Until recently, nebulisers have been reused by patients at home and in hospital. This reprocessing has varied between
- simply emptying the contents of the nebuliser out after use,
- washing in soapy water,
- cold sterilisation.
Manufacturers have clearly been aware of this practice, but have generally not voiced any concerns.
However, in recent years there have been a number of publications which have resulted in the present confusion.
ABHI and MDA publications
Firstly, in July 1994, ABHI (the Association of British Health-Care Industries) published their position paper on reuse of medical devices. Secondly, and perhaps more importantly, the Medical Devices Agency (MDA) published MDA DB 9501 in January 1995 (The Reuse of Medical Devices supplied for single use only). This latter publication defines reuse as
"For practical purposes, reuse may be defined as repeated episodes of use of a device in circumstances which make some form of reprocessing necessary. The reprocessing might consist of cleaning, disinfecting, refilling, re-sharpening or any like procedure."
"For devices intended by the manufacturer to be used more than once, and where reprocessing may affect performance and safety, the manufacturer should supply details of recommended reprocessing procedures to permit safe use. The number of reuses which may be undertaken should also be declared, where this is not otherwise obvious."
The document goes on to discuss items forÂ single patient use, which includes insulin syringes and intermittent urethral catheters. It notes that these products are capable of undergoing reuse for the same patient provided certain conditions are met.
The MDA document in particular caused concern amongst hospital staff with regard to nebulisers. Medical and nursing staff who had been following an apparently innocuous practice for years now found themselves being warned by some manufacturers that their current practice was not acceptable. The MDA document clearly states that users who reprocess single use products for further use may be transferring legal liability from the manufacturer to themselves or their organisation. These legal liabilities could be both criminal and civil.
An important concern within the NHS issue was the implied cost of these changes. At an average cost of Â£1.15 each, a patient in hospital for 10 days using a nebuliser 3 times a day will require 30 nebulisers instead of 1. Some estimates in Wales are that this could cost Â£30,000 and upwards per trust.
There would also be an increased cost for disposal, as most Trusts now have to pay for the disposal of clinical waste. It follows that there is also an environmental argument for attempting to recycle plastic devices.
Finally, hospital staff were forced to askÂ "is this practice safe, and will it affect my patient ?"
To answer this question, we must explore the possible problems with reprocessing nebulisers:
- If nebulisers are not cleaned correctly, and residual microorganisms remain in the unit (or are introduced during reprocessing) then the patient is at risk of infection.
- If the jet is not cleaned correctly, there could be a build up of crystallised drug which may reduce the flow rate or even prevent nebulisation. Reduced flow rates increase the time to nebulise, and increase the possibility that the patient may receive a reduced dose. (Complete blockage is mainly inconvenient for the patient.)
- Drop size
- The efficacy of nebulisers is highly dependent on drop size, which may be affected by build up of drug on the jet or mechanical cleaning of the jet.
- Residual drug and/or residuals from the cleaning process should be removed, as any contamination (such as detergents, which have surface active properties) can affect the size of the droplets. Excess surface active agents can cause foaming of the drug, resulting in poor nebulisation.
Any reprocessing activity should address these issues.
The MDA states that any organisation which reprocesses single use devices needs to demonstrate that:
- TheÂ processes (cleaning, disinfection, sterilisation) have been validated to prove that the methods produce a safe, effective and acceptable product.
- The properties of the construction materials remain unchanged.
- The number of times an item can safely be reused has been determined, and records are kept to ensure that this number has not been exceeded.
- Appropriate reprocessing records are kept and maintained.
The affect of the Medical Device Directives
The Medical Device Directives (93/42/EEC), came into effect in January 1995, and the transition period ends on 13 June 1998. After this date, all medical devices (with certain exceptions) will have to carry the CE mark. If the item is supplied as a reusable item, the label must provide information on the appropriate method of reprocessing and any restrictions on the number of reuses.
Thus after 13 June 1998, any nebuliser which is supplied as reusable must contain reprocessing information. If devices are not considered reusable, then the manufacturer must label the deviceÂ "for single use".
The requirements regulate devices "placed on the market". Thus if a hospital was reprocessing devices for another organisation, they would have to fulfil the requirements of the directive. However, if single use devices are reprocessed for use solely within the organisation, this is not regarded as "placement on the market" and hence the regulations do not apply. (This would not absolve the organisation from any legal liabilities however.)
Do not reuse nebulisers
Some manufacturers still label their devices asÂ "single use only". Although using these nebulisers once will solve the potential legal and clinical problems referred to above, the cost burden for many hospitals makes this an unacceptable solution.
Use "reusable" nebulisers
Some nebulisers are reusable, and are labelled as such. An example is theÂ Durable Sidestream from Medic-Aid. The advantages of such an approach are that the reprocessing validation has been carried out by the manufacturer already, and reprocessing instructions are supplied with the device. The products can also be used for extended periods (up to a year in the case of the Durable Sidestream) compared to the "disposable" type. Thus disposal costs are low as fewer products have to be disposed of compared toÂ single use only products.
The disadvantages are that
- the cost of each unit is higher,
- there is a cost associated with the reprocessing (staff time, documentation etc),
- there is still a risk of the reprocessing instructions not being followed exactly, resulting in the trust and/or user being liable for any adverse consequences.
The Durable Sidestream costs about Â£12.00.
Use "single patient use" nebulisers
The outcry from hospitals following the addition of "single use only" to nebuliser labelling resulted in many disposable nebuliser manufacturers changing their labelling fromÂ Single use only toÂ Single patient use only.
