FEBRUARY 1992, VOL 55, NO 2
AORN JOURNAL
Clinical Issues Environmental isssues concerning sterile reprocessing, disposal practices, recycling
Q
uestion: I am the director of surgical services, which includes the area of central sterile processing. The manager of the sterile processing department has asked me about reprocessing single-use disposable items to cut down on the amount of waste from the OR. Many of the items are labeled, “Do not resterilize,” and there are no manufacturer instructions for reprocessing these items. I have contacted the manufacturers of these items, but they are either unwilling or unable to provide any assistance. They state that their items are intended for single-use only. Without acceptable documentation from these manufacturers, I am uncomfortable with resterilizing single-use items. Is there anything that we can do to reprocess single-use items without jeopardizing patient safety?
A
nswer: Patient safety must be the primary concern when considering reprocessing devices intended for single-use. Reprocessing of single-use items is not recommended unless the manufacturer provides written instructions for resterilization, or 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 to be single-use is a controversial topic. The AORN recommended practices states that Factors to be considered in the decision to reprocess and/or reuse include,( 1 ) item function and safety following repro606
cessing, ( 2 ) legal and ethical issues nssociated with the item, and (3) economics. Each disposable device to be reprocessed should be considered on an individual basis after careful consideration of each item’s safety and efficacy following reprocessing. If a singleuse item cannot be cleaned, sterilized, or disinfected without damage to its integrity and/or function, then the item should not be reprocessed.‘ If a single-use, disposable device is reused, liability for that item reverts to the user.3 An established testing protocol should be used to validate the safety, efficacy, and integrity of a reprocessed, single-use, disposable device. The objective of this protocol is to assess whether a disposable device can be safely reprocessed. This protocol should apply to devices that have been used on a patient, opened and removed from their sterile packaging but not used, or items that were not used but have exceeded their expiration date. The protocol for your facility should include the following.4 1 . Check the package label and/or insert for the manufacturers’ guidelines for reprocessing and reuse. 2 . If the manufacturer does not provide guidelines for reprocessing, try to obtain information on the physical properties of the item (eg, stainless steel, rubber, latex) and information for cleaning, packaging, and resterilizing the item. 3. Form and function criteria that the reprocessed device will be expected to meet also must be addressed. This includes color, shape,
FEBRUARY 1992, VOL 55, NO 2
AORN JOURNAL
Decisions regarding the reprocessing and reuse of single-use items should not be taken lightly. size, motion, flexibility, and tensile strength. 4. The facility’s ability to demonstrate adequate cleaning and sterilizing of the item must be determined. 5. To determine if reprocessing an item is cost-effective, the following factors should be considered: cost; expected volume of use; labor, overhead, and the cost of the materials for reprocessing; and risk and consequences of device failure. 6 . A testing protocol must be established for each device that includes: sample size for adequate study; 0 the number of times the device can be reprocessed and still meet form and function criteria; 0 procedures, chemicals, and equipment used in cleaning and sterilizing; 0 process controls, quality assurance monitoring, and documentation of controls and monitoring activity; testing in simulated-use situations; the necessity for destructive testing to identify unacceptable changes in the device, or residual toxicity; documentation of all testing results; and 0 a method of labeling and tracking for successive reprocessing. 7. Review the test protocols and/or results with the facility’s administration, legal representative, infection control committee, and the device manufacturer. 8 . Establish policies regarding pricing, informed patient consent, and documentation of the use of the reprocessed devices. 9. Develop a system to periodically review the use of each reprocessed item that addresses patient safety, employee safety, and cost-effectiveness. Decisions regarding the reprocessing and
reuse of single-use items should not be taken lightly. In some situations it may be difficult, if not impossible, to document that a device can be reprocessed and still function safely and effectively. If reprocessing is done, it should be consistent throughout the facility, and all reprocessing should conform to the established policies and protocols of the fa~ility.~
Q
uestion: Our hospital is investigating disposal issues such as incineration vs. landfill and specific definitions of infectious waste, noninfectious waste, and hazardous waste to name a few. Is there any information that AORN has to help with these issues?
