Choosing A Reprocessing Method
WHICH INSTRUMENT REPROCESSING METHOD IS BEST FOR YOUR PATIENT?
The short answer to this question is that there is no single best method. There are many reprocessing methods available to hospitals and to Operating Rooms so any choice will depend on the particular situation at your facility and with your patients. The purpose of this article is to outline the factors to be considered when assessing or comparing reprocessing methods.
In the mid-1960s Dr. Earl Spaulding developed a framework to guide reprocessing decisionmaking. The system is based on the patient’s risk for infection that various types of instrument or equipment contact can create. The following table summarizes his system.’
Critical Contact – The normally sterile parts of the body that are covered by intact skin have no contact with the external environment or with the microorganisms that abound there. If, through inadequate or inappropriate instrument reprocessing, some of those external microorganisms are introduced into this normally sterile tissue, a patient’s risk for infection is high. A sterilization procedure, or use of a chemical germicide formulated as a sterilant, is recommended for reprocessing of instruments in order to keep patients safe.
Semi-Critical Contact – While there is still a risk for infection with mucous membrane contact, it is not as high as with trans-parenteral contact. Consequently, a high-level disinfection procedure is recommended for reprocessing semi critical instruments. Although chemical germicides formulated as high-level disinfectants do not kill high numbers of bacterial spores, they are active against all bacterial and viral pathogens and, as a result, they will still keep patients safe.
Non-Critical Contact – In a situation where a patient’s intact skin comes in contact with a reusable item (e.g. a blood pressure cuff on the arm), or does not come in direct contact with the item at all (e.g. lying on a bed covered by a fresh sheet), the risk of infection is very low. The safe level of reprocessing is also low. At this point it is important to note that intermediate and low level disinfectants have been designed for use on environmental surfaces and not on invasive medical devices.
Taking Spaulding’s system one-step further, the next table categorizes the reprocessing methods currently in use in Canada.
How to choose?
To choose a reprocessing method, the first step is to assess the type of contact the item will make with the patient. Use Spaulding’s classification in Table 1.
The second step is to identify the alternatives that will provide the minimum reprocessing level necessary to keep patients safe. Use Table 2.
The third step is to compare the choices within a selected category. Use Table 3 to identify the issues for comparison of the selected reprocessing methods.
In reviewing any reprocessing method, the first criterion to consider is efficacy. If the method is not effective against the spectrum of microorganisms of concern, patients will not be safe from infection. For example, during the reprocessing of anaesthetic equipment, tuberculosis is always a concern. Equipment must therefore receive high-level disinfection. The processing time for high-level disinfection is based on the time needed to kill M. tuberculosis var. bovis. Low-level disinfection procedures are not as potent as high-level disinfection and were not designed to be used on instruments.Following Spaulding’s classification will ensure appropriate spectrum efficacy.
Once efficacy is confirmed, a short cycle/contact time is usually preferable. This will allow instrument inventory to be turned around quickly as possible.
The effectiveness of any sterilization or high-level disinfection process must be monitored.2’3 Some monitoring requirements may be more onerous than others and this will have implications for ease of use.
Once it is determined that the efficacy of a system is appropriate, the next issue to address is safety. Staff using any system must be safe. Ideally, a reprocessing method will pose no occupational health or safety risks. If that is not possible, the risks associated with any process must be mitigated. Include the costs of mitigation when comparing systems or methods. Environmental safety is also a concern and the same considerations apply to it as to staff safety. Ideally, the method should cause no harm but, if it might, the costs of mitigation must be factored in to any comparison.
Confirm device compatibility with the reprocessing method(s) being considered. Contact the device or the reprocessing method manufacturer for written guidelines. Reprocessing instructions accompany all new reusable medical devices. Keep a copy on file.
BENEFITS AND LIMITATIONS
Once it has been determined that the processes being considered are both effective and safe, the in-use characteristics become relevant. Depending on the processes, there may be a wide variety of method-specific benefits or limitations to consider. The three listed in Table 3 are common to all reprocessing methods. Add any others that are relevant to your facility and to the specific methods being considered.
The choice of a reprocessing method depends on many factors and there is no one perfect method that suits all situations. The needs of patients, staff and the healthcare facility, as well as the types of products available at any given time, will all influence the decision. And that decision will not be final. Products change as do consumer needs. As a result the reprocessing decision will need to be reviewed, on a regular basis, in order to ensure that it remains current.
For further information on this topic, or if you have any questions, please contact the author at firstname.lastname@example.org.
1. Favero, M and Bond, W. Chemical Disinfection of Medical and Surgical Materials. In Block S. ed. Disinfection, Sterilization and Preservation. Philadelphia: Lippincott Williams & Wilkins, 2001:895-896.
2. Canadian Standards Association. Z 314.3-01 Effective Sterilization in Health Facilities by the Steam Process. CSA International. Toronto: 2001. pp 18-26.
3. Society of Gastroenterology Nurses and Associates, Guideline for the Use of High-Level Disinfectants and Sterilants for Reprocessing of Flexible Gastrointestinal Endoscopes p. 4. From the web www.sgna.org 30 August 2003.
Author: Barbara Bolding RN, BSN, MBA. Barbara Bolding is a Sterile Processing educator and consultant based in British Columbia. She currently works as a clinical educator for Johnson & Johnson Medical Products.
Copyright Operating Room Nurses Association of Canada Jun 2004
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