Instructions for Use (IFUs) from the manufacturer are essential for providing proper cleaning and sterilization directions for medical devices. The FDA mandates that device manufacturers supply instructions for all their products, including cleaning and sterilization guidance. While many departments have convenient access to IFUs, some do not. This article would like to share some solutions for when there is limited access or unclear instructions for reprocessing in the IFUs.

The What and Why of IFUs

The Joint Commission explains the purpose of IFUs as follows, “The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning and disinfection, the level of disinfection required (e.g., sterilization, high-level disinfection, low or intermediate-level disinfection), the frequency of disinfection, and the products which are compatible for use on the device. IFUs may include information about the maximum number of times the item may be reprocessed and storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection, and the organization expects to follow those instructions. Failure to follow such instructions or misuse creates a significant risk to safe, quality care.”

Accreditation Requirements and Resources
Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges. Accreditation brings great rewards. But staying compliant can be challenging, especially when manufacturers release subtle upgrades and additions to their equipment and accompanying documentation.

SP leaders and technicians have all experienced accreditation surveys. Leaders understand citing risks and citation codes, yet many technicians may not have access to the information requirements from each surveyor. As an accessible resource for those requirements, SP may use this as a guide to become familiar with government requirements for the Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), and Occupational Safety & Health Administration (OSHA).To access independent surveyors, SP can access The Joint Commission (TJC) and The Accreditation Association for Ambulatory Health Care (AAAHC) for ambulatory surgery centers. As we mentioned previously, in tandem with the MIFU, SP should refer to the Association for Advancement of Medical Instrumentation (AAMI) as the primary source of consensus standards for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals.

Exceptions

Device reprocessing instructions can be daunting at times. They can be lengthy and provide vague directions for processing technicians, not to mention on those occasions when surgical customers request that SP reprocess devices not approved by the FDA.

As a past surgical technician and sterile processing educator, I have experienced such occasions when surgeons, although creative, have developed a “homemade” instrument in their garage they believe will help to perform a surgical procedure better. Other times, I have seen spoons and other implements purchased from the local department store that are sent to SP to reprocess.

When an IFU is not available, SP faces a challenge in meeting the needs of their surgical customers while adhering to their infection prevention goals. Although they are committed to helping with instrument demands, their top priority is ensuring patient safety through proper cleaning, disinfection, and sterilization of instruments. While they cannot reprocess store-bought or homemade items without proper instructions, they are committed to finding a safe solution for their customers.

Bioseal Can Do It

For those items that the FDA may not have approved as a medical device which subsequently has no instructions for processing or reprocessing, Bioseal has a solution for such items like spoons, toothpicks, single-use gauze, and much more that arrive at the department unsterilized. Bioseal has developed a process to sterilize those special items and provides an IFU.

The To-Do List

When there are no instructions for use available for an FDA-approved medical device, sterile processing technicians should follow these steps:

1. Consult with the manufacturer or supplier: Technicians should try to contact the manufacturer or supplier of the device to request instructions for use. The manufacturer may be able to provide written instructions or may be able to give verbal instructions over the phone.
2. Research online resources: If the manufacturer or supplier cannot provide instructions, technicians can search online for resources related to the device. Resources may include articles or manuals from medical associations or professional organizations.
3. Consult with healthcare professionals: Technicians can consult with healthcare professionals, such as doctors or nurses, who have experience using the device. These professionals may be able to provide guidance on how to properly sterilize and handle the device.
4. Follow industry standards: In the absence of specific instructions for use, technicians should follow industry standards for sterilization and handling of medical devices. These standards may include guidelines set by the Association for the Advancement of Medical Instrumentation (AAMI), the Centers for Disease Control and Prevention (CDC), or other regulatory bodies.
5. Document the process: Technicians should document the steps they took to sterilize and handle the device in case the device is used in the future, or in case of any adverse events.

It is essential for sterile processing technicians to ensure that all medical devices are properly sterilized and handled to prevent the spread of infections and ensure patient safety.

In conclusion, manufacturers’ instructions for use (IFU’s) are crucial for proper cleaning and sterilization of medical devices, and accredited organizations must follow instructions for quality control of the process. When there are no instructions available for a medical device, sterile processing technicians should consult with the manufacturer or supplier, online research resources, consult with healthcare professionals, follow industry standards, and document the process. It is crucial to ensure that all medical devices are properly sterilized and handled to prevent the spread of infections and ensure patient safety. In cases where non-medical items need to be sterilized, Bioseal has developed this process to address the need.

Resources:

The Joint Commission Standards Interpretation Group. (2021, October 21). 000002250. The Joint Commission. Retrieved March 13, 2023, from https://www.jointcommission.org/standards/standard-faqs/ambulatory/infection-prevention-and control-ic/000002250/

Accreditation standards. OneSource. (2022, July 27). Retrieved March 13, 2023, fromhttps://www.onesourcedocs.com/knowledge-center/accreditation-standards/

Home. Bioseal. (n.d.). Retrieved March 14, 2023, from https://www.biosealnet.com/contact/