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Standards for packaging needed for improved safety
Guest editorial
Standards for ackaging needed For improved safety “Is this surgical tray sterile?” Assuming central service selected the elements of the tray properly, packaged and processed the tray effectively, then the most likely component that can fail and cause contamination is the packaging material itself. Packaging is a vital factor in ensuring microbiological safety in a surgical procedure. What standards exist today that give the necessary assurance? Actually, there are none. It seems to us that there are numerous reasons for this void: The myths of absolute sterility and the seeming simplicity of packaging, sterilizing, storing, and testing for sterility have survived until recently. Those responsible for sterilizing are now begin-
Bertha Yanis Litsky, PhD, is research associate, department of environmental sciences, University of Massachusetts, A mherst. Warren Litsky, PhD, is chairman of the department of environmental sciences and commonwealth professor of public health, University of Massachusetts.
M
ning to understand that it is a matter of probability and a complicated process. 0 Establishment and measurement of conformance to standards are beyond the scope of the average hospital clinical laboratory. The sophistication of the techniques and equipment and the amount and expense of meaningful testing would impose an unreasonable burden for any one hospital to bear. While these are valid reasons, they cannot be excuses for inadequate assurances of microbiological safety. Among those who have recognized this are Briggs Phillips and William Miller, Kay Lange, Peggy Ryan, Rose Marie McWilliams, and Carl W Bruch.’ We have looked at the problem and concluded that no one individual should presume to set the quality assurance standards for all of the many elements that can be involved in packaging of items for surgical procedures. This question must be resolved jointly by the central service, nursing, medical, and scientific communities in close collaboration with industry and government agencies. Some of the critical performance characteristics that should be included in the evaluation of packaging materials are bacterial barrier properties, time-temperature profiles, steam penetration, compatibility with ethylene oxide gas (EO), transfer of substances to the package contents, and generation of nonviable particles. Shelf-life testing requires a scientifically sound protocol and careful execution. Both clean room and sterile techniques must be
AORN Journal, January 1976, Val 23,No 1
21
practiced. Samples for sterility testing must be aseptically taken from packages that were prepared and stored under actual in-use conditions. The physical size and number of samples must be sufficiently large to determine accurately low levels of contamination. Enough samples must be evaluated to assure statistical validity. To obtain the time-temperature profile of a pack wrapped in the material under evaluation requires the testing of a properly constructed package and use of a recording pyrometer with carefully calibrated and properly placed thermocouples. These should be placed both within the pack that is placed in the cold spot of the autoclave and in the autoclave chamber cold spot as well. Steam penetration, on the other hand, can be demonstrated by the use of biological monitors and chemical controls placed in the center of a test pack located in the cold spot of the autoclave. Determination of penetrability by EO can be done by the use of biological monitors in every EO cycle and by following the other recommendations of the Sterilization Standards Subcommittee of the Association for the Advancement of Medical lnstnrmentation (AAMI) and the Food and Drug Administration (FDA). The present recommendations of AAMl and the FDA are based on the AAMl 279 Subcommittee on EO Sterilization.* The residuals of EO and its derivatives can be measured by gas chromatography. Standard methods may also be used to determine whether substances are transferred from the packaging material to the contents during sterilization. Testing for the generation of lint particles from the packaging material requires clean room technique and the use of appropriate counting and measuring equipment. While moisture repellency reduces the risk of contamination, it should not be the only criterion used to evaluate surgical wrap material. The complexity of the total evaluation of a surgical wrap requires that it be carried out by laboratories that are properly equipped and staffed by personnel with the requisite expertise. In the case of disposable wraps, it is incumbent upon the manufacturer to provide adequate test data of his own to assure
28
the user that the materials are safe. With the growing demands placed on the hospital community for improved safety, the establishment of standards for packaging must have high priority.
Bertha Y Litsky, PhD Warren Litsky, PhD Notes 1. Briggs Phillips, William Miller, eds. industrial Sterilization (Durham, NC:Duke University Press, 1973); Kay Lange, chairperson of Standards Committee for the Association of Operating Room Nurses, Standards now in preparation; Peggy Ryan, “Basics of packaging,” AORN Journal 21 (May 1975) 1091-1112; Rose Marie McWilliams, “The experts research: Q & A,” AORN Journal 19 (January 1974) 124. 2. AAMl 279 Ethylene Oxide Subcommittee, ”Proper use of ethylene oxide in hospitals and other medical facilities,” AORN Journal 19 (June 1974) 1290-1295.
Ruth P Satterfield AANA award recipient Ruth P Satterfield, CRNA, Lewistown, Pa, is the first recipient of the Agatha Hodgins Award for Outstanding Accomplishment of the American Association of Nurse Anesthetists (AANA). The award, established “to recognize individuals whose foremost dedication to excellence has furthered the art and science of nurse anesthesia,” was presented at the 42nd annual meeting and clinical session of the AANA in Chicago. Mrs Satterfield was honored for her outstanding contributions to the education of nurse anesthetists and to the association. A certified registered nurse anesthetist since 1941, she has devoted the majority of her anesthetist career to the Army Nurse Corps. She served as education director of all Army schools of nurse anesthesia and concluded her Army career as consultant to the army surgeon general. The Agatha Hodgins Award was named in honor of Agatha Hodgins, who was the founder and first president of the AANA.
