Obstetrics/Gynecology

Devices in the OB-GYN category are often in temporary or transient contact with the mother or child. Typical products would include ultrasound equipment, sensor devices for the mother or fetal monitoring and instruments used during natural birth or cesarean section (see also Urological/Reproductive Devices). NAMSA Technical Specialists can help design the appropriate safety evaluation program for these devices.

Standards and Regulation

Depending on the end use of the device, it may be classified as skin contact, mucosal tissue contact or wound contact. All materials would be subjected to the guidance in ISO 10993. First consideration should be given to vertical standards (an FDA guideline or ISO standard in use for a specific device). In the absence of such guidance, ISO 10993 should be consulted to determine potential areas of concern for these devices.

Test Categories

The following test categories should be considered for OB-GYN devices:

Characterization of Materials

Chemical characterization of potential extracted chemicals commensurate with the end use

Biocompatibility

Cytotoxicity by MEM Elution
Dermal sensitization or allergenicity
Intracutaneous Injection of extracts or Skin Patch test
Acute Systemic Toxicity of aqueous and non-aqueous extracts

Complete Sterility Assurance Program

Sterilization validation of products labeled sterile
Environmental Monitoring
Packaging validation and Shelf Life testing

This test program summary provides general guidance for the test evaluation of obstetric/gynecological devices that have limited contact to skin and mucosal tissue. More invasive devices may require a more extensive evaluation.