Editor’s Note: Questions can be e-mailed to jakridge@hpnonline.com, called in to Jeannie Akridge at HPN, (941)927-9345 ext.202, or mailed to: HPN CS Questions, 7650 So. Tamiami, Ste.10, Sarasota, FL 34231. Names and hospital identification will be withheld upon request.

Question: We are instituting a computerized tracking system for our surgical instruments and sets. We are having a difficult time coming to an agreement as to where the count sheet should be placed. Some of the O.R. staff insist that the count sheets need to be on the inside of the set while others claim that the count sheets can leach toxic residue onto the instruments posing a risk to patient safety. Can you help separate the myths from fact and advise us of what we should do?

Answer: The use of and placement of count sheets continues to be a controversial issue. There is no known or documented case involving an adverse patient outcome or incident resulting from count sheets placed inside an instrument set. We do however know that inks can and do leach and seeing evidence of this on sterilization containers is quite common. I don’t know of any hospitals that are using any special medical grade papers, printer inks or ribbons for count sheets. In fact in my research I have found no source or manufacturer that can supply medical grade printer paper or inks. It appears that most hospitals are using regular printer paper, inks and ribbons. Manufacturers of toners, inks, ribbons and printer paper who routinely sell to hospitals could provide no information on issues of toxicity because they have never tested their products in any sterilization method. Since there is no available research regarding the safety of toners, inks and printer papers placed inside of instruments sets and subjected to sterilization methods the safety of this practice is an unknown.  To date none of the professional associations or regulatory entities have published any written document, standard or recommendation regarding the placement of count sheets in instruments sets or product specifications for papers, toners or inks. Still the general consensus amongst healthcare professionals is that chemicals in the paper can pose a theoretical risk of reaction in some sensitized patients. Since there continues to be some concerns relative to the use and placement of count sheets in instrument sets it would make good sense to avoid and or minimize any intimate contact with the count sheets and surgical instruments. It is the responsibility of each hospital to establish a rationale policy and procedure, which addresses this issue and meets their individual and unique needs. Many hospitals are placing the count sheets on the outside of containers and wrapped sets, which eliminates their concerns. If it is essential to place your count sheets inside you can take the following measures to minimize the direct contact of the count sheet with instruments and the likelihood of leaching of chemicals and inks. Fold the count sheets either in thirds or half with printed side in and place in a medical grade paper pouch. When using a sterilization container system the folded count sheet can be place on the internal side between the container wall and instrument basket.

Question: What are the flash guidelines for instruments that have been dipped or color coded for specific trays using tape? We have been flashing these instruments for 10 minutes but some new staff state this is no longer a requirement.

Answer: Flash sterilization cycle times are influenced by the size of trays and the amount of metal mass, the complexity of instruments, their assembly and arrangement. It is essential that you obtain and follow the manufacturer’s instructions and recommendations for specific instruments, medical devices and accessories relative to their care, use and sterilization. This would include the manufacturer of the instrument identification tapes, labels and color coating you are utilizing. Most of the instrument identification tapes, when used in accordance with the manufacturers recommendations, can be processed through conventional sterilization cycles.

AAMI is a voluntary professional association comprised of members from the health care industry including manufacturers consultants, healthcare providers and users. Various committees and working groups review, revise and create recommendations and guidelines relative to sterilization processes and quality assurance. While this is a non-governing and voluntary organization the documents are non-binding guidelines and recommendations. Due to the creditability and quality of the documents produced by AAMI,the implementation and voluntary compliance of these recommendations has become the standard of practice in most hospitals. The documents are expected to be available for purchase by the end of August ’06. To obtain more information about AAMI or to order these documents contact AAMI directly at 703-525-4890 or visit their website at aami.org. HPN