Respiratory Products RFTHPV2014–015 - HealthShare Victoria

PART 5

STATEMENT OF REQUIREMENTS

Respiratory Products

RFTHPV2014–015

Part 5 – Statement of Requirements Page 1 of 37

Respiratory Products – RFTHPV2014–015 CONFIDENTIAL

TABLE OF CONTENTS

INTRODUCTION ............................................................................................. 3

5.1 Purpose ............................................................................................. 3

5.2 Scope ................................................................................................ 3

5.3 Product Categories .............................................................................. 3

5.4 Product Conditions ............................................................................... 5

5.5 Definitions .......................................................................................... 6

STATEMENT OF WORK .................................................................................... 8

5.6 Indicative Demand............................................................................... 8

5.7 Delivery ............................................................................................. 8

5.8 Training and Support ........................................................................... 9

5.9 Warranty ............................................................................................ 9

5.10 Key Performance Indicators .................................................................. 9

5.11 Reporting ........................................................................................... 9

GENERAL REQUIREMENTS ............................................................................ 10

5.12 Standards and Compliance .................................................................. 10

5.13 Recall Process ................................................................................... 10

5.14 Backorders and Discontinued Lines ...................................................... 10

5.15 Superseded Products ......................................................................... 10

5.16 Infection Control ............................................................................... 11

PRODUCT SPECIFICATIONS ......................................................................... 12

GENERAL SPECIFICATIONS .................................................................. 12

5.17 Substances of Concern ....................................................................... 12

5.18 Reusable Devices .............................................................................. 12

5.19 Compliance with Category Specifications ............................................... 12

CATEGORY SPECIFICATIONS ................................................................ 12

5.20 Category 1 – Oxygen Face Masks ......................................................... 12

5.21 Category 2 – Anaesthesia/Resuscitation Face Masks ............................... 13

5.22 Category 3 – Non-Invasive Ventilation Interfaces ................................... 14

5.23 Category 4 – Nasal Cannulae .............................................................. 15

5.24 Category 5 – Oxygen Tubing ............................................................... 15

5.25 Category 6 – Small Volume Jet Nebulizers ............................................. 15



5.26 Category 7 – Breathing Circuits and Accessories .................................... 16

5.27 Category 8 – Respiratory Filters ........................................................... 17

5.28 Category 9 – Gas Sampling Lines ......................................................... 18

5.29 Category 10 – Catheter Mounts and Connectors ..................................... 19

5.30 Category 11 – Rebreathing Bags .......................................................... 20

5.31 Category 12 – Oropharyngeal Airways (Guedel) ..................................... 20

5.32 Category 13 – Nasopharyngeal Airways ................................................ 20

5.33 Category 14 – Endotracheal Tubes ....................................................... 21

5.34 Category 15 – Intubation Stylets, Airway Catheters and Guides ............... 21

5.35 Category 16 – Laryngeal Mask Airways ................................................. 22

5.36 Category 17 – Tracheostomy Tubes ..................................................... 22

5.37 Category 18 – Yankauer Suction Devices .............................................. 23

5.38 Category 19 – Suction Catheters ......................................................... 24

5.39 Category 20 – Closed Ventilation Suction Systems ................................. 24

5.40 Category 21 – Suction Tubing ............................................................. 24

5.41 Category 22 – Closed Wall Suction Systems .......................................... 25

5.42 Category 23 – Manual Resuscitators ..................................................... 25

5.43 Category 24 – Carbon Dioxide Absorbents ............................................. 26

5.44 Category 25 – INTUBATION ASSISTANCE DEVICES ................................ 26

APPENDICES

APPENDIX 1 – PRODUCT LIST ............................................................. 27

APPENDIX 2 – INDICATIVE USAGE ....................................................... 32

APPENDIX 3 – REFERENCES ................................................................ 36

Introduction



INTRODUCTION

5.1 PURPOSE

The purpose of this Part 5 – Statement of Requirements, is to: 5.1.1

detail the scope and range of products sought under this Request for

Tender (RFT)

specify the requirements that Respondents and/or their offered products

must meet (these requirements also form part of any resulting Agreement

between HPV and any successful Respondent(s)).

5.2 SCOPE

HPV is seeking responses for respiratory products for use in Participating 5.2.1

Health Services for a duration of three (3) years plus two possible one (1)

year extensions (3+1+1).

The scope of this RFT includes: 5.2.2

respiratory products and patient circuits used in most clinical settings,

including:

o all critical care areas, from neonate to adult

o anaesthetics

o general wards and departments

products that are compatible with a range of equipment systems,

including:

o ventilators (mechanical, CPAP, BiPAP, acute care)

o anaesthetic machines

o suction systems

o humidification systems

o oxygen therapy systems.

5.3 PRODUCT CATEGORIES

The categories of respiratory products required under this RFT include: 5.3.1

CATEGORY

NUMBER CATEGORY NAME

1 Oxygen Face Masks

2 Anaesthesia/Resuscitation Face Masks

3 Non-Invasive Ventilation Interfaces

Introduction



CATEGORY

NUMBER CATEGORY NAME

4 Nasal Cannulae

5 Oxygen Tubing

6 Small Volume Jet Nebulizers

7 Breathing Circuits and Accessories

8 Respiratory Filters

9 Gas Sampling Lines

10 Catheter Mounts and Connectors

11 Rebreathing Bags

12 Oropharyngeal Airways (Guedel)

13 Nasopharyngeal Airways

14 Endotracheal Tubes

15 Intubation Stylets, Airway Catheters and Guides

16 Laryngeal Mask Airways

17 Tracheostomy Tubes

18 Yankauer Suction Devices

19 Suction Catheters

20 Close Ventilation Suction Systems

21 Suction Tubing

22 Closed Wall Suction Systems

23 Manual Resuscitators

24 Carbon Dioxide Absorbents

25 Intubation Assistance Devices

Respondents may offer products in one, some or all categories. 5.3.2

Only products that specifically fit within the category descriptions provided 5.3.3

will be considered.

Introduction



Products offered in ‘other’ subcategories will only be considered where the 5.3.4

product meets the specification and the Respondent is successful in at least

one of the specific subcategories of that category.

HPV reserves the right to not consider any additional products offered. 5.3.5

For a full list of product categories and subcategories, see Appendix 1 – 5.3.6

Product List.