Ac
nswer: At the pre-Congress Board meeting ie, April 1991) in Atlanta, the Board approved the formation of a Special Committee on Environmental Issues. The Committee’s responsibilities include: collecting data on the impact of perioperative nursing on the environment, disseminating information on waste management and resource conservation, 0 influencing legislative and regulatory activity, encouraging collaboration of perioperative nurses and industry to address environmental concerns, and fostering change through research and development on specific environmental practices and products.b Committee members will report to their findings to the Board, and members also will conduct one of two education sessions at the 1992 Congress on environmental concerns. Infectious waste, in its simplest terms, is waste capable of producing an infectious disease.7 Items such as blood and blood products, pathology samples, and stocks and cultures of pathogens, as well as items that contain blood 607
FEBRUARY 1992, VOL. 5 5 , NO 2
AORN JOURNAL
such as patient drapes, sponges, laparotomy sponges, gowns, gloves, and sharps, are examples of infectious waste. Noninfectious waste could include external wrappers, packaging materials, glove wrappers, or prepping materials and solutions that are not contaminated with blood or body fluids.x In addition, some thought is being given to classifying drapes, gowns, gloves, towels, or other disposable products as infectious even though they do not have any visible blood. When disposing of infectious waste, hospitals must comply with their local, state, or federal guidelines. Currently, landfills can be used only for noninfectious medical waste or waste that cannot be recycled or incinerated. Most of the infectious waste from hospitals is incinerated. Some hospitals have the capability of onsite incineration; other facilities use an off-site facility. There are benefits and limitations to incineration of infectious waste. Some benefits include reducing the volume of waste by 85% to 95%.9 If the incinerator is properly maintained and in compliance with regulations, it minimizes the environmental impact of waste disposal. Under optimal conditions, incineration kills all pathogens. The heating value of burned waste can be recovered as steam or electricity.’O Limitations to incineration are costs, which can range from $300 per ton for on-site incineration to $800 per ton for off-site processing. The cost to hospitals to bring existing incinerators into compliance or to construct a new incinerator range from $50,000 to $1.5 million. Leftover ash, which could contain toxic waste, must be sent to a landfill. The public has pressured local officials to ban construction of incinerators based on a “not in my backyard’ attitude.” Concerns regarding the environment have put pressure on industry as well as health care workers to improve and develop new disposal techniques. Issues of waste reduction, recycling, incineration, and landfill capacities are the concerns of everyone.
Q
uestion: Our operating room is doing everything possible to reduce medical
608
waste disposal. One thing that we are now addressing is the possibility of recycling some of the unused products in the OR. Is there any information on what products can be safely reprocessed and how we would deliver them to the appropriate site?
A
nswer: The public, hospital staff members, and industry are looking at recycling products in an attempt to reduce the amount of waste. Currently, 11% of municipal waste is recycled; however, the Environmental Protection Agency estimates that 25% could be recycled with more participation by the public.I2 Twenty-five percent of hospital waste is corrugated, and 20% is plastic, much of which is recyclable.” In setting up a program at your facility yo will want to consider: instructing the staff in separation procedures; addressing space, safety, and hygiene issues needed for storage on-site before recycling; and transporting materials to a reclamation site.14 In addition, other areas of the hospital that could consider recycling products may have disposable items such as newspaper print, computer paper, bottles, and aluminum cans. Whether specific medical items can be recycled if they are opened and not used will depend on the manufacturer of those items. You will need to contact individual companies for specific instructions. To help with recycling, many companies are researching ways to use recycled products in the development of their single-use disposable items. MARYO’NEALE,RN, BS, CNOR SPECIALIST CONSULTATIVE EDUCATION AND NURSING PRACTICE Notes 1. “Recommended practices for sterilization and disinfection,” i n AORN Standards and
Recommended Practices f o r Perioperative Nursing (Denver: Association of Operating Room Nurses, Inc, 1991) III:17-8. 2. lbid.
