Sterilization of Surgical Implants: Did You Know

Transcription

1 Sterilization of Surgical Implants: Did You Know by Rose Seavey, RN, MBA, CNOR, ACSP Many thanks to the team at 3M Health Care for working with Managing Infection Control to provide the following accre d i t e d course. IAHCSMM has awarded one (1) contact point for completion of this continuing education lesson toward IAHCSMM recertification. The CBSPD has preapproved this inservice for one (1) contact hour for a period of five (5) years from the date of publication, and to be used only once in a recertification period. This inservice is 3M Health C a re Provider approved by the California Board of Registere d Nurses, CEP 5770 for one (1) contact hour. This form is valid up to five (5) years from the date of publication. Instructions for submitting results are on page 95. Managing Infection Control and 3M Health Care will be working collaboratively to provide continuing education courses in monthly editions of Managing Infection Control. Objectives After completion of this self-study activity, the learner will be able to: 1. Define surgical implants/implantable devices. 2. Discuss the Association of perioperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation s (AAMI s ) recommended practice on sterilization of implants. 3. Explain why flash sterilization of implants is not recommended. 4. Develop a policy and procedure for sterilization of implants. 78 MANAGING INFECTION CONTROL

2 Test Questions True or False 1. Implants are devices that are placed inside the human body but removed within 30 days. 2. For dependable assurance of the sterility of processed items, it is essential that all phases of steam sterilization processing be performed and supervised by knowledgeable staff. 3. The efficacy of saturated steam sterilization depends on a dependable system for lowering and limiting bioburden before sterilization, appropriately preparing devices for sterilization, selecting the correct sterilization parameters, and establishing and implementing controls to maintain the sterility of sterilized items until they are used. 4. Implants should be held in quarantine until the results of the biological indicator (BI) are read as negative. 5. If an implant is released before the result of the BI is known in such cases like trauma-related orthopedics screw-plate sets, documentation is not necessary. 6. If an emergency situation makes flash sterilization unavoidable, a rapid-action biological monitoring device should be used along with a class V chemical integrator. The implant should not be released until the rapid-action indicator provides a negative result. 7. AAMI and AORN recommend flash sterilization of implants. 8. It is critical that sterilization documentation of all implants, including flashed items, is traceable back to the patient. 9. Regardless of whether the items are wrapped, there is no storage or shelf life of flash-sterilized items because of the higher probability of contamination after the sterilizer door is opened and the items are removed. 10. Flash sterilization should never be used for as a substitute for inadequate instrument or implant inventory. Introduction A major responsibility of healthcare providers is to minimize patient risks. In the operating room, this is particularly important in regard to surgical wound infections. A v i t a l way to help prevent surgical wound infections is to present s u rgical items that are free of contamination at the time of use. 1 Healthcare workers must make certain that all surgical instruments and medical devices used in procedures on patients have been appropriately cleaned, disinfected or sterilized according to the nature of the item and the manner in which it is to be used. Of particular importance is the sterilization assurance and documentation of surgical implants. Implants are foreign bodies that increase the threat of surgical site i n f e c t i o n. Therefore, they require additional attention to the sterilization and quality control process. 2 There is a higher degree of risk of infection to patients with an implant because: 1. First, they are left behind at surg e r y, so if there are microorganisms on them, these will remain in the body. Infections associated with implants may not be evident for up to a year after surgery. 2. Second, the placement of an implant often means the removal of tissue, with interruption of blood supply and significant manipulation of the tissues immediately adjacent to the implant, creating an area of potential safety for microorganisms to multiply, further increasing the risk of infection. 3. Third, because there is interrupted blood supply, antibiotics cannot easily get to the microorganisms if they do multiply enough to cause a clinical infection. 4. Fourth, the implant itself may be vital to continuing function of a body system, such as would occur with a total joint replacement, vascular graft, or intraocular lens placement. An infection may not be curable with the implant in place, and removing it could cripple or kill the patient. 3 In addition: The mortality rate (deaths) associated with infected total hip replacements approaches 50%, from the infection itself and from the complications associated with the resulting impaired mobility, such as blood clots and pneumonia. 3 This article will focus on sterilization of surgical implants as discussed in the new Association for the Advancement of Medical Instrumentation standard C o m p rehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79:2006, as well as the 2006 Association of Perioperative Registered Nurses ( A O R N ) Recommended Practices on Sterilization in the Perioperative Practice Setting. What is considered an implant or implantable device? According to the Food and Drug Administration (FDA), an implant/implantable device is a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also implants. [21 CFR 812.3(d)]. 2 Ideally, implants and implantable devices should come individually wrapped and sterile from the manufacturer. Sometimes this is not feasible, and the implantable devices must be processed by the healthcare facility. The preferred method for implants processed in a healthcare facilty is steam sterilization. For dependable assurance of the sterility of 80 MANAGING INFECTION CONTROL