5.4 PRODUCT CONDITIONS

Clinical Trials

Participating Health Services may, at their discretion, research or trial new 5.4.1

technology or use non-contracted products to perform clinical trials at any

time throughout any resulting Agreement.

Product Duplication

HPV will not consider any product that is subject to a current HPV Agreement. 5.4.2

Respondents must ensure that each product is offered in only one 5.4.3

subcategory. It is at the Respondent’s discretion to ensure that each product

is submitted in the most appropriate subcategory.

Product Information

Respondents must submit a copy of relevant product diagrams, specifications 5.4.4

or brochures to assist in accurately identifying products offered.

All product information submitted must: 5.4.5

be in electronic format (contained on a CD/DVD)

be in English

be specific to the product offered

contain the Respondent’s company name

include the product code.

To assist in managing this material, all product information submitted must 5.4.6

be labelled with the relevant HPV category and subcategory number. HPV

reserves the right to not consider any unlabelled submissions.

Product information will not be evaluated, but is necessary to assist in 5.4.7

accurately identifying products offered.

Where offered products are unidentifiable and the product information 5.4.8

provided is not clearly labelled, HPV reserves the right to remove these

products from evaluation.

Introduction



Respondents should not submit information relating to products that are not 5.4.9

called for in this Invitation to Supply.

Respondents should note that product samples and research papers are not 5.4.10

to be provided, unless specifically requested by HPV.

Third-Party Product Compatibility

Respondents tendering third-party items must provide clinical testing and 5.4.11

evidence of each item’s compatibility with specific models of OEM equipment.

Successful Respondents must also make these certificates of compliance 5.4.12

and/or evidence of testing available to Participating Health Services upon

request.

Further evidence of testing will be required for product variations requested 5.4.13

during the contract period. Certificates of compliance and/or evidence of

testing must not be more than two (2) years old at the time the variation

request is made.

HPV reserves the right to require further testing from successful Respondents 5.4.14

if:

a product quality issue is identified during the contract

an option period is exercised at the end of the contract principal period.

Ensuing clauses 5.4.13 and 5.4.14, in the event that HPV requires further 5.4.15

certificates of compliance and/or evidence of testing to be provided, HPV

reserves the right to remove products from contract if the successful

Respondent refuses to or cannot produce the required evidence.

5.5 DEFINITIONS

The following definitions apply to this Part 5 – Statement of Requirements, 5.5.1

unless otherwise stated.

TERM DEFINITION

business day Any weekday that is not gazetted as a public holiday in

Melbourne, Victoria.

consumable A component that is used continually until it is exhausted

and needs to be replaced.

may Indicates an optional element; it is at the Respondent’s

discretion to either meet or not meet this element, and

failure to meet this element will not have an impact during

evaluation.

must Indicates a mandatory requirement; failure to meet this

requirement will have a significant negative impact during

evaluation.

Introduction



TERM DEFINITION

Participating Health

Services

Public Hospitals and other Health or Related Services, as

those terms are defined in Section 3 of the Health Services

Act 1988 (Vic), that are described in Appendix 4 of Part 8.

reusable A device designed or intended by the manufacturer as

suitable for reprocessing and reuse (source: TGA,

Regulation of the Re-Manufacture of Single Use Medical

Devices).

semi-consumable A component that is used continuously until it deteriorates

or fails and needs to be replaced.

should Indicates a highly desirable element; unless justifiable

reason exists, not meeting this element may have a

medium impact during evaluation.

single use A device that is intended to be used on an individual

patient, during a single procedure, and then discarded

(source: TGA, Regulation of the Re-Manufacture of Single

Use Medical Devices).

single-patient use A device that can potentially undergo more than one

episode of use on one patient only. The device may need to

undergo some form of reprocessing between each use (in

accordance with manufacturers’ instructions).

will Indicates an anticipated future condition or requirement.

Statement of Work



STATEMENT OF WORK

5.6 INDICATIVE DEMAND

Appendix 2 contains indicative data on usage for Respiratory Products 5.6.1

(expressed in expenditure terms) for the current contract period to date.

Respondents are to note that any usage figures provided are indicative only, 5.6.2

and are provided to assist Respondents in the preparation of their

submission.

5.7 DELIVERY

Respiratory products must be delivered to the location(s) specified by 5.7.1

Participating Health Services within the shortest possible timeframe;

however, this must not exceed the following timeframes:

two (2) business days from receipt of order for metropolitan Participating

Health Services

three (3) business days from receipt of order for regional and rural

Participating Health Services.

Preference may be given to Respondents who can offer delivery within one 5.7.2

(1) business day.

Except where there is evidence of inappropriate handling by the receiving 5.7.3

Participating Health Service, all damaged or broken products and equipment

must be replaced free of charge.

Urgent Deliveries

For the purposes of this section, urgent deliveries refers to urgent requests 5.7.4

placed by an individual Participating Health Service, and does not include

state-wide emergency situations.

Respondents should be able to receive and action urgent delivery requests 24 5.7.5

hours a day.

Urgent deliveries must be received by Participating Health Services (at 5.7.6

specified locations) within the shortest possible timeframe; however, this

should not exceed the following timeframes:

12 hours from receipt of order for metropolitan Participating Health

Services

24 hours from receipt of order for regional and rural Participating Health

Services.

Statement of Work



5.8 TRAINING AND SUPPORT

Successful Respondents may be required to provide training and/or training 5.8.1

materials to facilitate the introduction of their respiratory products to

clinicians in their operating environment. Such training and/or materials must

be available to Participating Health Services upon request.

If requested by a Participating Health Service, successful Respondents must 5.8.2

provide a plan detailing how they will provide training to nominated staff. The

number of staff involved in training may vary greatly between Participating

Health Services.

Successful Respondents must ensure that the following is available to 5.8.3

Participating Health Services (in either hard-copy or electronic format):

the credentials of any staff who would be providing support

the hours of availability for support

the geographical area covered by the support (if support is available on-

site)

details of educational and/or support materials available to clinicians.

5.9 WARRANTY

Where applicable, products must be warranted for normal use. 5.9.1

Upon request, successful Respondents must provide information (printed or 5.9.2

electronic) explaining product warranty.

Repairs and Replacements under Warranty

The repair of any respiratory product under warranty will be at no cost to 5.9.3

Participating Health Services.

The cost of any pickup or delivery associated with a repair under warranty 5.9.4

will be borne by the successful Respondent.