AORN JOURNAL
3. Ibid. 4. A m e r i c a n Society for Hospital Central Service Personnel, “Guidelines for the reuse of disposable medical devices.“ Infection Control 7 (November 1986)562-563. 5. Ibid, 562-563. 6. V Pierce, “Board identifies legislative priorities, broadens AORN’s activities on environment and AIDS issues,” (Board Report) AORN Journal 54
(December 1991) 1168-1169. 7. “Guide for Infectious Waste Management.” pub1 no 530-SW-86-014 (Washington,DC: US
FEBRUARY 1992, VOL 55, NO 2
Environmental Protection Agency, 1986). 8. M F Fay et al, “Medical waste: The growing issues of management and disposal,” AORN Journal (June 1990) 1500. 9. Questions and Answers About Medical Waste and t h e Environment (McGaw Park, IL: Baxter Healthcare Corp, 1990) 3. 10. Ibid. 11. Ibid. 12. Ibid, 4. 13. Ihid. 14. Ibid.
Film Review
Cost-Effective Healthcare in a Hazardous Environment This 20-minute videotape and its study guide are designed to introduce perioperative nurses to the topic of waste management from generation to disposal. Using a documentary style, interviews with an infection control nurse, safety director, and operating room director illustrate the interdisciplinary approach necessary to develop an effective waste management program. The narrator states that more than 5 0 8 of infectious waste, which costs up to 10 times more to dispose of than general waste, is generated in the operating room. The videotape emphasizes that waste management program developers must look at factors besides cost, including staff and patient protection, risk management concerns, and environmental impact. The interviews in the videotape describe how several hospitals examined their waste management programs to develop disposal programs that comply with regulatory agencies, provide a safer work environment, and are more cost effective. Using a “waste stream survey.” interdisciplinary teams followed a trail of trash from generation to disposal. Suggestions include reducing what is considered infectious waste. One hospital team examined the contents of “red bags” of trash and found that 9 5 9 of the contents were not infec-
tious waste. Segregating trash into two containers was their solution. Noninfectious waste is then disposed of in a less costly manner. The videotape provides a good overview of a complex issue. It presents some thought-provoking suggestions for improving disposal programs. It would be a good media tool for an interdisciplinary group interested in developing a waste management program. It also would be useful to increase staff awareness about this huge problem. The videotape and study guide are available from Baxter Healthcare Corp, Operating Room Division, 1500 Waukegan Road, McGaw Park, IL 60085. Continuing education credit for viewing the videotape and reading the study guide is available for a fee upon completion of the test questions. BILLIEFERNSEBNER, RN, MSN, CNOR AUDIOVISUAL COMMITTEE
AORN JOURNAL
Clinical Issues Environmental isssues concerning sterile reprocessing, disposal practices, recycling
Q
uestion: I am the director of surgical services, which includes the area of central sterile processing. The manager of the sterile processing department has asked me about reprocessing single-use disposable items to cut down on the amount of waste from the OR. Many of the items are labeled, “Do not resterilize,” and there are no manufacturer instructions for reprocessing these items. I have contacted the manufacturers of these items, but they are either unwilling or unable to provide any assistance. They state that their items are intended for single-use only. Without acceptable documentation from these manufacturers, I am uncomfortable with resterilizing single-use items. Is there anything that we can do to reprocess single-use items without jeopardizing patient safety?
A
nswer: Patient safety must be the primary concern when considering reprocessing devices intended for single-use. Reprocessing of single-use items is not recommended unless the manufacturer provides written instructions for resterilization, or 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 to be single-use is a controversial topic. The AORN recommended practices states that Factors to be considered in the decision to reprocess and/or reuse include,( 1 ) item function and safety following repro606
cessing, ( 2 ) legal and ethical issues nssociated with the item, and (3) economics. Each disposable device to be reprocessed should be considered on an individual basis after careful consideration of each item’s safety and efficacy following reprocessing. If a singleuse item cannot be cleaned, sterilized, or disinfected without damage to its integrity and/or function, then the item should not be reprocessed.‘ If a single-use, disposable device is reused, liability for that item reverts to the user.3 An established testing protocol should be used to validate the safety, efficacy, and integrity of a reprocessed, single-use, disposable device. The objective of this protocol is to assess whether a disposable device can be safely reprocessed. This protocol should apply to devices that have been used on a patient, opened and removed from their sterile packaging but not used, or items that were not used but have exceeded their expiration date. The protocol for your facility should include the following.4 1 . Check the package label and/or insert for the manufacturers’ guidelines for reprocessing and reuse. 2 . If the manufacturer does not provide guidelines for reprocessing, try to obtain information on the physical properties of the item (eg, stainless steel, rubber, latex) and information for cleaning, packaging, and resterilizing the item. 3. Form and function criteria that the reprocessed device will be expected to meet also must be addressed. This includes color, shape,
