Where to we go from here?

by Natalie Lind, CRCST, CHL

Imagine being given an address in the heart of a strange city and being told to drive to that address without directions or a map. Imagine being given flour, sugar, eggs, and other ingredients and being asked to bake a specific dessert from scratch without a recipe or instructions. In either scenario, our chances of being successful would be very low. Directions and instructions are critical to the success of many of the tasks that we undertake every day. The use of directions and instructions is so prevalent that we almost take them for granted.

Let’s consider some medical scenarios. Imagine picking up a prescription from a pharmacy and finding that there were no written instructions for use. It just wouldn’t happen. Now imagine purchasing a new medical device and finding out that there were no instructions to clean or sterilize the device included. While you would never find a prescription without written instructions, it is common to receive medical devices that do not have written instructions for use. Something is very wrong with that scenario.

When the care, treatment, and ultimate safety of a patient depend on safe medical devices, instructions are critical. We should never be standing in the decontamination area or at the sterilizer asking “Where do we go from here?” Quality patient care demands that we have a solid plan to ensure that items are processed effectively. That plan begins with written instructions, standards and guidelines.

Q. I keep seeing that we are supposed to follow medical device manufacturer’s written instructions for all items we reprocess; however, it is not always easy to get that information. I have had sales reps tell me they don’t have that or that we should just do what we normally do. If I document that I contacted the sales rep and their response, is that enough?

A. No. Documenting that you asked and didn’t receive the information will not exempt you from needing the medical device manufacturers’ written instructions for cleaning and sterilization. Neither will statements that tell you to “do what you usually do.”

AAMI ST79: Section 7.2.2, states that the written recommendations of medical device manufacturer should always be followed. The document goes on to say that the medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized. The methods of cleaning and sterilization should be validated by the manufacturer and written instructions should be provided to the user. If the item is marketed as a medical device, it should have that information available. If your sales rep cannot provide it, contact the company’s technical support department. Explain to the sales rep that you require that information and enlist his/her help to obtain the information from the manufacturer.

Q. We recently received a new instrument system that requires a low temperature sterilization process that we do not have available in our department. Can you provide me with a resource that identifies alternative instructions for sterilization of items?

A. You will need to contact the manufacturer of the instrument system and ask if they have validated the system to any alternative method of sterilization. They are the only resource that can provide that information.

You may also want to contact the chair of your hospital value analysis committee and ask that questions regarding recommended cleaning and sterilization methods be included in the product considerations for items that must be reprocessed. The process for selecting any medical device that will be reprocessed by the healthcare facility should include requesting the device manufacturer’s written instructions for reprocessing (cleaning and sterilization) so your facility can determine if the device being considered can actually be processed by your department. Offer to review those instructions and provide input regarding the feasibility of reprocessing at your facility.

Q. You often refer to AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities and I agree that it is a great document. However, it only addresses steam sterilization.  What guidelines do you recommend for Ethylene Oxide sterilization?

A. The Association for the Advancement of Medical Instrumentation also has an excellent reference for Ethylene Oxide users. It is called AAMI ST41: <I>Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness<$>. The document, which was completely updated in 2008, provides guidance on several aspects of Ethylene Oxide sterilization from sterilization area design considerations, to preparation of devices for sterilization, to sterilization cycles and quality control. In addition, there are several helpful annexes included that address related topics such as occupational exposure to ethylene oxide, emission control technologies, selecting air quality monitoring systems for ethylene oxide and more. The document can be obtained at www.aami.org .

 Q. Do you know of a source that states what the cleaning requirements for central service work areas are?  

 A. AAMI ST79: Section 3.4 states: “Housekeeping procedures in the areas used for any aspect of decontamination, preparation, or sterilization, should be the same as those used to clean operating and delivery rooms and should ensure a high level of cleanliness at all times …”

That section of the document goes on to identify specific recommendations.

Q. Could you identify the proper location where you are to write the information on a paper-plastic peel package?

A. AAMI ST79: 8.3.2 states:  “… If a marking pen is used to label paper-plastic pouches, the labeling information should be written only on the plastic side of the pouch. …”

Q. I recently had a member from infection control ask me if there are any guidelines of specifications for ceilings in SPD areas. Can you provide any information regarding this?

A. ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, Section 3.3.6.2 states: “Work area ceilings should be constructed to create a flush surface with recessed, enclosed fixtures. Pipes and other fixtures above work areas should also be enclosed. Ceilings should be constructed of materials that are not of a particulate or fiber-shedding composition.”

Section 3 provides a great deal of information about design considerations in each of the basic central service work areas. It may also be helpful to compare the physical requirements for each work area against your actual work areas. Some variances may be able to be adjusted immediately and those that require more substantial changes can be added to plans for future renovations.

Q. We constantly have problems with communicating information about new instruments, instruments that are out for repair and instruments that have been removed from the system. Is that normal? What do other departments do?

A. To some degree it is normal. Changes happen swiftly and often in any surgical instrument system and it can be a challenge to ensure that everyone who needs to know about those changes finds out. Shift work and days off play a part in the problem as does a busy, sometimes hectic, environment. Things can be further complicated when changes are passed through by word of mouth instead of through a formal (written) process.

The good news is that there are ways to ensure that information is passed on to everyone. Departments that are successful at this type of communication use a systematic approach to communicate changes. That approach varies with the facility but usually includes a mechanism to provide a single source for changes and change-related information as well as point-of-use information. For example, there may be an electronic communication or electronic access to a recap of recent changes combined with a note left at the item’s storage location.

 The goal is to create a central source for information relating to changes that is easily accessed by anyone in CS or the OR. Your computer system can provide several options for that and can reduce time and effort used to find out about temporary (i.e. out for repair) or permanent (i.e. new item) changes. Manual options such as dry erase boards or notes can also be used. Find out what method or combination of methods works for your departments and then take steps to ensure that everyone knows how to find information. Follow up by holding people accountable to review change information and implement changes into their daily activities.

 Manufacturers’ instructions, written guidelines and standards, references, and information about system changes, provide a roadmap to help us provide our patients with safe medical devices. They answer the question “Where do we go from here?” and ensure that we always take the path towards patient safety.

Natalie Lind, CRCST, CHL, is the educational director for the International Association of Healthcare Central Service Materiel Management (IAHCSMM).