In the Spring of 2005 AAMI published a new document, TIR 12, which details the responsibilities of device manufacturers for designing, testing, and labeling their reusable medical devices for reprocessing in healthcare facilities. The document also details, by implication, the expectations Sterile Processing Departments (SPDs) should have of their medical device suppliers. From the Sterile Processing Department perspective, TIR 12 is the device reprocessor’s "Bill of Rights."

The introduction to TIR 12 states, "… this TIR can also be a resource in identifying the questions health care professionals should ask manufacturers when considering a product for purchase or when devising a reprocessing protocol for a product already being used."

The document stipulates that "Manufacturers of reusable medical devices have the responsibility to support product label claims of reusability by providing complete and comprehensive written instructions for the handling, cleaning, disinfection, testing, packaging, sterilization, and, if applicable, aeration of their products."

We as reprocessors are not free from obligation, however. TIR 12 further states, "Health care personnel have the responsibility to obtain and review manufacturers’ data and recommendations and to ensure that they have the necessary resources to follow manufacturers’ instructions thoroughly."

In an ideal world, SPD staff would perform such a review prior to the purchase of a device. Often, however, SPD is never even consulted—let alone given a seat at the evaluation table—on the purchase of a new device. Even so, reprocessing professionals have an obligation to the patient to have in place a procedure for evaluating both the new devices and their own ability to properly reprocess them.

TIR 12 is an extensive guideline with in-depth recommended practices for device manufacturers and for sterile processing departments. This article will highlight key recommendations for information that should be provided for decontamination. The authors strongly suggest that SPDs obtain their own copy of this important document.

Section 4 covers decontamination, a subject of vital importance for reprocessors. TIR 12 is quite specific regarding the obligations of the device manufacturer:

Most SPD professionals know that rinsing is a very important final step in the washing process. Water, enzymes, detergents and energy (in the form of ultrasound, mechanical spray from a spinner arm, or one’s elbow grease at the other end of a brush) break down the contaminating soils, but they do not remove them from the water. Without proper rinsing, these contaminates can reattach themselves to instruments. Further, the quality of water is often more important in this step than in the earlier ones, because water that is hard, for instance, may not attach itself to the contaminating soils and wash them away. If the water itself is loaded with impurities (organic and otherwise) it may deliver a new batch of contaminates to the instrument. TIR 12 states, "(4.2.3.5) If an analysis of the water used in the testing (for validation purposes by the Device Manufacturer) was performed, the results should be provided to the prospective device user," so that the user knows to use the same quality water.

In addition to discussing the cleaning agents, TIR 12 reviews the various methods for cleaning: Manual, ultrasonic, and mechanical. Specifically the document addresses the problem of contaminant aerosol created during manual cleaning, which brings the reprocessor in very close proximity to the contaminating soils. TIR 12 states, "(4.2.4.2) For devices that cannot be immersed, it is important that manufacturers provide instructions on how to clean and rinse such devices without creating aerosols." Manufacturers must keep the safety of reprocessing staff in mind—as must the reprocessor!

Special instruments often require special cleaning implements, and the manufacturer needs to specify these: "(4.2.4.2) For lumen-containing instruments that require brushing as part of the cleaning process, the manufacturer should specify the correct brush dimensions (length and diameter) that are appropriate for use with the lumen diameter of the instrument. Device manufacturers should provide information regarding any specialized implements or equipment that will be needed and direct the user to sources of such implements or equipment."

Of course, TIR 12 strongly promotes the use of mechanical cleaning devices whenever and wherever they can be used. "(4.3.1) Device manufacturers should provide users with one validated manual cleaning method and, if applicable, one automated cleaning method." These recommendations are made to ensure the safety of the reprocessor; contact between SPD staff away and instruments with gross contaminants should be kept to a minimum. "(4.2.4.3) Device manufacturers should evaluate at least one of the various cleaning methods that might be used and advise users on those that are appropriate or inappropriate for cleaning their devices. This evaluation should include validation studies by the device manufacturer, verification by the device manufacturer of data generated by equipment manufacturers that support processing of a particular device, and/or collaborative efforts by both the medical device and cleaning equipment manufacturers." This documentation should include a description of the cleaning procedures followed in this validated process.

