Are We Close to a Global Ban on Powdered Medical Gloves?

Patty Taylor,  V.P. Professional Education & Clinical Affairs, Ansell, US

Powdered medical gloves can cause allergic reactions, severe airway inflammation, wound inflammation, adhesions, and post-surgical scar tissue formation. These concerns provide the stimulus for the banning of powered gloves and the transition to the use of powder-free or synthetic gloves as the new standard of care.

Gloves are the most common type of Personal Protective Equipment (PPE). Gloves are considered a barrier protecting both healthcare worker and patient from the transfer of harmful microorganisms. Powder has been used as a lubricant in the manufacture of medical gloves in order to facilitate donning and to avoid blocking of the glove. Nowadays, the more widely used dusting powders are cornstarch that coats the glove inside, and Calcium Carbonate (CaCO3) that coats the outer surface.

Complications Associated with Glove Powder

Years of clinical studies, research and industry input have provided ample data about the adverse reactions to both workers and patients that may arise from the use of gloving powders. For healthcare workers, the reactions caused by powdered gloves vary from well-known allergy symptoms and upper respiratory-tract disorders to pleuritis, myocarditis and irritation of the central nervous system. For the patients, the reactions caused by powdered gloves includes the development of adhesions and granulomas, delayed healing and increased risk of surgical site infections.

The adverse effects of powdered gloves use are caused by the powder itself as it enters the patient’s body during surgery and contaminates the wound, despite glove washing or wiping prior to undertaking the surgical procedure. The wound retains a substantial amount of residual powder granules at the conclusion of the operation with the amount of residual granules found to be proportional to the number of powdered gloves used in the operating room, rather than directly related to whether the surgeon is using powdered or powder-free gloves. This is a critical issue as glove powder can act as a vehicle for opportunistic and pathogenic micro-organisms to spread and potentially act as a food source for bacteria including MRSA and VRE, which increase the risk for post-operative wound infections.

The presence of powder in the wound may trigger a range of responses such as a delay in the healing process, alteration of the normal reparative process and an increase of the wound’s inflammatory response. In addition, researchers have shown that the presence of glove powder significantly decreases the inoculum of bacteria required to produce abscesses. This increases the surgical site infections occurrence risk, which poses a significant burden on the hospital budget.

Another common problem that can arise from the use of powdered gloves is the development of adhesions triggered by the increased inflammatory response, and  granulomas. Adhesions are the major cause of postoperative intestinal obstruction. Uterine and fallopian tube adhesions, resulting from glove powder, are a significant risk of female infertility, which is the reason why powder-free gloves should be used even for routine vaginal examination. These effects have been well documented not only in the peritoneal cavity and uterus, but reported in almost every anatomical site such as the eyes, cranial cavity, middle ear, and thorax among others.

One of the best documented consequences of the use of powdered gloves in the healthcare setting is the sensitisation and development of diverse allergic reactions to Natural Rubber Latex (NRL) such as upper respiratory tract symptoms or eye irritation. These reactions are not caused by the powder itself, but rather by its capacity to bind with NRL protein antigens. These allergen/protein coated powder particles can be aerosolised when the gloves are donned or removed, thus contaminating the hospital environment. Powdered latex gloves aerosolise more latex proteins into the air than any other medical product in a hospital and those hospital areas where powdered gloves are used have 300 times more aerosolised latex proteins that areas of powder-free usage.

The inhalation or ingestion of these powder particles can remain in the air, on instruments and equipment for many hours, and can lead over time to the development of sensitisation and allergies. A decrease in the number of healthcare workers with suspected NRL allergy including occupational asthma and contact urticaria when powdered gloves are substituted by powder-free gloves has been reported. This is not surprising if we take into account that it is estimated that the use of powdered gloves will deposit in excess of 2kg of glove powder per year per theatre. The presence of glove powder can result in many other undesirable effects, such as the contamination of catheters, perfused donor kidneys and cosmetic dentistry materials (crowns, prostheses) among others.

All the issues outlined in this article can be easily reduced by switching from a powdered to a powder-free environment. This may have additional cost-savings in reduced healthcare personnel sickness and post-operative complications.

Also, it must be stated that the cost of washing surgical powdered gloves prior to use, has been reported as being at least seven times higher than the cost of using powder-free gloves while at the same time being inefficient in totally removing the glove powder.

Restrictions and Bans on Powdered Gloves

The documented adverse effects caused by the use of powdered gloves are the reason for a global decrease in powdered gloves usage, and a shift towards powder-free gloves. Realising the dangers of cornstarch on examination and surgical gloves, hospitals around the world starting moving to powder-free gloving alternatives. Germany's regulations of personal protective equipment banned the use of powdered medical gloves in 1997.In 2000, the Purchasing and Supply agency for the United Kingdom ceased to purchase any gloves lubricated with cornstarch.

