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E-Chamber ensures compliance and best practice

VIEWS: 12 PAGES: 8

									                                            ®



E-Chamber ensures compliance and best practice




                       www.birdhealthcare.com
                        About Bird Healthcare
Bird Healthcare is an established business specialising in the respiratory, sleep and dental markets of the global
medical industry.

Having developed several internationally patented products, which are fast becoming the gold standard for the respiratory
and sleep fields of medicine. We have been able to reverse the trend of increased cost to quality ratio.

With a combination of product knowledge and industry experience, Bird Healthcare has a strong standing in product
and corporate leadership. All this stems from Bird Healthcare’s commitment to client services and customer support.
Bird Healthcare offer personal and rapid response in customer service and support to specialised sections of the
medical industry.

Bird Healthcare has won many awards from overseas companies that have used their services as international
distributors.


Bird Healthcare is a progressive company that is well placed in the world market
to satisfy any client needs.
                                                                                      ®




     Introducing The NEW, Inexpensive, Unique,
        Semi-Disposable, Single Patient use.
•	 Unique	patented	lip	seal	mouth	piece	                 •	 Semi-disposable	–	6	month	life	span	from	opening
   with bite block
                                                         •	 Australian	owned	and	designed
•	 Large	510ml	chamber
                                                         •	 Offers	complete	infection	control	solutions	
•	 Antistatic	polypropylene	plastic	–	no	need	to	prime      from hospital, GP, pharmacy to the home
•	 Can	be	safely	incinerated	–	environment	friendly      •	 The	easy	and	inexpensive	alternative
•	 Unique	non-return	valve                               •	 Designed	to	accommodate	tidal	breathing
       Why E-Chamber is best practice
                        with	reference	to	the	new	TGA	guidelines
In	the	emergency	room,	MDIs	with	holding	chambers	are	as	effective	as	nebulizers	for	delivering	beta2	agonists	to	treat	
acute asthma in adults and children older than age two.
Departments	using	nebulisers	refer	to	Cochrane	study:	http://www.aafp.org/afp/20030101/cochrane.html
Emergency	Departments	refer	to	American	College	of	Chest	Physicians	Journal:	
http://www.chestjournal.org/cgi/reprint/103/3/665.pdf


Introduction:
Changes	in	the	management	of	semi-critical	and	non-critical	devices	used	in	hospitals	have	seen	the	way	spacers/chambers	
undergo	rapid	change.	These	changes	to	TGA	guidelines	mean	that	hospitals	are	not	able	to	process	their	spacers/chambers	
through	normal	hand	wash,	autoclave	or	thermal	disinfection	system	(with	the	exception	of	items	specified	as	being	TGA	
approved	for	multi-patient	use).	If	a	hospital	chooses	to	employ	the	process	of	re-using	a	TGA	approved	re-usable	spacer/
chamber	they	take	on	full	responsibility	as	the	manufacturer,	the	cost	of	reprocessing	varies	from	CSSD	department	from
hospital	to	hospital.	The	average	cost	for	reprocessing	one	spacer/chamber	in	a	CSSD	environment	as	per	TGA	is	$4.64	
and	a	spacer	unit	cost	averaging	$18.00.
In	response	to	the	new	TGA	guidelines,	the	high	cost	of	spacers/chambers	and	the	current	
situation of hospitals having to give or throw away expensive spacers Bird Healthcare
has	 developed	 the	 E-Chamber,	 two	 years	 in	 the	 making	 we	 are	 pleased	 to	
announce a low cost effective solution that leads the way with advanced technology
demanding	 a	 new	 standard	 in	 best	 practice	 at	 a	 price	 of	 $3.95	 for	 each	
E-Chamber	spacer.