FEBRUARY 1992, VOL 55, NO 2
AORN JOURNAL
Decisions regarding the reprocessing and reuse of single-use items should not be taken lightly. size, motion, flexibility, and tensile strength. 4. The facility’s ability to demonstrate adequate cleaning and sterilizing of the item must be determined. 5. To determine if reprocessing an item is cost-effective, the following factors should be considered: cost; expected volume of use; labor, overhead, and the cost of the materials for reprocessing; and risk and consequences of device failure. 6 . A testing protocol must be established for each device that includes: sample size for adequate study; 0 the number of times the device can be reprocessed and still meet form and function criteria; 0 procedures, chemicals, and equipment used in cleaning and sterilizing; 0 process controls, quality assurance monitoring, and documentation of controls and monitoring activity; testing in simulated-use situations; the necessity for destructive testing to identify unacceptable changes in the device, or residual toxicity; documentation of all testing results; and 0 a method of labeling and tracking for successive reprocessing. 7. Review the test protocols and/or results with the facility’s administration, legal representative, infection control committee, and the device manufacturer. 8 . Establish policies regarding pricing, informed patient consent, and documentation of the use of the reprocessed devices. 9. Develop a system to periodically review the use of each reprocessed item that addresses patient safety, employee safety, and cost-effectiveness. Decisions regarding the reprocessing and
reuse of single-use items should not be taken lightly. In some situations it may be difficult, if not impossible, to document that a device can be reprocessed and still function safely and effectively. If reprocessing is done, it should be consistent throughout the facility, and all reprocessing should conform to the established policies and protocols of the fa~ility.~
Q
uestion: Our hospital is investigating disposal issues such as incineration vs. landfill and specific definitions of infectious waste, noninfectious waste, and hazardous waste to name a few. Is there any information that AORN has to help with these issues?
Ac
nswer: At the pre-Congress Board meeting ie, April 1991) in Atlanta, the Board approved the formation of a Special Committee on Environmental Issues. The Committee’s responsibilities include: collecting data on the impact of perioperative nursing on the environment, disseminating information on waste management and resource conservation, 0 influencing legislative and regulatory activity, encouraging collaboration of perioperative nurses and industry to address environmental concerns, and fostering change through research and development on specific environmental practices and products.b Committee members will report to their findings to the Board, and members also will conduct one of two education sessions at the 1992 Congress on environmental concerns. Infectious waste, in its simplest terms, is waste capable of producing an infectious disease.7 Items such as blood and blood products, pathology samples, and stocks and cultures of pathogens, as well as items that contain blood 607
FEBRUARY 1992, VOL. 5 5 , NO 2
AORN JOURNAL
such as patient drapes, sponges, laparotomy sponges, gowns, gloves, and sharps, are examples of infectious waste. Noninfectious waste could include external wrappers, packaging materials, glove wrappers, or prepping materials and solutions that are not contaminated with blood or body fluids.x In addition, some thought is being given to classifying drapes, gowns, gloves, towels, or other disposable products as infectious even though they do not have any visible blood. When disposing of infectious waste, hospitals must comply with their local, state, or federal guidelines. Currently, landfills can be used only for noninfectious medical waste or waste that cannot be recycled or incinerated. Most of the infectious waste from hospitals is incinerated. Some hospitals have the capability of onsite incineration; other facilities use an off-site facility. There are benefits and limitations to incineration of infectious waste. Some benefits include reducing the volume of waste by 85% to 95%.9 If the incinerator is properly maintained and in compliance with regulations, it minimizes the environmental impact of waste disposal. Under optimal conditions, incineration kills all pathogens. The heating value of burned waste can be recovered as steam or electricity.’O Limitations to incineration are costs, which can range from $300 per ton for on-site incineration to $800 per ton for off-site processing. The cost to hospitals to bring existing incinerators into compliance or to construct a new incinerator range from $50,000 to $1.5 million. Leftover ash, which could contain toxic waste, must be sent to a landfill. The public has pressured local officials to ban construction of incinerators based on a “not in my backyard’ attitude.” Concerns regarding the environment have put pressure on industry as well as health care workers to improve and develop new disposal techniques. Issues of waste reduction, recycling, incineration, and landfill capacities are the concerns of everyone.
