a common practice and has a clear purpose: to control costs. The American Gastrointestinal Association believes that so long as reused SUDs are reprocessed safely, reuse should be allowed: "Labeling these products as 'single-use' greatly increases the cost of care without necessarily increasing the patients' safety." Many hospitals rely on third-party reprocessing services instead of attempting to sterilize the devices in-house. In addition to shifting potential liabilities from a hospital to a company, these services provide a 50% cost savings, as compared to purchasing a new device, according to the Association of Medical Device Reprocessors (AMDR). AMDR also highlights that third-party reprocessors often have more capital available than hospitals to invest in state-of-the-art cleaning, sterilization, and testing equipment. Most reprocessing companies also work in compliance with all applicable FDA Quality System Regulation (QSR) requirements.

At this time, there is no foolproof protocol assuring the safe reuse of SUDs. But to understand the sterilization process, healthcare workers, particularly those charged with sterilizing or purchasing equipment, should study the U.S. Environmental Protection Agency's (EPA) definitions of cleansers and the hospital environmental control guidelines created by the U.S. Centers for Disease Control and Prevention (CDC).

When to Use Antimicrobials

The EPA classifies antimicrobial agents as substances or solutions that destroy or suppress the growth of harmful bacteria, viruses or fungi on objects and surfaces. Different medical devices call for different antimicrobial treatments, but disinfectants, sanitizers and sterilizers comprise the majority of antimicrobials used in hospitals and homes. Disinfectants are chemical-based products, such as chlorine bleach, which destroy or irreversibly inactivate most pathogens. Sanitizers are products that reduce the number of living microorganisms by significant numbers, but do not destroy or eliminate all microorganisms. Sterilizers destroy all forms of microbial life. Often in the form of pressured steam, liquid or gaseous chemicals, or dry heat, sterilizers are crucial in a hospital environment.

The CDC divides patient-care equipment into three general categories: noncritical items, semicritical items, and critical items. Noncritical items consist of crutches, bedboards and other accessories. A chemical-based detergent is all that is necessary to remove, rather than kill, any of the microorganisms present. Semicritical items are exposed to bodily fluids and tissue, but do not penetrate the body's surfaces; examples being rigid fiberoptic endoscopes, endotracheal tubes, and anesthesia breathing circuits. In most cases, the CDC recommends that hospitals employ high-level disinfectants if not steam sterilization. Sterilization is imperative for all critical items. These are the objects that are introduced directly into the bloodstream or other sterile areas. Examples are surgical instruments, cardiac catheters, implants, and the blood compartment for a hemodialyzer.

Lessons to Be Learned

The debate on medical equipment reuse seeks to achieve the delicate balance between quality and affordability. Whether the risks associated with reusing SUDs outweigh the benefits remains to be determined. Healthcare professionals must adhere to federal guidelines that attempt to ensure the safety of medical equipment and minimize the threat of device contamination.

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