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Resterilizing single-use items; technique for changing contaminated gloves; effectiveness of tacky mats
AUGUST 1988, VOL. 48, NO 2
AORN JOURNAL
Clinical Issues Resterilizing single-use items; technique for changing contaminated gloves; effectiveness of tacky mats
Q
uestion. I am the assistant nurse manager of the central sterile processing department in our hospital. In recent months, the OR supervisor (who also is the head of my department) has sent an increasing number of single-use disposable items to our area for reprocessing. Most of these items are clearly labeled, “Do not resterilize,” and they do not have manufacturer instructions for reprocessing. When I contact the companies, they are either unwilling or unable to provide any assistance, and they will say only that the items are intended for single use. The OR supervisor believes that if the item looks all right after resterilization, it is acceptable to use. I am uncomfortable resterilizing without manufacturer instructions, but I am unable to convince the OR supervisorthat to do so represents unsafe practice. Can you assist us with this problem ?
A
nswer. Patient safety should be the primary concern when considering reprocessing single-use devices. Reprocessing is not recommended unless the manufacturer provides written instructions for resterilizing single-use devices, or unless the health care facility can demonstrate and document that patient safety, device effectiveness, and device integrity are not compromised. The reprocessing of disposable devices intended by the manufacturer for single use is controversial. There is little research available on the subject. The AORN “Recommended practices for sterilization and disinfection” identify three areas to consider when making a decision regarding reprocessing: (1) device function and safety 356
following reprocessing, (2) legal and ethical issues associated with the device, and (3) economic concerns.’ Each single-use device should be considered on an individual basis after careful validation of the safety and efficacy of the item following reprocessing. A single-use device that cannot be cleaned, sterilized, or disinfected without damage to its integrity and/or function should not be reprocessed. If a single-use, disposable device is reused, the liability for that item reverts to the user? Validation of the safety, efficacy, and integrity of a reprocessed, single-use, disposable device should be based on an established reuse testing protocol. The objective of this protocol is to determine whether a disposable device can be safely reprocessed and reused. The protocol should apply to devices that have been used; to devices that are unused, but have exceeded their expiration date; and to devices that have been opened and removed from their sterile packaging, but not used. The protocol should include the following steps? Check package labels and insert information for manufacturer guidelines for reprocessing and reuse. If there are no manufacturer guidelines, contact the manufacturer for information on the physical properties of the device (eg, vinyl and latex) and, if possible, obtain information for cleaning, packaging, and resterilizing the device. Establish form and function criteria that the reprocessed device will be expected to meet, such as physical characteristics (eg, color, ~~
AUGUST 1988, VOL. 48, NO 2
AORN JOURNAL
shape, and size) and function (eg, motion, flexibility,and tensile strength). 4. Determine the facility’s ability to demonstrate adequate cleaning and sterilizing of the device, considering the physical prop erties of the item. 5. Determine the cost-effectiveness of reprocessing: 0 cost of the device, expected volume of use, 0 labor, overhead, and materials cost of reprocessing, and 0 risk and consequences of device failure. 6. Establish a testing protocol for each device, taking into consideration: necessary sample size for adequate study, 0 number of times the device can be reprocessed and still meet form and function criteria, procedures, chemicals, and equipment used in cleaning and sterilizing, process controls, quality assurance monitoring, and documentation of controls and monitoring activity, testing in simulated use situations, necessity for destructivetesting to identify unacceptable changes in the device, or residual toxicity, documentation of all testing results, and method of labeling and tracking for successive reprocessing. 7. Review test protocols and results with the facility’s administrative body, legal counsel, infection control committee, and the device manufacturer. 8. Determine policies on pricing, informed patient consent, and documentation of the use of reprocessed devices. 9. Periodically review the use of reprocessed devices to address patient safety, employee safety, and cost-effectiveness. The decision to reprocess single-use, disposable devices should not be taken lightly. In some instances it may be extremely difficult, if not impossible, to document that a device can be reprocessed without residual toxicity and still function safely and effectively. If reprocessing is done, it should be consistent throughout the health 358
care facility, and all reprocessing should conform to the established policies and protocols in the facility!
Q
uestion. The nurses in our OR disagree about how to change a contaminated glove during a surgical procedure. Some of the n u m insist on using the closed-glove technique, and others insist on the open-glove technique. Those who want to use the closed-glove technique become very upset and angry when the circulating nurse does not pull the stockinette cuff down over the hand when removing the contaminated glove. This may seem like an unimportant question, but it is creating a lot of dissention in our operating room. What is the proper way to change a contaminated glove during a surgical procedure?
