_

Statement of Principles

concerning

OSTEOMYELITIS

No. 90 of 2014

for the purposes of the

Veterans’ Entitlements Act 1986

and

Military Rehabilitation and Compensation Act 2004

Title

1. This Instrument may be cited as Statement of Principles concerning osteomyelitis No. 90 of 2014.

Determination

2. The Repatriation Medical Authority under subsection 196B(2) and (8) of the Veterans’ Entitlements Act 1986 (the VEA):

(a) revokes Instrument No. 5 of 2004 concerning osteomyelitis; and

(b) determines in its place this Statement of Principles.

Kind of injury, disease or death

3. (a) This Statement of Principles is about osteomyelitis and death from osteomyelitis.

(b) For the purposes of this Statement of Principles, "osteomyelitis" means inflammation of bone caused by infection. This definition includes Brodie’s abscess.

(d) In the application of this Statement of Principles, the definition of "osteomyelitis" is that given at paragraph 3(b) above.

Basis for determining the factors

4. The Repatriation Medical Authority is of the view that there is sound medical-scientific evidence that indicates that osteomyelitis and death from osteomyelitis can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the Military Rehabilitation and Compensation Act 2004 (the MRCA).

Factors that must be related to service

5. Subject to clause 7, at least one of the factors set out in clause 6 must be related to the relevant service rendered by the person.

Factors

6. The factor that must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting osteomyelitis or death from osteomyelitis with the circumstances of a person’s relevant service is:

(a) having a wound, laceration, or other injury or disease disrupting the skin or mucosa at the site or adjacent to the site of osteomyelitis, within the two years before the clinical onset of osteomyelitis; or

(b) having a dental, medical or surgical procedure which breaches the skin or mucosa within the two years before the clinical onset of osteomyelitis; or

(c) having septicaemia, bacteraemia or systemic fungal infection within the two years before the clinical onset of osteomyelitis; or

(d) having a foreign body at the site or adjacent to the site of osteomyelitis at the time of the clinical onset of osteomyelitis; or

(e) having diabetes mellitus at the time of the clinical onset of osteomyelitis; or

(f) having a disease from Specified List 1 at the time of the clinical onset of osteomyelitis; or

(g) having chronic ischaemia of the affected limb from:

(i) chronic venous insufficiency of the lower limb; or

(ii) atherosclerotic peripheral vascular disease of the lower limb;

at the time of the clinical onset of osteomyelitis; or

(h) having chronic lymphoedema of the affected limb at the time of the clinical onset of osteomyelitis; or

(i) being in an immunosuppressed state at the time of the clinical onset of osteomyelitis; or

(j) having received a cumulative equivalent dose of at least ten sieverts of ionising radiation to the affected site before the clinical onset of osteomyelitis; or

(k) undergoing a course of therapeutic radiation for cancer, where the affected site was in the field of radiation, before the clinical onset of osteomyelitis; or

(l) having internal deposition of radium-224, radium-226, or radium-228 before the clinical onset of osteomyelitis; or

(m) having osteonecrosis at the site of osteomyelitis before the clinical onset of osteomyelitis; or

(n) having diabetes mellitus at the time of the clinical worsening of osteomyelitis; or

(o) having a disease from Specified List 2 at the time of the clinical worsening of osteomyelitis; or

(p) having chronic ischaemia of the affected limb from:

(i) chronic venous insufficiency of the lower limb; or

(ii) atherosclerotic peripheral vascular disease of the lower limb;

at the time of the clinical worsening of osteomyelitis; or

(q) having chronic lymphoedema of the affected limb at the time of the clinical worsening of osteomyelitis; or

(r) being in an immunosuppressed state at the time of the clinical worsening of osteomyelitis; or

(s) inability to obtain appropriate clinical management for osteomyelitis.

Factors that apply only to material contribution or aggravation

7. Paragraphs 6(n) to 6(s) apply only to material contribution to, or aggravation of, osteomyelitis where the person’s osteomyelitis was suffered or contracted before or during (but not arising out of) the person’s relevant service.

Inclusion of Statements of Principles

8. In this Statement of Principles if a relevant factor applies and that factor includes an injury or disease in respect of which there is a Statement of Principles then the factors in that last mentioned Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.

Other definitions

9. For the purposes of this Statement of Principles:

"a disease from Specified List 1" means:

(a) chronic renal failure;

(b) cirrhosis of the liver;

(d) osteopetrosis; or

(e) sickle cell disorder;

"a disease from Specified List 2" means:

(a) chronic renal failure;

(b) cirrhosis of the liver; or

"an immunosuppressed state" means a condition in which the immune response is substantially diminished. Examples of circumstances giving rise to this include haematological or solid organ malignancy, administration of immunosuppressive drugs, acute exposure to high doses of ionising radiation, severe malnutrition and human immunodeficiency virus infection;

"chronic renal failure" means having a glomerular filtration rate of less than 60 mL/min/1.73 m2 for a period of at least three months, or the presence of irreversible kidney damage;

"cumulative equivalent dose" means the total dose of ionising radiation received by the particular organ or tissue. The formula used to calculate the cumulative equivalent dose allows doses from multiple types of ionising radiation to be combined, by accounting for their differing biological effect. The unit of equivalent dose is the sievert. For the purposes of this Statement of Principles, the calculation of cumulative equivalent dose excludes doses received from normal background radiation, but includes therapeutic radiation, diagnostic radiation, cosmic radiation at high altitude, radiation from occupation related sources and radiation from nuclear explosions or accidents;

"death from osteomyelitis" in relation to a person includes death from a terminal event or condition that was contributed to by the person’s osteomyelitis;

"ICD-10-AM code" means a number assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Australian Modification (ICD-10-AM), Eighth Edition, effective date of 1 July 2013, copyrighted by the Independent Hospital Pricing Authority, and having ISBN 978-1-74128-213-9;

"osteonecrosis" means death of bone due to obstruction of its blood supply;

"osteopetrosis" means a genetic disease characterised by abnormally dense bone due to defective reabsorption of immature bone known as marble bones disease;

"relevant service" means:

(a) operational service under the VEA;

(b) peacekeeping service under the VEA;

(d) British nuclear test defence service under the VEA;

(e) warlike service under the MRCA; or

(f) non-warlike service under the MRCA;

"terminal event" means the proximate or ultimate cause of death and includes:

(a) pneumonia;

(b) respiratory failure;

(d) circulatory failure; or

(e) cessation of brain function.

Application

10. This Instrument applies to all matters to which section 120A of the VEA or section 338 of the MRCA applies.

Date of effect

11. This Instrument takes effect from 17 November 2014.

Dated this seventeenth day of October 2014

The Common Seal of the )

Repatriation Medical Authority )

was affixed at the direction of: )

PROFESSOR NICHOLAS SAUNDERS AO

CHAIRPERSON