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I am the Clinical Director at an Ambulatory Surgery Center where we just had a Joint Commission survey a couple weeks ago. We use colored marking tape to identify some of our surgical instruments. The surveyor stated that using tape to identify instruments was not a recommended practice. She also said that if we do use tape then we shouldn’t overlap the ends, just join the ends together. She advised that we should consider discontinuing the use of tape all together. Her comments were news to me. We have used marking tape for as long as I can remember with absolutely no problems. Is this practice no longer acceptable?
A Use of instrument marking tape is an acceptable practice. You want to be certain that the tape is intended for use on medical devices and that the manufacturer can provide product performance validation for the intended use, including sterilization. The manufacturer must also provide instructions for use (IFU). The IFU should provide detailed information and instructions for applying the tape as well as routine care, inspection and maintenance. It is the responsibility of the end-user to comply with and follow the manufacturer’s IFU. I am not sure where the surveyor got her information regarding not overlapping the tape ends. The manufacturer’s IFU will give directions for applying the tape to instruments. IFUs may differ amongst specific manufacturers and their products. Below is a sample of directions taken from one manufacturer’s IFU.
- Secure adhesive back to instrument being marked.
- Wrap the tape around itself at least once.
- The instrument should then be autoclaved. This effectively shrinks the tape around the instrument and sets the tape to tape adhesion.
- The instrument can then be washed in the normal fashion and then be circulated.
- During normal usage, the tape should retain its color for about 2-6 months.
- It may be removed by cutting with a sharp knife.
- Any adhesive remaining on the instrument may be removed by scrubbing with an instrument cleaning brush
- The use of hot water may soften the adhesive and help with removal.
Q I work for a private, doctor-owned cosmetic surgery service with four ambulatory centers within a 150-mile radius. We do share information and some resources but each location operates independently. Recently we have had some issues with some unique cannulated instruments which have led to some questions on sterilization processes. Some of our centers have vacuum sterilizers and a few have gravity only. We have no standard times or temperatures that are used. Our administrative director has decided that we should just follow the most stringent parameters for the sterilizers we use. Is it correct to assume that this would provide the greatest assurance that items are sterilized effectively?
A No, this is not a wise, acceptable or safe practice at all. Some medical devices may not be compatible with gravity while others may not be processed in prevac. Some devices may require an alternative low temperature method of sterilization. Regardless of the required method of sterilization there may also be specific cycle parameters (e.g., time, temperature, etc.) for different medical devices. Using the wrong method and or parameters could result in sterilization failures and damage to the medical device. Either could place patients at serious risk of injury and infection.
The assumption that more stringent parameters would provide greater assurance of sterilization is quite wrong and a dangerous practice. The processing and sterilization of medical devices requires qualified, educated personnel with a thorough knowledge of processing equipment, medical devices, and sterilizers. Individuals managing and performing these critical duties should be certified. It is imperative that you obtain and follow the medical device manufacturer’s instructions for use (IFU). These instructions should include (validated) details for the cleaning and sterilization of the medical device in question. This should include the sterilization method and appropriate parameters.
If you do not have an IFU for a medical device or surgical instrument, then it should not be processed. If a manufacturer does not have, or cannot provide such documentation then you should file a MedWatch report with FDA (https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/
UCM163919.pdf). If you do not have the proper processing equipment, washer, sterilizer, etc., to comply with an IFU then you should not attempt to process the device.
Q We are about to purchase our first ultra-sonic washer, but since we will only have one we are debating if we should place it in the prep and sterile room instead of decontamination. This would make it easier to clean an instrument that might not pass inspection and need to be re-cleaned. Since each side may have cleaning needs which would be the most appropriate location for the ultra-sonic?
A The answer is quite simple — just ask yourself the following questions: What is the ultra-sonic used for? The correct answer is, of course, cleaning. The next question is where is cleaning conducted? The answer is, in the decontamination room. Thus the appropriate location for the ultra-sonic is in the decontamination area. If an instrument does not pass inspection and requires additional cleaning, it should be passed back to the decontamination room for cleaning.