cep 07020 buyers’ guide: sharps pads & boxes - cedar sharps... · cep 07020: december 2007...

29
Buyers’ guide Sharps pads & boxes CEP07020 December 2007

Upload: leminh

Post on 21-Mar-2018

216 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Buyers’ guide

Sharps pads & boxes

CEP07020

December 2007

Page 2: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Contents 2

CEP 07020: December 2007

Introduction............................................................................................... 3

Technical considerations.......................................................................... 4

Operational considerations....................................................................... 6

Purchasing ............................................................................................... 8

Market review ........................................................................................... 9

Acknowledgements ................................................................................ 16

References ............................................................................................. 17

Appendix 1: Evaluation protocol............................................................. 18

Appendix 2: User evaluation results....................................................... 21

Appendix 3: Product images .................................................................. 22

Appendix 4: Supplier & product details .................................................. 27

Author and report information................................................................. 29

Page 3: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Introduction 3

CEP 07020: December 2007

Sharps pads and boxes are used during theatre procedures to safely store used sharps while allowing them to be easily counted at the end of the operation, prior to safe disposal in a sharps bin. Sharps pads generally consist of a folding foam pad with a semi-rigid backing (card or plastic) and an adhesive surface. Sharps boxes are formed of rigid plastic and can contain a variety of systems for holding sharps. Some boxes include a system for removing scalpel blades. The Health Act 2006 [1] requires NHS organisations to ensure that patients, staff and other persons are protected against the risks of acquiring healthcare associated infections, so far as is reasonably practicable. Needlestick injuries are one of the most common injuries experienced by NHS staff but all sharps injuries are considered to be potentially preventable [2,3]. Current standards for best practice in operating theatres [4] state that used needles on the sterile field should be retained in a disposable, puncture-resistant needle container but no specific guidelines for use are included. There are no guidelines for how to use sharps pads and boxes, so procedures vary between locations according to different nurse and surgeon preferences. A literature survey and consultation with stakeholders was initially used to identify key factors affecting procurement decision making. Two evaluation processes were then developed to compare the different products provided by suppliers and manufacturers (see Appendix 1). Four factors were tested objectively: 1) accidental opening of the pad or box; 2) pads opening after short time duration; 3) dislodgement of sharps from the adhesive or magnetic surface; and 4) needle penetration of the pad or box (see Appendix 1, page 17). Needle penetration was included because seven incidents of sharps puncturing the casing were reported in a small user evaluation study in Scotland testing three types of sharp pads and two boxes [3]. Objective testing of samples was performed by a UKAS accredited independent testing organisation and the results [5] are shown in the Market Review tables (pages 8 - 14). General conclusions from these test results are also discussed in Operational considerations. A user evaluation protocol was also devised to assess a broader range of issues which had emerged from stakeholder discussions (see Appendix 1, pages 18 & 19). These were primarily concerned with ease of use, which is important for reducing stress and the risk of accidents [6]. Theatre staff in 7 different hospitals in several areas of the UK completed the user evaluation questionnaires to encompass a wide range of practices and preferences. The user evaluation scores were combined with user comments and observational data to form the basis of the Operational considerations (pages 4-6). Detailed, device specific comments are listed in Appendix 2 (page 20). This Buyers’ guide contains guidance on technical, operational and purchasing considerations for the use of sharps pads and boxes. These considerations have been identified by stakeholders as important when making purchasing decisions. This Buyers’ guide also contains a comparative review of devices available on the UK market.

Page 4: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Technical considerations 4

