let's be decisive about devices

Let’s be decisive about devices

Medical device terminology and identification standards

Ministry of HealthPHARMAC

New Zealand Universal List of Medicines

My list of medicines and devices

My list of medicines and devicesAllergies and adverse events

Problems and indications

From the New Zealand health strategyMedical devices and wearables are options for everyone who needs themThe national electronic health record includes personal medical device information as core contentOur regulatory environment and systems readily enable the uptake of new technologyCommon information standards for devices are implemented across the health system

Current state in New ZealandOur pharmaceutical management agency decides which medicines and devices will be fundedA national pharmaceutical schedule lists the funded productsNew Zealand’s 20 district health boards purchase from a national product catalogue based on GS1 standardsCommunity and hospital electronic prescribing and dispensing systems use the SNOMED CT based New Zealand Medicines TerminologyWe need a medical device terminology for clinical documentation and clinical decision support that exists in harmony with supply chain standards

Some medical device typesOrthopaedic implants, arterial stents, pacemakers and prosthesesColostomy bags, catheters and other appliancesWound care productsPeritoneal dialysis equipment and suppliesDiagnostic scanners and therapeutic nuclear medicine machinesIn vitro diagnostic devices and laboratory test equipmentWearables and home based monitors Equipment such as hospital beds

New Zealand Medicines Terminology

Medicinal Product (MP)paracetamol

Medicinal Product Unit of Use (MPUU)paracetamol 500 mg tablet

Medicinal Product Pack (MPP)paracetamol 500 mg tablet, 20

Trade Product (TP)Panadol

Trade Product Unit of Use (TPUU)Panadol 500 mg tablet: film-coated, 1

tablet

Trade Product Pack (TPP)Panadol 500 mg tablet: film coated, 20

tablets

Containered Trade Product Pack (CTPP)

Panadol 500 mg tablet: film-coated, 20 tablets, blister pack

New Zealand Medicines TerminologyLists over 2000 medicines and 14,000 devicesUses SNOMED CT concept identifiers from a New Zealand namespaceNew Zealand Universal List of Medicines adds drug interactions, funding details from the pharmaceutical schedule and safety information from the national regulation authorityNew Zealand Formulary further includes indications, contraindications and cautions for medicines and devices, which is information used for clinical decision support

Unique Device Identifier (UDI)UDIs identify manufactured productsDevice identifier component – the scheme adopted in New Zealand is the Global Trade Item Number (GTIN) – indicates the manufacturer and the specific type of device, including any optionsProduction identifier component includes the batch number, expiry date and serial number for each individual physical item

Linking the clinical and supply sides

Unique Device Identifier (UDI)Physical device identified for

supply chain purposesPossibly many per CTPP

Device TerminologyAbstract medical device description representing

relevant clinical features


Production Identifier (PI) Batch number

Expiry dateSerial number

Device Identifier (DI)GTIN

Universal list of devices









National product catalogue









National pharmaceutical schedule









Device labels and barcodes









Clinical documentation









Alerting examplePatient is in hospital for management of recurrent venous ulcersPatient has recorded diagnosis of congestive heart failureClinician begins to prescribe compression hosiery Contraindication alert is raisedPatient also has recorded latex allergyNurse scans wound care products before useAllergy alert is raised

Recall exampleElectronic health record documents each device dispensed to a patient, including both the clinical device description from the terminology and the UDI for the physical productAny adverse events involving a device are captured in the electronic health recordA safety issue is raised and a given batch of a product is recalledHealth providers query the electronic health record to identify the patients affected and make contact with them

Next stepsSupport international efforts to develop a GTIN based UDI standard and a SNOMED CT based device terminology Rebuild the national pharmaceutical schedule to use the new device terminologyUse SNOMED CT concepts for products, substances, indications, contraindications and cautionsUse SNOMED CT concepts exclusively for allergy, adverse reaction and problem list data in the electronic health record

let's be decisive about devices

Health & Medicine