Q
uestion: Our operating room is doing everything possible to reduce medical
608
waste disposal. One thing that we are now addressing is the possibility of recycling some of the unused products in the OR. Is there any information on what products can be safely reprocessed and how we would deliver them to the appropriate site?
A
nswer: The public, hospital staff members, and industry are looking at recycling products in an attempt to reduce the amount of waste. Currently, 11% of municipal waste is recycled; however, the Environmental Protection Agency estimates that 25% could be recycled with more participation by the public.I2 Twenty-five percent of hospital waste is corrugated, and 20% is plastic, much of which is recyclable.” In setting up a program at your facility yo will want to consider: instructing the staff in separation procedures; addressing space, safety, and hygiene issues needed for storage on-site before recycling; and transporting materials to a reclamation site.14 In addition, other areas of the hospital that could consider recycling products may have disposable items such as newspaper print, computer paper, bottles, and aluminum cans. Whether specific medical items can be recycled if they are opened and not used will depend on the manufacturer of those items. You will need to contact individual companies for specific instructions. To help with recycling, many companies are researching ways to use recycled products in the development of their single-use disposable items. MARYO’NEALE,RN, BS, CNOR SPECIALIST CONSULTATIVE EDUCATION AND NURSING PRACTICE Notes 1. “Recommended practices for sterilization and disinfection,” i n AORN Standards and
Recommended Practices f o r Perioperative Nursing (Denver: Association of Operating Room Nurses, Inc, 1991) III:17-8. 2. lbid.
AORN JOURNAL
3. Ibid. 4. A m e r i c a n Society for Hospital Central Service Personnel, “Guidelines for the reuse of disposable medical devices.“ Infection Control 7 (November 1986)562-563. 5. Ibid, 562-563. 6. V Pierce, “Board identifies legislative priorities, broadens AORN’s activities on environment and AIDS issues,” (Board Report) AORN Journal 54
(December 1991) 1168-1169. 7. “Guide for Infectious Waste Management.” pub1 no 530-SW-86-014 (Washington,DC: US
FEBRUARY 1992, VOL 55, NO 2
Environmental Protection Agency, 1986). 8. M F Fay et al, “Medical waste: The growing issues of management and disposal,” AORN Journal (June 1990) 1500. 9. Questions and Answers About Medical Waste and t h e Environment (McGaw Park, IL: Baxter Healthcare Corp, 1990) 3. 10. Ibid. 11. Ibid. 12. Ibid, 4. 13. Ihid. 14. Ibid.
Film Review
Cost-Effective Healthcare in a Hazardous Environment This 20-minute videotape and its study guide are designed to introduce perioperative nurses to the topic of waste management from generation to disposal. Using a documentary style, interviews with an infection control nurse, safety director, and operating room director illustrate the interdisciplinary approach necessary to develop an effective waste management program. The narrator states that more than 5 0 8 of infectious waste, which costs up to 10 times more to dispose of than general waste, is generated in the operating room. The videotape emphasizes that waste management program developers must look at factors besides cost, including staff and patient protection, risk management concerns, and environmental impact. The interviews in the videotape describe how several hospitals examined their waste management programs to develop disposal programs that comply with regulatory agencies, provide a safer work environment, and are more cost effective. Using a “waste stream survey.” interdisciplinary teams followed a trail of trash from generation to disposal. Suggestions include reducing what is considered infectious waste. One hospital team examined the contents of “red bags” of trash and found that 9 5 9 of the contents were not infec-
tious waste. Segregating trash into two containers was their solution. Noninfectious waste is then disposed of in a less costly manner. The videotape provides a good overview of a complex issue. It presents some thought-provoking suggestions for improving disposal programs. It would be a good media tool for an interdisciplinary group interested in developing a waste management program. It also would be useful to increase staff awareness about this huge problem. The videotape and study guide are available from Baxter Healthcare Corp, Operating Room Division, 1500 Waukegan Road, McGaw Park, IL 60085. Continuing education credit for viewing the videotape and reading the study guide is available for a fee upon completion of the test questions. BILLIEFERNSEBNER, RN, MSN, CNOR AUDIOVISUAL COMMITTEE