A
nswer. There are two correct methods for changing a contaminated glove during a surgical procedure. The preferred method is for one member of the sterile team to glove the other. The contaminated glove should be removed by the circulating nurse, and a new glove presented by a member of the scrubbed surgical team. If this is not possible, the contaminated glove should be changed by the open-glove method. When using this method, the scrubbed person should be careful that the gown cuff is not pulled down or does not slip down over the hand. This prevents contact of the cleaner area (the hand) with the less clean area (the stockinette cuff of the gown). Stockinette is a moisture collecting fabric and is not an effective microbial bamer. Once the original gloves are donned, the stockinette cuff should be considered contaminated.5 If the cuff is considered contaminated, it would be improper technique to draw it down over the clean hand for successive gloving. The correct method for open gloving follows. 1. Turn away from the sterile field. 2. Extend the contaminated hand to the circulating nurse, who grasps the outside of the glove near the top and pulls it down and off, removing the glove inside out. 3. Pick up the new sterile glove with the gloved hand, keeping the gloved hand under the cuff of the new glove.
4. Insert the ungloved hand into the glove. 5. Pull the glove cuff up over the stockinette
cuff of the gown, covering the stockinette completely. At no time during this procedure should the ungloved hand come in contact with the exterior surface of the glove. To use the closed- gloving technique, the stockinette cuff of the gown must be sterile at the time the gloves are donned. Using this technique to replace a contaminated glove would require changing both gown and gloves. Many operating room n u m are resistant to the open-gloving method because it is less often used and therefore less often practiced. The technique is not difficult. It can be easily learned; and like any other skill, “practice makes perfect.”
Q
uestion. I am a new operating room supervisor and would like to make some changes in our OR. We are currently using tacky mats at the entrance to our department, but I have read that these mats are no longer necessary and could be eliminated. Some of the surgeons agree with me, but others are unwilling to allow the mats to be removed. They believe the mats are an important infectioncontrol measure because they clean the wheels of the patient carts after being out on the patient care units. Are tacky mats recommended?
A
nswer. The Centers for Disease Control (CDC), Atlanta, recommends that tacky or antiseptic mats not be used for infection control.6 This recommendation has been given a Category I rating. The CDC has categorized its recommendations into Categories I, 11, and 111. According to the CDC, measures in Category I are strongly supported by welldesigned and controlled clinical studies. Measures in Category I1 are supported by highly suggestive clinical studies in general hospitals or by definitive studies in specialty hospitals that might not be representative of general hospitals. Measures in Category 111 have been proposed by some investigators, authorities, or organizations, but lack supporting data, a strong theoretical rationale, or an indication that the benefits expected from them are costeffective.’
The problem with the tacky mats is that although the number of bacteria on shoe soles and cart wheels may be reduced intially, the bacteria quickly build up on the mat. These mats, unless frequently changed, become a haven for bacteria and may actually work against the principle for which they were originally intended. After the mat has been crossed several times, the next set of wheels or shoes may actually pick up bacteria deposited during a preceding trip.” DOROTHY M. FOGG, RN, BSN ASSISTANTDIRECTOR OF EDUCATION/ CONSULTATION Notes 1. “Recommended practices for sterilization and disinfection,” in AORN Srcmdarcls and Recommended practices for Penoperative Nursing (Denver: Association of Operating Room Nurses, Inc, 1988) 11114-
8. 2. Ibid. 3. American Society for Hospital Central Service
Personnel, “Guidelines for the reuse of disposable medical devices,” Infection Control 7 (November 1986) 562-563. 4. Ibid. 5. J Kneedler, G Dodge, Penoperative Parient Care: The Nursing Perspective, second ed (Boston: Blackwell Scientific Publications, 1987) 446-451. 6. J Gamer, M Favero, Guideline for Prevention of Surgical Wound Infections, 1985 (Atlanta: Centers for Disease Control, 1985) 8. 7. Ibid. 8. H Polk Jr ed, Infection and the Surgical Patient (New York City: Churchill Livingstone, 1982) 33.