3 processed items, it is essential that all phases of steam sterilization processing be performed and supervised by knowledgeable staff. Effective sterilization is vital, and manufacturers written instructions for appropriate sterilization time for each type of implant must be followed. The ideal method for sterilization, especially implants, is wrapped (or containerized). The main function of packaging is to allow the sterilization of the contents, maintain the sterility until the package is opened and provide for aseptic presentation at the point of use. Packaging allows for labels, such as process indicators, product identification, and lot numbers and expiration statements, to be affixed to the item. Steam sterilization One of the oldest methods to sterilize medical devices used in healthcare facilities is steam under pressure. In-house facility processed implants are most commonly sterilized via steam. Since steam sterilization has been around for so long it is thought to be an uncomplicated method, one that is understood and easily controlled. Conversely, steam depends on four phases that are significantly dependant on each other to produce and maintain a sterile product. The efficacy of saturated steam sterilization depends on a dependable system for lowering and limiting bioburden before sterilization, appropriately preparing devices for sterilization, selecting the correct sterilization parameters, and establishing and implementing controls to maintain the sterility of sterilized items until they are used. 2 Personnel considerations Accountability for performing sterilization processes should be assigned to competent individuals who have knowledge of all aspects of disinfection and sterilization procedures and safety precautions. Supervisory personnel responsible for sterilization and disinfection should have formal training and be knowledgeable about each method used. They should be aware of the need to acquire and follow the device and sterilizer m a n u f a c t u r e r s written instructions for use that may require extended sterilization cycles. As with all processing activities, employees performing these duties should be given special training, and their competencies should be verified. 2 Release criteria for implants Each implant should be labeled with a lot control identifier (sterilizer identification number or code, date of sterilization and cycle number) to assist in the event of a recall. Ideally, every reprocessed medical device, especially an implant, should be fully traceable to the patient on whom it is used or in whom it is implanted; such traceability can be accomplished by recording the sterilizer load identifier on the patient chart or the patient name on the load record. 2 Sterilization records should be maintained for each cycle. This information should include: lot number; contents of load; exposure time and temperature if not on a recording chart; operator identification; results of BI testing; results of the Bowie-Dick testing; results of chemical indicator (CI) in the PCD (BI challenge test pack, BI challenge test tray, CI challenge test pack); any reports of inconclusive or nonresponsive CIs in the load. The sterilizer operator should review the physical monitors, the results of the external chemical indicator on every package, the internal chemical indicator inside each package, and the BI for the BI PCD (process challenge device) in each load to determine if the results are appropriate. If not, the load should be reprocessed. Implants should be held in quarantine until the results of the BI are read as negative. A A M I s newest master document on sterilization, C o m p rehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79: 2006), has specific recommendations on the release criteria for implants (10.6.3). 82 MANAGING INFECTION CONTROL

