Compliance With the Manufacturer's Instructions for Use

By Nancy Chobin, RN, AAS, ACSP, CSPM

Q:  Recently, I refused to process a device based on the following manufacturer’s instructions provided: “The xxx parts are made of durable aluminum and can be cleaned with ultrasound and any cleaning agents. Any standard sterilization technique is acceptable. There are no moving parts to maintain.” I contacted the company to alert them the instructions for use (IFUs) were insufficient. The company replied that “reprocessing is a different concept from cleaning and sterilizing a simple instrument for reuse.” They stated that the particular instrument in question “is a simple "instrument" like a retractor or a mallet. These instruments are reused; do not have critical "parts" that need to be retested between uses. They need to be cleaned and sterilized. It is a simple device with no moving parts or cavities or other complicating factors. How does one handle this?

A:  Complying with manufacturer’s instructions for use (IFUs) is an important patient safety issue.  For the past 15 years or so, we have been dealing with an explosion of highly sophisticated instrumentation driven by the more sophisticated surgical procedures being performed.  Many of these procedures are performed using minimally invasive instrumentation making their reprocessing more challenging compared to basic surgical instruments that were more commonly used in the past. In addition, due to our aging population of Baby Boomers (those born in the mid-1940s) we have many patients who are at an age when joint replacement surgery is needed. Joint replacement surgery has also seen advances in technique and instrumentation, many of which have special and extended decontamination protocols. Therefore, we need specific reprocessing instructions to ensure the safety of the instruments.

The Food and Drug Administration (FDA) requires 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.  Manufacturers also have the responsibility to conduct and document any testing necessary to validate the suitability of these instructions. Manufacturers have these obligations under U.S. Food and Drug Administration (FDA) labeling regulations (21 CFR 801). Detailed FDA recommendations are provided in the FDA guidance document, Labeling reusable medical devices for reprocessing in health care facilities: FDA reviewer guidance (FDA, 1996).

On the other hand, healthcare 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. We did not manufacture the instruments; we have no way of knowing which chemicals are best to clean the instruments, which cleaning process (e.g., manual cleaning, ultrasonic cleaning, mechanical cleaning) will provide the best cleaning result, how to assemble and package the device and how to sterilize the device (sterilization method; cycle type, temperature, exposure time, aeration, etc.)  Therefore, users (healthcare processing personnel) must rely on the instrument manufacturer to provide us with the specific information needed to ensure a safe device when being used.

According to the FDA, ‘’Device manufacturers may forgo qualification studies if they can demonstrate that a device being considered represents no greater challenge to the cleaning process than another similar device that has been qualified. Equivalency evaluation should include consideration of device materials and design, intended clinical use, and actual clinical soil exposure, as well as the cleaning process and instructions that will be provided to the user.”  This means that if a manufacturer knows their instrument is similar in composition, complexity, etc. to an existing instrument, then the instrument does not have to be retested for the FDA. However, the manufacturer is still required to provide written instructions for use for all phases of reprocessing from cleaning to sterilization.

The FDA classifies medical devices based on their potential risk to the patient. Class I devices are judged by FDA to present relatively low risk to patients; while Class II are moderate risk and Class III are high risk. According to the FDA, “The “general controls” provisions of the Food, Drug and Cosmetics Act are considered sufficient to ensure the safety and effectiveness of these devices.” These requirements are the least stringent level of the regulation.  In actuality, many Class I devices can even be marketed without advance clearance by FDA. Some examples of Class I devices include ultrasonic cleaners and most hand-held surgical instruments.

The FDA is so concerned about end users not receiving the information they need to safely reprocess devices that they encourage end users to report any company that fails to provide specific, detailed instructions for use. This information can be reported on the FDA’s Medwatch program at:
http://www.fda.gov/Safety/MedWatch/default.htm.

The best way to avoid these issues is to develop a policy and procedure stating your facility will not evaluate, purchase or trial a device until the manufacturer’s instructions have been provided.  Then you need to review them to see if you can comply with all of the instructions or if additional information is needed. You should not bring an instrument or device into your facility unless you are sure you can safely reprocess it. By obtaining and reviewing this information you can ensure:
- Time to train/in-service staff in the reprocessing requirements
- You have the required processing equipment
- You have the recommended cleaning implements (some manufacturers specify certain cleaning implements to ensure effective cleaning
- The sterilization method recommended is available.

If the instrument/device requires high level disinfection, you need to ensure you have the recommended disinfectant available.  If not, then you would need to purchase it and ensure staff is trained in its use as well as the recommended processing protocols.

By obtaining and reviewing this information in advance, you may also determine that you do not recommend the purchase (if it requires major changes in training or processing protocols) or that you cannot meet the reprocessing requirements.  It also will prevent a “crisis” when the expectation is that the device will be available, but it is not.  This decision would have to be made collaboratively with Infection Prevention, the OR and Sterile Processing. 

In summary, anyone who fails to comply with manufacturer’s IFUs is putting their patients at risk.  Some sterile processing personnel feel they cannot comply with all the different IFUs. Non-compliance is not an option. Instead, you should work with administration, risk management and infection prevention to get the staffing and equipment needed to effectively reprocess all devices for patients. Enforce your policy of not processing any device without complete IFUs.  Patient safety must always take precedence.

Nancy Chobin, RN, AAS, ACSP, CSPM, is a sterile processing consultant and educator.