AORN Journal, January 1976, Vol23, No 1
Standards for ackaging needed For improved safety “Is this surgical tray sterile?” Assuming central service selected the elements of the tray properly, packaged and processed the tray effectively, then the most likely component that can fail and cause contamination is the packaging material itself. Packaging is a vital factor in ensuring microbiological safety in a surgical procedure. What standards exist today that give the necessary assurance? Actually, there are none. It seems to us that there are numerous reasons for this void: The myths of absolute sterility and the seeming simplicity of packaging, sterilizing, storing, and testing for sterility have survived until recently. Those responsible for sterilizing are now begin-
Bertha Yanis Litsky, PhD, is research associate, department of environmental sciences, University of Massachusetts, A mherst. Warren Litsky, PhD, is chairman of the department of environmental sciences and commonwealth professor of public health, University of Massachusetts.
M
ning to understand that it is a matter of probability and a complicated process. 0 Establishment and measurement of conformance to standards are beyond the scope of the average hospital clinical laboratory. The sophistication of the techniques and equipment and the amount and expense of meaningful testing would impose an unreasonable burden for any one hospital to bear. While these are valid reasons, they cannot be excuses for inadequate assurances of microbiological safety. Among those who have recognized this are Briggs Phillips and William Miller, Kay Lange, Peggy Ryan, Rose Marie McWilliams, and Carl W Bruch.’ We have looked at the problem and concluded that no one individual should presume to set the quality assurance standards for all of the many elements that can be involved in packaging of items for surgical procedures. This question must be resolved jointly by the central service, nursing, medical, and scientific communities in close collaboration with industry and government agencies. Some of the critical performance characteristics that should be included in the evaluation of packaging materials are bacterial barrier properties, time-temperature profiles, steam penetration, compatibility with ethylene oxide gas (EO), transfer of substances to the package contents, and generation of nonviable particles. Shelf-life testing requires a scientifically sound protocol and careful execution. Both clean room and sterile techniques must be
AORN Journal, January 1976, Val 23,No 1
21
practiced. Samples for sterility testing must be aseptically taken from packages that were prepared and stored under actual in-use conditions. The physical size and number of samples must be sufficiently large to determine accurately low levels of contamination. Enough samples must be evaluated to assure statistical validity. To obtain the time-temperature profile of a pack wrapped in the material under evaluation requires the testing of a properly constructed package and use of a recording pyrometer with carefully calibrated and properly placed thermocouples. These should be placed both within the pack that is placed in the cold spot of the autoclave and in the autoclave chamber cold spot as well. Steam penetration, on the other hand, can be demonstrated by the use of biological monitors and chemical controls placed in the center of a test pack located in the cold spot of the autoclave. Determination of penetrability by EO can be done by the use of biological monitors in every EO cycle and by following the other recommendations of the Sterilization Standards Subcommittee of the Association for the Advancement of Medical lnstnrmentation (AAMI) and the Food and Drug Administration (FDA). The present recommendations of AAMl and the FDA are based on the AAMl 279 Subcommittee on EO Sterilization.* The residuals of EO and its derivatives can be measured by gas chromatography. Standard methods may also be used to determine whether substances are transferred from the packaging material to the contents during sterilization. Testing for the generation of lint particles from the packaging material requires clean room technique and the use of appropriate counting and measuring equipment. While moisture repellency reduces the risk of contamination, it should not be the only criterion used to evaluate surgical wrap material. The complexity of the total evaluation of a surgical wrap requires that it be carried out by laboratories that are properly equipped and staffed by personnel with the requisite expertise. In the case of disposable wraps, it is incumbent upon the manufacturer to provide adequate test data of his own to assure
28
the user that the materials are safe. With the growing demands placed on the hospital community for improved safety, the establishment of standards for packaging must have high priority.
Bertha Y Litsky, PhD Warren Litsky, PhD Notes 1. Briggs Phillips, William Miller, eds. industrial Sterilization (Durham, NC:Duke University Press, 1973); Kay Lange, chairperson of Standards Committee for the Association of Operating Room Nurses, Standards now in preparation; Peggy Ryan, “Basics of packaging,” AORN Journal 21 (May 1975) 1091-1112; Rose Marie McWilliams, “The experts research: Q & A,” AORN Journal 19 (January 1974) 124. 2. AAMl 279 Ethylene Oxide Subcommittee, ”Proper use of ethylene oxide in hospitals and other medical facilities,” AORN Journal 19 (June 1974) 1290-1295.
Ruth P Satterfield AANA award recipient Ruth P Satterfield, CRNA, Lewistown, Pa, is the first recipient of the Agatha Hodgins Award for Outstanding Accomplishment of the American Association of Nurse Anesthetists (AANA). The award, established “to recognize individuals whose foremost dedication to excellence has furthered the art and science of nurse anesthesia,” was presented at the 42nd annual meeting and clinical session of the AANA in Chicago. Mrs Satterfield was honored for her outstanding contributions to the education of nurse anesthetists and to the association. A certified registered nurse anesthetist since 1941, she has devoted the majority of her anesthetist career to the Army Nurse Corps. She served as education director of all Army schools of nurse anesthesia and concluded her Army career as consultant to the army surgeon general. The Agatha Hodgins Award was named in honor of Agatha Hodgins, who was the founder and first president of the AANA.
AORN Journal, January 1976, Vol23, No 1