The US Food and Drug Administration (FDA) enacted a rule banning the use of powdered surgical gloves, powdered exam gloves, and absorbable powder for lubricating surgical gloves. The ban, first proposed in March 2016, was announced by the FDA on December 19, 2016 and became effective on January 18, 2017. FDA’s rationale for the ban is based on the risk of illness or injury to patients and healthcare providers exposed to the powdered gloves, when internal body tissue is exposed to the powder, which may include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body's immune response, which can lead to an array of conditions from allergic reactions to surgical complications. Alternatively, there are other medical gloves available that are powder-free and provide the same degree of protection, hand dexterity, and performance without posing the same risks to individuals.

In addition, on January 8, 2017, the Saudi Food and Drug Authority (SFDA) banned the manufacture, import, sale and distribution of powdered surgical and patient examination gloves as well as the absorbable powder used to facilitate wearing of medical gloves. In a statement on its website www.sfda.gov.sa, the Authority explained that the reason for the ban is the probable link of using such gloves with many health risks, including acute respiratory infections; anaphylaxis; allergic asthma; inflammation and damage of lungs' airways (bronchial tubes); skin rash and adhesions of abdominal membranes. The ban is to go into effect March 27, 2017.

On December 27, 2016 Japan announced their intention to enact a similar ban with a two-year transition through to December 2018.  The Ministry of Food and Drug Safety Korea in a January 24th 2017 meeting announced they too are considering a powdered glove ban transition through to December 2018.

Hospital Authority (HA) of Hong Kong implemented a ban to local hospitals effective 19th January 2017, following the ruling of US FDA. This applies to government hospitals which is under the responsibilities of HA. Private hospitals which are not under control of HA have also adopted the same stance.

Improved Glove Technology

Improved technologies and manufacturing techniques can eliminate the need for powder entirely. The application of a polymer coating to the inside film of latex or synthetic gloves enhances the donning attributes of the glove in both wet and dry conditions. A wide array of synthetic glove choices are available today such as polyisoprene, neoprene or nitrile which are latex free (safe for those with a latex / Type I allergy), some are chemical free (safe for those with a chemical / Type IV allergy) and all provide excellent barrier protection. The bottom line is: there are other, better clinically relevant solutions available that have all the same fit, feel and comfort of powdered gloves.

And while many healthcare providers have already moved away from powdered gloves, many are still actively exploring the new offerings to determine which option is right for them. That’s where education is critically important to help workers select the best option that ensures performance, protection and safety. When it comes to clinical education in this area, Ansell leads the way globally with a comprehensive program available for healthcare professionals around the world.

Financial Savings

The prices for these new technologies can besomewhat higher. But the return on investment for powder-free gloves well outweighs the initial higher cost: protection afforded to both the worker and patient and reduced adverse events associated with gloves powder. The FDA estimates that total annual benefits of the powdered ban in the United States are expected to range between $26.6 million and $29.3 million. As powdered bans continue, the global impact in terms of savings will be measured potentially in the hundreds of millions of dollars.

Conclusion

Undeniably, we need gloves which provide excellent barrier protection, which do no harm to patient or worker, and provide a financial benefit. The literature indicates that these gloves should be powder-free. The use of powder-free gloves has been demonstrated to reduce the spread of infection, improve the safety and health of patients and healthcare professionals, as well as provide a financial benefit to the healthcare facility.

References:

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15. US Food and Drug Administration. https://www.federalregister.gov/documents/2016/12/19/2016-30382/banned-devices-powdered-surgeons-gloves-powdered-patient-examination-gloves-and-absorbable-powder  Accessed January 31, 2017.
16. Saudi Food and Drug Authority Prohibits Manufacturing, Importing, Selling, Distributing of Powdered Gloves. http://www.spa.gov.sa/viewstory.php?lang=en&newsid=1578447  Accessed January 31, 2017.
17. https://www.pmda.go.jp/files/000216103.pdf  Accessed March 2, 2017.
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19. US Food and Drug Administration. https://www.federalregister.gov/documents/2016/12/19/2016-30382/banned-devices-powdered-surgeons-gloves-powdered-patient-examination-gloves-and-absorbable-powder  Accessed January 31, 2017.

-- Issue 36 --

Author Bio

Patty Taylor

Patty is a registered nurse with international experience focusing on perioperative safety and education. Patty utilises her years of experience in healthcare, knowledge of perioperative practice, and concern for infection prevention to support CLINICAL research, create accredited education courses, lecture, and author articles.

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