Single use instruments

SINGLE PATIENT USE INSTRUMENTS

Solmed supplies many medical instruments and devices and some confusion exists as to what the labels mean if it says "Single Use" or "Single Patient Use". Many members ask us "Can we use this Instrument again?"

In Australia we have strict laws governing the correct labeling of Medical Devices. This is governed and audited by the Therapeutic Goods Administration "TGA" Act. Legislation has been enacted to protect the patient where applicable.

Traditionally the expensive European Instruments were manufactured using high quality expensive Stainless Steel and they were designed for many uses after reprocessing through proper cleaning and sterilizing. Hospitals and Clinicians started to realise that many of these expensive instruments could not be cleaned properly and many clinical studies supported this.

Over the last decade, manufacturing has changed to a lesser grade of stainless steel to produce instruments that were still good quality but at a tenth of the price of the European Versions. These instruments were designed to be cheaper and safer as a Hospital or Clinician could use it and then discard it. It was cheaper that the cost of reprocessing. It also meant safety for the patient. Incidentally these stainless steel instruments can be recycled.

In a Clinical, Medical Centre or Hospital Setting:

If a product is labeled "Single Use" or "Single Patient use, it cannot be used on a separate patient unless the TGA accredited Reprocessing is completed.

The TGA rules only apply to Clinical settings where they undertake reprocessing procedures of Instruments. It does not apply to Individuals who use these devices for their own use.

You may be using a nebulizer which is labeled "Single Patient use", then it is up to the individual how many times you use it. We do recommend cleaning any device after use.

You may have Forceps or Scissors and want to reuse them, then as an individual then it is quite alright.

If you are a Clinical Operation then you need to discard unless you have compliant autoclave facilities or sterile reprocessing options. If this is the case you then come under the legislation of being a manufacturer and strict penalties would apply if you were found not to have cleaned an instrument properly.

Purchasing these devices for use in a First Aid Kit for personnel use does not come under the legislation. Even if the device is past it's sterility expiry date, the product is still sterile unless the package is open.

If the package is opened that is still OK to use providing it hasn't been in touch with Blood, Tissue or Bodily Fluids.

The fact that these instruments may have been made using a lesser quality stainless steel, we submit that they are very good instruments as proven by their use in Hospital Settings, and providing they are clean, you can reuse many times. Remember though, that they will gradually wear down the more times you process them after heat stress.

The cost of these devices is less than the reprocessing costs, so it makes sense to use them.

If any member would like a copy of the TGA Regulations regarding this topic, please contact Solmed for a complimentary copy.

Solmed will continue to provide helpful guides to assist members in buying safely and from reputable suppliers.

WARNING: Please make sure before you buy any Medical Device that it has a current ARTG Number which means it is listed with the TGA.

Solmed is a responsible Device Supplier and as such wants to advise in association with the TGA, the proper requirements for using single use Devices. It is the buyers responsibility to ensure they use Medical Devices in accordance with the current legislation.

The Legislation does not apply to Individuals for personal use when they purchase instruments such as scissors and other types of Medical Single Use Devices for use in their First Aid Kits, at home etc.

It does apply to Medical Centres and GP's who intend to reuse these devices and there are specific requirements for reprocessing these devices for reuse.

Please make yourself aware by reading these extracts:

Single use devices (SUDs) and the reuse of SUDs

Overview

Single Patient Use

can be used multiple times on one patient. Single patient use devices are able to be reprocessed and reused on the same patient in accordance with the manufacturer's instructions

If the device is only intended to be for single use this must be clearly stated on the device, the label or the

Instructions for Use in accordance with Essential Principle 13.4, Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002.

If a SUD (for example, an orthopaedic plate or screw) is trialled during the surgical/medical procedure and comes in contact with blood, tissue or bodily fluids during the surgical/medial procedure it is regarded as used.

The TGA will include the device in the ARTG based on the manufacturers intended purpose. Therefore, the TGA does not conduct any pre-market assessments to determine if a device can be reused if the manufacturer states that the device is for single use or single patient use.

There may be several reasons why a medical device is for single use or single patient use, including that the:

Materials used in the manufacture of the device may not withstand repeated reprocessing, design of the device may not facilitate adequate cleaning and sterilisation, device may not perform as intended by the manufacturer if it is reused.

The reuse of SUDs may lead to:
Potential risks of cross infection/contamination associated with using inadequately cleaned and sterilised devices.
Failure of the device to perform as intended.
Material degradation.
Biocompatibility issues.
Endotoxic reactions caused by the residues from reprocessing SUDs that are opened but unused.

The regulation of the remanufacture of SUDs does not include those SUDs that are opened but unused.

"Opened but unused" is the term used to refer to a SUD whose packaging has been opened but the device was not used and did not come in contact with blood, tissue or bodily fluids.
The TGA regards opened but unused as having the same meaning as packaging that is damaged. In the case of a sterile device the original manufacturer is required under Essential Principle 13.4, Item 12 to provide advice on what to do when the packaging is damaged.

From the

Therapeutic Goods (Medical Devices) Regulations 2002 – Schedule 1 Part 2…

13.4

Instructions for use

12 For a device that is intended by the manufacturer to be supplied in a sterile state:

(a) an indication that the device is sterile; and

(b) information about what to do if sterile packaging is damaged; and

but the device is not used.

The Instructions for Use may be considered by the TGA if the application under goes a pre-market assessment before the device is included on the Australian Register of Therapeutic Goods (ARTG).

The TGA will assess the Instructions for Use against the Medical Device Standards Order (Standards for Medical Devices Required to be Sterile) 2008 that maps Essential Principle 13.4 Item 12 to the international standard ISO 17664: 2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilisable medical devices.

Reusing SUDs

When a SUD is reused, the TGA considers that the device has been remanufactured as the:

intended purpose and design specifications for the device are altered from single use to reusable

device may undergo manufacturing processes, such as sterilisation

device may need to have components replaced so that it can be reused

original manufacturer can no longer be considered responsible for the safety and performance of the device

The person responsible for undertaking these remanufacturing activities is considered to be a manufacturer under section 41BG(2) of the

Therapeutic Goods Act 1989 and must comply with the therapeutic goods legislation relating to the manufacture of medical devices. From the Therapeutic Goods Act 1989…

41BG

(1) The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person’s name, whether or not it is the person, or another person acting on the person’s behalf, who carries out those operations.

(2) If subsection (1) does not apply to a medical device, the manufacturer of the device is the person who, with a view to supplying the device under the person’s name, does one or more of the following using ready made products:

(a) assembles the device;

(b) packages the device;

(d) fully refurbishes the device;

(e) labels the device;

(f) assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following:

(i) the labelling on the device;

(ii) the instructions for using the device;

(iii) any advertising material relating to the device.

Reuse of SUDs for personal use

The TGA does not regulate the practice where people clean and reuse products such as single use enteral feeding tubes, urinary catheters, etc as long as it is for their own use.

Health care professionals who give advice on reusing SUDs

Healthcare professionals often advise their patients about the reuse of the SUDs. They are not undertaking any work but are providing advice on how the device may be cleaned for reuse. The healthcare professional may be professionally liable if the information provided contradicts the information provided in the manufacturers Instructions for Use .

Regulatory requirements for remanufacturing SUDs

The Australian regulatory framework for medical devices is designed to ensure that the reprocessing of devices that were not originally intended for reprocessing does not compromise the safety and effectiveness of the device.

Under these regulatory controls the reprocessing facility is regulated as a manufacturer and is required to demonstrate the reprocessed device is equivalent to the original and will continue to perform without additional risk to the patient.