The TGA consultation (somewhat inhibited by the difficulty of finding its discussion paper) regarding the potential for mandatory reporting of medical device adverse events by healthcare facilities involves people answering the following questions -
1. Potential introduction of mandatory reporting
- Should Australia introduce mandatory reporting for medical device-related adverse events by healthcare facilities?
– Why should Australia introduce mandatory reporting for medical device- related adverse events by healthcare facilities?
– Why should Australia not introduce mandatory reporting for medical device-related adverse events by healthcare facilities?
- Can you identify any unintended consequences of introducing mandatory reporting of adverse events by healthcare facilities?
2. Healthcare facilities that could be included or excluded
- Are there any healthcare facilities licensed/accredited through national schemes (listed in the discussion paper) that should not be included in any proposed mandatory reporting of medical device adverse event reports? – If so, why?
- Are there any other frequent users of medical devices that could potentially be included? Please select from the provided list or provide examples of other:
– Public and private ambulance services
– Dental and orthodontic practices
– Chiropractic practices (who conduct diagnostic imaging)
– Pharmacy practices (who supply medical devices)
– Non-medical specialist cosmetic procedure centres
– Other residential care providers
– General practices
– Specialist medical practices
– Allied health practices
– Community-based health services (e.g., district nursing services)
– Other (Please provide)
- Are you aware of a reporting, accreditation or licencing body that would be able to mandate potential mandatory reporting of medical device- related adverse events?
- Are you aware of any specific state and territory legislation, health service licencing or other requirements that would prevent potential mandatory reporting?
3. Types of medical device incidents to report
- What type of medical device-related incidents or events do you consider should be reported through to the TGA?
– Incidents resulting in death
– Incidents resulting in serious injury
– Near misses that could have resulted in death or serious injury
– Issues identified during routine maintenance where the device is fixed or replaced prior to use
– Incidents that occur outside of a hospital setting e.g. malfunction of an implant and the patient presents to a healthcare facility
– Other (please specify and provide reason)
- If you work in a healthcare facility, will the harm metrics that your healthcare facility utilises allow for identification of reportable incidents (including the types mentioned in the preceding question)?
- When an adverse event occurs, what medical device related information is collected by facilities through incident or other information management systems?
– The suspected involvement of a medical device
– The brand/trade name of the medical device
– Where the medical device came from (e.g. facility/health professional)
– The current location of the medical device – Other (please specify)
4. Recognising and reporting events that might cause (or be causing) harm
- Do current reporting systems need to be improved to incorporate patient symptoms that might have been caused by a medical device? – If so, what needs to be improved? What level of patient symptoms should be flagged by healthcare facilities? – symptoms causing pain or discomfort – symptoms that cause impairment of function – symptoms that require additional medical care
- Do healthcare facilities routinely collect the following information relating to potential or actual device malfunctions? a. Issues identified during routine maintenance where the device is fixed or replaced prior to use: ▪ Is this information recorded? If so, Where is this information recorded? ▪ Is this information reported? If so, Who or where is this information reported to? b. Issues successfully managed by clinical staff e.g. near misses: ▪ Is this information recorded? If so, Where is this information recorded? ▪ Is this information reported? If so, Who is this information reported to? c. Incidents that occur outside of a hospital setting e.g. malfunction of an implant and the patient presents to a healthcare facility: ▪ Is this information recorded? If so, Where is this information recorded? ▪ Is this information reported? If so, Who is this information reported to?
5. Reducing duplication of data entry
- What platform/s does your organisation currently use (or provide, if you are a software vendor) to record medical device-related incidents, adverse events, potential incidents, or device failures (examples below)? o Patient medical records (for symptom related data) o Incident management systems (for events that impact upon patients) o Workplace health and safety systems (for incidents that impact upon staff) o Equipment maintenance records or databases o Hospital purchasing records (e.g. for returned products) o Patient/staff complaints data o Other (please specify)
- Does the platform include the capability to generate or send reports or summaries of the incidents in standards and formats such as FHIR, XML or JSON?
- If a healthcare facility, do you already submit data to the TGA for COVID-19 vaccine reaction reporting? I
- f you have more than one platform that records device incidents, are there issues with integrating current information systems?
- Is it feasible for an adverse event module to be added to your current platform/s to facilitate data transfer to the TGA? – If so, please outline how this integration could occur, the potential costs and timeframes, and any potential blockers. – If not, could a system adaptor be utilised? If so, please outline which information systems would benefit from an adaptor, the potential costs and timeframes, and any potential blockers. If not, why?
6. Quality assurance of the incident information
- Is there a current minimum data set that is collected for adverse event/incident reporting? – If so, what does this data set consist of? –
- Does this currently undergo quality assurance checks? – If so, who is responsible for undertaking this check?
- Within healthcare facilities, which health professionals are responsible for reporting adverse events as part of their accreditation requirements? – Nurse manager – Quality and safety consultant – Clinical nurse specialist – Bio-medical engineer – Clinician – Other (please specify)
7. Accountability for mandatory reporting
- What existing legislative, accreditation or other mechanisms should be explored in relation to potential mandatory reporting and why?
- What type of compliance schemes could be implemented to reinforce potential mandatory reporting? – Modification to current accreditation schemes – Organisational recognition and reward schemes – Risk-adjusted funding arrangements