TGA Regulatory Framework:
The	 regulatory	 framework	 for	 the	 re-manufacture	 of	 medical	 devices	
labelled	as	single	use	(SUDs)	applies	to	those	persons	who,	in	the	process	
of	 re-manufacturing	 a	 SUD,	 also	 meet	 the	 definition	 of	 a	 manufacturer	
under	section	41	BG	Therapeutic	Goods	Act	1989	(the	Act).	When	an	SUD	is	
re-manufactured	for	reuse	it	undergoes	these	steps	of	manufacture	and	the	
intended purpose of the device is changed from single use to reusable.


TGA Regulation:
Facilities	choosing	to	re-manufacture	SUDs	need	to	have:
Undergone	Conformity	Assessment	by	the	Therapeutic	Goods	Administration	(TGA);
•		 Obtained	a	TGA	Conformity	Assessment	Certificate	and	included	the	remanufactured	SUDs	on	the		
	 Australian	Register	of	Therapeutic	Goods	(ARTG).


Conformity assessment may include:
•		 Review	of	documentation	and	on	site	audit	of	the	re-manufacturers	quality	management	system	to	ISO	13485:2003	-		
	 Medical	devices	quality	management	systems	-	requirements	for	regulatory	purposes;
•		 Assessment	of	the	design	dossier/technical	file	and	assessment	of	compliance	to	the	essential	principles	for	safety		
    and performance.
Asthma spacers and nebulisers
Asthma spacers and nebulisers labelled as single use are only intended to be used once and those labelled as single
patient use are only intended to be used for one patient. A person who reprocesses these devices and supplies the device
for reuse on other persons would be captured as a manufacturer of a medical device and would need to comply with all the
regulatory requirements under the Act.
In	this	situation	the	options	available	are:
•		 Use	only	once	or	for	one	patient	consistent		with	the	intended	purpose	on	the	label
•		 Use	nebulisers	and	asthma	spacers	that		are	labelled	“reusable”	and	follow	the	TGA	instructions	for	reprocessing
The	latest	TGA	guidelines	are	available	at: Website: http://www.tga.gov.au/devices/devices.htm


Cost analysis of single patient use versus processing spacer/chambers
The	distribution	of	budget	cost	for	purchasing	and	reprocessing	spacers/chambers	differ	from	department	to	department	
and hospital to hospital. In purchasing spacers many departments take on these costs with a varying market value from
product	to	product	for	single	use	ranging	from	($8	to	$20	per	spacer/chamber).	The	reprocessing	is	either	costed	to	the	
department,	 pharmacy,	 CSSD	 or	 hospital	 budget	 –	 reprocessing	 to	 the	 mentioned	 TGA	 guidelines	 or	 giving	 away	 $18	
spacers	is	an	expensive	option	and	is	paid	for	at	some	level	by	the	hospital.	The	best	alternative	is	a	performing	cheap	
single	 patient	 use	 E-Chamber,	 in	 standardising	 on	 the	 E-Chamber	 the	 hospital	 comes	 in	 line	 with	 the	 current	 TGA	
requirements,	saves	up	to	70%	on	previous	expenditure	and	promotes	best	practice.		


