Biomedical subjects

John G Thacker

Publications and source records attributed to John G Thacker.

6 recordsLinked to original sources

PubMed2003

Reducing accidental injuries during surgery.

Extensive clinical investigations have demonstrated that double-gloves and blunt-tipped surgical needles dramatically reduced the risk of accidental injuries during surgery. During the last decade, double-glove hole puncture indication systems have been developed that reduce the clinical risk of accidental needlestick injuries as well as detect the presence of glove hole puncture in the presence of fluids. When the outer glove is punctured, the colored underglove becomes apparent through the translucent outer glove, necessitating glove removal, hand washing, and donning of another double-glove hole puncture Indicator system. This article presents the first biomechanical performance study that documents the puncture resistance of blunt surgical needles in latex and nonlatex single gloves and double-glove hole puncture indication systems. The technique for measuring glove puncture resistance simulates the standard test for material resistance to puncture outlined by the American Society for Testing and Materials. The maximum puncture resistance force was measured by the compression load cell and recorded in grams with a strip chart recorder. Ten puncture resistance measurements for the taper point needle, blunt taper point needle, and blunt needle were taken from five samples of the Biogel Indicator underglove, Biogel Super-Sensitive glove, Biogel glove, Biogel Skinsense N Universal underglove, and Biogel Skinsense Polyisoprene glove; and the Biogel, Biogel Super-Sensitive, and Biogel Skinsense Polyisoprene double-glove hole puncture indication systems. The magnitude of puncture resistance forces recorded was influenced by several factors: glove material, number of glove layers, and type of surgical needle. For each type of curved surgical needle,the resistance to needle penetration by the nonlatex gloves was significantly greater than those encountered by the latex glove materials. The resistance to needle puncture of all three double-glove systems was significantly greater than that of either the nonlatex or latex underglove or outer glove. The taper point needle encountered the lowest puncture resistance forces in the five single gloves and the three double-glove systems. Blunting the sharp end of the taper point needle markedly increased its resistance to glove puncture in the five single gloves and five double-glove systems. The blunt-point surgical needle elicited the greatest needle penetration force in all of the single and double-glove systems.

Accidents, Occupational↗

PubMed2003

Reliability and performance of innovative surgical double-glove hole puncture indication systems.

During operative procedures, operating room personnel wear sterile surgical gloves designed to protect them and their patients against transmissible infections. The Food and Drug Administration (FDA) has set compliance policy guides for manufacturers of gloves. The FDA allows surgeons' gloves whose leakage defect rates do not exceed 1.5 acceptable quality level (AQL) to be used in operating rooms. The implications of this policy are potentially enormous to operating room personnel and patients. This unacceptable risk to the personnel and patient could be significantly reduced by the use of sterile double surgical gloves. Because double-gloves are also susceptible to needle puncture, a double-glove hole indication system is urgently needed to immediately detect surgical needle glove punctures. This warning would allow surgeons to remove the double-gloves, wash their hands, and then don a sterile set of double-gloves with an indication system. During the last decade, Regent Medical has devised non-latex and latex double-glove hole puncture indication systems. The purpose of this comprehensive study is to detect the accuracy of the non-latex and latex double-glove hole puncture indication systems using five commonly used sterile surgical needles: the taper point surgical needle, tapercut surgical needle, reverse cutting edge surgical needle, taper cardiopoint surgical needle, and spatula surgical needle. After subjecting both the non-latex and latex double-glove hole puncture indication systems to surgical needle puncture in each glove fingertip, these double-glove systems were immersed in a sterile basin of saline, after which the double-gloved hands manipulated surgical instruments. Within two minutes, both the non-latex and latex hole puncture indication systems accurately detected needle punctures in all of the surgical gloves, regardless of the dimensions of the surgical needles. In addition, the size of the color change visualized through the translucent outer glove did not correlate with needle diameter. On the basis of this extensive experimental evaluation, both the non-latex and latex double-glove hole puncture indication systems should be used in all operative procedures by all operating room personnel.

Equipment Design↗

PubMed2003

Resistance of double-glove hole puncture indication systems to surgical needle puncture.

Double-gloving has been shown to reduce conclusively the risk of operating room personnel's exposure to blood. Limiting risk of exposure to blood by double-gloving provides protection against the transmission of bloodborne diseases. Realizing the importance of double-gloving, a double-glove hole puncture indication system exists that accurately detects the presence of glove hole puncture in the presence of fluid. Once a glove puncture is recognized by this double-glove hole puncture indication system, it provides a warning to the surgeon to remove the punctured gloves, wash hands, and don a new, sterile double-glove hole puncture indication system. While accurately identifying the presence of glove hole puncture in the presence of fluid, this double-glove hole puncture indication system also has resistance to needle puncture superior to that of single gloves. It is the purpose of this study to document the resistance to needle puncture of latex and non-latex double-glove hole puncture indication systems using a reproducible experimental model. The resistance to needle puncture of the double-glove systems was significantly greater than that of the undergloves or outer gloves alone. The resistance to glove puncture of the non-latex and latex single and double-glove systems was significantly greater than those encountered by the latex single and double-glove systems, respectively. On the basis of their accuracy in detecting glove hole puncture, combined with their demonstrated superior resistance to surgical needle puncture as compared to single gloves, these latex and non-latex double-glove hole puncture indication systems are recommended for all surgical procedures.

