Australian Standards and Safety Compliance for Medical Clinics
In Australia we have standards and guidelines for medical clinics that should be followed help minimize risk and increase patient safety.
The importance of patient safety
In any healthcare environment, patient safety and user safety is of the utmost importance. In a setting where the objective is to heal patients, there are hazards and risks involved that we should be aware of. In Australia we have standards and guidelines for medical clinics that should be followed help minimize risk and increase patient safety.Do you own a medical practice?
Are you in a practice manager's role?
Are you looking to gain practice accreditation?
Do you use electromedical equipment to treat or diagnose patients on a daily basis?
... If you answered yes to any of these, then this guide is most applicable to you, so please read on. We will cover the Australian Standards for:
|Medical Device Safety - AS/NZS 3551:2012
|electrical installation safety - AS/NZS 3003:2018
|Autoclave validation - AS/NZS 4815:2006
|General Test & Tag - AS/NZS 3760:2022
Do these standards apply to me and my practice?
Oftentimes it can be difficult to determine which standards need to be followed in a medical setting, or if any at all. Especially when there are a broad range of patient care environments - Cardiology, Surgical, General Practice, Dental, and so on.
Typically, each type of medical practice has their own set of guidelines to follow. For example the RACGP produce the core guidelines that should be followed by all general practices, and the NSQHS standards are for all day surgery, hospital and dental clinics.
However, no matter which guidelines your clinic is directed by, each standard has the same goal: to reduce risk and increase safety for both the caregiver and the one being cared for.
From a biomedical engineers perspective, there are 3 core Australian standards we must observe to ensure we are reducing risk and increasing safety in an environment where electromedical equipment are being used. These are sometimes referred to collectively as the 'patient safety triangle':
It is important note that everyone has a part to play in reducing risk of patient harm. If you work in a patient care environment, you should be aware of all potential electrical hazards, and how to reduce the risk of patient harm.
AS/NZS 2500:2020 - Safe use of Electricity in Patient Care
AS/NZS 3551:2012 - Safe Management of Medical Equipment
Under this standard, we will make sure that all medical devices in the clinic are safe from defects that could cause electric shock. We will also verify the correct operation of the equipment's safety functions, in the case of an electrical fault. We are also checking that the equipment are in line with defined acceptance criteria from the standard and performing to the manufacturer's specifications.
If you are opening a new practice and have purchased new capitol, you will want to make sure those have had acceptance tests to ensure they are electrically safe and performing as intended. Over time, medical equipment will degrade due to wear and tear, so it is best that the equipment is re-checked every 12 months.
AS 3003:2018 - Safe Electrical Installations
In the previous standard, we ensure safety of medical equipment. In this standard, we will ensure the power point installations are also safe. This standard outlines how the electrical wiring should be installed in the practice. These guidelines will be followed by your electrician when you decide to build or make renovations to your practice.
The installation will either be made as body-protected or cardiac-protected, depending on what kind of medical procedures take place in the rooms. The electrical installations will be made with circuit protective devices, mainly residual current devices (RCDs). In the event of an electrical fault, these RCDs should cut off the supply of electricity, protecting your equipment, and more importantly, people's lives.
You may want to reduce risk in your practice, by having your electricals commissioned upon installation and then re-validated every 12-months.
Further standards for Medical Practices
AS 4815:2006 - Validation for Steam Sterilisers
Validation is a mandatory process described by Australian standard (AS/NZS 4815:2006) that should be undertaken upon installation and then at least once every year on your autoclave. This process is a legal obligation to ensure that your autoclave is sterilising correctly and removes the risk of cross contaminant diseases being passed to your patients.
To find out more, please click here.
AS 3760:2022 - Safety Tests for General Electrical Equipment
Further to the requirements of having medical equipment tested and tagged, you may want to have all the general electrical equipment tested also. Under this standard, all equipment that plugs into the wall will be safety inspected and tested. If you require to have all the electrical equipment tagged, it is practical to have it done at the same time as the testing of the medical equipment.
There are two main ways to ensure safety in the practice:
- Safe Medical Equipment - AS/NZS 3551:2012: as a baseline you should have all the medical equipment in the practice tested every 12 months.
- Safe Electrical Installations - AS/NZS3003:2018: If you are testing your equipment, it also makes sense to test and verify the electrical installations of the practice.
Further to the standards for medical safety, you may be required to follow:
- Autoclave Validation - AS/NZS 4815:2006: If your practice has an autoclave steam sterilizer, it must be validated and serviced every 12 months.
- General Electrical Test & Tag - AS/NZS 3760:2022: You may want to have all the other electrical equipment in the practiced verified according to this standard.
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