Question

Three medical doctors, each specializing in different areas, agree to set up a practice together. Suggest three (3) medical devices (one for each of the areas of specialization but not necessarily to be used exclusively in one area) that the doctors may wish to purchase.

For each device,

1. i) justify why it is necessary for, and how it can be used in, the joint practice;

2. ii) explain why it is classified as a medical device;

3. iii) state, with justification, at least two different ways of classifying the device (for

   example, diagnostic or therapeutic, and so on);

4. iv) identify the measurand and the source of the measurand.

b) Discuss three (3) factors for consideration in the procurement of these devices. Part of
the discussion must focus on whether a cross-functional team approach to the procurement process is necessary.

Note:
You will need to select the areas of specialization of the doctors before suggesting devices. Devices of Low Risk are not to be used in answering the question.

Answer 1

Medical Device definition:

A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body.

• Specialization of the 3 medical doctors: Gastroenterologist,

   Gyanecologist,

Cardiologist.

Device1- Ultrasound instrument-- It is the instrument used by the Gastroenterologist if the patient comes with stomach pain, nausesa and any other GI symptoms to detect any abnormalities such as ulcer, polyps in the GI tract.

Device2- Hysteroscopy- It is the instrument used by the Gyanecologist if the patient comes with abnormal menstrual bleeding, to detect and treat any abnormalities such as endometriosis, polyps and any other disorders in the uterus, ovaries and fallopian tubes.

Device3- Stent - It is a medical device used by Cardiologist to treat coronary artery stenosis and strokes in the case of fat deposits in coronary artery ( Atherosclerosis).

From the Therapeutic Goods Act 1989...

41BD What is a medical device

1. A medical device is:
2. any instrument, apparatus, appliance, material or other article to be used for human beings for the purpose of the following:
3. diagnosis, prevention, monitoring, treatment or alleviation of disease;

• So, These are called as medical devices as these are used for diagnostic and therapeutic purposes.

• Classification:

Diagnostic- Ultrasound instrument, Hysteroscopy as these are used to diagnose the problems in GI tract and Uterus, and heart.

Therapeutic- The devices used for therapeutic purpose are Hysteroscopy and Stent as these are used for treatment purposes.

Factors for procurement of these device:

• Ultrasound can be used by 3 doctors.
• Primarily used to detect problems before treatment.
• Stent can be used in treatment of crdiac and GI disorders.