CEP 07020: December 2007

Normally sharps should be placed in a sharps container immediately after use but during complicated theatre procedures numerous needles and blades are used and it is important that all sharps are accounted for at the end of the procedure. Sharps pads and boxes are intended to provide a secure place for temporary storage of all sharps during the procedure. Surgical procedures differ in their requirements for sharps storage resulting in different product preferences. This section outlines the range of technical features and issues that should be considered when choosing a sharps pad or box. More detailed product specific information is given in Appendix 2. Closure mechanism Sharps pads and boxes must close securely to ensure safe handling during disposal. The closing mechanism should ensure that the device will not open if dropped or is left in a temporary location prior to disposal. Pads are held closed by adhesive and reopening is not a normal operation. Boxes vary in design and can include an automatic or manual locking mechanism. Automatic locking is easy to operate and they usually snap shut. Theoretically reopening, accidentally or otherwise, is prevented but some boxes can be deliberately reopened, for example by using a pointed tool to depress the catch. Unlocked boxes have a simple snap open and shut catch of varying design and strength and most require a small force or manipulation to reopen the box so reducing the risk of accidental opening. Manual locking usually combines a snap open and shut catch with the addition of sliding locks on the side. It is important to ensure that the slide locks are not so stiff that users avoid using this extra safety feature. Secure adhesion All these products should ensure that sharps are held securely, so that they cannot be dislodged and lost or cause injury, whilst remaining visible for counting at the end of a procedure. Pads and boxes may contain one or a combination of methods for attaching sharps. Adhesive pads or strips allow sharps (needles and blades) to be stuck directly onto their surface so the sharps lie flat and are clearly visible. This method is effective for most sharps. The adhesive surfaces on the pads generally appear to be stickier than those in sharps boxes. Hypodermic needles placed in pads with their hubs protruding may be at risk of being accidentally dislodged. Magnetic surfaces in boxes tend to have a lower strength than adhesive strips or foam pads. This is quite adequate for most uses but large suture needles can become dislodged, particularly when a suture is still attached. Magnetic surfaces are not suitable for retaining hypodermic needles. Magnetic surfaces were not given ratings in the suture adhesion tests since no significant differences were found between them and products often contain both magnetic and adhesive surfaces. Small strips of magnetic material are often found in combination with other adhesive systems and are generally used for storing blades.

Page 5: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Technical considerations 5

CEP 07020: December 2007

Thick foam pads or narrow foam strips may also be provided for needle insertion. Foam strips require needles to be inserted horizontally so usually both ends of the needle are visible. Foam pads allow needles to be inserted vertically with the blunt end protruding sufficiently for it to be obvious. This provides secure storage for most needles but large suture needles may be difficult to store neatly and small needles may be hidden in the foam. Neither foam storage methods are suitable for blades. Needle Penetration With good product design and careful use, sharps should not penetrate the container. Boxes offer better protection than pads.

Page 6: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Operational considerations 6

CEP 07020: December 2007

Sharps pads and boxes are intended to provide a secure place for temporary storage of all sharps during the procedure. Safety can be improved by using ergonomically designed pads or boxes with adequate instructions and training. This section outlines the range of operational features and issues that should be considered when choosing a sharps pad or box. More detailed product specific information is given in Appendix 2. Visibility The ability of the user to see all sharps clearly is very important to ensure the counting is quick and accurate. The favoured background colour appears to be influenced by individual preference. Some boxes have a clear plastic lid which permits re-counting of sharps after the box is shut. Many products have segmented areas or numbered sections which are intended to facilitate counting. If these are used they should be selected carefully to ensure the range of sharps used in the surgical procedure will fit neatly into the spaces provided to avoid potential miscounting or confusion. Blade removers Scalpel blades may also be placed in a sharps pad/box. Some products contain a mechanism to assist in the removal of scalpel blades and are intended to improve the safety and ease of removing blades from scalpel handles. Closed blade removers contain the blade as it is removed giving increased protection, particularly against blades breaking or jumping during removal. When using closed blade removers the blades are normally counted in to the container, rather than at the end of the procedure. Not all blade removers will work for all sizes of blades and using an inappropriate size may be hazardous.

Many people using blade removers for the first time found them difficult to use correctly. Blade removers may be helpful but clear instructions, adequate training and information about what blade sizes can be safely removed with each device is essential and may improve user confidence in this feature. Appendix 2 contains product specific comments. Size A wide range of sizes are available to suit a variety of different procedures since the type, number and sizes of sharps will vary. The size of the sharps bin, and the dimensions of the opening flap may also influence purchasing decisions. Pads and mid-range box sizes usually provide adequate storage without excessive disposal requirements. Instructions and training Clear, simple instructions would be useful given the lack of standard procedures, particularly where a sharps box contains a number of different storage systems. A statement of which blades can be used, easy-to-follow instructions and training are strongly recommended where blade removers are included. Product specific information is included in Appendix 2.