In general, these nebulisers now have labelling and instructions which allows a single patient to reuse the nebuliser as long as appropriate cleaning instructions are followed. As with the "reusable" nebulisers, there are costs associated with reprocessing, and hospital staff must now be aware that the manufacturer's reprocessing instructions should be followed carefully. However, this solution appears to be the most acceptable, as it enables hospitals to continue using similar nursing and purchasing procedures that they have been used to, as well as keeping the cost of the nebuliser unit low.
Hospitals should evaluate which of these two solutions (reusableÂ versus disposable) is the most cost effective solution for their circumstances and usage patterns.
SMTL have been acting on behalf of WHCSA (the Welsh Health Common Services Authority) and NHS Trusts in Wales to determine what action has or will be taken by each manufacturer. The sections below describe the current status with each manufacturer.
Hudson RCI and Henleys have performed validation studies to demonstrate that the small volume Micro Mist nebulisers may be reused on the same patient for 30 days at three treatments per day, provided the user cleans the nebuliser as per their instructions after every treatment.
Hudson RCI emphasise that the above cleaning procedure does not sterilise the nebuliser, and recommend that the nebuliser be replaced after each treatment if the patient has an infectious disease as a precautionary measure against cross contamination.
Hudson RCI also state that:
|"Bearing the above in mind, Hudson RCI recommends that any cleaning/disinfecting procedure should first be approved by the individual hospital or care provider to ensure that the cleaning process will be effective in the specific environment of that institution prior to the repeated use of any disposable medical device. Neither Hudson RCI nor the distributor can assure that any cleaning or disinfecting process will be effective against the risk of cross contamination under any given circumstances in particular environment. Therefore, cleaning, disinfecting and repeated use is at the sole discretion of the respective institution and its staff, and neither Hudson RCI nor the Distributor warrant, guarantee or accept responsibility for the outcome."|
In February 1997, Intersurgical wrote that they were unable to provide information regarding the reprocessing of their nebulisers, as that may change their performance characteristics.
They are reviewing their position as of August 1997.
Lifecare labelled their nebuliser asÂ Single patient use (Discard after 1 months use) in March/April 1997 also. Their labelling is as follows:
|"Cleaning Procedure (must be cleaned after every use).Â
This procedure does not sterilise the nebuliser. Therefore if the patient has an infectious disease, the nebuliser should be discarded.
Medic Aid were one of the first nebuliser manufacturers to relabel their disposable Sidestream nebulisers asÂ Single patient use only.
Medic Aid carried out validation studies to show that the nebuliser could be reused for one month if their cleaning protocol was followed.
The labelling, which appeared in March/April 1997, is as follows:
|"After each use, unscrew nebuliser into three parts, wash nebuliser in warm soapy water and rinse well. Remove excess water using a paper towel and leave in a clean area to air dry. Wipe mask with a clean damp cloth. Never put tubing in water. Single patient use for one month normal in-hospital use, Flow rate 6-8 L/min."|
The Sidestream Durable nebuliser is guaranteed for one year from the date of purchase (based on 4 x 6 minute treatments per day) as long as it is cleaned in accordance with the instructions shown in the brochures for the Medi-Aid Porta-Neb and Freeway Lite compressors as detailed below.Â NOTE - the following instructions are for the Durable nebuliser, not the disposable nebuliser.
|".... rinse the Sidestream (durable) drug container in clean water. Fix the coiled Duratube back onto the drug container and switch on the Freeway Lite/Porta-Neb for a few seconds to push out any drug that was trapped. Switch off and take the long tubing off the Sidestream drug container. Take apart the Sidestream drug container into three pieces. Wash these parts in warm soapy water along with the mouthpiece or mask. Then rinse them in clean water and let them dry. The Sidestream drug container must be boiled once a week in water with a little washing up liquid for 6-10 minutes. (Take apart the Sidestream drug container before boiling).|
SIMS Intertech supply nebulisers for single patient use (Series 22, 23 and 77 nebulisers), and recommend that the product can be used for up to 30 days (private correspondence from SIMS). As of the 17th March 1997, they did not supply cleaning instructions with the nebulisers, but did make available cleaning instructions as follows:
Care should be taken to ensure products are only used by one patient.
In a letter dated 29th August, SIMS note that they will be including their cleaning instructions with the Instructions for Use as part of the process to CE mark the devices.
The following table summarises the nebulisers made by each manufacturer and the status of each product. Some of the nebulisers in the table haven't been included in the previous section as the manufacturers haven't responded to requests for information. Thus the information in this table is necessarily incomplete.
|Flexicare||Not known.||Information not available|
|Hudson/Henleys||Micro Mist||Single patient use.||30 days.|
|Intersurgical||Cirrus||Single use only||Single use|
|Lifecare||Micro Neb||Single patient use||Up to 1 months use.|
|Medic Aid||Sidestream||Single patient use||Up to one month|
|Medic Aid||Durable Sidestream||Single patient use/reusable.||Up to 1 year.|
|SIMS Intertech||Series 22, 23 and 77 nebulisers.||Single patient use.||Up to 30 days.|
|Vickers||Venticaire||Information not available.|
|Vital Signs/Baxter||Misty Neb||Single patient use.||No information|
|Marquest Medical Products||Acorn II||Single patient use at present.||Information being produced to allow re-use.|
The information in this document was based on the latest information provided to SMTL by the manufacturers in question. However, the instructions which have been duplicated above have been provided for information only - the manufacturers latest literature and labelling should be regarded as the definitive advice on using and cleaning their products.
|Revision:||$Revision: 1.7 $|
|Revision Date:||$Date: 2000/11/13 12:23:21 $|