Requirements for Medical Practices around Medical Device Yearly Maintenance and Accreditation

Requirements for Medical Practices around Medical Device Yearly Maintenance and Accreditation

Why are some clinics under accreditation guidelines while others are not? 
Accreditation is only required for hospitals, day procedure services and public dental services in Australia. 
These are licenses private hospitals and day procedure centres. Licensing depends on what procedures are taking place at the practice. 
The exact definition of a Day Procedure centre is as follows and taken from the Day Procedure Centres Regulation 1996:

This regulation applies to and in respect of all day procedure centres.

The definition of a day procedure centre: the prescribed treatment and circumstances are as follows:

  1. surgical treatment that involves the administration of a general, spinal, epidural or major regional block anaesthetic or intravenous sedative otherwise than for the purpose of simple sedation,
  2. endoscopic treatment that involves the administration of a general anaesthetic or intravenous sedative otherwise than for the purpose of simple sedation,
  3. treatment that involves dialysis, haernofiltration or haemoperfusion,
  4. treatment that involves prolonged intravenous infusion of a single cytotoxic agent or sequential intravenous infusion of more than one cytotoxic agent
  5. treatment that involves cardiac catheterisation.  
Services that have a operating theater and have patients go under for procedures must be licensed and accredited. Otherwise, if the only procedures undertaken are in general rooms, the practice is not required to be licensed or accredited. They may use the standards as guidelines, but this is optional.

NSWHS Standards

NSWHS Standards must be followed in order to achieve accreditation. Below is an excerpt from the standards about medical device maintenance. 

Safe environment for the delivery of care – Safe environment - Action 1.29 – The health service organisation maximises safety and quality of care:

  1. Through the design of the environment
  2. By maintaining buildings, plant, equipment, utilities, devices and other infrastructure that are fit for purpose

Implement a schedule of review to ensure that all buildings, plant and equipment are fir for purpose, safe and in good working order at all times.

Strategies for improvement:

  1. Clear and easy-to-use documentation of maintenance and repairs
  2. Records of all plant and equipment, including (as a minimum) the date of purchase, preventative maintenance schedule, location and serial number
  3. Details of routine and preventative maintenance performed for each item of equipment and plant, including electromedical equipment
  4. Records of dates when equipment is regularly tested to ensure its readiness, including information relating to generators and battery backup.
  5. The Australian standards for medical devices should be reflected in the organisation’s policies and procedures so that purchases, repairs and replacements are carried out following a specific standard. The manufacturers guidelines for medical devices should be followed.

Evidence of this Action:

  1. Policy documents that describe the requirements for maintaining medical devices
  2. Maintenance schedule for medical devices
  3. Audit results of compliance with maintenance schedules and inspections of equipment
  4. Register of equipment that is assigned to meet individual patient’s needs
  5. Audit results of the use of a pre-purchase checklist and risk assessment to identify suitability of all new equipment
  6. Incident reporting

RACGP Standards for general practices, 5th edition

Guidelines for GP practices in Australia. 

Criterion GP5.2 – Practice equipment

GP5.2A Our practice has equipment that enables us to provide comprehensive primary care and emergency resuscitation.

You must:

  1. have all required equipment. 

You could:

  1. maintain a checklist of equipment that you need in consultation rooms
  2. maintain an equipment register, including all of the required equipment
  3. perform a regular audit of the practice’s equipment.

GP5.2B Our practice maintains our clinical equipment in accordance with each manufacturer’s recommendations.

You must:

  1. demonstrate that you keep all clinical equipment in good working order in accordance with manufacturers’ recommendations.

You could:

  1. keep a maintenance log that includes receipts from any external companies that test and calibrate equipment.

GP5.2C Our practice has one or more height-adjustable beds.

You must:

  1. have at least one height-adjustable bed. 

You could:

  1. have a height-adjustable bed in each consultation space.

GP5.2D Our practice has timely access to a spirometer and electrocardiograph

You must:

  1. demonstrate that you have timely access to a spirometer and an electrocardiograph.

GP5.2E Our practice has a defibrillator.

You could:

  1. have a defibrillator
  2. conduct a risk assessment to determine if you need a defibrillator onsite
  3. educate the practice team so they know how patients can access defibrillation when required. 

Maintaining clinical equipment

Your practice must ensure that all clinical equipment is maintained and in working order at all times. You could maintain a register that lists all clinical equipment in the practice, along with schedules for servicing and maintenance.

Equipment that requires calibration, or which is electrical or battery-powered (eg electrocardiographs, spirometers, autoclaves, vaccine refrigerators, scales and defibrillators), must be serviced regularly in accordance with the manufacturer’s instructions so that it remains in good working order. You could keep receipts from companies that have provided external equipment testing and calibration so you can schedule regular maintenance checks. You could also maintain a checklist of equipment used in your consultation rooms so you can record dates of servicing and regularly check that maintenance is up to date.

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