Dressings and other products for wound treatment Concept of dressings

Definition of dressings

The term "dressings" is legally defined in Section 31 (1a) SGB V. It states:

"Dressings are objects, including fixation material, whose main effect is to cover surface-damaged parts of the body, to absorb body fluids from surface-damaged parts of the body or to accomplish both. The property of a dressing does not cease to apply if an article has additional effects that serve to heal wounds in the human body without pharmacological, immunological or metabolic action, for example by keeping a wound moist, cleaning, absorbing odors, being antimicrobial or metal-coated. [...] The Federal Joint Committee regulates the details of the distinction between dressings and other products for wound treatment [...]"

The following categories of wound treatment products can be derived from this:

• "classic" dressings

• Dressings with complementary properties

• Other products for wound treatment

Delimitation by the G-BA in the Medicinal Products Directive

The more detailed regulation of the distinction between the individual categories was assigned to the Joint Federal Committee (G-BA). The G-BA has now complied with this by amending the Drug Guideline. The distinction between the product categories is regulated in detail in §§ 52-54.

Dressings with a complementary effect

Section 53 para. 3 sentence 3 of the Drug Guideline contains a definition of dressings with a complementary effect:

"[Dressings with a complementary effect] are characterized by a quality which, in addition to the purposes according to paragraph 2 sentence 1 numbers 1 and 2 [wound covering, absorption of fluid, stabilization/immobilization/compression] without pharmacological, immunological or metabolic mode of action in the human body, creates an environment that is as physiological as possible and thus supports natural wound healing (complementary property)."

The main effect of the product must therefore still be to cover the wound, absorb fluid or provide stabilization, immobilization or compression. The supplementary effect must be to create an environment that is as physiological as possible and thus supports natural wound healing. The following supplementary properties are specified in the law:

• Keeping the wound moist

• cleansing

• Odor control

• Antimicrobial effect

• Metal coating

This list is not exhaustive. For example, the G-BA has also recognized the anti-adhesive property, which prevents the dressing from sticking to the wound or enables atraumatic dressing changes, as a supplementary property in Annex Va to the Medicinal Products Directive. The anti-adhesive property is not explicitly mentioned in the law. Dressing manufacturers should therefore check whether their product fulfills one of the aforementioned properties or has another comparable property and be able to justify this accordingly. The property must fulfill the purpose of creating an environment that is as physiological as possible and thus supports natural wound healing. An exemplary assignment of products to the individual properties can be found in Annex Va of the Medicinal Products Directive.

It is also striking that the metal coating mentioned in the law is not a property, but describes the product itself. The term "metal coating" must therefore be interpreted restrictively to mean that the metal coating has a healing-promoting effect and does not, for example, merely stabilize the outer surface of the dressing.

No pharmacological, immunological or metabolic effect

Negatively, the dressing must not have a pharmacological, immunological or metabolic effect on the human body. As soon as this is the case, it is an other product for wound treatment.

It should be noted that the law is not based on whether the manufacturer ascribes a corresponding purpose to the product, but that Section 31 para. 1a SGB V is designed in such a way that the existence of the pharmacological, immunological or metabolic mode of action is objectively important. The decisive factor is therefore not the mode of action attributed to the product by the manufacturer, but the mode of action that it objectively develops. For example, even if a product has a pharmacological effect without the manufacturer's intention to do so, it loses its status as a dressing and becomes another wound treatment product.

A pharmacological effect is a typical interaction at the molecular level between a substance or its metabolites and a component of the human body (cells or their components, blood components, etc.) that leads to the triggering, enhancement, reduction or blocking of physiological functions or pathological processes. Immunological effect means an effect in or on the body by stimulation and/or mobilization of cells and/or their products involved in a specific immune response. Metabolic effect means an effect, of a substance or its metabolites, on a biochemical process involved in or supporting normal body function. This includes starting, stopping or altering such a process.

MDCG 2022 - 5, p. 5 ff.

This means that dressing manufacturers must check whether their product has one of the aforementioned modes of action. If this is the case, the product is generally excluded from the supply of dressings and must only be included again by a decision of the G-BA.

Other products for wound treatment

Other products for wound treatment are all other products that cannot be classified as either dressings or dressings with additional properties (e.g. non-stable preparations such as gels, creams or ointments for covering wounds). The legal consequences of the classification are immense: while dressings and dressings with supplementary properties can continue to be prescribed at the expense of the SHI, the situation is different for other products for wound treatment: these products are generally not included in SHI care. They can be prescribed by way of exception if the G-BA has included them in care in the same way as medical devices can be prescribed.

This requires proof of the medical necessity of the use of such products on the basis of studies with the highest possible level of evidence and, if necessary, further literature. This follows from Section 40 (1) in Chapter 4 of the G-BA's Rules of Procedure. It further states:

"On the basis of systematic literature searches, it must be demonstrated that there is a consensus in the relevant professional circles , adequately supported by scientific studies, on a diagnostic or therapeutic benefit of the medical device for the treatment of the condition."

Furthermore, a dressing is only medically necessary (see Section 39 in Chapter 4 of the G-BA's Code of Procedure) if

• it is suitable for medical treatment within the meaning of Section 27 (1) sentence 1 SGB V and Section 28 AM-RL in accordance with its intended purpose in terms of the type and extent of the intended purpose,

• there is a need for diagnostic or therapeutic intervention,

• the diagnostic or therapeutic benefit corresponds to the generally recognized state of medical knowledge and

• another, more appropriate treatment option is not available.

The hurdle for modern wound treatment products to be reimbursed by the SHI is thus set very high. The burden of proof for the corresponding evidence lies with the manufacturer. In a statement, BVMed assumes that more than 400 products will lose their previous status as dressings and thus their eligibility for reimbursement.

Manufacturers should therefore check at an early stage which of the three categories their products fall into, as the reimbursability of their products depends on this.