William C Beck, MD Paul F Nora, MD
ASTM standard for surgical gloves
A new “Standard for surgical gloves” has been written by a committee of the American Society for Testing and Materials (ASTM), a standardization organization. This standard is a minimum specification of the attributes of a surgical glove. It is not a legal requirement that all surgical gloves conform to this minimum standard. Nurses or surgeons may, however, use it when they buy surgical gloves or recommend it to the hospital’s product evaluation committee. I n fact, they may recommend more than
William C Beck, MD, F A C S , is president of the Donald Guthrie Foundation for Medical Research, Sayre, Pa. He is a consultant to the A O R N Technical Standards Committee and a graduate of Northwestern University Medical School, Evanston, Ill. Paul F Nora, MD, F A C S , is associate professor of surgery, Northwestern University Medical School, and chairman of the department of surgery, Colu mb us-Cuneo-Cabrini Med ical Center, Chicago. He is a graduate of Loyola University of Chicago Medical School and received his M S and PhD i n surgery from Northwestern University Medical School.
this standard’s requirement. Knowledge of the provisions of the standard is essential if one is involved in the product purchase of surgical gloves. Copies of the standard may be obtained from the ASTM, 1916 Race St, Philadelphia, Pa 19103. It would be worthwhile for every operating room nurse to have a copy on file and to have a n understanding of its provisions. The elements of the new standard in which we are interested are: 0 the sterility of the gloves and the test method for sterility 0 the number of holes in gloves and the test method for detecting holes 0 the dimensions for the glove including the thickness 0 the tensile strength, elongation, and resistance to stress both new and after aging. Each element will be discussed separately. The standard also mentions the lubricant but refers the reader to the United States Pharmacopeia (USP) under the heading “absorbable dusting powder.” Further elaboration of this is described. Noteworthy is the lack of any reference concerning electrical resistance of gloves, which can be important when handling electrosurgical equipment.
AORN Journal, April 1977, Vol25, No 5
869
M
ethod of testing important in glove specifications.
This will also be considered in our discussion. The sterility of the gloves. The standard requires that all gloves be sterile and defines the testing methods as described in the latest USP. It stresses importance of monitoring the methods of sterilization and employment of biologic indicators rather than the sterility testing. Actually, only 20 gloves of each sterilizer load need to be incubated for ten days for a proof of sterility if adequate biologic indicators are used in each load. Holes in the glove. Special attention should be paid to the standard’s allowance of 1.5% of new gloves t o contain holes and still be acceptable for sale. (As originally written, the standard permitted 2.5% to contain holes. Possibly as the result of protests by both the Association of Operating Room Nurses and the American College of Surgeons, the final draft was changed to read 1.5%.) Our primary concern would be that all gloves be tested for holes, actually not how many gloves should be examined from each batch. The gloves are tested by fastening them t o a circular device much like a large cork with a piece of tubing going through its center. The glove is inflated with air to a high gauge pressure (1.5 K Pa). It is then inserted into a water bath ensuring it to a depth at least to the cuff level. Air bubbles coming through the glove reveal the hole. 870
In accordance with this standard, the number of gloves to be so tested from each batch is determined by a rather complex formula. This formula has been found statistically accurate in determining the percent of failures in each batch. The final standard requires the maximum to be less than 1.5%. Physical dimensions. In the standard, gloves are sized by the length from the tip of the second finger to the terminal edge of the cuff. The width of the glove is measured across the palm along the distal flexion crease. Although glove sizes in the United States are a reflection of their width in inches, all the sizes in the standard are given in millimeters with a width tolerance of & 6 mm. The length is also at a minimum. (Hand sizes are presently under study t o see if a better understanding of dimensions might not result in a more perfect fit. Often people are forced to wear gloves that fit in the palm but whose fingers are too short or too long. This may be reflected in future standards.) The thickness of the gloves is given a t a minimum of 0.1 mm (4/1,000 inch). No maximum thickness is given. The thickness is measured at 13 mm from the tip of the index finger, the palm between the middle and ring finger 33 mm from the interdigital level, and the cuff 25 mm from its edge. The Acceptable Quality Level (AQL)
AORN Journal, April 1977, Vol25, N o 5