Page 7: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Operational considerations 7

CEP 07020: December 2007

Pads vs. boxes In general, pads are simple devices that perform well and are easier to store and dispose of, while boxes contain more features and offer greater protection to users and others. Pads

Simple in design and easy to use Low in weight and volume, a benefit for both storage and disposal Close securely in most cases Generally offer better sharps adhesion than boxes Not designed to re-open

! Easier to penetrate with a needle ! They may not fully enclose hypodermic needles

Boxes

May contain more features than pads Most are able to fully contain hypodermic needles Very difficult to penetrate with a needle Can usually be reopened and some can lock shut

! Higher in weight and volume than pads ! Can be more complicated to use

Points marked with a are positive Points marked with a are general comments Points marked with a ! should be carefully considered

Page 8: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Purchasing 8

CEP 07020: December 2007

To achieve best value when purchasing sharps pads or sharps boxes the benefits of using an individual product needs to be balanced against the whole life costs. A product will provide an overall economic benefit if it decreases the risk of needle stick injuries and counting or recounting delays by being easy to use and suitable for the purpose. Usability factors are therefore important so practical evaluation by the clinical users of a potential new product is essential. The outcome of technical evaluation of key safety features should also be considered when assessing the benefits of an individual product. Costs to consider include: Staff injury cost Sharps boxes and pads should protect staff against needle stick injuries which can potentially result in serious illness or fatalities [2]. “Taken as a whole throughout the NHS, the cost of needle stick injuries is £300 million” [7]. The ease of use is important for reducing stress and the risk of accidents [6]. Operating time cost A device that clearly displays the used sharps may make sharps counting easier and help to avoid recounting delays Purchase cost Prices quoted in this report are the suppliers/manufacturers list price (ex VAT) although most are negotiable depending on volume and frequency of orders. Cost savings can therefore be achieved by (a) ordering only one or two models that meet the needs of all users, (b) placing bulk purchase orders providing there are sufficient appropriate storage facilities and over stocking does not result in sterile items going “out of date”. Disposal cost All products will require incineration and the cost is normally based on weight. Additionally an increase in the product size may require more frequent collection of sharps bins.

Page 9: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Market review 9

CEP 07020: December 2007

Sharps pads supplied by 7 companies (10 products) are summarised on pages 9-10. Sharps boxes were supplied by 4 companies (28 products) and information on these products are documented on pages 11 to 14. The market review tables contain a summary of product features and objective evaluation results. Most results are given a star rating where indicates the best performance (see Appendix 1). User evaluation results relating to specific products are listed in Appendix 2. How to use the market review tables

Notation Used Location for

further information

Adhesive - Indicates feature is present Page 4

Magnetic - Indicates feature is present 30 - Indicates feature is present and has divisions eg 30 a - Indicates a small strip of the feature is present

Page 4

Foam pad - Indicates feature is present 30 - Indicates feature is present and has divisions eg 30

Page 5

Foam strip - Indicates feature is present 30 - Indicates feature is present and has divisions eg 30

Page 5

Blade remover - Indicates feature is present b - Indicates two sizes of blade remover are present c - Indicates blade removers at both ends

Pages 5 & 21

Locking mechanism - Indicates device can be locked Pages 4, 18 & 21

Re-opens - Indicates device can be reopened d - Indicates device can be opened with a pointed object

Pages 4, 18 & 21

Feat

ures

Instructions - Indicates instructions are included Pages 6 & 21

Length (mm) External length of device in mm Page 6 Width (mm) External width of device in mm Page 6

Thickness (mm) External thickness of device in mm Page 6

Phys

ical

Weight Unpackaged weight of a single device in grams Page 6

Opening Force - Indicates opening force Pages 4 & 18

Locked Opening Force - Indicates locked opening force (boxes only) e – One out of five samples had low test values f – Three out of five samples had low test values

Pages 4 & 18

Closure Duration - Pad remained shut for at least 8 hours - Some samples opened in less then 10 minutes

Pages 4 & 18

Suture Adhesiveness - Indicates adhesion quality if applicable Pages 4, 5 & 18

Eval

uatio

n

Needle Penetration - Indicates level of protection Pages 5 & 18 Number in Pack Number of devices in pack as supplied List price / unit ex VAT List price per unit in GBP excluding VAT Page 8

Page 10: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Market review: Sharps pads 10