Equipment Design↗

PubMed2003

Ease of donning of new powder-free non-latex and latex double-glove hole puncture indication systems.

Cornstarch on surgical gloves is often used as a detackifying agent and a lubricant to facilitate glove donning. During the last century, scientific studies have demonstrated that cornstarch produces tissue injury in literally every part of the body. Because this glove lubricant cannot be removed from the glove, Dr. David Podell, an ophthalmologic surgeon, and his cousin, Howard Podell, a chemical engineer, devised the first powder-free surgical glove that could be donned easily. They coated the inner surface of the surgical glove with a methacrylate polymer lining that was bonded to the natural rubber latex. This special coating acts as a lubricant to facilitate donning with damp, wet, or dry hands. In our earlier experimental studies, we confirmed that these polymer-lined latex gloves could be donned with either wet or dry hands. More recently, the polymer-coated latex gloves were incorporated into a double-glove hole puncture indication system that accurately detected glove holes in the presence of fluid. Because this discovery has been expanded into the development of a non-latex double-glove hole puncture indication system, we have expanded our biomechanical performance studies to examine the glove donning forces of the latex and non-latex glove hole puncture indication systems. The maximum donning forces recorded for the non-latex undergloves were significantly lower than those encountered by the same respective sizes of the latex underglove. The donning forces of the thin Biogel Super-Sensitive outer gloves were remarkably similar to the donning forces of the Biogel Indicator undergloves. The thicker Biogel outer gloves encountered greater donning forces than that noted for the Biogel Super-Sensitive outer gloves. The donning forces recorded for the non-latex outer gloves were remarkably similar to those noted for the latex Biogel outer gloves. Because the results of this biomechanical performance study demonstrated that the latex and non-latex double-glove hole puncture indication systems can be easily donned by surgeons using relatively low donning forces, this study provides convincing evidence that these double-glove hole puncture indication systems can be used in all surgical procedures.

Biomechanical Phenomena↗

PubMed2003

Creating another barrier to the transmission of bloodborne operative infections with a new glove gauntlet.

While disposable surgical gowns are designed to be either liquid-resistant or liquid-proof apparel, the woven cuffs of surgical gowns are easily permeable to water, an invitation to the transmission of bloodborne infections. Regent Medical has redesigned the diameter of some of its surgical glove gauntlets to enhance the security of the glove/surgical cuff interface. The purpose of this biomechanical performance study was to evaluate the benefit of a narrow glove gauntlet in enhancing the security of the gown and cuff interface. Using three types of disposable gown, the narrow glove gauntlet significantly increased the security of the gown-glove interface. On the basis of this biomechanical performance study, Regent Medical has announced that it will be using this narrow glove gauntlet design on more of their glove products to further reduce the transmission of bloodborne operative infections.

Biomechanical Phenomena↗

PubMed2002

An innovative surgical suture and needle evaluation and selection program.

This report describes an innovative suture and needle clinical evaluation program jointly designed by hospital representatives of Consorta, Inc., a healthcare resource management and group purchasing organization, and United States Surgical/Davis & Geck Sutures (USS/D&G), manufacturer of surgical biomaterials. Nineteen Consorta shareholder hospitals enrolled 699 surgeons to participate in Phase I of this nonexperimental observational study of the clinical performance of surgical needles and sutures. Performance characteristics of the sutures and needles produced by USS/D&G, which were evaluated in 3407 surgical procedures, included packaging and ease of opening, needle strength and sharpness, tissue drag, knot security, tensile strength, and clinically acceptable and unacceptable determinations. In these 30-day studies, the surgeons concluded that the needles and sutures were clinically acceptable in 98.1% of the evaluations. The general, cardiothoracic, and orthopedic surgeons, who performed 73.8% of the product evaluations, reported that the suture and needle products were clinically acceptable in 97.2% of the evaluations. More than half (50.1%) of the evaluations involved the POLYSORB* braided synthetic sutures,which received a clinically acceptable rating in 98.4% of the evaluation. The next most frequently used sutures were the SOFSILK*, followed by the monofilament nylon suture. SOFSILK* was found to be clinically acceptable in 98.7% of the evaluations, whereas the monofilament nylon was noted to be clinically acceptable in 96.3% of the evaluations. Surgical needles made by USS/D&G had a 97.9% clinical acceptability rating.

Attitude of Health Personnel↗