If you have questions you would like addressed in the “Clinical Issues” column of the AORN Journal, please send them to the AORN Consulmion Divkw4 I0170 E Mksksippi Ave, Denver, CO 80231. All questions will be considered for inclusion in thk column
AORN JOURNAL
Clinical Issues Resterilizing single-use items; technique for changing contaminated gloves; effectiveness of tacky mats
Q
uestion. I am the assistant nurse manager of the central sterile processing department in our hospital. In recent months, the OR supervisor (who also is the head of my department) has sent an increasing number of single-use disposable items to our area for reprocessing. Most of these items are clearly labeled, “Do not resterilize,” and they do not have manufacturer instructions for reprocessing. When I contact the companies, they are either unwilling or unable to provide any assistance, and they will say only that the items are intended for single use. The OR supervisor believes that if the item looks all right after resterilization, it is acceptable to use. I am uncomfortable resterilizing without manufacturer instructions, but I am unable to convince the OR supervisorthat to do so represents unsafe practice. Can you assist us with this problem ?
A
nswer. Patient safety should be the primary concern when considering reprocessing single-use devices. Reprocessing is not recommended unless the manufacturer provides written instructions for resterilizing single-use devices, or unless the health care facility can demonstrate and document that patient safety, device effectiveness, and device integrity are not compromised. The reprocessing of disposable devices intended by the manufacturer for single use is controversial. There is little research available on the subject. The AORN “Recommended practices for sterilization and disinfection” identify three areas to consider when making a decision regarding reprocessing: (1) device function and safety 356
following reprocessing, (2) legal and ethical issues associated with the device, and (3) economic concerns.’ Each single-use device should be considered on an individual basis after careful validation of the safety and efficacy of the item following reprocessing. A single-use device that cannot be cleaned, sterilized, or disinfected without damage to its integrity and/or function should not be reprocessed. If a single-use, disposable device is reused, the liability for that item reverts to the user? Validation of the safety, efficacy, and integrity of a reprocessed, single-use, disposable device should be based on an established reuse testing protocol. The objective of this protocol is to determine whether a disposable device can be safely reprocessed and reused. The protocol should apply to devices that have been used; to devices that are unused, but have exceeded their expiration date; and to devices that have been opened and removed from their sterile packaging, but not used. The protocol should include the following steps? Check package labels and insert information for manufacturer guidelines for reprocessing and reuse. If there are no manufacturer guidelines, contact the manufacturer for information on the physical properties of the device (eg, vinyl and latex) and, if possible, obtain information for cleaning, packaging, and resterilizing the device. Establish form and function criteria that the reprocessed device will be expected to meet, such as physical characteristics (eg, color, ~~
AUGUST 1988, VOL. 48, NO 2
AORN JOURNAL
shape, and size) and function (eg, motion, flexibility,and tensile strength). 4. Determine the facility’s ability to demonstrate adequate cleaning and sterilizing of the device, considering the physical prop erties of the item. 5. Determine the cost-effectiveness of reprocessing: 0 cost of the device, expected volume of use, 0 labor, overhead, and materials cost of reprocessing, and 0 risk and consequences of device failure. 6. Establish a testing protocol for each device, taking into consideration: necessary sample size for adequate study, 0 number of times the device can be reprocessed and still meet form and function criteria, procedures, chemicals, and equipment used in cleaning and sterilizing, process controls, quality assurance monitoring, and documentation of controls and monitoring activity, testing in simulated use situations, necessity for destructivetesting to identify unacceptable changes in the device, or residual toxicity, documentation of all testing results, and method of labeling and tracking for successive reprocessing. 7. Review test protocols and results with the facility’s administrative body, legal counsel, infection control committee, and the device manufacturer. 8. Determine policies on pricing, informed patient consent, and documentation of the use of reprocessed devices. 9. Periodically review the use of reprocessed devices to address patient safety, employee safety, and cost-effectiveness. The decision to reprocess single-use, disposable devices should not be taken lightly. In some instances it may be extremely difficult, if not impossible, to document that a device can be reprocessed without residual toxicity and still function safely and effectively. If reprocessing is done, it should be consistent throughout the health 358
care facility, and all reprocessing should conform to the established policies and protocols in the facility!
Q
uestion. The nurses in our OR disagree about how to change a contaminated glove during a surgical procedure. Some of the n u m insist on using the closed-glove technique, and others insist on the open-glove technique. Those who want to use the closed-glove technique become very upset and angry when the circulating nurse does not pull the stockinette cuff down over the hand when removing the contaminated glove. This may seem like an unimportant question, but it is creating a lot of dissention in our operating room. What is the proper way to change a contaminated glove during a surgical procedure?
