# Presentation: 107132

## The Physical Hazards of Foreign MaterialsPresentation for the Public Meeting on Foreign Material Contamination Sept 24, 2002

- David P. Goldman, M.D., M.P.H.
- Human Health Sciences Division
- Food Safety and Inspection Service

## Objectives

- Describe generally the physical hazards of ingested foreign bodies
- Review epidemiologic and clinical data on foreign body ingestion
- Describe Federal efforts, based on the characteristics of the foreign material, to minimize risks to human health

## What Parts of the Human Anatomy are at Risk?

- Digestive Tract
- Respiratory Tract
- Mouth and Teeth
- Extremities (Hands)

## Hazards to the Digestive Tract

- Esophageal laceration
- Esophageal perforation
- Fistula formation
- Laceration or perforation of other portions of the digestive tract
- Pharynx
- Stomach
- Intestine

## Slide 5

## Slide 6

## Hazards to the Respiratory Tract

- Choking--occlusion of the airway
- Children under age 3 at greatest risk
- Common hazards are foreign objects (coins or toys) or food, *though not foreign objects in food*
- Objects may become lodged in the upper esophagus and cause choking/asphyxiation by compression of the trachea

## Hazards to the Respiratory Tract

- Aspiration--inhalation of foreign matter into the bronchial tree--may result in:
- partial lung collapse
- secondary infection
- destruction of lung tissue from retained material

## Slide 9

## Hazards to the Mouth and Teeth

- Lacerations of the mouth
- Lacerations of the tongue
- Chipped teeth
- Broken fillings
- Damage to prosthetics

## Other Hazards

- Lacerations on the hands occurring during food preparation
- Illness complaints
- Nausea and vomiting
- Diarrhea
- Headache, fever and dizziness
- Chest pain

## Clinical Observations about Foreign Body Ingestion

- About 80% of foreign body (FB) ingestions occur in the pediatric age group
- 80-90% of FBs ingested will pass spontaneously over 4-7 days
- Estimated that 1-5% of FBs ingested will result in injury

## Clinical Observations about Foreign Body Ingestion

- Sharp objects account for about 10% of FB ingestions, but a disproportionate number of injuries
- In a case series of foreign bodies removed surgically, 37% were in the airway and 63% were in the upper digestive tract

## Clinical Observations about Foreign Body Ingestion

- In a review of FDA consumer complaints of foreign materials in food, the most frequently reported injury was mouth or throat laceration
- In the FDA review glass was the foreign material most frequently reported as causing illness or injury

## Characteristics of Foreign Materials that May be Hazardous

**Size of the Object**
- FSIS in its 1995 Public Health Hazard Analysis Board on bone particles concluded:
- bone particles < 1 cm not a safety hazard;
- particles 1-2 cm are a low risk;
- particles > 2 cm have the potential to be a safety hazard and may cause injury

## Characteristics of Foreign Materials that May be Hazardous

**Size of the Object**
- FSIS (1995):  The presence of foreign material other than bone may pose a potential hazard, and each instance should be considered on a case-by-case basis, irrespective of size

## Characteristics of Foreign Materials that May be Hazardous

**Size of the Object**
- Consumer Product Safety Commission (1995):  spherical objects < 1.75 inches in diameter are dangerous to children under 3 years (choking, ingestion or aspiration)
- CPSC uses a Small Parts Test Fixture (a cylinder) to judge other non-spherical objects for choking hazard

## Characteristics of Foreign Materials that May be Hazardous

**Size of the Object**
- FDA Health Hazard Evaluation Board conclusions in cases of foreign materials (1972-1997) found that 56% of objects 1-6 mm might pose a limited acute hazard
- For objects > 6 mm, only 2.9% were judged to present no hazard

## Characteristics of Foreign Materials that May be Hazardous

**Size of the Object**
- FDA/ORA Compliance Policy Guide
- Criteria for direct reference seizure:  Hard or sharp objects 7-25 mm and RTE
- Criteria for recommending legal action :
- 7-25 mm and requires additional preparation
- < 7 mm and intended for special-risk group
- > 25 mm in length

## Characteristics of Foreign Materials that May be Hazardous

**Shape of the Object**
- Spherical or cylindrical shaped objects present a greater risk for choking
- Slender and sharp or pointed objects present a greater risk for laceration or perforation

## Characteristics of Foreign Materials that May be Hazardous

**Consistency of the Object**
- rigid objects (e.g., coins) caused most choking deaths in children 3 years and older
- conforming objects (e.g., balloons) caused more choking deaths in children under age 3 years

## Conclusions

- Foreign material contamination does occur in food items
- Injuries have resulted from foreign materials in foods
- Size matters:  particles in food that are small are more likely to escape detection, but less likely to cause injury

## 
David Goldman, Deputy Director, Human Health Sciences Division, OPHS/FSIS/USDA
david.goldman@fsis.usda.gov
		202-690-6409

**David Goldman, Deputy Director, Human Health Sciences Division, OPHS/FSIS/USDA**
- _[david.goldman@fsis.usda.gov](mailto:denise.lewis@dchqexs1.hqnet.usda.gov)_
- 		202-690-6409

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