Mary J. Cox

A new hazard of cornstarch, an absorbable dusting powder

Cornstarch is currently the only powder used in the manufacture of surgical and examination gloves. The purpose of this study was to determine if cornstarch damages local tissue defenses in contaminated wounds. It was found that in contaminated wounds, cornstarch enhanced the growth of bacteria and elicited exaggerated inflammatory responses as measured by wound induration. As a result of this investigation, we do not recommend the use of gloves with cornstarch powders.

EASE OF DONNING SURGICAL GLOVES: AN IMPORTANT CONSIDERATION IN GLOVE SELECTION

It is a commonly held belief among physicians that powder free surgical gloves are more difficult to don than cornstarch powdered gloves. This difficulty is supposedly enhanced when the physicians hands are wet, a situation commonly encountered when regloving during surgical procedures. This investigation dispels these beliefs by demonstrating that the forces required to don powder free gloves do not differ significantly from those required to don gloves coated in cornstarch lubricant. Moreover, Biogel, a new powder free glove with an inner hydrogel lining, is shown to don easily and safely without ripping, even with wet hands, a circumstance not encountered with other gloves.

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.

Considerations in the selection of surgical gloves for tape wound closure

One of the reasons that tape closure of wounds is rarely used in the emergency department is that it is difficult for the emergency physician wearing powdered, latex gloves to handle skin closure tapes. Because the skin closure tapes adhere aggressively to powdered latex gloves, it is difficult for the emergency physician to separate the tape from his glove and apply the tape to the skin. The advent of a new powder free glove allows the emergency physician to handle the tapes and accomplish tape wound closure.

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, Germanys 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 Citizens 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.

Severe burn injury from recreational gasoline use

This report describes the case of a 13-year-old boy who suffered severe burns with inhalation injury during the recreational use of gasoline. Gasoline sniffing is a popular form of solvent abuse for young children and adolescents in isolated, rural communities. In addition to the neurological and physiological complications of gasoline inhalation, gasoline sniffers face the significant threat of severe burn injury or death resulting from ignition of the gasoline vapor as well as from extensive physical contact with the constituents of liquid gasoline.

Failure of glove hole detection device for synthetic gloves.

Holes in latex gloves can be reliably detected by commercially available electronic devices. The purpose of this study was to compare the performance of an electronic glove hole detection device using latex gloves to that of neoprene, vinyl, and nitrile latex-free gloves. The electronic hole detection device accurately detected holes in the latex gloves during the 2-h study. In contrast, the latex-free gloves were immediately conductive of electricity in the absence of holes. Consequently, electronic glove hole detection devices cannot be reliably used with latex-free gloves.

DEVELOPING AN ORGANIZED APPROACH IN THE FOOD AND DRUG ADMINISTRATION TO BAN DANGEROUS DEVICES THAT CAN INJURE THE PATIENT AND HEALTH CARE WORKER

*Distinguished Professor Emeritus of Plastic Surgery, Biomedical Engineering and Emergency Medicine, University of Virginia Health System, Charlottesville, Virginia, †Research Assistant with Dr. Richard Edlich, Brush Prairie, Washington, ‡Eye Physicians of Southern New Jersey, Voorhees, New Jersey, and §Orthopedic Trauma, Division of Orthopedic Surgery, Duke University Medical Center, Durham, North Carolina Reprint Address: Richard F. Edlich, MD, PHD, FACEP, FACS, FASPS, Distinguished Professor Emeritus of Plastic Surgery, Biomedical Engineering and Emergency Medicine, University of Virginia Health System, Charlottesville, VA 22908

A Wakeup Call to The Food and Drug Administration to Ban Cornstarch on Medical Gloves