4 As with all cycles, the sterilizer operator should review the sterilizer chart or printout and the results of other indicators that have been used to monitor the sterilization process. The load should be quarantined until the results of the BI testing are available (CDC, 2003a). When documented medical exceptions dictate (e.g., the need for trauma-related orthopedic screw-plate sets), it could be necessary to release an implantable device before the BI results are known. In this case, the release of the device before the BI results are known should be documented; the BI result obtained later should also be documented. [See Annex L, p. 84 and 86, for examples of an implant log and an exception form.] It is critical that this documentation be fully traceable to the patient. Releasing implants before the BI results are known is unacceptable and should be the exception, not the rule. Emergency situations should be defined in written guidance developed in consultation with infection prevention and control, the surgeon, and risk management. Steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistent patterns of events that are causing emergency release and that could be corrected. Rationale: Patient safety could be adversely affected by the implantation of a nonsterile device. The sterilization of implantables should be closely monitored and each load containing implants should be quarantined until it is verified that BI testing has yielded negative results. In defined e m e rgency situations in which the quarantine of implants cannot be maintained, breaking of the quarantine is allowed for documented medical exceptions in accordance with facility policies and procedures. 2 Annex L (Informative) Example of documentation of premature release of implants This Annex provides an Implantable Devices Load Record and an Exception Form for Premature Release of Implantable Device/Tray, as examples of the forms recommended in Section Implantable Devices Load Record Date Description Dept. Time Sterilizer # Load # Date/time Date/time Early Date/time Released of implants sterilized BI in and release? released by (specify incubator BI result to OR (full name) AM/PM) Figure L.1 Implantable devices load record 84 MANAGING INFECTION CONTROL

5 Exception Form for Premature Release of Implantable Device/Tray N O T E In a documented emergency situation, implantable devices will be released from quarantine in Central Service without the biological monitor result. This form should accompany the implant to the Operating Room. Operating Room personnel should complete this form and return it to Central Service within 24 hours. PLEASE COMPLETE ALL INFORMATION: DATE: SHIFT: TIME: AM PM PERSON COMPLETING THIS REPORT IN CENTRAL SERVICE: The following implantable devices/trays were prematurely released to the Operating Room: NAME OF OR PERSON REQUESTING PREMATURE RELEASE OF DEVICES: OPERATING ROOM REPORT: PATIENT NAME: SURGEON NAME: TIME OF PROCEDURE: AM PM DATE: REASON PREMATURE RELEASE WAS NEEDED: WHAT COULD HAVE PREVENTED PREMATURE RELEASE OF THIS DEVICE/TRAY? NAME OF OR PERSON COMPLETING THIS REPORT: DATE REPORT COMPLETED: RETURNED TO CENTRAL SERVICE ON: Figure L.2 Exception form for premature release of implantable device/tray Reprinted with permission from the Association for the Advancement of Medical Instrumentation, Inc. Copyright 2006 AAMI. All rights reserved. Healthcare facilities need to develop written guidance as to what emergency situations are. This guidance should be developed by a committee that includes infection prevention and control, the surgeon, and risk management. What are some examples of emerg e n c y situations? Is it when the life or limb of the patient would be lost if the surgery was not done? Healthcare facilities usually have some kind of reporting structure for documenting unusual incidents, sometimes called incident reports. These incident reports are usually reviewed by risk management. As a result of these reports, risk assessments are frequently conducted to decrease the occurrence of this type of incident. In the same way that other incidents are reviewed, the documentation of the medical exceptions for early release of implants should be reviewed by risk management, infection control and surg e r y. These records can be very useful in determining the causes of emerg e n c y release of implants and how that could be corrected. T h e analysis may show: which devices or implants are in short supply due to case volume. This may help justify the purchase of additional items for necessary backup if an item is broken or dropped. which surgeons are not contacting vendors soon enough to allow appropriate sterilization of implants. which vendors, if contacted soon enough, are not delivering the items in time to allow appropriate sterilization of implants. 86 MANAGING INFECTION CONTROL

6 which vendors do not have enough instruments and/or implants for the number of facilities they are supplying. surgical schedules that do not allow enough time to process implants by the wrapped or containerized methods. lack of communication between the Operating Room and the Sterile Processing Department. the need to increase sterile processing departments hours of operation if not 24/7. the need for a BI that can be read out in a shorter amount of time. In all cases the objective is to not release implants before the BI is negative so that patient safety is not adversely affected. Frequently with implants, especially those that are used often or are borrowed, timing is a huge factor in the sterilization process. Much of that time is spent waiting for the BI to incubate and show a negative before being able to release the implants. Some types of BIs contain spores with an enzyme-based early-readout capability. With this type of BI, implants can be released in one or three hours after incubation of the spore, rather than having to wait up to 48 hours. If using early-readout with spore growth, periodic verification of the early readout with spore growth should be performed in accordance with the manufacturer s instructions and facility policy and procedures. 2 At the Children s Hospital in Denver, for all but a very few emergency cases, we are able to quarantine our implants until the BI, with an enzyme-based early-readout capability, has been read as negative. This gives us a three-hour window once the BI is placed into the incubator. Steam sterilized devices need a cool down phase, usually about one hour, before they can be touched. Once they can be removed from the sterilizer rack, we place them on another waiting rack until the BI results are read, before we release them either to the shelf or to the OR for use. For emergencies, we document the incident and reason for early release using the hospital incident reporting process. MANAGING INFECTION CONTROL 87

