CTO Safety Standards & Documentation 5 — Questions and Answers
Question 1: Which standard governs the quality management system most commonly adopted by orthotic device manufacturers seeking ISO certification?
- ISO 13485 (Correct answer)
- ISO 9001
- ISO 14001
- ISO 45001
Correct answer: ISO 13485
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?
- Place in a labeled, puncture-resistant sharps container (Correct answer)
- Wrap in paper towels and place in regular trash
- Rinse and reuse until dull
- Return to the patient for home disposal
Correct answer: Place in a labeled, puncture-resistant sharps container
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?
- To enable targeted recalls if a material is found to be defective (Correct answer)
- To calculate the technician's production bonus
- To satisfy billing codes for insurance
- To compare pricing across vendors
Correct answer: To enable targeted recalls if a material is found to be defective
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?
- Confirmed absence of patient metal allergy before using metal hardware (Correct answer)
- The color preference of the patient's family
- The technician's preferred rivet brand
- The ambient temperature of the lab that day
Correct answer: Confirmed absence of patient metal allergy before using metal hardware
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?
- U.S. Food and Drug Administration (FDA) (Correct answer)
- Occupational Safety and Health Administration (OSHA)
- Centers for Medicare & Medicaid Services (CMS)
- Department of Labor (DOL)
Correct answer: U.S. Food and Drug Administration (FDA)
The FDA regulates medical devices and has the authority to mandate or oversee recalls of defective orthotic devices.
Question 6: A practitioner writes a prescription for a 'custom-fabricated AFO.' The work order arrives without a diagnosis code. What should the technician do?
- Hold fabrication and request the diagnosis code from the practitioner's office (Correct answer)
- Fabricate the device and add any plausible diagnosis code later
- Proceed using the previous prescription's diagnosis code
- Fabricate without a code since it is the practitioner's responsibility
Correct answer: Hold fabrication and request the diagnosis code from the practitioner's office
Complete documentation including diagnosis codes is required before fabrication to ensure medical necessity compliance and proper billing.
Question 7: What does the 'right of access' provision under HIPAA mean for orthotic technicians handling patient records?
- Patients have the right to inspect and receive copies of their own health information (Correct answer)
- Technicians can access any patient record for quality assurance at any time
- Insurance companies have unrestricted access to all fabrication records
- Only physicians may access patient files
Correct answer: Patients have the right to inspect and receive copies of their own health information
HIPAA's Privacy Rule grants patients the right to access their own protected health information (PHI) held by covered entities.
CTO Safety Standards & Documentation 5
Which standard governs the quality management system most commonly adopted by orthotic device manufacturers seeking ISO certification?