CEP 07020: December 2007

Intelligent Discard pad

J&J Discard-a-pad

Medasil DP1

Medasil DP2

Nipro Europe Disgard

P3 Medical Disposafe

P3 Medical Disposafe plus

Adhesive Magnetic Foam pad Foam strip

Blade remover Adhesive fastening

Re-opens

Feat

ures

Instructions

Length (mm) 122 120 120 120 134 120 121 Width (mm) 74 73 73 75 98 73 72

Thickness (mm) 6 6 8 6 16 6 6

Phys

ical

Weight 8g 12g 11g 8g 21g 12g 14g

Opening Force Closure Duration

Suture Adhesiveness

Eval

uatio

n

Needle Penetration

Number in Pack 100 300 50 50 20 300 300 List price / unit ex VAT £0.51 £1.06 £0.35 £0.30 £0.50 £0.47 £0.52

Page 11: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Market review: Sharps pads 11

CEP 07020: December 2007

Pennine Healthcare

AP1000 Universal

Protectapad Universal Disgard

Adhesive Magnetic Foam pad Foam strip

Blade remover Adhesive fastening

Re-opens

Feat

ures

Instructions

Length (mm) 122 122 134 Width (mm) 74 72 98

Thickness (mm) 6 6 16

Phys

ical

Weight 8g 11g 21g

Opening Force Closure Duration

Suture Adhesiveness

Eval

uatio

n

Needle Penetration

Number in Pack 100 50 20 List price / unit ex VAT £0.51 £0.42 £0.50

Page 12: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Market review: Sharps boxes 12

CEP 07020: December 2007

ASM 70424

ASM 70119

ASM 70730

ASM 70411

ASM 70361

ASM 70362

ASM 70110

Adhesive Magnetic 10 30 a 10 Foam pad 20 10 Foam strip 30 30

Blade remover Locking mechanism

Re-opens

Feat

ures

Instructions

Length (mm) 114 112 113 56 120 120 113 Width (mm) 55 54 54 44 93 93 54

Thickness (mm) 36 14 14 30 16 17 14

Phys

ical

Weight 44g 32g 41g 14g 44g 48g 33g

Opening Force

Locked Opening Force n/a n/a n/a n/a n/a n/a n/a Suture Adhesiveness n/a n/a

Eval

uatio

n

Needle Penetration

Number in Pack 64 96 96 96 96 96 96 List price / unit ex VAT £3.73 £2.35 £3.09 £3.12 £3.33 £3.45 £2.25

Page 13: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Market review: Sharps boxes 13

CEP 07020: December 2007

Covidien 1530

Covidien 1110

Covidien 1260

Covidien 1200

Covidien 1560

Covidien 1615

Covidien 1940

Adhesive Magnetic 30 30 60 20 60 Foam pad 40 Foam strip 30

Blade remover Locking mechanism

Re-opens

Feat

ures

Instructions

Length (mm) 113 120 120 116 120 120 120 Width (mm) 55 93 93 47 93 93 92

Thickness (mm) 16 16 16 10 16 16 35

Phys

ical

Weight 37g 55g 68g 27g 70g 56g 68g

Opening Force Locked Opening Force n/a Suture Adhesiveness n/a n/a n/a n/a n/a n/a n/a

Eval

uatio

n

Needle Penetration

Number in Pack 96 64 64 168 64 64 64 List price / unit ex VAT £2.00 £1.29 £1.39 £1.12 £2.31 £2.31 £2.31

Page 14: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Market review: Sharps boxes 14

CEP 07020: December 2007

Covidien 1942

Covidien 1922

Covidien 1920

Covidien 1630

Covidien 1660

Covidien NC 1925

Covidien NC 1535

Adhesive Magnetic a a a a 10 25 Foam pad 40 20 20 20 Foam strip 30 60

Blade remover b b Locking mechanism

Re-opens

Feat

ures

Instructions

Length (mm) 120 114 114 114 120 113 113 Width (mm) 92 55 55 55 93 55 55

Thickness (mm) 35 32 32 16 16 32 32

Phys

ical

Weight 59g 31g 37g 29g 46g 42g 46g

Opening Force Locked Opening Force Suture Adhesiveness n/a n/a n/a n/a n/a

Eval

uatio

n

Needle Penetration

Number in Pack 64 96 96 96 64 96 96 List price / unit ex VAT £2.31 £1.60 £2.19 £1.47 £2.31 £1.60 £1.36