7 Implants should NOT be flashed A O R N s 2006 Recommended Practice on Sterilization in the Perioperative Practice Setting (RPIV 6.) does not recommend flash sterilization of implants. Flash sterilization should not be used for i m p l a n t a b l e d e v i c e s. Implants are foreign bodies, and they increase the risk of s u rgical site infections. Careful planning, appropriate packaging, and inventory management in cooperation with suppliers can minimize the need to flash sterilize implantable medical devices. When an implantable device is sterilized at a health care facility, a biological i n d i c a t o r should be run with the load and the implant should be quarantined until the results of the biological indicator are known. If an emergency situation makes flash sterilization unavoidable, a rapid-action biological monitoring device should be used along with a class V chemical integrator. The implant should not be released until the rapid-action indicator provides a negative result. After the rapid-action negative result is obtained, the implant can be released for use in the immediate situation. If the implant is not used, it cannot be saved as sterile for future use. Resterilization of the device is required. If the biological indicator is later determined to have 88 MANAGING INFECTION CONTROL

8 a positive result, the surgeon should be notified as soon as the results are known. 1 Each facility should have written guidelines on what constitutes an emergency situation. If it is determined per the facility s written policy that flashing of implants is unavoidable, it is extremely important that appropriate documentation is completed and traceable to the patient for whom the implants were used. A sterilization log or database should include information on each load, including: Device(s) processed Patient receiving the items(s) Reason for flash sterilization. 1 If you must flash Flash Sterilization (i.e., abbreviated/express cycle) is defined as a process designed for the steam sterilization of patient care items for immediate use. 1,2 Flash sterilization should be used only in selected clinical circumstances and in a restricted manner, and the use of flash sterilization should be kept to a bare minimum. If you must use flash sterilization, AORN recommends that the following conditions are met: The device manufacturer s written instructions are available and followed. Items are disassembled and thoroughly cleaned with detergent and water to remove soil, blood, body fats and other substances. Lumens are flushed with the cleaning solution and rinsed thoroughly. Items are placed in a sterilization container or tray in a manner that allows steam to contact all instrument parts. Measures are taken to prevent contamination during transfer to the sterile field. Documentation of cycle information and monitoring results is maintained to provide tracking of flashed items(s) to the individual patient. 1 Figure 1 shows an example of documentation for flash cycles that we currently use at our hospital (Record of Flash Sterilization, p.90). This record is used for any flash cycle and MANAGING INFECTION CONTROL 89

9 Figure 1 Record of Flash Sterilization The Children s Hospital Denver Perioperative Services Steam Sterilizer ID 90 MANAGING INFECTION CONTROL