for defects in physical dimensions is stated to be 4% so that a maximum for each batch may contain 4% outsized for length, width, or thickness. The number of each batch to be tested is prescribed. Physical requirements. These vary somewhat depending on whether the glove was formed from rubber compounded as a n emulsion (type I) or solution (type 11). Type I has a higher tensile strength and elongates more both before and after aging to a modest degree. Aging is studied by means of generally accepted accelerated aging test. This is carried out in air oven for 166 hours a t 70 C (160 F). The AQL for defects in physical requirements is also an average of 4%. The sampling level is given for each batch depending on its size. Discussion, We have already commented that a t present the requirements of this standard are not mandatory for manufacturers. It appears to us, however, that they will become so under the 1976 Medical Device Amendments to the Food and Drug Act. The Food and Drug Administration is now responsible for the efficacy and safety of all medical devices, and surgical gloves certainly will be priority items. The AORN and the Committee on the Operating Room Environment of the American College of Surgeons have both officially protested the ac-
ceptability of a n AQL of 2.5% for holes. Many in the industry unofficially tell us they can achieve a n AQL of less than 1%by the underwater test described in this standard. It is very important to discuss the method of testing when reviewing glove specifications with vendors. We believe that eventually as high a level of performance as required for sterility will be achieved in the AQL for holes. It might mean a change in the manufacturing process with a double dip for the glove. It will also demand 100% testing. We understand this has been achieved by several manufacturers, but not by the test described in the standard. Thus the manufacturer who does lOW? testing must show the relative merits of his test in comparison to the one described in the standard. Hospital product evaluation committees or hospital purchasing services should be aware of these constraints. Rubber surgeon’s gloves are generally single-use items and, therefore, constitute a great expense for the hospital. But a cost saving by purchasing inferior gloves is negligible if the gloves do not fulfill their prime function even when new. There is much evidence that the absorbable dusting powder used as a lubricant for the glove can be harmful when it is shed in serious cavities such as a peritoneum. Absorbable dusting powder, described in USP XIX, con-
AORN Journal, April 1977, Val 25, No 5
87 1
sists of a processed cornstarch and is not to contain more than 2.0% of a magnesium oxide. While the standard refers to the USP, it would appear to us that the exact composition of the powder, its presence on the glove, and directions about its removal should appear on the package. If foodstuff packages are required to describe the chemical composition of their content, should not materials to be introduced directly into tissues be similarly described? The electrical conductivity of the glove has been questioned by some manufacturers of electrical endoscopic equipment. There have been statements in the literature concerning the potential for shocks when the surgical gloves are worn wet and the equipment defective. There is a need to develop test methods, preferably of lowvoltage characteristics. Gloves would be filled with an electrolyte and immersed into another solution. The passage of a current across the rubber barrier should be noted after a period of time. The rate of development of the leakage could be used as an index. For operations in which electrical equipment is employed, the user should know the relative merits of different gloves. These should be available from any ,vendor. Conclusions. A “Standard for surgical gloves” has been created by the American Society for Testing Materials. Nurses responsible for the choice of gloves in each hospital should be familiar with this standard. They can use it as a baseline and can confront glove salespeople with demands consistent with or even better than this standard.
872
Football ankle injuries can be serious The frequency and severity of knee injuries in football are alarming, but the team physician and orthopedic surgeon for the Detroit Lions, Edwin R Guise, MD, believes ankle injuries do not get the attention they deserve. Ankle injuries are the most common trauma in football, and it is now possible to distinguish the serious from the less serious type of sprain, he told a sports medicine symposium at the annual meeting of the American Orthopaedic Foot Society. The common ankle sprain follows the typical inward turning of the foot and gives the least trouble. The athlete‘s recovery is relatively rapid, usually after a few days with taping. “However, when the foot turns outward, almost every ligament around the ankle may rupture and yet not show on x-rays because there’s no fracture,” said Dr Guise, chairman of the department of orthopedic surgery, Henry Ford Hospital, Detroit, and assistant professor of surgery, University of Michigan. “The physical properties of changing directions in a 230-lb running back produce almost 1,000 pounds of stress on the lateral ankle if the foot is placed in an abnormal position, and rupture of the ligaments can easily occur,“ he said. He noted these severe injuries need complete rest in a plaster cast and rehabilitation after the soft tissues have healed. Dr Guise stated that the vast majority of ankle injuries on a professional team are considered negligible. But, he emphasized, “at the younger player level, where conditioning standards are so different, every such injury should be carefully evaluated as soon as an injury occurs. The injured boy should be sidelined until all pain and swelling are gone. High school team physicians should watch out especially for youngsters with flat feet because they‘re more susceptible to the severer type of ankle injury.”
