Carefully read labels, manuals

May 1, 2002
The labeling on products and equipment provides very important information to doctors and staff.

The labeling on products and equipment provides very important information to doctors and staff. "Labeling" is interpreted as written information about the product which includes the labels on the product as well as information on associated packages, package inserts, and instruction (operator's) manuals.

When the U.S. Food and Drug Administration (FDA) clears medical devices for sale in the U.S. market, it must determine that the devices are safe, effective, and properly labeled. These include several items used in infection control such as sterilizers, spore-tests, ultrasonic cleaners, instrument washers, dental units, handpieces, instruments, gloves, masks, protective eyewear, protective clothing, and liquid sterilants. The U.S. Environmental Protection Agency (EPA) also must determine if disinfectants are safe, effective, and labeled properly.

These determinations are made from data presented to the FDA or EPA by the manufacturers of the products and equipment. If the data provided support label claims and all else is appropriate, then the FDA clears a device for marketing, or the EPA registers the disinfectant. If the data provided to the FDA or EPA do not support label claims, then the item is not cleared or registered. Or, if already on the market, it is indicated as being "misbranded" and likely re-called.

Disinfectant labels

The label on a disinfectant has 11 sections in addition to the product's name.

1. Directions for use - this section also includes the statement: "It is a violation of federal law to use this product in a manner inconsistent with its labeling."

2. Precautionary statements - danger to humans and domesticated animals and how to protect against these dangers; environmental hazards (e.g., danger to wildlife, fish, plants) and how to avoid such hazards; and physical and chemical hazards (e.g., corrosivity, flammability)

3. Storage and disposal instructions

4. "Keep out of the reach of children" plus a signal word like "danger," "caution," or "warning"

5. First aid instructions - with statements of practical treatment protocols such as: "If swallowed," "If inhaled," "If in eyes," or "If on skin"

6. Active ingredients - and "other (inert) ingredients"

7. Warranty statement - intended to limit the company's liability or to act as a disclaimer or as a warranty for the product

8. Name and address of the manufacturer or distributor - sometimes the phone number

9. Net weight/net contents of the container - this identifies how much disinfectant is in the container.

10. EPA registration number (E.P.A. Reg. No. XXXXX) - this number shows that the EPA has reviewed the product and that the EPA has determined the product can be used with minimal risk if you follow the directions on the label properly. The number is not an endorsement or guarantee of product effectiveness.

11. Establishment number (E.P.A. Est. No. XXXX) - this number identifies the facility where the final phase of production of the product took place.

Considerations for use

Disinfectant labeling is meant to provide clear directions for effective product performance while minimizing risks to human health and the environment. Be sure to read the entire label when learning how to use the product. For example, a disinfectant label may indicate that the product kills the AIDS virus in one minute, but that does not mean that you should use a contact time of one minute for all of your disinfection needs. Since disinfectants kill the AIDS virus fairly easily, the label will likely describe longer contact times for other microbes. Since you do not know exactly what kinds or amounts of microbes may be present on surfaces that you wish to clean and disinfect, it is safest to use the longest contact time indicated on the product label - frequently 10 minutes.

Another important aspect of the disinfectant label is that it may instruct you to clean the surface before disinfecting. It is important to do a good job in removing the bioburden in this cleaning step so that the disinfectant will have the best chance to work in the subsequent disinfection step. For example, if you simply cannot let a disinfectant stay on a surface for the full 10 minutes, at least you will have removed most of the bioburden in the cleaning step - reducing the challenge to the disinfectant.

Sterilizer manuals

Sterilizer operator's manuals are indispensable. Read them and save them! One example of their importance is that sterilizers can "outlive" staff members, and new personnel need to be periodically trained on how to operate the sterilizer. The operator's manual serves as the prime resource in this training, as well as for troubleshooting should problems arise. Passing on instructions by word-of-mouth is very risky, particularly when dealing with such a critical safety device as a sterilizer. While many sterilizers are simple to operate, the procedure still must be learned correctly.

Manuals contain other important information. A common misuse of sterilizers is overloading the chamber. The manual describes the maximum loads for each cycle and instruct on how they should be loaded. Manuals also describe how to do spore-testing, maintenance, and cleaning. Take care to save these manuals. Locate all of the equipment manuals in the office and store them in one file marked "Manuals."

Disinfectant labels and sterilizer operating manuals are valuable. They describe how to safely use these products and equipment to obtain the desired result. The labels and operator's manuals for other products and equipment also are important. Read and save them.

Chris H. Miller, PhD, is professor of oral microbiology and executive associate dean at the Indiana University School of Dentistry.