Successful Respondents must provide Participating Health Services with a 5.9.5

suitable replacement item of the same make and model until the repaired

item is returned. This will be done at no cost to Participating Health Services.

5.10 KEY PERFORMANCE INDICATORS

Refer to Schedule 6 of Part 7 – Draft Agreement for Key Performance 5.10.1

Indicators.

5.11 REPORTING

Refer to Schedule 7 of Part 7 – Draft Agreement for reporting 5.11.1

requirements.

General Requirements



GENERAL REQUIREMENTS

5.12 STANDARDS AND COMPLIANCE

All items offered must comply with relevant Australian Standards (or their 5.12.1

equivalent International Standards). Refer to ‘Appendix 3 – References’ for a

list of the minimum relevant standards.

All items offered must be approved by the Australian Therapeutic Goods 5.12.2

Administration (TGA). Respondents must provide evidence of this (i.e. ARTG

certificates) in their response.

Successful Respondents must provide evidence of ARTG certification to 5.12.3

Participating Health Services upon request.

5.13 RECALL PROCESS

All recalls must be managed in line with the Uniform Recall Procedure for 5.13.1

Therapeutic Goods (2004).

Within three (3) months of contract commencement, all recalls and/or hazard 5.13.2

alerts must also be completed using GS1 Recallnet.

Class 1 recalls (as defined by the TGA’s Uniform Recall Procedure for 5.13.3

Therapeutic Goods) must also meet the requirements under section 5.9

(Warranty), where applicable.

5.14 BACKORDERS AND DISCONTINUED LINES

In the event that a product is unavailable for a period of two or more 5.14.1

consecutive weeks, successful Respondents must contact (at a minimum):

the Clinical Product Advisor (where applicable)

the Nurse Unit Manager

supply departments

HPV.

Successful Respondents must inform the affected Participating Health 5.14.2

Services and HPV of:

the anticipated timeframe for resolving the issue

the availability of an agreed substitute product.

5.15 SUPERSEDED PRODUCTS

Where a contracted item is superseded by a new product, the new product 5.15.1

must be offered at the price of the original item, and the price of the original

item must be reduced until it has been phased out.

General Requirements



5.16 INFECTION CONTROL

Where applicable, all items must meet the requirements of the Australian 5.16.1

Guidelines for the Prevention and Control of Infection in Healthcare (2010).

Upon request by Participating Health Services, successful Respondents must 5.16.2

provide specific cleaning instructions for all reusable products. Recommended

cleaning products must be available for purchase within Australia.

Product Specifications



PRODUCT SPECIFICATIONS

GENERAL SPECIFICATIONS

5.17 SUBSTANCES OF CONCERN

Preference may be given to products (including their accompanying 5.17.1

packaging) that are latex-free, unless otherwise stated.

Preference may be given to products that are DEHP-free. 5.17.2

5.18 REUSABLE DEVICES

For reusable devices, the following information must be readily available to all 5.18.1

Participating Health Services in either hardcopy and/or electronic format:

instructions for cleaning, sterilisation and reuse

warranty information.

5.19 COMPLIANCE WITH CATEGORY SPECIFICATIONS

Products offered with optional components must also comply with the 5.19.1

specifications for other relevant categories (where applicable).

CATEGORY SPECIFICATIONS

5.20 CATEGORY 1 – OXYGEN FACE MASKS

A range of single-patient use, clinically clean oxygen face masks is required, 5.20.1

including:

a full range of sizes from neonates to adults

low, medium, high and variable/multiple concentration oxygen face masks

with and without a nebuliser

for connection to a humidification system

tracheostomy masks, direct tracheostomy connection and face tents

with and without oxygen tubing

masks with access for end tidal sampling.

Note: Oxygen face masks with oxygen tubing must also comply with the 5.20.2

specifications for Category 5 (Oxygen Tubing).

Note: Oxygen face masks with a nebuliser must also comply with the 5.20.3

specifications for Category 6 (Small Volume Jet Nebulizers).




The body of each face mask must: 5.20.4

be malleable

fit under the patient’s chin to fit effectively around the face

have no rough or sharp edges

incorporate:

o a securely fixed inlet adaptor connected under the nosepiece

o a retaining elasticised strap that can be easily repositioned to hold the

mask firmly in place.

Oxygen therapy masks must incorporate an inlet adaptor that connects 5.20.5

securely with standard oxygen tubing, and must be able to deliver up to 15

litres of oxygen per minute without detachment.

Where oxygen tubing is provided with the oxygen therapy mask, the tubing 5.20.6

must:

be a minimum of two metres in length

incorporate a connector that can attach to a standard oxygen nipple

connection

be able to deliver up to 15 litres of oxygen per minute without

detachment.

If the oxygen mask includes a nose clip, then the nose clip must be securely 5.20.7

attached to the body of the mask.

For variable/multiple oxygen concentration masks, instructions for use 5.20.8

(including assembly and the method of varying the FiO2) must be included on

individual item packaging or as a package insert.

Preference may be given to variable/multiple oxygen concentration masks 5.20.9

that offer the widest range of FiO2 and total gas flow.

5.21 CATEGORY 2 – ANAESTHESIA/RESUSCITATION FACE MASKS

A range of clinically clean face masks is required to meet clinical needs for 5.21.1

anaesthesia and resuscitation, including:


single use and reusable

scented and unscented

round and anatomically shaped

with and without:

o an inflatable cushion seal

o colour-coded sizes




a range of materials.

Anaesthesia/resuscitation face masks must have no rough or sharp edges. 5.21.2

Reusable anaesthesia/resuscitation face masks that have a cushion seal must 5.21.3

incorporate an inflation valve to allow reinflation of the cushion.

5.22 CATEGORY 3 – NON-INVASIVE VENTILATION INTERFACES

A range of clinically clean non-invasive ventilation interfaces is required, 5.22.1

including:


for use in a variety of clinical settings including ED, ICU, acute, subacute,

rehabilitation, sleep laboratories and perioperative

for CPAP and BiPAP

helmets, full face, total face, oral and nasal masks, and nasal pillows and

prongs


vented and non-vented

with and without:

o inflation port

o expiratory port

o anti-asphyxiation valves

a quick release mechanism for rapid removal during an emergency

any replacement parts or individual components that are sold separately

(including head gear).

