What is a count sheet?
The count sheet is a safety measure used in healthcare organizations that list the name of the instruments/items in a surgical/procedural instrument tray and the number of each instrument/item contained in that tray. Count sheets are an integral part of the surgical counting process used in the operating room to account for all surgical instruments/items before, during, and at the conclusion of a surgery or procedure to ensure that no instruments/items are unaccounted for and potentially left inside the patient. Typically, count sheets are paper, printed by the Sterile Processing Department, and placed inside the instrument tray prior to sterilization.
What does the literature tell us about count sheets?
There is very little literature out there regarding paper count sheets and their placement inside instrument trays, however, healthcare care organizations should weigh the risks and benefits of placing a non-validated product, such as a count sheet in instrument trays. Why?
In 2005, the AORN Recommended Practices Committee, collaborated with major toner companies to determine if the count sheets created a patient care risk when utilizing toner ink and paper commonly used by healthcare facilities. Even though there were no known reports of adverse reactions or events related to the sterilized count sheets, there is research in the literature related to the safety of toner ink and various papers that are used in the instrument trays during the sterilization process. This study states that there is the potential that the chemicals used in the manufacturing of paper and toner inks pose a potential risk of reaction in some sensitized individuals.
This limited controlled study, employing commonly used inks and paper under extremely exaggerated conditions, found that label and toner inks transferred to instruments during sterilization were not cytotoxic. The results from this study made no definitive conclusions regarding the safety of all count papers and all inks used in count sheets placed within sterilized instrument sets.
Regarding cytotoxicity, count sheets, when placed in contact with surgical instruments during steam sterilization, can transfer ink to the instruments. To eliminate any safety concerns, stainless steel instruments were placed on top of completely inked paper and subjected to steam sterilization, extracted, and tested for cytotoxicity. Preprinted labels were examined similarly. Extracts from stainless steel devices exposed to ink, toner, or labels showed no significant cytotoxic response, although the ink residue on the devices after steam sterilization was difficult to remove and detrimental to the instrument. Placing a barrier between the count sheet and the devices facilitates the life cycle of the instruments (Lucas, et al).
What are the recommendations regarding patient safety and count sheets?
The practice of using count sheets and pre-printed labels with stainless steel instruments during steam sterilization for the specific materials tested in the above-mentioned study does not appear to generate any significant cytotoxicity, however, this does not guarantee that this is a safe practice. The practice of using count sheets does not appear to pose an immediate health concern. However, it can be very difficult to clean some devices after they are steam sterilized in direct contact with printed inks and paper. Some of the devices used in this project were discarded because cleaning proved too arduous.
AORN guidelines recommend placing a count sheet in a medical-grade, all-paper peel pouch inside the instrument set to prevent the transfer of ink to the devices, thus facilitating the reuse and prolonged life of the devices. Another device out on the market is an external, reusable, holder system, which is compatible with steam, that you can place your count sheet in during sterilization. Additionally, there are automated instrument tracking systems that can generate instrument count sheets at the point of use or be able to perform the instrument count within the computer. The automated system would eliminate the need to print a hard copy count sheet.
The project did not evaluate whether paper debris remains on instruments or whether linting leads to a buildup of debris in the inner sterilizer chamber. The cumulative linting effects to the inner sterilizer chamber, filters, and drains over time are not known. There is literature suggesting that the copy paper could shred fibers into the tray, which could then transfer to the patient’s wound and cause a foreign body reaction or occlusion. This is something that needs additional research.
In summary, this study provides preliminary information to suggest that label and toner ink transferred during sterilization is not cytotoxic. Additional research is needed that will incorporate a larger sample, various sterilization methods, and instruments of different compositions and address additional concerns regarding the use of count sheets inside instrument sets and packaging.
It is important to remember, non-validated items need to remain outside of the sterile instrument trays, reducing the possibility of infection, potential impediment of the sterilization process and other adverse events. As healthcare continues to try to understand the causes of surgical site infections and surgical complications, it is essential that we explore and understand the risks created by our processes and always attempt to mitigate those risks. During survey, surveyors may inquire about your count sheet process. Keeping those Instructions for Use (IFUs) on hand is essential as you may be asked to validate your processes during a survey.
To learn more about Sterile Processing contact the Courtemanche and Associates Team at 704-573-4535 or email us at infor@courtmanche-assocs.com.
References
- AORN Guidelines 2019, Packaging System, pg. 569.
- Steam Sterilization and Internal Count Sheets: Assessing the Potential for Cytotoxicity, D. Lucas PhD, Nancy Chobin RN, AAS, ACSP, CSPDM, Ramona Conner RN, MSN, CNOR , Edward A. Gordon AA , Sheila Mitchell RN, BSN, MS, CNOR , Ben Perry , Mel E. Stratmeyer PhD , AORN Journal, Volume 89, Issue 3, March 2009, Pages 521-522, 525-531.
- Managing Interruptions and Distractions during Surgical Counts, Katherine A. Bubric, MSc, TJC Website, September 9, 2021.
- Instrument Count Sheets, Communique, July/August 2015.