AORN Journal, April 1977, Vol25, No 5
ASTM standard for surgical gloves
A new “Standard for surgical gloves” has been written by a committee of the American Society for Testing and Materials (ASTM), a standardization organization. This standard is a minimum specification of the attributes of a surgical glove. It is not a legal requirement that all surgical gloves conform to this minimum standard. Nurses or surgeons may, however, use it when they buy surgical gloves or recommend it to the hospital’s product evaluation committee. I n fact, they may recommend more than
William C Beck, MD, F A C S , is president of the Donald Guthrie Foundation for Medical Research, Sayre, Pa. He is a consultant to the A O R N Technical Standards Committee and a graduate of Northwestern University Medical School, Evanston, Ill. Paul F Nora, MD, F A C S , is associate professor of surgery, Northwestern University Medical School, and chairman of the department of surgery, Colu mb us-Cuneo-Cabrini Med ical Center, Chicago. He is a graduate of Loyola University of Chicago Medical School and received his M S and PhD i n surgery from Northwestern University Medical School.
this standard’s requirement. Knowledge of the provisions of the standard is essential if one is involved in the product purchase of surgical gloves. Copies of the standard may be obtained from the ASTM, 1916 Race St, Philadelphia, Pa 19103. It would be worthwhile for every operating room nurse to have a copy on file and to have a n understanding of its provisions. The elements of the new standard in which we are interested are: 0 the sterility of the gloves and the test method for sterility 0 the number of holes in gloves and the test method for detecting holes 0 the dimensions for the glove including the thickness 0 the tensile strength, elongation, and resistance to stress both new and after aging. Each element will be discussed separately. The standard also mentions the lubricant but refers the reader to the United States Pharmacopeia (USP) under the heading “absorbable dusting powder.” Further elaboration of this is described. Noteworthy is the lack of any reference concerning electrical resistance of gloves, which can be important when handling electrosurgical equipment.
AORN Journal, April 1977, Vol25, No 5
869
M
ethod of testing important in glove specifications.
This will also be considered in our discussion. The sterility of the gloves. The standard requires that all gloves be sterile and defines the testing methods as described in the latest USP. It stresses importance of monitoring the methods of sterilization and employment of biologic indicators rather than the sterility testing. Actually, only 20 gloves of each sterilizer load need to be incubated for ten days for a proof of sterility if adequate biologic indicators are used in each load. Holes in the glove. Special attention should be paid to the standard’s allowance of 1.5% of new gloves t o contain holes and still be acceptable for sale. (As originally written, the standard permitted 2.5% to contain holes. Possibly as the result of protests by both the Association of Operating Room Nurses and the American College of Surgeons, the final draft was changed to read 1.5%.) Our primary concern would be that all gloves be tested for holes, actually not how many gloves should be examined from each batch. The gloves are tested by fastening them t o a circular device much like a large cork with a piece of tubing going through its center. The glove is inflated with air to a high gauge pressure (1.5 K Pa). It is then inserted into a water bath ensuring it to a depth at least to the cuff level. Air bubbles coming through the glove reveal the hole. 870
In accordance with this standard, the number of gloves to be so tested from each batch is determined by a rather complex formula. This formula has been found statistically accurate in determining the percent of failures in each batch. The final standard requires the maximum to be less than 1.5%. Physical dimensions. In the standard, gloves are sized by the length from the tip of the second finger to the terminal edge of the cuff. The width of the glove is measured across the palm along the distal flexion crease. Although glove sizes in the United States are a reflection of their width in inches, all the sizes in the standard are given in millimeters with a width tolerance of & 6 mm. The length is also at a minimum. (Hand sizes are presently under study t o see if a better understanding of dimensions might not result in a more perfect fit. Often people are forced to wear gloves that fit in the palm but whose fingers are too short or too long. This may be reflected in future standards.) The thickness of the gloves is given a t a minimum of 0.1 mm (4/1,000 inch). No maximum thickness is given. The thickness is measured at 13 mm from the tip of the index finger, the palm between the middle and ring finger 33 mm from the interdigital level, and the cuff 25 mm from its edge. The Acceptable Quality Level (AQL)
AORN Journal, April 1977, Vol25, N o 5