A
nswer. There are two correct methods for changing a contaminated glove during a surgical procedure. The preferred method is for one member of the sterile team to glove the other. The contaminated glove should be removed by the circulating nurse, and a new glove presented by a member of the scrubbed surgical team. If this is not possible, the contaminated glove should be changed by the open-glove method. When using this method, the scrubbed person should be careful that the gown cuff is not pulled down or does not slip down over the hand. This prevents contact of the cleaner area (the hand) with the less clean area (the stockinette cuff of the gown). Stockinette is a moisture collecting fabric and is not an effective microbial bamer. Once the original gloves are donned, the stockinette cuff should be considered contaminated.5 If the cuff is considered contaminated, it would be improper technique to draw it down over the clean hand for successive gloving. The correct method for open gloving follows. 1. Turn away from the sterile field. 2. Extend the contaminated hand to the circulating nurse, who grasps the outside of the glove near the top and pulls it down and off, removing the glove inside out. 3. Pick up the new sterile glove with the gloved hand, keeping the gloved hand under the cuff of the new glove.
4. Insert the ungloved hand into the glove. 5. Pull the glove cuff up over the stockinette
cuff of the gown, covering the stockinette completely. At no time during this procedure should the ungloved hand come in contact with the exterior surface of the glove. To use the closed- gloving technique, the stockinette cuff of the gown must be sterile at the time the gloves are donned. Using this technique to replace a contaminated glove would require changing both gown and gloves. Many operating room n u m are resistant to the open-gloving method because it is less often used and therefore less often practiced. The technique is not difficult. It can be easily learned; and like any other skill, “practice makes perfect.”
Q
uestion. I am a new operating room supervisor and would like to make some changes in our OR. We are currently using tacky mats at the entrance to our department, but I have read that these mats are no longer necessary and could be eliminated. Some of the surgeons agree with me, but others are unwilling to allow the mats to be removed. They believe the mats are an important infectioncontrol measure because they clean the wheels of the patient carts after being out on the patient care units. Are tacky mats recommended?
A
nswer. The Centers for Disease Control (CDC), Atlanta, recommends that tacky or antiseptic mats not be used for infection control.6 This recommendation has been given a Category I rating. The CDC has categorized its recommendations into Categories I, 11, and 111. According to the CDC, measures in Category I are strongly supported by welldesigned and controlled clinical studies. Measures in Category I1 are supported by highly suggestive clinical studies in general hospitals or by definitive studies in specialty hospitals that might not be representative of general hospitals. Measures in Category 111 have been proposed by some investigators, authorities, or organizations, but lack supporting data, a strong theoretical rationale, or an indication that the benefits expected from them are costeffective.’
The problem with the tacky mats is that although the number of bacteria on shoe soles and cart wheels may be reduced intially, the bacteria quickly build up on the mat. These mats, unless frequently changed, become a haven for bacteria and may actually work against the principle for which they were originally intended. After the mat has been crossed several times, the next set of wheels or shoes may actually pick up bacteria deposited during a preceding trip.” DOROTHY M. FOGG, RN, BSN ASSISTANTDIRECTOR OF EDUCATION/ CONSULTATION Notes 1. “Recommended practices for sterilization and disinfection,” in AORN Srcmdarcls and Recommended practices for Penoperative Nursing (Denver: Association of Operating Room Nurses, Inc, 1988) 11114-
8. 2. Ibid. 3. American Society for Hospital Central Service
Personnel, “Guidelines for the reuse of disposable medical devices,” Infection Control 7 (November 1986) 562-563. 4. Ibid. 5. J Kneedler, G Dodge, Penoperative Parient Care: The Nursing Perspective, second ed (Boston: Blackwell Scientific Publications, 1987) 446-451. 6. J Gamer, M Favero, Guideline for Prevention of Surgical Wound Infections, 1985 (Atlanta: Centers for Disease Control, 1985) 8. 7. Ibid. 8. H Polk Jr ed, Infection and the Surgical Patient (New York City: Churchill Livingstone, 1982) 33.
If you have questions you would like addressed in the “Clinical Issues” column of the AORN Journal, please send them to the AORN Consulmion Divkw4 I0170 E Mksksippi Ave, Denver, CO 80231. All questions will be considered for inclusion in thk column