During the last 30 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 throughout the world (1–4). 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 1977 (5). In 2000, the Purchasing and Supply Agency for the United Kingdom ceased to purchase any gloves lubricated with cornstarch (6). Our “Citizen’s Petition to the Food and Drug Administration to Ban Cornstarch Powder on Medical Gloves in the United States” was sent on September 24, 2008 to Andrew Von Eschenbach, MD, Commissioner, Food and Drug Administration (FDA), 5600 Fishers Lane, Rockville, MD 20857, and to Daniel G. Shultz, MD, director, Center for Devices and Radiological Health, FDA, 9200 Corporate Blvd, Rockville, MD 20850 (6). In 2009, our Citizen’s Petition to the Food and Drug Administration to Ban Cornstarch Powder on Medical Gloves was reported in this Journal (7). The health professionals involved felt very optimistic that the FDA would comply with the Citizen’s Petition and ban cornstarch onmedical gloves. In the Citizen’s Petition, we highlighted the decreased frequency of usage of cornstarch on medical gloves in our country. The University of Virginia Healthcare System was the first in the United States to ban cornstarch from all of its surgical and examination gloves. The basis for this decision was outlined in a published collective review of the hazards of powder on surgical and examination gloves (8). In addition, a team of scientists demonstrated that powder-free latex gloves have been designed so that they have the same donning forces as gloves with cornstarch (9). Some major hospitals, including Johns Hopkins Hospital in Baltimore and the Cleveland Clinic’s network of nine hospitals, have switched to synthetic surgical gloves. These two health care facilities converted their hospitals and clinics entirely to powder-free, non-latex surgical and examination gloves (10). In 2000, Jackson et al. conducted a global inventory of hospitals using powder-free gloves. Their study, using a global Internet search, identified 70 hospitals in the United States that use only powder-free gloves (11). They did not include the Legacy Healthcare System in Washington and Oregon that in 2001 banned the use of cornstarch gloves in their hospitals and hospice under the leadership of Dr. William B. Long III, Director of Trauma Specialists LLP, Legacy Emanuel Medical Center, Portland, OR. In 2008, Dr. Wendy Huber (Oakland, CA) confirmed that all Kaiser Permanente clinics and hospitals in our country use only powder-free latex or synthetic examination and surgical gloves. An extensive survey by GHX Market Intelligence (Louisville, CO) of the second-quarter 2008 market research data regarding gloves used in the United States showed the following for the total examination glovemarket (physician offices, surgery centers, and hospitals): Powder-free examination gloves (units) 94.4%; powdered examination gloves (units) 5.6%. In the second quarter of 2008, market research showed the following for the total surgical glovemarket: Powder-free surgical gloves (units) 64.6%; powdered surgical gloves (units) 35.4%. After the successful development of technology to produce powder-free examination and surgical gloves, the United States has sufficient resources for all physicians and health care workers to use powder-free examination and surgical gloves.

Discontinuing the use of dangerous cornstarch powder on medical gloves.

To the Editor: Because of the dangers to patients and health care professionals from cornstarch powder, numerous manufacturers have developed powder-free latex and synthetic surgical examination and surgical gloves. It has been well-documented that the cornstarch powder on medical gloves presents health hazards to patients and health care workers by 4 different mechanisms. First, the cornstarch powder on gloves 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 of latex allergen reaction to sensitized patients. These well-documented hazards have caused the United Kingdom and Germany to ban cornstarch powder on medical gloves approximately 10 years ago. Realizing the documented dangers of cornstarch powder listed earlier, on September 24, 2008, 11 health care professionals submitted a Citizen’s Petition to the Food and Drug Administration (FDA) to ban immediately the use of cornstarch powder in the manufacture of surgical and examination gloves. Because of the dangers of this dangerous powder on medical gloves, since 1998, many manufacturers have introduced a large supply of powder-free, high-quality, inexpensive, easily donned, natural rubber latex, and synthetic gloves. An extensive survey of the second quarter 2008 market research data of gloves used in the United States by GHX Market Intelligence in Louisville, CO, showed the following for total examination glove market (physician offices, surgery centers, and hospitals): powder-free examination gloves (units) 94.4%; and powdered examination gloves (units) 5.6%. The second quarter 2008 market research data showed the following for total surgical glove market: powder-free surgical gloves (units), 64.4%; and powdered surgical gloves (units), 35.4%. After the successful development of technology to produce powder-free examination and surgical gloves, the United States has sufficient resources for all physicians and health care workers to use powder-free examination and surgical gloves. On Monday, November 8, 2010, the FDA indicated that in 1 to 2 months it would publish a notice in the Federal Register requesting health-care professionals and companies to submit comments or provide any scientific documentation that cornstarch powder on medical gloves is safe and can be used without any damaging effects on patients or health care professionals. From February 5 to April 25, 2011, the Federal Register was opened for comments from healthcare professionals and glove manufacturers regarding the risks and benefits of cornstarch powder on medical gloves. Of the 280 comments posted on the Federal Register, all comments focused on the benefits of banning cornstarch on medical gloves in the United States. They also emphasized that warning labels on medical glove packages that contain medical gloves coated with cornstarch were of no value because most health-care professionals do not have the opportunity to ever read them. On May 31, 2011, the Pharmaceutical & Medical Packaging News.com wrote an article regarding banning powdered latex gloves. In this report, it was pointed out that almost no health-care professionals use powdered medical gloves in our country. “A report by Global Industry Analysts, Inc. of San Jose on the disposable glove market in 2010 found that only 7% of gloves in the US market were powdered. Some 92% of examination gloves were powder free and 94% of surgical gloves were powder free. Despite the increased cost of powder free gloves, the report says, Global Industry Analysts Inc. predicts further reduction in the use of powder gloves by 2015.” We also thank Dr. William C. Lineaweaver, Editor-in-Chief of Annals of Plastic Surgery, who encouraged our team of health care professionals to publish articles in this Journal regarding the need for the FDA to ban cornstarch on medical gloves. Dr. Lineaweaver personally contacted the FDA about the dangers of cornstarch powder on medical gloves and got no response. Regardless of the decision of the FDA, it appears that no health professionals or patients will be endangered by cornstarch powder by 2015. A wonderful ending to a challenging journey!