148k views
2 votes
Who is the approval authority for all medical investment equipment and high cost expense medical equipment?

User NoamG
by
7.7k points

1 Answer

3 votes

Final answer:

The approval authority for all medical investment equipment and high cost expense medical equipment is the Center for Devices and Radiological Health (CDRH). They ensure that medical equipment meets the necessary standards before it can be used. Hospitals and their staff are responsible for following cleaning and sterilization protocols developed by government agencies and can be held liable for any breach.

Step-by-step explanation:

The approval authority for all medical investment equipment and high cost expense medical equipment is the Center for Devices and Radiological Health (CDRH), which is a branch of the FDA. CDRH is responsible for premarket approval, manufacturing oversight, performance evaluation, and safety of medical devices. They ensure that medical equipment meets the necessary standards before it can be used.

The protocols for cleaning or sterilizing medical equipment are developed by government agencies like the FDA and other scientific organizations. These protocols are then adopted by medical device and equipment manufacturers. The end-users, such as hospitals and their staff, are responsible for following these procedures and can be held liable if there is a breach.

To learn more about the FDA's approval process for medical devices, you can visit their website or refer to the JAMA Internal Medicine article titled 'Medical Device Recalls and the FDA Approval Process'.

User John Vrbanac
by
7.8k points