10 Flash sterilization should never be used as a substitute for inadequate instrument inventory. documents the load number, room number, sterilization parameters, patient identification, contents of the load, and the results of chemical integrator and BI results (if used). In the rare instance in which we must flash implants such as trauma-related orthopedic sets including implants, we run BIs and document it on this sheet. We use the enzyme-based early-readout BI that gives us results within one hour. For the most part, the BI is read before the implant is placed in the patient. If the emergency situation dictates the implant goes in before the one-hour window, we have all the information documented on this sheet. If the BI is positive, the physician, infection control and risk management are notified immediately. AAMI states: A flash sterilization cycle is one that has been designed to meet the following criteria: 1. The cycle is preprogrammed to specific time-temperature setting established by the manufacturer based on the sterilizer control (i.e., gravity-displacement, dynamic air-removal) and selected by the user based on the configuration of the load (i.e., the presence or absence of porous materials). 2. The items to be processed are usually unwrapped, although a single wrapper may be used in certain circumstances if the sterilizer or packaging manufacturer s instructions permit. Some rigid sterilization container systems have been designed and validated by the container manufacturer for use with flash cycles. 3. Since drying time is not usually part of a preprogrammed flash cycle, the items processed are assumed to be wet at the conclusion of the cycle. 4. The processed item(s) must be transferred immediately, using aseptic technique, from the sterilizer to the actual point of use, usually the sterile field in an ongoing surgical procedure. Regardless of whether the items are wrapped, there is no storage or shelf life of flash-sterilized items because of the higher probability of contamination after the sterilizer door is opened and the items are removed. 2 How to avoid flash sterilization Sterilization by the flash method should be used only when there is inadequate time (e.g., urgent situations) to process by the preferred wrapped or container method. Flash sterilization should never be used as a substitute for inadequate instrument inventory. Eliminating the need to flash sterilize implantable device can be achieved through cautious planning, suitable packaging (e.g., see through packaging that permits the user to visualize the item for proper size and confirmation of features), and inventory management in collaboration with the vendor. 1,2 MANAGING INFECTION CONTROL 91

11 Most hospitals use some kind of block scheduling for the OR. This means that surgeons are given blocks of time to schedule their cases. This works well for both the surgeon and the OR. Unfortunately, block scheduling is the cause for a lot of the flashing that is done in hospitals. The physicians want to do back-to-back cases in their assigned block time. Frequently they need the same type of instruments or implants. If the inventory does not allow time to reprocess the items in the usual way, flashing of the items is done. The Children s Hospital of Denver has developed another approach to decrease the incidents of flashing orthopaedic instruments and implants. The orthosurgical team meets once a week to discuss its upcoming cases. The Ortho Nursing Service Leader reviews the list of needed versus available instruments and implants. If loaner medical devices are needed, the Ortho Nursing Service Leader makes arrangements to get the loaner items into the hospital in time to be reprocessed in-house by the wrapped or containerized method. A special documentation form called O rtho Loaner Instrument and Implant Tr a c k i n g Form (See Figure 2 on p. 93) was created. Once this document is completed, a copy of the form is then sent to the Sterile Processing Department so its members can anticipate the arrival of these loaner items. Summary Healthcare providers are responsible for minimizing the risks to patients. The risk of surgical wound infections can be decreased by ensuring that all surgical items are free of contamination at the time of use. Implants are devices that are placed inside the human body and intended to remain there for 30 days or more. Because they are foreign bodies, implants pose an increased risk of surgical site infections. It is imperative these devices are sterile. The defined medical exceptions, such as the use of e m e rgency trauma-related orthopedic screw-plate sets, should be developed in consultation with infection control, the s u rgeon and risk management. In emergency situations, it may be necessary to release an implantable device before the BI 92 MANAGING INFECTION CONTROL

12 Figure 2 An Example of a Tracking Form The Children s Hospital Ortho Loaner Instrumentation and Implants Tracking Form Patient s Name Procedure Type Surgeon Procedure Date: Time: Instruments needed Implants needed Ordered by When ordered Date: Time: * Estimated Delivery time Date: Time: Mfg. reprocessing Requested when ordered? Yes instructions *Items must be delivered directly to SPD decontam no later than 5 p.m. the night before the case is scheduled. results are known. This should be documented as a medical exception. It is critical that this documentation be fully traceable to the patient. Releasing implants before the BI results are known is unacceptable and should be the exception, not the rule. Flash sterilization of implants is not recommended. Flash sterilization may be connected to an increased risk of infection to patients because pressure on personnel may result in the omitting of one or more steps in the cleaning process as well as the demands to release the flashed items before the BI results are read. If an emergency situation makes flash sterilization unavoidable, a rapidaction biological monitoring device should be used along with a class V chemical integrator. The implant should not be released until the rapidaction indicator provides a negative result. It is imperative that the device m a n u f a c t u r e s written instructions for temperature and exposure times are consulted and followed. Documentation of cycle information and monitoring results must be maintained to provide tracking of flashed items(s) to the individual patient. And, finally, flash sterilization should NEVER be used as a substitute for inadequate instrument or implant inventory. MANAGING INFECTION CONTROL 93