Ultrasonic cleaning warrants a special warning. While a very effective method for cleaning many instruments, in certain situations and with some instrument ultrasonic cleaning is highly unadvisable: "(4.2.4.3) Because ultrasonic energy can loosen the fine screws of delicate instruments, can destroy the glues or amalgam used in certain complex instruments, and may not penetrate very long or narrow lumens, the device manufacturer should warn the user if an ultrasonic cleaner will damage the device or be ineffective."

Any procedure(s) the manufacturer specifies for cleaning must include written directions for the user. Further, manufacturers must provide reprocessing staff with hands-on training, training videos, or (at a minimum) illustrated directions for instruments that are particularly difficult to clean. Instructions must tell the user not only how to clean, but also how to verify that proper cleaning has occurred, either through direct inspection or through use of an analogous device:

"(4.3.5) The device manufacturer should provide users, on request, with a summary and interpretation of test data or other information that verifies the efficacy of the manufacturer’s recommendations for cleaning agents and cleaning procedures. Manufacturers should strive to develop and validate test procedures that can be replicated easily in a health care facility and that can help users recognize whether cleaning was effective for all device surfaces. Such tests would be particularly important for devices with components that cannot be readily inspected for cleanliness (e.g., spring hinges, lumens, porous materials, crevices).

Section 6 lays out the responsibility of the manufacturer for developing, validating, and describing at least one method of sterilization for those devices that require it. Further, the method(s) recommended for sterilization need to be those commonly used by healthcare facilities (steam, EtO, gas-plasma, etc.). We, as users, also have a responsibility; namely, to verify that we can get the device sterile using our equipment: "(6.1)The device manufacturer is responsible for qualifying the sterilization process for the device, and health care personnel are responsible for showing that they can replicate this process exactly and consistently."

Section 6 of TIR 12 specifically covers:

Packaging is another major consideration. The manufacturer either should provide a packaging vessel (e.g., tray) that has been tested and validated to allow proper sterilization of the instruments contained, or describe a procedure using packaging methods commonly employed in healthcare facilities that has been demonstrated to allow for proper sterilization.

With their labeling and instructions for use, the manufacturer should provide detailed instructions, including:

Early adoption of TIR 12

Some manufacturers are already implementing the TIR 12 guidelines. In May 2005, Smith & Nephew updated its Cleaning and Sterilization Guide for Orthopedic Instruments. The following are two excerpts from the new user guide:

"The quality of water should be carefully considered for use in cleaning reusable devices. Water hardness is a concern because deposits left on medical devices may result in ineffective decontamination. The use of deionized water will reduce the mineral deposits on the devices."

"Ultrasonic Cleaners should be monitored routinely to ensure that they are working properly. Recommended monitoring methods are: 1) Sonocheck monitoring vials (from Healthmark Industries Co., St. Clair Shores, MI) which change color when the ultrasonic cleaner is supplying sufficient energy and conditions are correct."

These excerpts are examples of the manufacturer providing specific details to the end user. They address questions important to the cleaning process, such as, is the equipment working properly? Is the correct type of water being used?

Getinge is another manufacturer that has stepped up to the TIR 12 plate. Getinge has developed a performance monitoring program that allows users to independently verify that key parameters of the cleaning equation are under their control.

This article has highlighted just a few sections of TIR 12. Hopefully sterile processing professionals will recognize how important this updated TIR 12 is to their departments and will obtain and use the document as one of their standard references. Now an SPD staff has a manual it can refer to before making a purchase. When they request for a new product, they can now specify that it meet the requirements found in TIR 12.