# Presentation: 266734

## The severity of the immediate reaction 

**depends upon:**

**The person’s degree of sensitivity, how contact occurs and the amount of latex allergen to which the person is exposed. **

**The greatest danger of severe reactions occurs when latex comes into contact with **_**mucosal tissues, moist areas of the body or internal surfaces during surgery,**_** because more of the allergen can rapidly be absorbed into the body.**

## The severity of the immediate reaction 

**depends upon:**

**The person’s degree of sensitivity, how contact occurs and the amount of latex allergen to which the person is exposed. **

**The greatest danger of severe reactions occurs when latex comes into contact with **_**mucosal tissues, moist areas of the body or internal surfaces during surgery,**_** because more of the allergen can rapidly be absorbed into the body.**

## How a product is made determines the amount of latex allergens retained in the finished item. 

***Latex allergy is an allergic response to certain proteins retained in varying amounts in finished products manufactured from Hevea NRL such as gloves, medical equipment, balloons, condoms and toys.***
***How a product is made determines the amount of latex allergens retained in the finished item.***

## Slide 4

## Frost & Sullivan, a marketing 

**Frost & Sullivan, a marketing **
**consulting company, **
**recently reported that the North American market for **
**non-medical gloves**
** ****has had an ****annual growth rate of around 4.5%.**

## Slide 6

## Billions of gloves, both natural rubber latex and synthetic gloves, are imported into the U.S. market from Asia every year. 

- However, some of those gloves fail to meet the requirements of the U.S. Food and Drug Administration (FDA) for medical standards or Class I medical examination gloves.
- Importers and distributors find alternative, non-medical markets for their gloves including law enforcement, durable goods manufacturing,
- beauty salons, automotive,
- and of course, food.

## From farm....

**From farm....**

## To table.....

**To table.....**

## Slide 10

## Slide 11

## How a product is made determines the amount of latex allergens retained in the finished item. 

***Latex allergy is an allergic response to certain proteins retained in varying amounts in finished products manufactured from Hevea NRL such as gloves, medical equipment, balloons, condoms and toys.***
***How a product is made determines the amount of latex allergens retained in the finished item.***

## Slide 13

## Frost & Sullivan, a marketing 

**Frost & Sullivan, a marketing **
**consulting company, **
**recently reported that the North American market for **
**non-medical gloves**
** ****has had an ****annual growth rate of around 4.5%.**

## Slide 15

## Billions of gloves, both natural rubber latex and synthetic gloves, are imported into the U.S. market from Asia every year. 

- However, some of those gloves fail to meet the requirements of the U.S. Food and Drug Administration (FDA) for medical standards or Class I medical examination gloves.
- Importers and distributors find alternative, non-medical markets for their gloves including law enforcement, durable goods manufacturing,
- beauty salons, automotive,
- and of course, food.

## From farm....

**From farm....**

## To table.....

**To table.....**

## Slide 19

## Slide 20

## Reporting Reactions

## How to Report Reactions

**Natural Rubber Latex**
- We all know from our own life experiences that if a problem goes unreported or is just ignored, it simply won't be resolved. By reporting adverse reactions to products made from natural rubber latex/natural rubber (NRL), to the appropriate agencies, authorities, product manufacturers, and pertinent organizations; patients, workers, and consumers play an essential role in the development of better health and safety standards.

**How to Report Reactions**

**Reporting = Awareness = Action**

## How a reaction is reported depends on:WHAT the product is and WHO has the allergic reaction.

**How to Report Reactions**
**Medical Gloves and Medical Devices**
**Food Service Gloves**
**Non-Medical Gloves and Consumer Products**

## Medical Gloves and Medical Devices
	FDA MedWatch 1-800-FDA-1088
	Report Reactions to the product's manufacturer 
	Report Reactions to the facility or business where the exposure occurred

**	**FDA MedWatch 1-800-FDA-1088
- 	Report Reactions to the product's manufacturer
- 	Report Reactions to the facility or business where the exposure occurred

**OSHA **
- Work-related reactions  202-693-1999
- OSHA Worker’s Page -** **From this area, you may obtain a complaint form or file a report online.