Page 15: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Market review: Sharps boxes 15

CEP 07020: December 2007

Covidien NC 1635

Covidien 1910

Covidien 1100

Covidien 1105

J&J Disarmer

P3 Medical NB-100

Universal 510050

Adhesive Magnetic 10 10 a Foam pad 10 Foam strip 15 15 30

Blade remover b c Locking mechanism d

Re-opens

Feat

ures

Instructions

Length (mm) 113 75 116 114 110 114 95 Width (mm) 55 53 47 55 100 55 91

Thickness (mm) 32 29 10 16 20 15 20

Phys

ical

Weight 38g 24g 21g 24g 51g 39g 48g

Opening Force always locked always locked Locked Opening Force n/a e n/a f Suture Adhesiveness n/a n/a n/a n/a n/a

Eval

uatio

n

Needle Penetration

Number in Pack 96 96 168 96 84 20 25 List price / unit ex VAT £1.60 £1.60 £0.97 £0.80 £2.20 £0.70 £1.25

Page 16: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Acknowledgements 16

CEP 07020: December 2007

We would like to thank all the manufacturers and suppliers for providing samples for evaluation free of charge. We also thank the stakeholders who helped us to prepare this Buyers’ guide, in particular: Jane Ashworth, Team Administrator, NHS Supply Chain, Chester

Jan Collins, Theatre Manager, Princess of Wales Hospital, Bridgend

Jill Clash, Main Theatres, University Hospital of Wales, Cardiff

Craig Davey, Evaluation Centre Manager, Bath Institute of Medical Engineering, Bath

Paul Fram, Technical Officer, SMTL#, Princess of Wales Hospital, Bridgend Stuart Gray, Chief Health and Safety Adviser, NPHS Microbiology Cardiff, Cardiff

Gavin Hughes, Technical Manager, SMTL#, Princess of Wales Hospital, Bridgend

John Hughes, Senior Operating Department Practitioner, Royal United Hospital, Bath

David Jessop, Waste Compliance Manager, Cardiff and Vale NHS Trust, Cardiff

Lorraine Kruger, Clinical Leader, Main Theatres, University Hospital of Wales, Cardiff

Lynn Owens, Clinical Procurement Specialist, Whiston Hospital, Merseyside

Andrea Payne, Theatre Manager, University Hospital of Wales, Cardiff

Peter Phillips, Acting Director, SMTL#, Princess of Wales Hospital, Bridgend

Susan Pirie, Professional Officer, Association for Perioperative Practice, Harrogate

Mo Randall, Main Theatres, Dorset County Hospital, Dorset

Maureen Reeve, Clinical Products Manager, Norfolk and Norwich University Hospital, Norfolk

Angela Timms, Purchasing Department, Grantham Hospital, Grantham

Alun Tomkinson, Consultant, University Hospital of Wales, Cardiff

Paul Warman, Princess of Wales Hospital, Bridgend

Neil Warren, Manager, Welsh Institute for Minimal Access Therapy (WIMAT), Cardiff Medicentre, Cardiff

Page 17: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

References 17

CEP 07020: December 2007

1. Department of Health. The Health Act 2006 (Code of Practice for the Prevention and

Control of Health Associated Infections), 2006. http://www.dh.gov.uk/prod_consum_dh/idcplg?IdcService=GET_FILE&dID=26826&Rendition=Web

2. NHS Scotland. Needlestick Injuries: Sharpen your Awareness, Scottish Executive

Health Department, 2001. http://www.show.scot.nhs.uk/sehd/publications/nisa/nisa.pdf

3. C Paterson & A G Elder. Safer Sharps Devices: An Evaluation of Utility in NHS Scotland, Scottish Executive Health Department, 2003. http://www.show.scot.nhs.uk/sehd/publications/DC20050822safesharps.pdf

4. Association for Perioperative Practice. Standards and Recommendations for Safe

Perioperative Practice, 2007. http://www.afpp.org.uk/publications.cfm?start=51

5. SMTL. Sharps Disposal Pads – Physical Investigation (Report 07/2287/01), 2007.

6. ECRI. Sharps Safety Devices, Health Devices, 2006; 35: 337-347.

7. House of Commons Hansard Debates for 26 Feb 2003 (pt 5) c262-264. http://www.publications.parliament.uk/pa/cm200203/cmhansrd/vo030226/debtext/30226-05.htm

Page 18: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Appendix 1: Evaluation protocol 18

CEP 07020: December 2007

Technical Evaluation The technical evaluation was performed at the Surgical Materials Testing Laboratory (SMTL). Where sterile and non-sterile samples were supplied the sterile samples were used when possible, however no differentiation was made in the results.