Non-invasive ventilation masks must have no sharp or rough edges. 5.22.2

Non-invasive ventilation masks must be permanently labelled with sizing 5.22.3

information.

Each interface must incorporate a strap; the strap must be removable if it 5.22.4

contains latex.

Where masks require assembly, kits must include assembly information as an 5.22.5

insert.

Kits must clearly identify any latex content on the kit packaging. 5.22.6

Preference may be given to Respondents who provide customer support for 5.22.7

patients receiving home therapy.


provide a list of compatible parts and equipment for connection and use.




5.23 CATEGORY 4 – NASAL CANNULAE

A range of single-patient use, clinically clean nasal cannulae (nasal prongs) is 5.23.1

required, including:


straight, curved and flared prongs

humidified and non-humidified nasal prongs

with and without:

o tubing attached

o end tidal CO2 monitoring, with or without filters

with ‘over-the-head’ and ‘around-the-ears’ methods of attachment

nasal O2 catheters

additional components and accessories.

Note: Nasal cannulae with tubing attached must also comply with the 5.23.2


Nasal prongs must: 5.23.3

be smooth, soft and pliable to maximise patient comfort

have no sharp or rough edges.

The body of the cannulae must be malleable and fit under the patient’s nose 5.23.4

to allow prongs to sit within the nostrils.

5.24 CATEGORY 5 – OXYGEN TUBING

A range of single-patient use, clinically clean, flexible oxygen tubing is 5.24.1


for attachment to oxygen therapy and aerosol therapy masks

pre-cut lengths and rolls of tubing

with and without female connectors to fit standard oxygen delivery

equipment

corrugated tubing, with and without integral cuffs

smooth bore, bubble-type and crush-resistant tubing.

5.25 CATEGORY 6 – SMALL VOLUME JET NEBULIZERS

A range of clinically clean, single-patient use, non-electrical small volume jet 5.25.1

nebulizers is required to meet clinical needs. This includes:

with and without oxygen tubing

individual components and kits.




Note: Nebulizers with tubing attached must also comply with the 5.25.2


Where oxygen tubing is provided, it must: 5.25.3

be a minimum of two metres in length

incorporate a connector that can attach to a standard oxygen nipple

connection

be able to deliver up to 15 litres of oxygen per minute without

detachment.

Preference may be given to nebulizers that: 5.25.4

perform effectively at the greatest maximum tilt angle

have the lowest residual volume.

Preference may be given to kits that have the recommended gas flow for 5.25.5

optimal performance included as a package insert.


provide the following information (in either hard-copy or electronic format):

the useful life for each nebulizer (considering the frequency of use)

cleaning instructions for when the nebulizer is reused on the same patient

particle size.

5.26 CATEGORY 7 – BREATHING CIRCUITS AND ACCESSORIES

A range of individually packaged breathing circuits is required, including: 5.26.1


non-heated and heated

for use in anaesthesia, to suit a wide range of anaesthetic delivery

systems

single-, dual-, and triple-limb formats

analgesic circuits

for ventilation in an ICU setting, to suit a range of mechanical ventilators

for non-invasive ventilation in an acute clinical setting (e.g. CPAP and

BiPAP), to suit a range of non-invasive ventilators

fixed and extendable

smooth and corrugated bore

with and without:

o Y-piece

o rebreathing bag limb and rebreathing bag




o bacterial/viral filter

o other optional components (for example, mouth pieces and face masks,

where applicable)

humidifier circuits with oxygen:

o of varying lengths

o single and dual limb formats

o smooth and corrugated bore

o with and without accessories

o with and without heating wires.

Note: Breathing circuits with a bacterial/viral filter must also comply with the 5.26.2

specifications for Category 8 (Respiratory Filters).

Note: Breathing circuits with a rebreathing bag must also comply with the 5.26.3

specifications for Category 11 (Rebreathing Bags).

Breathing circuits must: 5.26.4

have a smooth transition of the inside surface (between the body of the

breathing tube and the ends) to minimise gas turbulence

be made of materials that:

o are compatible and resistant to deterioration

o have low absorption and permeability with substances that they may

contact during the intended use.

Preference may be given to kits/breathing circuits that have the contents 5.26.5

printed on the packaging or included as a package insert.

5.27 CATEGORY 8 – RESPIRATORY FILTERS

A range of single-patient use respiratory filters is required, including: 5.27.1


heat and moisture exchangers (HME), bacterial/viral filters and combined

HME/bacterial/viral filters

for use on spontaneously breathing and mechanically ventilated patients

sterile and clinically clean

with and without:

o accessory ports

o connectors

o catheter mounts

o right angles




o elbow

o tubing.

Note: Respiratory filters with oxygen tubing must also comply with the 5.27.2


Note: Respiratory filters with gas sampling tubing must also comply with the 5.27.3

specifications for Category 9 (Gas Sampling Lines).



physical dimensions in millimetres

recommended flow rate in litres

recommended range of tidal volume in millilitres

moisture output (in relation to tidal volume) in milligrams of H2O per litre

resistance to flow in centimetres of H2O at litres per minute

recommended maximum period of continuous use before disposal (in

hours)

compliance (millilitres per kPa-1)

dry weight in grams.

5.28 CATEGORY 9 – GAS SAMPLING LINES

A range of clinically clean, single-use and consumable gas sampling lines for 5.28.1

use during ventilation is required, including:


for use with:

o end tidal CO2 monitoring

o anaesthetic agent monitoring

with male/male and male/female luer lock connectors

with and without:

o filter

o sampling port

o sampling cuvette

single and multiple channels

a range of materials

a range of lengths and diameters to suit a wide range of capnographs and

gas spectrometers.




Note: Gas sampling lines with respiratory filters must also comply with the 5.28.2

specifications for Category 8 (Respiratory Filters), where applicable.

Where filters are incorporated, they must protect the sampling lines from 5.28.3

moisture and bacterial contamination.

5.29 CATEGORY 10 – CATHETER MOUNTS AND CONNECTORS

A range of single-use and reusable catheter mounts is required, including: 5.29.1


for connection to breathing circuits


straight and angled

with and without:

o suction port

o swivel elbow

o gas sampling access

o metered dose elbow

standard and extendable


additional components.

A range of single-use and reusable connectors is required, including: 5.29.2


for connection to breathing circuits


straight and angled

with and without:

o suction port

o single and double swivel elbow(s)/connector(s)

o gas sampling access

o luer ports

o port caps

o metered dose elbow


additional components.




