No Defense for Processing a Device Incorrectly

By Nancy Chobin, RN, AAS, ACSP, CSPM, CRER

Q: We have a new surgeon on staff who brought in one of his own instruments for us to sterilize. We asked for the manufacturer’s instructions for use. When we received them, we noticed that the sterilization instructions stated the instrument should be sterilized at a temperature of 273 degrees F. pre-vac for 4 minutes. We contacted the instrument manufacturer and explained that this temperature was not a validated temperature on our sterilizers. The manufacturer told us that we could sterilize it at that temperature. We are now being told by administration we must sterilize this instrument since the other facilities this surgeon worked at always sterilized this instrument with no issues. The surgeon now states that if we cannot sterilize it, we can high-level disinfect it; however, this instrument will be used to take biopsies. We are under tremendous pressure to process this instrument and no one is listening to our concerns.

A: This is a difficult situation for you and your staff, but it should not be. Today, sterile processing is highly regulated with specific guidelines to ensure devices are processed correctly and safely. The first problem occurs when you are not able to follow manufacturer’s instructions because they are not consistent with the sterilizer, biological indicator or chemical indicator manufacturers IFUs (instructions for use). Your sterilizer manufacturer’s user manual specifies the cycles (i.e. gravity displacement, dynamic air removal), temperatures and exposure times which the company validated. This means that you must comply with those stated values. Generally, in the U.S., sterilizers are cleared for dynamic air removal cycles operating at 270 degrees F with a minimum 4-minute exposure time or 275 degrees F with a minimum 3-minute exposure time. Some of the newer sterilizers are validated for both temperatures. They also usually have a gravity displacement cycle functioning at 250 degrees F with a 30-minute exposure time. Unless the device manufacturer recommends an extended cycle (long exposure time) you should comply with the cycles specified in the user manual. If the 273-degree F temperature is not listed as a validated cycle; you should not use it. The 273-degree F temperature is usually used by European sterilizers.

The second issue is that your packaging materials (wrappers and rigid containers), biological indicators and chemical indicators are most likely not validated for the 273-degree F temperature as well. Per AAMI ST-79, section 13.5.3.1, “Healthcare personnel should select BIs that consist of spores of Geobacillus stearothermophilus, that comply with ANSI/AAMI/ISO 11138-3, and that are suitable for use in the specific sterilization cycle (see the written IFU of the BI manufacturer and the sterilizer manufacturer)." This same AAMI guidance is noted for chemical indicators in section 13.5.2.1 which states, “All indicators should be used for the cycle(s) for which they are labeled and used in accordance with the manufacturer's written IFU." Under section 13.5.2.2.2, “Selection of Sterile Barrier System, AAMI states, “..the sterile barrier system should be compatible with the intended methods of sterilization, sterilization parameters, and the devices to be sterilized." Therefore, unless your packaging material, BIs and CIs have been validated for use with this 273oF. temperature, you should not use these products in that temperature.

Regarding high-level disinfection, this process also cannot be used. According to the Spaulding Classification, devices that penetrate the mucosal barrier should be sterile when used. Since this instrument can be used for biopsies, it must be sterile when used. In addition, unless the instrument manufacturer provided high-level disinfection instructions, this process cannot arbitrarily be used.

This entire situation is wrong on so many levels. It is concerning that when sterile processing provides documentation why a device cannot be safely processed, the issue becomes a “sterile processing problem.” Just because another facility failed to follow the standards and guidelines for processing devices, does not mean you should follow suit. In a court of law, how would you defend your actions? The sterile processing department is responsible to provide dependable, reliable and sterile devices to their customers (i.e. surgeons, patients). If an SPD knowingly processes a device incorrectly, there is no defense for this action, and it also creates a liability for the facility.

It is recommended you take this information to your institution's risk management and infection prevention departments. You need a strong administrative policy that will support your department to provide safe devices. Your policy should state: "Before purchase, all devices (including specialty instruments) being considered for purchase must include decontamination and sterilization instructions. These instructions must be provided to the sterile processing manager for review to see if the process can be followed. The SPD manager should be included in the capital purchasing process for the facility." Without IFUs that you can follow, you should refuse to process the device and work collaboratively with the OR to find an alternative product. If the device manufacturer provides cycle times/temperatures not validated for SPD by the sterilizer manufacturers, or if the high-level disinfection instructions differ from national standards or the high-level disinfectant/liquid chemical sterilant instructions, do not process the device. Instead, contact the technical services department of the device manufacturer to resolve the discrepancy.

In summary, processing of devices requires vigilance in reviewing manufacturer’s IFUs to ensure they can be replicated in the healthcare facility. Patient safety should never be compromised. Compliance with recommended standards, that provide for patient safety of devices, is not optional. We must have strong administrative support to ensure patient safety of the devices we process.

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

References:

ANSI/AAMI: ST79:2017. “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities.”

Basics of Sterile Processing 6th Edition. Sterile Processing University, LLC. Lebanon, NJ.

Centers for Disease Control. Guideline for Disinfection and Sterilization, 2008.

Food and Drug Administration (FDA) labeling regulations (21 CFR 801).

FDA guidance document, Labeling reusable medical devices for reprocessing in health care facilities: FDA reviewer guidance (FDA, 1996).