CHT Regulatory Standards & Infection Control 2

Question 1

Which federal agency enforces the Safe Medical Devices Act as it applies to hyperbaric chambers?

Accepted Answer

FDA

Answer

The FDA regulates hyperbaric chambers as Class II or Class III medical devices under the Safe Medical Devices Act.

Question 2

Under NFPA 99, a monoplace hyperbaric chamber operating with 100% oxygen is classified as which category of hyperbaric facility?

Accepted Answer

Category A

Answer

NFPA 99 Category A hyperbaric facilities use chambers pressurized primarily with oxygen, including monoplace chambers.

Question 3

According to CMS Conditions of Participation, a hospital-based hyperbaric program must maintain treatment records for a minimum of how many years for adult patients?

Accepted Answer

5 years

Answer

CMS requires hospital records, including hyperbaric treatment records for adults, to be retained for at least 5 years from the date of discharge.

Question 4

Which organization's Hyperbaric Oxygen Therapy Committee publishes the Undersea and Hyperbaric Medical Society (UHMS) approved indications list?

Accepted Answer

UHMS

Answer

The UHMS Hyperbaric Oxygen Therapy Committee reviews evidence and publishes the official list of approved HBO2 indications.

Question 5

When must a hyperbaric facility report a serious device malfunction involving patient harm to the FDA?

Accepted Answer

Within 10 working days

Answer

The Safe Medical Devices Act requires facilities to report device-related deaths or serious injuries to the FDA within 10 working days.

(CHT) Certified Hyperbaric Technician Practice Test

(CHT) Certified Hyperbaric Technician Practice Test

CHT Regulatory Standards & Infection Control 2