A Review on the 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. 6 e 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 POLISORB* 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.

An Update on the Innovative Surgical Double-Glove Hole Puncture Indication Systems: Reliability and Performance.

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 cardio point 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.

Revolutionary advances in enhancing patient comfort on patients transported on a backboard.

BACKGROUND: Patients with suspected spinal cord injuries are immobilized to a backboard during ambulance and helicopter air transport. It has been well documented that patients who are immobilized to a backboard experience discomfort and eventually become susceptible to pressure ulcer formation. Because the patient lying on a backboard is subjected to high skin interface pressures, it is imperative to improve patient comfort and prevent pressure ulcer formation. OBJECTIVE: Realizing the dangers of the potentially preventable pressure ulcers, our team of scientists, surgeons, and trauma nurses performed a comprehensive study of the Back Raft system that was designed to reduce patient discomfort and skin interface pressure. METHODS: Pressure under the occipital, scapula, and sacral regions of the back was measured using the Tactilus pressure analyzer of 10 healthy volunteers immobilized on a backboard and a backboard with a Back Raft air mattress system. Discomfort levels of each volunteer were measured using a Visual Analog Scale. RESULTS: Data from this study indicated that the Back Raft significantly reduces discomfort as well as tissue interface pressure in the occipital, scapula, and sacral regions of the back. CONCLUSIONS: The implementation of an air mattress system analogous to the Back Raft would facilitate the prevention of pressure ulcer formation during prehospital care and transportation. In 2008, The Centers for Medicare and Medicaid Services enacted a policy in which the Centers for Medicare and Medicaid Services can refuse payment for hospital-acquired conditions. Pressure ulcers were among the hospital-acquired conditions within the final rule.

Reducing accidental injuries during surgery.

All surgical healthcare professionals and their patients should be aware of exposure to blood from individuals infected with potentially transmissible disease. The site that was most susceptible to sharp injuries was the index finger of the surgeon's hand. It is also important to note that needles cause the vast majority of sharp injuries. During the last two decades, there have been two revolutionary advances in preventing accidental needlestick injuries during surgery that include the development of blunt tapering point needles as well as the double-glove hole indication systems. During the innovative development of blunt taper point needles, a glove manufacturer, Molnlycke, Inc., devised non-latex and latex double-glove hole puncture indication systems that are being used throughout the world. The reliability of these double-glove hole indication systems in detecting holes in the outer glove has been reliably documented by scientific studies that are published in peer-reviewed journals. On the basis of these extensive quantitative studies, the authors recommended that the double-glove hole indication system be used in all operative procedures to prevent the transmission of deadly bloodborne viral infections.

Revolutionary advances in the management of traumatic wounds in the emergency department during the last 40 years: part I.

BACKGROUND AND OBJECTIVES: This report provides an overview of advances in wound repair devised by our research team during the last four decades. This collective review is presented in two parts. DISCUSSION: The following components are included in Part I: 1) search and treat life-threatening trauma; 2) conduct a thorough history; 3) examine the wound using aseptic technique; 4) anesthetize the wound before cleansing; 5) hair removal, skin disinfection, hemostasis, surgical debridement, and mechanical cleansing; 6) antibiotics, drains, and open wound management. CONCLUSION: On the basis of these comprehensive research studies, we have noted a marked reduction in the incidence of wound infection in traumatic wounds.

Revolutionary advances in the management of traumatic wounds in the emergency department during the last 40 years: part II.

BACKGROUND AND OBJECTIVES: During the last four decades, our research team has devised advances in wound repair that are highlighted in Part II of this collective review. DISCUSSION: There are several different methods to provide an accurate and secure approximation of the skin edges-sutures, tapes, staples, and tissue adhesives. Ideally, the selection of the wound closure technique will be based on the biologic interaction of the materials employed, tissue configuration, and biomechanical properties of the trauma wound. Selection of the appropriate wound dressing is another important consideration in the management of the trauma wound. CONCLUSION: On the basis of the comprehensive research and clinical studies, we have individualized the wound closure techniques for traumatic wounds so that healing can be achieved with more aesthetically pleasing scars.

Dangers of cornstarch powder on medical gloves: seeking a solution.

This article reviews information on the hazards of cornstarch powder on medical gloves. Dusting powders were first applied to latex gloves to facilitate donning. After 1980, manufacturers devised innovative techniques without dusting powder. It has been well documented that these powders on gloves present a health hazard to patients and health care workers by 5 different mechanisms. First, the glove cornstarch has documented detrimental effects on wound closure techniques. Second, this powder potentiates wound infection. Third, cornstarch induces peritoneal adhesion formation and granulomatous peritonitis. Finally, these powders serve as carriers as latex allergen and they precipitate a life-threatening allergic reaction in sensitized patients. These well-documented hazards of glove powder have caused the United Kingdom and Germany to ban cornstarch powder on medical gloves over 10 years ago.

Citizen's Petition to Food and Drug Administration to ban cornstarch powder on medical gloves: Maltese cross birefringence.

BACKGROUND: During the last 25 years, scientific experimental and clinical studies have documented the dangers of cornstarch powder on examination and surgical gloves because the cornstarch promotes wound infection, causes serious peritoneal adhesions and granulomatous peritonitis, and is a well-documented vector of the latex allergy epidemic in the world. Realizing the dangers of cornstarch on examination and surgical gloves, Germany's regulations of personal protective equipment banned the use of surgical glove powder cornstarch in 1997. In 2000, the Purchasing and Supply agency for the United Kingdom ceased to purchase any gloves lubricated with cornstarch. DISCUSSION: Realizing the dangers of cornstarch-powdered gloves, many hospitals and clinics in the United States have banned the use of cornstarch-powdered examination and surgical gloves. Hospitals that have banned cornstarch in their examination and surgical gloves have noted a marked reduction in the latex allergy epidemic in their facilities. Realizing the dangers of cornstarch-powdered examination and surgical gloves, Dr Sheila A. Murphey, branch chief, Infection Control Devices Branch, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation, Center for Devices and Radiological Health of the Food and Drug Administration (FDA), recommended that a Citizen's Petition be filed to the FDA to ban cornstarch on surgical and examination gloves. CONCLUSION: The 12 authors of this report have attached the enclosed petition to the FDA to ban the use of cornstarch on all synthetic and latex examination and surgical gloves used in the United States.

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.

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.

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.

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.

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.

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.