Introduction.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 for 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.
Legal Concerns. 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
Financial Concerns.An important concern within the NHS issue was the
implied cost of these changes. At an average cost of £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 £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.
Clinical concerns.Finally, hospital staff were forced to ask "is
this practice safe, and will it affect my patient ?"
To answer this question, we must explore the possible problems with
reprocessing activity should address these issues.
- 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.
Reprocessing requirements.The MDA states that any organisation which
reprocesses single use devices needs to demonstrate that:
- The processes (cleaning, disinfection, sterilisation) have been
validated to prove that the methods produce a safe, effective and acceptable
- 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 device "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 as
"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 the 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 to 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,
- 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
The Durable Sidestream costs about £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 from Single
use only to 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 (reusable
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
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
- The micro mist nebuliser is emptied of any residual drug that may be
left in the nebuliser chamber. The nebuliser chamber may be re-filled
with water and re-run for approximately one minute to assist the removal
of any additional drug residue that may be present in the base/chamber.
- The micro mist nebuliser is disassembled into its three components -
top, base/chamber and jet baffle.
- The micro mist nebuliser's components should be washed in "hand hot"
- The nebuliser's components may also be soaked in one part hot water
and one part vinegar for a period of thirty minutes, rinsed again under
"hand hot" tap water and then allowed to air dry. The nebuliser should
not be placed in a dishwashing machine as these machines tend to get too
hot and may distort the plastic components of the nebuliser. In addition
the nebuliser should not be boiled. NOTE - it is important that no sharp
instrument be used to clear the nebuliser's jet, as this may result in
damage to the nebuliser rendering it unable to mist and perform
- Re-assemble the micro mist nebuliser and initially run as empty to
remove any remaining water.
- Store in a clean dry place before repeated use.
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
Hudson RCI also state that:
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.
|"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." |
They are reviewing their position as of August 1997.
Lifecare labelled their nebuliser as
Single patient use (Discard after 1 months use) in March/April
1997 also. Their labelling is as follows:
Medic Aid were one of the first
nebuliser manufacturers to relabel their disposable Sidestream nebulisers as
Single patient use only.
|"Cleaning Procedure (must be cleaned after every
This procedure does not sterilise the nebuliser. Therefore if
the patient has an infectious disease, the nebuliser should be discarded.
- Empty residual drug and run nebuliser containing water for 1 min.
- Wash the three individual components (base, jet and top) in hot,
- Rinse in clean water to remove all soap residue and thoroughly dry.
- Assemble and run empty nebuliser on the compressor to remove excess
- Store in a dry, clean place. (Alternatively, store in a Milton
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. NOTE - the
following instructions are for the Durable nebuliser, not the disposable
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:
|".... 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
These steps should be carried out after each use, or as a
minimum once a day.
- Wash the nebuliser chamber and mask or mouthpiece with warm soapy
water and rinse thoroughly.
- Wipe the tubing (if present) with a damp cloth, then dry. DO NOT
immerse in water.
- Blow the equipment dry by connecting together and using the
compressed air or oxygen to dry it, or dry using a disposable paper
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.
Summary TableThe 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
||Information not available
||Single patient use.
||Single use only
||Information not yet available.
||Single patient use
||Up to 1 months use.
||Single patient use
||Up to one month
||Single patient use/reusable.
||Up to 1 year.
||Series 22, 23 and 77 nebulisers.
||Single patient use.
||Up to 30 days.
||Information not available.
||Single patient use.
|Marquest Medical Products
||Single patient use at present.
||Information being produced to allow re-use.
Additions.If you know of a manufacturer or nebuliser that is not
included in this list, please send as much information as possible to email@example.com.
Important.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.
Document Revision Information
||Date: 1997/10/17 13:56:56
||Peter Phillips [firstname.lastname@example.org]|
This site (page) was originally set up with the aid of
sponsorship from the Value for Money Unit, Welsh Office and an educational grant from
All materials copyright © 1992-1999 by the Surgical
Materials Testing Lab. unless otherwise stated.
Originally posted at: http://www.smtl.co.uk/MDRC/Nebulisers/neb-reuse.html
Last Modified: Friday, 17-Oct-1997 14:56:57 BST
Posted with permission 2/16/00.