Note: If a catheter mount is attached to a respiratory filter, then this product 5.29.3

must be offered in Category 8 (Respiratory Filters).

5.30 CATEGORY 11 – REBREATHING BAGS

A range of clinically clean single-use and reusable rebreathing bags is 5.30.1



plain and assembled neck

open- and closed-ended

standard and anti-static

a range of materials.

Rebreathing bags must be manufactured from materials that are compatible 5.30.2

with clinical concentrations of anaesthetic agents, and must have low

absorption and permeability.


provide (in either hard-copy or electronic format) compliance data for

rebreathing bags.

5.31 CATEGORY 12 – OROPHARYNGEAL AIRWAYS (GUEDEL)

A range of individually wrapped, single-patient use oropharyngeal airways is 5.31.1

required to meet clinical needs. This includes:



with and without colour coding.

5.32 CATEGORY 13 – NASOPHARYNGEAL AIRWAYS

A range of individually wrapped, single-patient use nasopharyngeal airways is 5.32.1



sterile and clinically clean.

Nasopharyngeal airways must: 5.32.2

be manufactured from soft, compliant materials with a smooth finish

(including rounded edges to minimise insertion trauma and maximise

patient comfort)

be kink resistant

incorporate a flange at the external end.




5.33 CATEGORY 14 – ENDOTRACHEAL TUBES

A range of sterile endotracheal tubes is required, including: 5.33.1



standard, for use in laser surgery, reinforced, preformed and others (e.g.

for endobronchial intubation, intended for left or right bronchus)

PVC and silicone

cuffed and uncuffed

for short- and long-term intubation

where applicable:

o Murphy eye

o low-pressure cuff

o subglottal

kit presentations.

Endotracheal tubes must: 5.33.2

be packaged individually with a connector included

incorporate a radio-opaque line extending the length of the tube.

5.34 CATEGORY 15 – INTUBATION STYLETS, AIRWAY CATHETERS AND GUIDES

A range of flexible intubation stylets, airway catheters and guides is required, 5.34.1

including:

to assist intubation in adult, paediatric, infant and neonatal patients

(including difficult intubation)

a range of:

o sizes and lengths

o tip configurations




with and without graduations

hollow and solid lumen

additional components

individually wrapped and bulk packaged.




Intubation stylets, airway catheters and guides must: 5.34.2

have a smooth surface and atraumatic tip

incorporate an outer coating or surface that helps reduce friction between

the stylet and tube.

5.35 CATEGORY 16 – LARYNGEAL MASK AIRWAYS

A range of laryngeal mask airways is required, including: 5.35.1



standard and reinforced

silicone and PVC

with and without:

o gastric access tube

o introducer

o inflation pressure indicator.

For reusable laryngeal masks, successful Respondents must provide the 5.35.2

following information (in either hard-copy or electronic format) to

Participating Health Services upon request:

instructions for cleaning, sterilisation and reuse

the recommended number of uses and reuse conditions for a single

laryngeal mask airway

the recommended process for tracking the use of each laryngeal mask

airway.

5.36 CATEGORY 17 – TRACHEOSTOMY TUBES

A range of sterile single-patient use tracheostomy tubes is required, 5.36.1

including:


for short-, medium- and long-term implantation

for surgical and percutaneous introduction

for establishing an airway in an emergency situation

cuffed and uncuffed

fenestrated and non-fenestrated

standard and reinforced

with and without:

o adjustable flange




o integral suction port

o inner cannula

o various fasteners

percutaneous insertion kits with and without tracheostomy tube

spare and additional components, including but not limited to:

o speaking valves with colour-coding

o inner cannulae

o plugs

o brushes

emergency cricothyrotomy kits.

Note: For the purposes of this RFT, customised tracheostomy tubes that are 5.36.2

manufactured to meet individual patient needs are considered out of scope.

Tracheostomy tubes with air-filled cuffs must incorporate a self-sealing 5.36.3

inflation valve.

The contents of tracheostomy kits must be printed on the label of individual 5.36.4

kits.

Diagrammatic details of tube dimensions should be provided either on or in 5.36.5

product packaging.

5.37 CATEGORY 18 – YANKAUER SUCTION DEVICES

A range of sterile, single-patient use Yankauer suction devices is required, 5.37.1

including:


with and without:

o finger control vent

o sump tip

single-wrapped and double-wrapped


Yankauer suction devices must: 5.37.2

be a one-piece construction

have a smooth, rounded eye

have no sharp or rough edges

have a male end that is permanently fixed to the shaft and that allows a

secure attachment with the connectors on standard suction tubing.




5.38 CATEGORY 19 – SUCTION CATHETERS

A range of sterile, single-use suction catheters is required, including: 5.38.1


straight and angled

a range of tip configurations

with and without depth markings along the shaft


5.39 CATEGORY 20 – CLOSED VENTILATION SUCTION SYSTEMS

A range of single-patient use closed ventilation suction systems is required to 5.39.1

facilitate the suctioning of patients receiving mechanical ventilation. This

includes:


for connection to endotracheal tubes and tracheostomy tubes


a range of tip configurations

with and without:

o irrigation line

o one-way irrigation port

o swivel connection

o T-piece

o metered dose inhaler (MDI) connection

o spare and additional parts for multi-port access

for various periods of continuous use.

Ventilation suction systems must incorporate: 5.39.2

a tactile sleeve to enhance practitioner control during the suction

procedure

a thumb valve

depth markings on the suction catheter.

5.40 CATEGORY 21 – SUCTION TUBING

A range of single-use suction tubing is required, including: 5.40.1

rolls and pre-cut lengths

with and without integral connectors

kink-resistant, bubble, wide-bore and heavy-duty types





single and double-wrapped sterile pre-cut tubing lengths


5.41 CATEGORY 22 – CLOSED WALL SUCTION SYSTEMS

A range of closed suction systems for connection to wall suction outlets is 5.41.1


a range of canister/container volumes with compatible liners

with and without:

o shutoff valves

o filters

relevant hardware to effectively set up the system


Note: For the purposes of this RFT, suction systems that do not incorporate a 5.41.2

disposable collection liner are considered out of scope.

