Dear colleagues,
On 25 February 2021, the Therapeutic Goods Administration (TGA) introduced new definitions and regulatory requirements for a category of Personalised Medical Devices (PMDs) currently known as custom-made medical devices which are designed and manufactured for individual patients. The framework has been introduced by the Australian Government to ensure an appropriate level of regulation is applied to PMDs in order to manage the risks associated with their use.
PMDs are currently defined in two categories: custom made medical devices and adaptable medical devices. The new definitions result in four categories: custom made medical devices, patient matched medical devices, devices produced using a medical device production system and adaptable medical devices.
Metro North Health is required to submit a notification of transition to the TGA and register with the Global Medical Device Nomenclature (GMDN) Agency for access to identify GMDN codes before 25 August 2021. The notification will need to include the areas within Metro North Health that manufacture PMDs and the kinds of PMDs being manufactured/sponsored. Additional work to categorise PMDs to assist with determining which devices may be included under one Australian Register of Therapeutic Goods number, confirming the device classification, GMDN code and manufacturer. There is an urgency to identify the relevant areas which may include but not be limited to surgical, oral health, medical imaging and allied health areas and the kinds of PMDs being manufactured/sponsored within Metro North Health.
Further compliance with the updated requirements will need to be completed by 1 November 2024 as communicated in the Patient Safety Communique 04/21.
The Clinical Governance, Safety, Quality, and Risk Unit will coordinate Metro North’s registration process. Further information will be disseminated to impacted areas to outline the updated TGA requirements. In the interim, if you are currently designing or manufacturing PMDs or you would like further information, please contact MN_RiskandCompliance@health.qld.gov.au.
Feedback from consumers is actively encouraged as a key strategy for improving the safety and quality of care and services. Feedback and complaints management forms part of Standard 1 – Clinical Governance within the National Safety and Quality Health Service Standards.
Between October 2020 and March 2021 Metro North recorded 3,143 compliments and 2,115 complaints. Inpatient Services received 1,224 compliments (38.9% of total compliments) in the six-month period October 2020 to March 2021 and 777 complaints (36.7% of total complaints). Compliments continue to outnumber complaints for inpatients. With regard to complaints, treatment continues to be the main theme, followed by communication and access / timing.
All Metro North Health facilities are developing revised Capacity Management Plans in response to high demand with patient flow.
During the month of May there were six incidents relating to harm from falls across Metro North Health. In the month of August the Metro North Health Clinical Governance, Safety, Quality and Risk team in partnership with clinical directorates and facilities are implementing a safety and quality campaign across the health service to increase awareness to aim to prevent falls and reduce the number harm from falls to ensure our patients are receiving good quality of care. Should you wish to see anything included during this campaign please don’t hesitate to contact us MN_ClinGovQandRisk@health.qld.gov.au.
A big shout-out to our colleagues within the Clinical Skills Development Service who, as of Wednesday 28 July, have facilitated more than 11,186 fit tests for frontline workers, including Metro North healthcare staff, Queensland Police Service and other essential services. Thank you to all those staff who have been involved with fit testing across Metro North facilities, as well as our great Metro North Health staff for taking responsibility and getting fit tested to help keep ourselves, your colleagues and patients safe.
If any areas require a specific fit testing session locally, please contact the MNHHSFitTestingProgram@health.qld.gov.au email account. All completed fit test results are uploaded into the TMS for individual, manager and service line reporting.
Kind regards,
Michele