1) Opening force – How easy is it to accidentally open the pad or box after use? Adhesive pads were loaded with four hypodermic needles and two strips of binding material that extended out of the pad. They were closed using a roller and 55N force# around the outer edge. A tensiometer was used to pull the binding material, forcing the pad apart. The maximum force achieved was recorded. Five samples of each model were tested and the mean opening force calculated. Boxes were similarly tested by placing binding material in indents filed into their edges. They were closed and the tensiometer used to pull the binding material, forcing the box open. The maximum force achieved was recorded. Boxes were not loaded, since this was not thought to affect the closure mechanism. Boxes with an optional locking capability were tested in both the locked and unlocked state.

2) Closure Duration – Will pads remain safely closed? Adhesive pads were closed using a roller and 55N force# then observed over a period of seven days to determine if they reopened. Three samples of each adhesive pad were tested. Boxes were not tested. A indicates that all samples tested remained shut for over 8 hours and indicates that some samples of this product opened in less than 10 minutes.

3) Sharps Adhesiveness – How well do suture needles adhere to sticky or magnetic surfaces? Adhesive mats, strips and magnetic areas were tested using the same technique and in a wet and dry state. A suture needle with suture attached was placed on the surface and pressed down for 60 seconds with a 500g weight#. The tensiometer was used to pull the suture upwards and the peak force to remove the suture needle was recorded. Five samples of each model were tested and the mean value calculated.

4) Needle Penetration – What protection is there against a needle piercing the box or pad? A square section of material was cut from each box or pad and pierced using a hypodermic needle. The maximum force to penetrate the material was recorded. Three sections, each from a different sample of the same product, were tested and the mean force calculated. # In the absence of any agreed standard, the forces which were applied to close the adhesive pad and to press the sutures onto the pad were chosen after measuring the range of forces applied by laboratory staff.

Summary of star rating boundaries for technical evaluation results

Key factor

Opening Force (N) 0 – 4.9 5 – 9.9 10 – 25 25 – 60 >60 Sharps adhesiveness (N) 0 – 0.049 0.05 – 0.099 0.1 – 0.149 0.15 + Needle penetration (N) 0 – 4.9 5 – 9.9 10 – 14.9 15 + > 38 Note: Opening force rating boundaries are not equally spaced to highlight those products that open very easily.

Page 19: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Appendix 1: Evaluation protocol 19

CEP 07020: December 2007

User Evaluation Scrub Nurses from seven different hospital sites, including four members of the National Network of Clinical Procurement Specialists, were recruited to conduct the user evaluation study. The evaluator asked each user to perform all tasks using gloves and needle holders at all times, to read any available instructions for the product and to place the sharps according to these instructions. If instructions were unavailable the users were asked to place the sharps according to their understanding of best practice. Each user was given a randomly selected sharps pad or box. The sharps were provided by the evaluator in sealed packets for each evaluation and consisted of 3 different sized suture needles (commonly 13mm, 30mm & 60mm), 2 different sized scalpel blades (usually size 15 & size 23) and one hypodermic syringe needle (monoject) to place in the pad/box. They performed these tasks according to manufacturer instructions, as far as they felt safe to do so, in accordance with normal surgical procedures at their hospital. During each evaluation the user completed a questionnaire (see page 19) concerning the ease of use, safety and need for additional instructions for each item. At the end of each sharps pad evaluation the sealed sharps pad/box was placed in a sharps bin, for disposal. The 43 different types of sharps pads/boxes were randomly allocated between the users and the order of testing was also random. The randomised selection method ensured that every model was tested twice at each hospital location and an equal number of times in total. The score sheet and the sharps pad were both labelled with a code for that product. Users wrote their own scores on the score sheet as the evaluation proceeded. There was also space for comment and, as far as time allowed, the evaluator asked for verbal feedback of their experience and also noted their own observations of the use of the device. Most nurses performed 2 – 5 evaluations each and two evaluations were completed for most items at each hospital location. Only one hospital site routinely used blade removers or boxes, the other two hospitals were more familiar with using sharps pads. None of the equipment was required to be sterile for the evaluation tests, however in the interests of consistency and safety a new set of sharps was used for each evaluation, with the previous ones being disposed of in the sharps pad/box. The same gloves were used throughout one users set of evaluations. The needle holders were reused throughout the evaluation process without sterilising. The resulting user scores were assessed for trends by converting all responses for each feature into a score value so 1 represented poor response (eg “strongly disagree” to “blades are stored securely”) and 5 indicated a good response. The percentage of users that scored the feature as “4” or 5 was then calculated and a results table was coded in four separate colours according to whether the percentage of users was 0-24%, 25-49%, 50-74% or 75-100%. Visual assessment of the aggregated scores and review of comments from individual users was used to form the basis of the operational considerations reported in this Buyer’s guide. Detailed comments and observations are included in Appendix 2.

