CTO Safety Standards & Documentation 5

Question 1

Which standard governs the quality management system most commonly adopted by orthotic device manufacturers seeking ISO certification?

Accepted Answer

ISO 13485

Answer

ISO 13485 is the medical device-specific quality management standard used by O&P manufacturers and suppliers.

Question 2

A technician must dispose of sharps (trimming blades, needles from casting) used during patient care. What is the required method?

Accepted Answer

Place in a labeled, puncture-resistant sharps container

Answer

OSHA bloodborne pathogen standards require sharps to be disposed of in approved, puncture-resistant biohazard containers.

Question 3

What is the primary reason an orthotics technician must document the lot number of every material used in device fabrication?

Accepted Answer

To enable targeted recalls if a material is found to be defective

Answer

Lot number documentation allows a facility to identify and quarantine all devices made with a defective batch in the event of a supplier recall.

Question 4

When performing a strap attachment on a metal KAFO, which safety consideration related to material compatibility must be documented?

Accepted Answer

Confirmed absence of patient metal allergy before using metal hardware

Answer

Metal allergies (e.g., nickel) must be screened and documented before using metal hardware components in direct-contact orthoses.

Question 5

Which federal agency has authority to recall defective orthotic devices classified as medical devices in the United States?

Accepted Answer

U.S. Food and Drug Administration (FDA)

Answer

The FDA regulates medical devices and has the authority to mandate or oversee recalls of defective orthotic devices.

(CTO) Certified Orthotic Technician Practice Test