Medical devices are distributed in packages, which are themselves labeled with a UDI, and which can be nested:

Example:

A carton containing 4 boxes, each box containing an individual plastic bag with the device (e.g. a dressing) in it.

Rationale:

The resource DeviceDefinition represents a model of device with its various characteristics. It would not be optimal to use also this resource to represent packages of devices. It seems more appropriate to have a single instance of DeviceDefinition representing the model of device, and be able to express the various packaging of this device model, as properties of DeviceDefinition. Hence the proposed change below.

Proposed change:

Add an optional and repeatable Backbone element "packaging" specified as follows:

packaging       0..*      BackboneElement

– identifier     0..*      Identifier

– type            0..1      CodeableConcept                              defines the specific type of packaging

– count          0..1      integer                                               #items contained in the package (devices or sub-packages) 

– distributor   0..*      BackboneElement                             a distributor of this packaging

     – name       0..1   string                                                       distributor's human-readable name

     – organizationReference   0..* Reference(Organization)     distributor as an Organization resource

– udiDeviceIdentifier   0..*      BackboneElement               Unique Device Identifier (UDI) Barcode string on the packaging

     – deviceIdentifier       1..1   string                       identifier to be associated with every instance for issuer and jurisdiction

     – issuer                       1..1  uri                                     The organization that assigns the identifier algorithm

    – jurisdiction             1..1  uri                                    The jurisdiction to which the deviceIdentifier applies                

– packaging   0..*      see packaging                                    allows to nest packages within packages