5.42 CATEGORY 23 – MANUAL RESUSCITATORS

A range of manual resuscitators is required, including: 5.42.1

for all patient demographics (i.e. from neonates to adults)

single-patient use and reusable

with and without:

o swivel connector

o masks

o tubing

o a connection for attaching a PEEP valve

o a pressure release valve

presentation:

o individual components

o pre-assembled.

Preference may be given to pre-assembled resuscitators. 5.42.2

Manual resuscitators must incorporate: 5.42.3

a reservoir bag

a low dead-space patient valve assembly.




Paediatric and infant models must incorporate a pressure relief valve to 5.42.4

minimise the risk of over-inflation.

For all reusable manual resuscitators offered, Respondents must provide 5.42.5

cleaning, assembly and testing instructions to Participating Health Services

upon request.

5.43 CATEGORY 24 – CARBON DIOXIDE ABSORBENTS

A range of carbon dioxide absorbents is required for use in anaesthesia. This 5.43.1

includes:

to suit a range of flow situations

a full range of sizes and presentations, including single use and bulk

packs.

Carbon dioxide absorbents must: 5.43.2

be designed so as to minimise powdering during normal use

undergo a colour change once exhausted

be highly permeable to gases

provide only minimal resistance to gas flow.



the particle size and shape

for single-use presentations, a list of compatible equipment (i.e.

machine/brand/model names).

5.44 CATEGORY 25 – INTUBATION ASSISTANCE DEVICES

A range of single-use and reusable laryngoscope blades, handles and all-in-5.44.1

one units is required including:

standard and specialty blades

fibre optic

Note: Blades should meet ISO7376 green system, so that all blades are 5.44.2

interchangeable.

For single-use blades, battery and/or globe life must be clearly labelled on 5.44.3

the packaging.

For handles, battery type must be clearly labelled on the product. 5.44.4

Appendices



APPENDICES

APPENDIX 1 – PRODUCT LIST

A full list of products and descriptions is provided in Part 6 Tender Response Worksheet.

The following table provides a summary of Categories and Subcategories.

CATEGORY SUBCATEGORY

1 Oxygen Face Masks 1.01 Oxygen Face Mask, Medium Concentration

1 Oxygen Face Masks 1.02 Oxygen Face Mask, High Concentration

1 Oxygen Face Masks

1.03 Oxygen Face Mask, Variable/Multiple

Concentration

1 Oxygen Face Masks 1.04 Oxygen Face Mask, Aerosol Therapy Mask

1 Oxygen Face Masks 1.05 Oxygen Face Mask, Tracheostomy

1 Oxygen Face Masks 1.06 Oxygen Face Mask, Face Tent

1 Oxygen Face Masks 1.07 Oxygen Face Mask, Other

2 Anaesthesia / Resuscitation

Face Masks 2.01

Anaesthesia/Resuscitation Face Mask, Single

Use

2 Anaesthesia / Resuscitation

Face Masks 2.02

Anaesthesia/Resuscitation Face Mask,

Reusable

3 Non Invasive Ventilation

Interfaces 3.01

Non Invasive Ventilation Interfaces, CPAP,

Single Use, Full Face Masks


Interfaces 3.02


Single Use, Nasal Masks


Interfaces 3.03


Reusable, Full Face Masks


Interfaces 3.04


Reusable, Nasal Masks


Interfaces 3.05

Non Invasive Ventilation Interfaces, BiPAP,

Single Use, Full Face Masks


Interfaces 3.06


Single Use, Nasal Masks


Interfaces 3.07


Reusable, Full Face Masks


Interfaces 3.08


Reusable, Nasal Masks


Interfaces 3.09

Non Invasive Ventilation Interfaces, CPAP

Replacement Parts

Appendices





Interfaces 3.10


Replacement Parts

4 Nasal Cannulae 4.01 Nasal Cannulae, With Tubing

4 Nasal Cannulae 4.02 Nasal Cannulae, Without Tubing

5 Oxygen Tubing 5.01 Oxygen Tubing, Smooth Bore, Roll

5 Oxygen Tubing 5.02 Oxygen Tubing, Smooth Bore, Pre-cut

5 Oxygen Tubing 5.03 Oxygen Tubing, Bubble-type, Roll

5 Oxygen Tubing

5.04 Oxygen Tubing, Corrugated, with Integral

Cuff, Roll

5 Oxygen Tubing

5.05 Oxygen Tubing, Corrugated, without Integral

Cuff, Roll

5 Oxygen Tubing 5.06 Oxygen Tubing, Crush Resistant, Pre-cut

6 Small Volume Jet Nebulizers 6.01 Small Volume Jet Nebulizers

6 Small Volume Jet Nebulizers 6.02 Small Volume Jet Nebulizers Kits

7 Breathing Circuits and

Accessories 7.01 Heated Breathing Circuit Kits, Single Limb


Accessories 7.02 Heated Breathing Circuit Kits, Dual Limb


Accessories 7.03 Non Heated Breathing Circuit Kits, Single Limb


Accessories 7.04 Non Heated Breathing Circuit Kits, Dual Limb


Accessories 7.05 Breathing Circuit Accessories


Accessories 7.06 Anaesthetic Breathing Circuits


Accessories 7.07 Analgesic Breathing Circuits


Accessories 7.08 Humidifier Circuits with Oxygen


8.01 Respiratory Filter, Heat and Moisture

Exchangers (HME)