for defects in physical dimensions is stated to be 4% so that a maximum for each batch may contain 4% outsized for length, width, or thickness. The number of each batch to be tested is prescribed. Physical requirements. These vary somewhat depending on whether the glove was formed from rubber compounded as a n emulsion (type I) or solution (type 11). Type I has a higher tensile strength and elongates more both before and after aging to a modest degree. Aging is studied by means of generally accepted accelerated aging test. This is carried out in air oven for 166 hours a t 70 C (160 F). The AQL for defects in physical requirements is also an average of 4%. The sampling level is given for each batch depending on its size. Discussion, We have already commented that a t present the requirements of this standard are not mandatory for manufacturers. It appears to us, however, that they will become so under the 1976 Medical Device Amendments to the Food and Drug Act. The Food and Drug Administration is now responsible for the efficacy and safety of all medical devices, and surgical gloves certainly will be priority items. The AORN and the Committee on the Operating Room Environment of the American College of Surgeons have both officially protested the ac-
ceptability of a n AQL of 2.5% for holes. Many in the industry unofficially tell us they can achieve a n AQL of less than 1%by the underwater test described in this standard. It is very important to discuss the method of testing when reviewing glove specifications with vendors. We believe that eventually as high a level of performance as required for sterility will be achieved in the AQL for holes. It might mean a change in the manufacturing process with a double dip for the glove. It will also demand 100% testing. We understand this has been achieved by several manufacturers, but not by the test described in the standard. Thus the manufacturer who does lOW? testing must show the relative merits of his test in comparison to the one described in the standard. Hospital product evaluation committees or hospital purchasing services should be aware of these constraints. Rubber surgeon’s gloves are generally single-use items and, therefore, constitute a great expense for the hospital. But a cost saving by purchasing inferior gloves is negligible if the gloves do not fulfill their prime function even when new. There is much evidence that the absorbable dusting powder used as a lubricant for the glove can be harmful when it is shed in serious cavities such as a peritoneum. Absorbable dusting powder, described in USP XIX, con-
AORN Journal, April 1977, Val 25, No 5
87 1
sists of a processed cornstarch and is not to contain more than 2.0% of a magnesium oxide. While the standard refers to the USP, it would appear to us that the exact composition of the powder, its presence on the glove, and directions about its removal should appear on the package. If foodstuff packages are required to describe the chemical composition of their content, should not materials to be introduced directly into tissues be similarly described? The electrical conductivity of the glove has been questioned by some manufacturers of electrical endoscopic equipment. There have been statements in the literature concerning the potential for shocks when the surgical gloves are worn wet and the equipment defective. There is a need to develop test methods, preferably of lowvoltage characteristics. Gloves would be filled with an electrolyte and immersed into another solution. The passage of a current across the rubber barrier should be noted after a period of time. The rate of development of the leakage could be used as an index. For operations in which electrical equipment is employed, the user should know the relative merits of different gloves. These should be available from any ,vendor. Conclusions. A “Standard for surgical gloves” has been created by the American Society for Testing Materials. Nurses responsible for the choice of gloves in each hospital should be familiar with this standard. They can use it as a baseline and can confront glove salespeople with demands consistent with or even better than this standard.
872
Football ankle injuries can be serious The frequency and severity of knee injuries in football are alarming, but the team physician and orthopedic surgeon for the Detroit Lions, Edwin R Guise, MD, believes ankle injuries do not get the attention they deserve. Ankle injuries are the most common trauma in football, and it is now possible to distinguish the serious from the less serious type of sprain, he told a sports medicine symposium at the annual meeting of the American Orthopaedic Foot Society. The common ankle sprain follows the typical inward turning of the foot and gives the least trouble. The athlete‘s recovery is relatively rapid, usually after a few days with taping. “However, when the foot turns outward, almost every ligament around the ankle may rupture and yet not show on x-rays because there’s no fracture,” said Dr Guise, chairman of the department of orthopedic surgery, Henry Ford Hospital, Detroit, and assistant professor of surgery, University of Michigan. “The physical properties of changing directions in a 230-lb running back produce almost 1,000 pounds of stress on the lateral ankle if the foot is placed in an abnormal position, and rupture of the ligaments can easily occur,“ he said. He noted these severe injuries need complete rest in a plaster cast and rehabilitation after the soft tissues have healed. Dr Guise stated that the vast majority of ankle injuries on a professional team are considered negligible. But, he emphasized, “at the younger player level, where conditioning standards are so different, every such injury should be carefully evaluated as soon as an injury occurs. The injured boy should be sidelined until all pain and swelling are gone. High school team physicians should watch out especially for youngsters with flat feet because they‘re more susceptible to the severer type of ankle injury.”
AORN Journal, April 1977, Vol25, No 5