13 Ordering Information AAMI ANSI/AAMI ST79:2006, C o m p rehensive guide to steam sterilization and sterility assurance in health care facilities Order code: ST79 or ST79-PDF Available in an attractive binder featuring sturdy metal rings, l e d g e r-weight pages, and a laminated tab for each section for easy navigation. AAMI will issue revised pages that can be substituted into the binder when changes are made. Also available in PDF format and as part of AAMI s electronic CD and subscription products. Price/Member discount price: $200/$100 AAMI documents can be purchased through AAMI by credit card using the following four options: 1. Internet: 2. Call: , ext 217 or , ext Fax: Mail: AAMI, Customer Service Center, 1100 N. Glebe Road, Suite 220, Arlington, VA AORN AORN Standards can be purchased through AORN using the following options: 1. Internet: www. a o r n. o rg / b o o k s t o r e / o r d e r i n g. h t m 2. Call: , ext 1 or ext 1 (Monday-Friday, 8 a.m. to 4:30 p.m. MST) 3. Fax: By mail: AORN, Inc., Customer Service/Book Orders, 2170 South Parker Road, Suite 300, Denver, CO Payment can be made by VISA, MasterCard, American Express or Discover, either online or by mail/fax/phone. By authorized PO, and AORN will bill you ($100 minimum purchase). Sorry, we cannot accept POs for education conferences or services. (Not available for online orders.) A CD-rom of the standards is available for the first time this year. 94 MANAGING INFECTION CONTROL

14 References 1. Recommended Practices for Sterilization in Perioperative Practice Settings. A s s o c i a t i o n of perioperative Registered Nurses. AORN Standards, Recommended Practices, and Guidelines The Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. A N S I / AAMI ST79: Schultz, Janet. Monitoring and Load Release for Implants Sterilized by Steam Wi t h i n Healthcare Facilities. Managing Infection Control. Jan 2004 Sterile Process and Distribution CEU Information CEU Applicant Name Address City State Zip Code The CBSPD (Certification Board for Sterile Processing and Distribution) has pre-approved this inservice for 1 contact hour for a period of five years from the date of publication and to be used once in a re-certification period. Successful completion of the lesson and post test must be documented by facility management and those records maintained by the individuals until re-certification is required. DO NOT SEND LESSON OR TEST TO CBSPD. For additional information regarding Certification contact: CBSPD, 2 Industrial Park Road, Suite 3, Alpha, NJ or call or visit Web site at IAHCSMM has awarded 1 contact point for completion of this continuing education lesson toward IAHCSMM recertification. Rose Seavey, RN, MBA, CNOR, ACSP, is the Director of the Sterile Pro c e s s i n g Department at The Children s Hospital of Denver and past president of A S H C S P (2003), on whose board of directors she has served for three years. She was elected o n the AORN National Nominating Committee and has served on the national Recommended Practices Committee for AORN. She is a past president of the Denver Chapter of AORN. In addition, she is a member of several AAMI working g roup committees that are developing recommended practices and is currently a co-chair for the AAMI ST8, Hospital steam sterilizer working group. ANSWERS 1. F 2. T 3. T 4. T 5. F 6. T 7. F 8. T 9. T 10. T Nursing CE Application Form 3M Health Care provider approved by the California Board of Registered Nurses, CEP 5770 for 1 contact hour. This form is valid up to five years from the date of publication. 1. Make a photocopy of this form. 2. Print your name, address and daytime phone number and position/title. 3. Add your social security number or your nursing license number. 4. Date the application and sign. 5. Answer the CE questions. 6. Submit this form and the answer sheet to: Workhorse Publishing Managing Infection Control PO Box 25310, Scottsdale, AZ Participants who score at least 70% will receive a certificate of completion within 30 days of Managing Infection Control s receipt of the application. Application Please print or type. Name Mailing Address City, State, Country, Zip Daytime phone ( ) P o s i t i o n / Ti t l e Social Security or Nursing License Number Date application submitted Signature _ Offer expires November 2011 On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this program for the following: 1) Overall content 2) Met written objectives 3) Usability of content <11/06> Reprint with permission from Workhorse Publishing L.L.C Copyright 2007/Workhorse Publishing L.L.C./All Rights Reseved. MANAGING INFECTION CONTROL 95