E-Chamber versus nebulisers
The	 trend	 of	 departments	 like	 emergency	 and	 wards	 are	 favoring	 the	 use	 of	 single	 patient	 use	 spacers/chambers	 over	
nebulisers	due	to	the	concerns	of	infection	control.	In	the	past	the	use	of	a	nebuliser	is	costed	at	about	$4.50	plus	per	
patient	 to	 process	 so	 it	 was	 considered	 more	 cost	 effective	 than	 disposing	 of	 a	 more	 valuable	 spacer.	The	 E-Chamber	
@	$3.95	now	challenges	this	and	enables	the	hospital	to	provide	the	patient	with	their	own	spacer	for	the	period	of	the	
patients stay, reducing overheads, supporting best practice, saving time and money.
It is well documented in many studies that the two are comparable although it is also recognised that nebulisers raise serious
infection control issues not only to other patients but also the working environment of the healthcare professional.
The	 Cochrane	 review	 of	 spacers	 (holding	 chambers)	 versus	 nebulisers	 for	 treat-                                      ment
of acute asthma covers both children and adults was completed in February
2002.
The	objective	of	spacer	versus	nebuliser	review	of	880	children	and	
444	adults	included	in	21	trials	was	to	assess	the	effects	of	the	
delivery	systems	for	beta2	agonists	for	acute	asthma.
The	 relative	 risk	 of	 hospital	 admission	 for	 children	 was	
0.65	(95%	confidence	interval	0.4	to	1.06).	One	study	in	
children found a significantly shorter length of stay
in the emergency department when the spacer was
used,	 with	 a	 weighted	 mean	 diference	 of	 -0.62	
hours,	 95%	 confidence	 interval	 -0.84	 to	 -0.40	
hours. For adults, the relative risk of admission for
spacer	 versus	 nebuliser	 was	 0.88	 (95%	 confidence	
interval	0.56	to	1.38).	Adults	length	of	stay	in	the	
emergency department was similar for the two
delivery methods.
Peak flow and forced expiratory volume were also similar for the two delivery methods. Pulse rate was lower for spacer in
children,	weighted	mean	difference	-7.8%	baseline	(95%	confidence	interval	-10.2	to	-5.3).
The	Cochrane	reviewers	concluded	that	spacers	produced	results	that	were	at	least	equivalent	to	nebuliser	delivery	and	
for children there may be some advantage.
Finally, a key point to bear in mind is that in comparison with spacers, in the community setting, nebulisers are more
expensive, require a power source and need regular maintenance.


How does the E-Chamber perform:
The	E-Chamber	is	considered	a	large	volume	spacer	(510ml),	in	design	it	was	important	in	relation	to	dose	delivery	and	
cost analysis that the volume of the spacer received considerable attention. We are pleased that the planning in design
has	paid	off	in	clinical	trials	and	dose	delivery	facts;
E-Chamber;	Salbutamol	Test
Dose	exiting	Chamber	(UG)																																															   =		37.23+/-6.93
Respirable	Dose	exiting	Chamber	(UG)																																				   =		33.68+/-5.89							
Respirable	Dose	(%	of	dose	exiting)		(UG)																					 	           =		90.6+/-3.7												
Flow	Volume	Simulation	Study
Tidal	FVS	(ug)																																																					 	      =		24.31+/-3.85
Slow,	maximal	inhalation																																						      	      =		42.12+/-2.06


Full	trial	results	can	be	obtained	by	emailing:	
sales@birdhealthcare.com
How to Order E-Chamber

            Order	code	-	BHC-E32H
            E-Chamber	Single	Patient	Use	
            Semi-disposable	Asthma	spacer
            Box	quantity	32

            Price $3.95ea
            ($126.40	per	box)


            Place order by:
            Phone			 1300	365	561
            Fax			   (03)	9645	3379
            Email    sales@birdhealthcare.com

            FREE sample kits now available
                  Other Products by Bird Healthcare

                                                    NEW Disposable Noseclip
                                                    59c	each
                                                    In	packs	of	100		
                                                    order	part	#	BHC-NC100
                                                    Single	patient	use	disposable
                                                    Priced to ensure compliance
                                                    with	TGA	guidelines




                                                    CPAP Tubing
                                                    $3.49	each
                                                    Box	quantity	25
                                                    order	part	#	BHC-CPAPtube25
                                                    Single	patient	use	re-usable




Respiratory and Lung Function Filters for peak flows, disgnostic & therapy equipment
Suregard	filters	are	colour	coded	for	ease	of	machine	application.	Extensive	range	of	adapters	also	available




  Purple - RJVKB2                         Clear - RJVKB6               Pink - RJVKB1     Blue - RJVKB3          Green - RJVKB4




                                   Ph: +61 3 9645 2977 Fax: +61 3 9645 3379 Toll Free: 1300 365 561
                                        Email: sales@birdhealthcare.com www.birdhealthcare.com
                                         1/11 Sabre Drive Port Melbourne 3207 Victoria Australia




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