**CDC NIOSH **
- 1-800-35-NIOSH
- NIOSH conducts field investigations of possible health hazards in the workplace.

## MedWatch Reporting by Consumers

***MedWatch Reporting by Consumers***
- MedWatch is the Food and Drug Administration's (FDA) program for reporting **serious reactions** and **problems** with medical products, such as drugs and medical devices.
- If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the **reporting form** to your doctor. Your health care provider can provide clinical information based on your medical record that can help us evaluate your report.
- However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the **Online Reporting Form** yourself via the internet.
- You will receive an acknowledgement from FDA after we receive your report. You will be personally contacted only if we need additional information.
- For information about a medical product, please call the FDA's toll-free information line, 1-888-INFO-FDA (1-888-463-6332).

## JACHO

**	**1-800-994-6610
- 	 To report a complaint related to patient safety issues and latex allergy in a Health Care Organization.

**FDA CFSAN**
**	**** ****Report allergic reactions from food handled by workers wearing latex gloves:**
- FDA Center for Food Safety and Applied Nutrition
- Karl. C. Klontz

**CPSC**
- Non-Medical Gloves & Consumer Products
**	**1-800-994-6610

## www.fda.gov

**How do I report non-emergencies **
**about food?**
- To report problems, including adverse reactions, related to any food except meat
- and poultry, contact the **district office consumer complaint coordinator**
- for your geographic area.

**www.fda.gov**

## Published Recommendations

## Latex gloves should be used only as mandated by accepted Universal Precautions standards. The routine use of latex gloves by food handlers, housekeeping, transport and medical personnel in low risk situations (e.g. food handling, bed transport, routine physical examination) should be discouraged.

*This statement was developed by a joint subcommittee of the American College of Allergy, Asthma and Immunology (ACAAI) and the American Academy of Allergy, Asthma and Immunology (AAAAI). 1997*

## Provide workers with non-latex gloves to use when there is little potential for contact with infectious materials (for example, in the food service industry). 

**Latex allergy can be prevented only if employers adopt policies to protect workers from undue latex exposures. NIOSH recommends that employers take the following steps to protect workers from latex exposure and allergy in the workplace: **

**Provide workers with non-latex gloves to use when there is little potential for contact with infectious materials (for example, in the food service industry). **

## Primary prevention involves reducing potential development of allergy by reducing unnecessary exposure to NRL proteins for all workers. Food service workers or gardeners, for example, do not need to use NRL gloves for food handling or gardening purposes. 

***Primary prevention involves reducing potential development of allergy by reducing unnecessary exposure to NRL proteins for all workers. ******Food service workers or gardeners, for example, do not need to use NRL gloves for food handling or gardening purposes. ***

## J Allergy Clin Immunol. 2002 Jan;109(1):31-4.   Natural rubber latex allergy after 12 years: recommendations and perspectives.Charous BL, Blanco C, Tarlo S, Hamilton RG, Baur X, Beezhold D, Sussman G, Yunginger JW. 

- Natural rubber latex (NRL) allergy is a "new" illness whose prevalence reached epidemic proportions in highly exposed populations during the last decade. In children with spina bifida and in patients exposed to NRL during radiologic procedures, institution of prophylactic safety measures has had demonstrable effects in preventing allergic reactions. The risk of NRL allergy appears to be largely linked to occupational exposure, and NRL-associated occupational asthma is due almost solely to powdered latex glove use. ..........
- For these reasons, adoption of the following institutional policies designed to prevent new cases of NRL allergy and maximize safety is recommended: **(1) NRL gloves should be used only as mandated by accepted Standard Precautions;** (2) only nonpowdered, nonsterile NRL gloves should be used; and (3) nonpowdered, sterile NRL gloves are preferred for use. Low-protein powdered, sterile gloves may be used, but only in conjunction with an ongoing assessment for development of allergic reactions.