8 Respiratory Filters 8.02 Respiratory Filter, Bacterial/Viral Filter


8.03 Respiratory Filter, Combined

HME/Bacterial/Viral Filter

9 Gas Sampling Lines 9.01 Gas Sampling Line

Appendices




9 Gas Sampling Lines 9.02 Gas Sampling Line, Accessories

10 Catheter Mounts and

Connectors 10.01 Catheter Mounts

10 Catheter Mounts and

Connectors 10.02 Connectors

11 Rebreathing Bags 11.01 Rebreathing Bag, Single Use, Closed End

11 Rebreathing Bags 11.02 Rebreathing Bag, Single Use, Open End

11 Rebreathing Bags 11.03 Rebreathing Bag, Reusable, Closed End

11 Rebreathing Bags 11.04 Rebreathing Bag, Reusable, Open End

12 Oropharyngeal Airways

(Guedel) 12.01 Oropharyngeal Airways (Guedel), Sterile

12 Oropharyngeal Airways

(Guedel) 12.02

Oropharyngeal Airways (Guedel), Clinically

Clean

13 Nasopharyngeal Airways 13.01 Nasopharyngeal Airways, Sterile

14 Endotracheal Tubes 14.01 Endotracheal Tube, Uncuffed


14.02 Endotracheal Tube, Cuffed for Short-term

Intubation


14.03 Endotracheal Tube, Cuffed for Long-term

Intubation

14 Endotracheal Tubes 14.04 Endotracheal Tube, Cuffed, Preformed

14 Endotracheal Tubes 14.05 Endotracheal Tube, Uncuffed, Preformed

14 Endotracheal Tubes 14.06 Endotracheal Tube, Cuffed, Reinforced

14 Endotracheal Tubes 14.07 Endotracheal Tube, Uncuffed, Reinforced

14 Endotracheal Tubes 14.08 Endotracheal Tube, Cuffed, for Laser Surgery


14.09 Endotracheal Tube, Uncuffed, for Laser

Surgery


14.10 Endotracheal Tube, for Endobronchial

Intubation

14 Endotracheal Tubes 14.11 Endotracheal Tube, Microlaryngeal

14 Endotracheal Tubes 14.12 Endotracheal Tube, Other

15 Intubation Stylets, Airway

Catheters and Guides 15.01

Intubation Stylets, Airway Catheters and

Guides, Single-use, sterile

15 Intubation Stylets, Airway

Catheters and Guides 15.02

Intubation Stylets, Airway Catheters and

Guides, Single-use, clinically clean

15 Intubation Stylets, Airway 15.03 Intubation Stylets, Airway Catheters, and

Appendices




Catheters and Guides Guides, Reusable

16 Laryngeal Mask Airways 16.01 Laryngeal Mask Airways, Single Use, standard

16 Laryngeal Mask Airways

16.02 Laryngeal Mask Airways, Single Use,

reinforced

16 Laryngeal Mask Airways 16.03 Laryngeal Mask Airways, Reusable, standard

16 Laryngeal Mask Airways 16.04 Laryngeal Mask Airways, Reusable, reinforced

17 Tracheostomy Tubes 17.01 Tracheostomy Tube, Cuffed

17 Tracheostomy Tubes 17.02 Tracheostomy Tube, Uncuffed

17 Tracheostomy Tubes 17.03 Tracheostomy Tube, Reinforced

17 Tracheostomy Tubes 17.04 Tracheostomy Tube, Fenestrated

17 Tracheostomy Tubes 17.05 Tracheostomy Kit with Tracheostomy Tube

17 Tracheostomy Tubes 17.06 Tracheostomy Kit without Tracheostomy Tube


17.07 Tracheostomy Spare and Additional

components - Speaking Valves



components - Inner Cannulae



components - Plugs



components - Brushes



components - Other

17 Tracheostomy Tubes 17.12 Cricothyrotomy Kits


18.01 Yankauer Suction Devices, Sterile, Single-

wrapped


18.02 Yankauer Suction Devices, Sterile, Double-

wrapped

19 Suction Catheters 19.01 Suction Catheter, Straight

19 Suction Catheters 19.02 Suction Catheter, Angled

20

Close Ventilation Suction

Systems 20.01

Close Ventilation Suction System, Single

lumen, for Endotracheal Tubes, for up to 24

hours

20 Close Ventilation Suction

Systems 20.02


lumen, for Endotracheal Tubes, for > 24 hours


Systems 20.03


lumen, for Tracheostomy Tubes, for up to 24

Appendices




hours

20


Systems 20.04


lumen, for Tracheostomy Tubes, for > 24

hours


Systems 20.05

Close Ventilation Suction System, Double

lumen, for Endotracheal Tubes, for > 24 hours

20


Systems 20.06

Close Ventilation Suction System, Double

lumen, for Tracheostomy Tubes, for up to 24

hours

21 Suction Tubing

21.01 Suction Tubing, Pre-cut lengths, Non-sterile,

Individually wrapped

21 Suction Tubing

21.02 Suction Tubing, Pre-cut lengths, Sterile,

Single-wrapped

21 Suction Tubing

21.03 Suction Tubing, Pre-cut lengths, Sterile,

Double-wrapped

21 Suction Tubing 21.04 Suction Tubing, Bulk Rolls, Non-Sterile

21 Suction Tubing 21.05 RESERVED

21 Suction Tubing

21.06 Suction Tubing, Wide bore, Heavy Duty, Pre-

cut, Sterile, Double Wrapped

21 Suction Tubing 21.07 Suction Tubing, Bubble, Bulk Rolls

22 Closed Wall Suction Systems 22.01 Closed Wall Suction System, Liner


22.02 Closed Wall Suction System, Hardware -

Canisters


22.03 Closed Wall Suction System, Hardware - Wall

Bracket



Baskets



Other Components

23 Manual Resuscitators 23.01 Manual Resuscitator

24 Carbon Dioxide Absorbents 24.01 Carbon Dioxide Absorbents, Single Use

24 Carbon Dioxide Absorbents 24.02 Carbon Dioxide Absorbents, Bulk Pack

25 Intubation Assistance Devices 25.01 Laryngoscope Blade, Single use

25 Intubation Assistance Devices 25.02 Laryngoscope Blade, Fibre-Optic

25 Intubation Assistance Devices 25.03 Laryngoscope Blade Components

Appendices



APPENDIX 2 – INDICATIVE USAGE

The following table provides indicative usage of each subcategory for HPVC2011-015

Respiratory Products for the period 1 July 2011 – 31 December 2013.

CAT CATEGORY DESCRIPTION CONTRACT

SPEND

1 Oxygen Face Masks 667,349

2 Anaesthesia / Resuscitation Face Masks 905,583

3 Non Invasive Ventilation Interfaces 891,610

4 Nasal Cannulae 426,838

5 Oxygen Tubing 703,180

6 Small Volume Jet Nebulizers 287,958

7 Breathing Circuits and Accessories 1,043,816

8 Respiratory Filters 1,401,188

9 Gas Sampling Lines 689,751

10 Catheter Mounts and Connectors 498,232

11 Rebreathing Bags 77,694

12 Oropharyngeal Airways (Guedel) 128,744

13 Nasopharyngeal Airways 160,563

14 Endotracheal Tubes 1,864,005

15 Intubation Stylets, Airway Catheters and Guides 769,786

16 Laryngeal Mask Airways 4,124,133

17 Tracheostomy Tubes 1,098,634

18 Yankauer Suction Devices 273,497

19 Suction Catheters 590,242

20 Close Ventilation Suction Systems 854,747

21 Suction Tubing 1,098,624

22 Closed Wall Suction Systems 2,083,146

23 Manual Resuscitators 703,976

24 Carbon Dioxide Absorbents 543,444

25 Intubation Assistance Devices 29,254

Total $21,915,994

Appendices



The following table provides indicative usage by each Participating Health Service for

HPVC2011-015 Respiratory Products for the period 1 July 2011 – 31 December 2013.

