ANATOMY OF A DEFECTIVE BARRIER - SEQUENTIAL GLOVE LEAK DETECTION IN A SURGICAL AND DENTAL ENVIRONMENT

Objectives: a) To determine the frequency of perforations in latex surgical gloves before, during, and after surgical and dental procedures; b) to evaluate the topographical distribution of perforations in latex surgical gloves after surgical and dental procedures; and c) to validate methods of testing for latex surgical glove patency. Design: Multitrial tests under in vitro conditions and a prospective sequential patient study using consecutive testing. Setting: An outpatient dental clinic at a university dental school, the operating suite in a medical school affiliated with the Veteran's Hospital, and a biomechanics laboratory. Personnel: Surgeons, scrub nurses, and dental technicians participating in 50 surgical and 50 dental procedures. Methods: We collected 679 latex surgical gloves after surgical procedures and tested them for patency by using a water pressure test. We also employed an electronic glove leak detector before donning, after sequential time intervals, and upon termination of 47 surgical (sequential surgical), 50 dental (sequential dental), and in three orthopedic cases where double gloving was used. The electronic glove leak detector was validated by using electronic point-by-point surface probing, fluorescein dye diffusion, as well as detecting glove punctures made with a 27-gauge needle. Results: The random study indicated a leak rate of 33.0% (224 out of 679) in latex surgical gloves; the sequential surgical study demonstrated patency in 203 out of 347 gloves (58.5%); the sequential dental study showed 34 leaks in the 106 gloves used (32.1%); and with double gloving, the leak rate decreased to 25.0% (13 of 52 gloves tested). While the allowable FDA defect rate for unused latex surgical gloves is 1.5%, we noted defect rates in unused gloves of 5.5% in the sequential surgical, 1.9% in the sequential dental, and 4.0% in our electronic glove leak detector validating study. In the sequential surgical study, 52% of the leaks had occurred by 75 mins, and in the sequential dental study, 75% of the leaks developed by 30 mins. In terms of the anatomical localization, the thumb and forefinger accounted for more than 60% of the defects. There were no differences in the frequency of glove leaks between the left and right hand. Leak rates were highest for the surgeon (52%), followed by the first assistant (29%) and the scrub nurse (25%). No false negatives were noted using the electronic glove leak detector; one false positive was seen out of 225 gloves tested (0.44%), as noted in our validation studies. Conclusions: Significantly high glove leak rates were noted after surgical and dental procedures, indicating that the present day latex surgical gloves can become an incompetent barrier once they are used. Unused latex surgical gloves demonstrated a higher rate of defects than allowed by the Food and Drug Administration standards, indicating substantial non-compliance of quality control standards by manufacturers as well as inadequate governmental oversight. Double gloving, or the use of thicker latex surgical gloves, would probably reduce the frequency of glove leaks. Latex surgical gloves should be tested for patency before use and during surgical and dental procedures.