scope:

Introduction and scope

Traditionally, surgical gowns, other protective apparel, and surgical drapes have been intended to help prevent wound infections by providing a barrier between nonsterile and sterile areas. However, given the increasing concerns related to bloodborne pathogens such as the human immunodeficiency virus (HIV) and the increasing number of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections among health care personnel, the protection of the surgical team and other health care personnel has become an important issue.

Protective apparel and surgical drapes are fabricated from either multiple-use materials or single-use materials. Each of these two basic types of products has advantages and disadvantages. Within the material types available, design and performance characteristics vary considerably. This variation stems from trade-offs in economy, comfort, and the degree of protection required for particular surgical and other health care procedures. Consequently, health care personnel are faced with a complex decision-making process when choosing the types or performance levels of products that will best serve their needs.

This technical information report (TIR) is intended to assist health care personnel in the selection of protective apparel and drapes that are listed by and have received marketing clearance from the Food and Drug Administration (FDA). These products are classified as medical devices and are subject to FDA's labeling, premarket notification (510[k]),¹ and medical device reporting (MDR) regulations. In addition, under FDA's quality system regulation (QSR), good manufacturing practices (GMPs) must be used in the manufacture and commercial reprocessing of these devices.

This TIR is also meant to serve as a resource that health care professionals can use when directing questions to manufacturers about the performance characteristics of specific products and when choosing products for use in particular surgical and other invasive or patient care procedures.

The scope of this TIR includes

a) types of protective materials,

b) safety and performance characteristics,

c) product evaluation and selection,

d) guidelines for choosing the level of barrier performance, and

e) care of protective apparel and surgical drapes.

Definitions of terms and informative annexes are also provided.

This TIR might not cover all the requirements that a health care facility could deem necessary to select a product, nor does it address criteria for evaluating experimental products.

¹ For new or changed products introduced to the market after May 28, 1976, manufacturers are required to submit a premarket notification to FDA. Products found to be substantially equivalent to existing products are "cleared" by FDA for marketing. This clearance for marketing does not constitute FDA approval of the product's safety and effectiveness.