Participating Health Service Spend

Melbourne Health $ 5,922,746.13

Monash Health $ 2,962,116.31

Alfred Health $ 1,835,027.41

Austin Health $ 1,743,786.61

Eastern Health $ 1,386,462.79

Barwon Health $ 1,034,261.93

Peninsula Health $ 922,283.14

Ballarat Health Services $ 581,097.32

Bendigo Health Care Group $ 553,155.54

Royal Children's Hospital $ 541,835.98

South West Healthcare $ 424,085.03

Goulburn Valley Health $ 374,158.85

Albury Wodonga Health $ 373,534.52

Ambulance Victoria $ 359,256.61

Latrobe Regional Hospital $ 324,830.11

Peter MacCallum Cancer Institute $ 287,368.89

Northeast Health Wangaratta $ 253,983.99

Dental Health Services Victoria $ 220,864.46

Central Gippsland Health Service $ 162,697.47

West Wimmera Health Service $ 143,272.33

West Gippsland Healthcare Group $ 130,098.02

Echuca Regional Health $ 104,007.90

Bairnsdale Regional Health Service $ 103,535.78

Djerriwarrh Health Services $ 61,941.50

Kilmore And District Hospital $ 60,145.09

Swan Hill District Health $ 59,399.65

Stawell Regional Health $ 55,752.16

Kyneton District Health Service $ 46,374.37

East Grampians Health Service $ 43,773.96

Maryborough District Health Service $ 41,397.04

Castlemaine Health $ 38,904.20

Bass Coast Regional Health $ 36,070.54

Appendices




Western District Health Service $ 30,776.82

Portland District Health $ 27,466.10

Seymour Health $ 27,206.80

Colac Area Health $ 27,159.97

Gippsland Southern Health Service $ 25,260.70

Royal Women's Hospital $ 24,484.03

Mercy Public Hospitals Incorporated $ 20,301.50

Benalla Health $ 17,878.91

St Vincent's Health Melbourne $ 17,007.00

Rural Northwest Health $ 15,430.09

Cobram District Health $ 13,981.10

Alexandra District Hospital $ 13,432.92

Kerang District Health $ 9,621.54

Edenhope & District Memorial Hospital $ 8,262.51

Hepburn Health Service $ 7,351.19

Mansfield District Hospital $ 5,578.07

South Gippsland Hospital $ 4,357.62

Cohuna District Hospital $ 4,291.47

Rochester And Elmore District Health Service $ 4,098.31

Mildura Base Hospital $ 2,600.00

Numurkah District Health Service $ 2,456.52

Timboon And District Healthcare Service $ 2,003.65

Casterton Memorial Hospital $ 1,326.08

East Wimmera Health Service $ 1,243.95

Orbost Regional Health $ 718.66

Boort District Health $ 612.20

Kyabram And District Health Services $ 441.12

Upper Murray Health & Community Services $ 418.51

Paramedic Services Victoria $ 376.56

Yarram And District Health Service $ 294.48

Beechworth Health Service $ 293.10

Inglewood And Districts Health Service $ 192.93

Yarrawonga Health $ 176.00

Robinvale District Health Services $ 148.36

Appendices




Terang & Mortlake Health Service $ 130.00

Omeo District Health $ 107.95

Northern Health $ 74.06

Nathalia District Hospital $ 73.00

Heywood Rural Health $ 34.94

Alpine Health $ 33.00

Kooweerup Regional Health Service $ 27.00

Mallee Track Health & Community Service $ 16.52

Heathcote Health $ 6.61

Tallangatta Health Service $ 4.83

Total $ 21,505,982.31

Appendices



APPENDIX 3 – REFERENCES

Standards

The references to the below standards include any amendments, revisions or consolidations to

those standards.

STANDARD NUMBER STANDARD NAME

AS 10993 Biological evaluation of medical devices

AS 1600 Medical equipment - Conical fittings with a 6% (Luer) taper for

syringes, needles and certain other medical equipment

AS 2488 Resuscitators intended for use with humans

AS ISO 5361 Anaesthetic and respiratory equipment – Tracheal tubes and

connectors

AS ISO 5366 Anaesthetic respiratory equipment – Tracheostomy tubes

AS/NZS 2496 Breathing attachments for anaesthetic purposes for human use

AS/NZS 4236 Respiratory therapy equipment – Jet nebulizers and jet

nebulizer air pumps

ISO 10079 Medical suction equipment

ISO 14408 Tracheal tubes designed for laser surgery – Requirements for

marking and accompanying information

ISO 17510 Sleep apnoea breathing therapy

ISO 4135 Anaesthetic and respiratory equipment – Vocabulary

ISO 5356 Anaesthetic and respiratory equipment – Conical connectors

ISO 5364 Anaesthetic and respiratory equipment – Oropharyngeal

airways

ISO 5367 Breathing tubes intended for use with anaesthetic apparatus

and ventilators

ISO 7376 Anaesthetic and respiratory equipment – Laryngoscopes for

tracheal intubation

ISO 8836 Suction catheters for use in the respiratory tract

ISO 9360 Anaesthetic and respiratory equipment - heat and moisture

exchangers (HMEs) for humidifying respired gases in humans

Appendices



Legislation

The references to the below legislation include any amendments, revisions or consolidations to

those references.

Therapeutic Goods (Medical Devices) Regulations 2002

Therapeutic Goods Act 1989

Guidelines and Other References

The references to the below guidelines include any amendments, revisions or consolidations to

those guidelines.

NHMRC (2010), Australian Guidelines for the Prevention and Control of Infection in

Healthcare, Commonwealth of Australia

Therapeutic Goods Administration (2004), Uniform Recall Procedure for Therapeutic

Goods, Commonwealth of Australia

Therapeutic Goods Administration (2011), Australian Regulatory Guidelines for Medical

Devices

Respiratory Products RFTHPV2014–015 - HealthShare Victoria

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