Instructions For Use: Chaos or Common Sense
The U.S. Food and Drug Administration (FDA) provides general recommendations for the structure and content of Instructions for Use (IFU) documents for medical devices. IFU’s are an incredibly important and critical component to the field of Sterile Processing. The ability of Sterile Processing Technicians to read and interpret IFU’s is an art and a skill depending on the quality of a manufactures writing practice. While specific requirements may vary depending on the device type and its classification, here are some common elements typically included in IFUs according to FDA guidance:
- Title and Identification: The IFU should have a clear and descriptive title, indicating the name of the device, its model or catalog number, and any specific version or revision information. It should also contain the manufacturer's name, address, and contact information.
- Intended Use: The IFU should clearly state the intended use of the device, including its indications, limitations, and specific patient population or conditions for which it is intended.
- Device Description: Provide a detailed description of the device, including its components, features, and any relevant technical specifications. Include information about any accessories or optional components that may be used in conjunction with the device.
- Instructions for Proper Use: Provide step-by-step instructions for correctly using the device. This should include preparation, assembly, operation, and any necessary maintenance or calibration procedures. Clearly describe any user interfaces, controls, or settings, and provide guidelines for safe and effective device use.
- Safety Information: Include safety precautions, warnings, and contraindications to ensure safe device operation. Highlight any potential risks or hazards associated with device use, as well as instructions for mitigating those risks.
- Cleaning and Sterilization Instructions: If applicable, provide instructions for cleaning, disinfection, and/or sterilization of the device. This should include recommended methods, materials, and any specific requirements or restrictions. (The hope for this section is that a manufacture uses standard sterilization and cleaning processes that are easy to replicate and verify in real time. Manufacturers that create “special parameters” or use non standard equipment setup very difficult situations for Sterile Processing departments.)
- Storage and Transportation: Provide guidelines for proper storage conditions, including temperature, humidity, and any other specific environmental requirements. If the device requires special considerations during transportation or shipping, include instructions to ensure its integrity and safety.
- Troubleshooting and Maintenance: Include information on common issues, troubleshooting steps, and recommendations for maintenance, including routine inspection and servicing.
- Disposal and Environmental Considerations: Provide guidance on proper disposal of the device, including any specific instructions for handling hazardous materials or components. Include information on environmentally responsible practices for device disposal, if applicable.
- Revision History: Maintain a clear record of the IFU's revision history, including dates, version numbers, and a summary of changes made in each revision.
It is important for manufacturers to adhere to FDA guidelines and regulations specific to their device type, classification, and intended use. These recommendations are meant to ensure that IFUs provide comprehensive, accurate, and easily understandable information to users, promoting safe and effective device use.
For specific requirements related to a particular device or situation, I recommend referring to the FDA's regulations, guidance documents, and industry-specific standards. Additionally, consulting with regulatory experts or legal counsel familiar with FDA requirements can provide more precise guidance.
Share
Let customers speak for us
from 159 reviews
Hi these cards are of quality and value easy to learn and just amazing thanks

I just registered class about one week ago, and finished two modules. I have to say this 101 class make the process of preparing the CRCST exam much more easier. I mean each module is kind of short but full of necessary information for the exam and follow up with some practice questions with an answer page. I also have flash cards on the way, cannot wait to see it!!! I am planning to take my exam no later than August probably in the middle of August, hope I can pass it on my first attempt. 🙏
I took my test today for my provisional and I PASSSED! I bought the flash card bundle. I can say honestly your flash cards seem like a lot of hard work went into them. I’ll be honest i didn’t really use them as much but i found your practice test very helpful. I would take them every two weeks and it helped me a lot on my test. So thank you very much.

Taking my CIS in July. These are a very good study guide. Thank You.

I felt pretty confident going into my CIS exam, but I wanted some extra reassurance so I decided to purchase the practice exam. Not only did it give me peace of mind, it also showed me where I could use a little extra last minute studying. The questions felt true to the test and were far better than any of the free study options. 10/10 would recommend!

I really loved this practice exam, it helped me a lot in preparing for my CIS exam. I especially appreciated how the practice exams are linked with the HSPA CIS book, providing page numbers to review whenever you choose an incorrect answer. This feature made it easy to revisit and understand the material better.

I really loved this practice exam, it helped me a lot in preparing for my CER exam. I especially appreciated how the practice exams are linked with the HSPA CER book, providing page numbers to review whenever you choose an incorrect answer. This feature made it easy to revisit and understand the material better.

Fast shipping and excellent customer service..love how informative you are and everything is very detailed on

I will recommend anyone trying to site for his or her endoscopy certificate examination to get the book it will indeed help you thanks

Update: thanks so much I received my digital copy

The practice questions gave me full insight of what will come out of exam. Thanks sterile guy for putting this together. Amazing work. I will. Buy another package again for my CIS.

This has helped me in so many ways getting ready to take my certification. The practice tests are super helpful, and it was definitely worth it!!

From the initial answers I got after asking questions before purchasing, to the easy to checkout process, to receiving my order in the mail (in an impressive amount of time), to the quality of the flashcards, I was impressed, in fact, I am still impressed.
I must say, this Sterile Processing Supreme Bundle delivers.
You'll just have to make the purchase to see exactly what I mean when I say, "The flashcards are 'matter-of-fact' evidence to the standard of academic excellence 'the sterile guy' has committed to."

These cards were exactly what I was looking for! Excellent information and made with care. Huge thank you to The Sterile Guy!

I recently purchased the sterile processing flash cards, and I couldn't be more pleased! These cards are incredibly informative and well-organized, making it easy to review key concepts and terminology. The visuals are clear, and the information is presented in a concise manner, which helps reinforce learning. I've found them to be an invaluable resource for both studying and quick reference. I highly recommend these flash cards to anyone in the sterile processing field or those preparing for certification. They truly enhance the learning experience!