Page 20: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Appendix 1: Evaluation protocol 20

CEP 07020: December 2007

Questionnaire for user responses before and during testing of each sharps pad/box

Please open the packaging and sharps pad or sharps box, read the instructions for use (if available) and then respond to the following statements:

Stro

ngly

Agr

ee

Agr

ee

Nei

ther

Dis

agre

e

Stro

ngly

dis

agre

e

Comment

1. The instructions provided were easy to understand ○ ○ ○ ○ ○ ○N/A

2. I have used a similar sharps pad before ○YES ○NO

Now dispose of the sample sharps according to the instructions for use, always using needle holders. Leave the pad/box open.

3 It was difficult to remove the adhesive backing paper. ○ ○ ○ ○ ○ ○N/A

4 All the sharps were clearly visible when placed on pad ○ ○ ○ ○ ○

5 It was easy to count the sharps ○ ○ ○ ○ ○

6 Repositioning the sharps was difficult ○ ○ ○ ○ ○

7 Suture needles are stored securely ○ ○ ○ ○ ○

8 Syringe needles are stored securely ○ ○ ○ ○ ○

9 Blades stored are stored securely ○ ○ ○ ○ ○

10 Is there an aid to removing blades? ○YES ○NO

10a Blade removal was unsafe / difficult ○ ○ ○ ○ ○

Now close the pad/box according to the instructions

11 The pad closes securely ○ ○ ○ ○ ○

12 No additional instructions are required ○ ○ ○ ○ ○

13 Additional training is required ○YES ○NO

Do you have any additional comments?:

Page 21: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Appendix 2: User evaluation results 21

CEP 07020: December 2007

User evaluation results for specific products

Issue

Product Information

Blade removers

• The Universal box (510050) has blade removers on both ends, facilitating use with either hand

• Larger blades may not be removable using most Covidien and ASM removers (Covidien 31181459, 31181467, 31313425 contain two sizes of blade remover and the larger blades were successfully removed)

• The arrow indicating the location of the blade remover on Covidien boxes caused confusion. Many users placed the blade the wrong way around

• J&J Disarmer and UHS Sharps safety boxes have enclosed blade removers, containing the blade as it is removed

• J&J Disarmer scored better than other devices for blade removal, although blade removers were not popular possibly due to many users being unfamiliar with them. One evaluator shook the UHS box and managed to shake blades loose from the container

Locking mechanism

• Products which do not close securely are not recommended • Medasil DP2 pad was observed to open spontaneously only a few

minutes after closure during user evaluations and this was confirmed by the technical evaluation data

• ASM products have two alternative closure mechanisms. Those on products 70424, 70119 and 70362 have a higher opening force

Instructions and training

• ASM provided generic instructions following a specific request. These are not adequate for blade removal without further information and training (ASM comment: Suitable instructions will be added)

• Instructions are printed on boxes of products for the Disgard pad, supplied by Nipro and UHS

• Instructions are enclosed with each J&J Disarmer box and J&J Discard a pad. Further training is recommended for blade removal

• Covidien products are supplied with generic instructions but the contained information is not adequate for blade removal

• Instructions are enclosed with boxes of products for the UHS sharps safety box. Further training is recommended for blade removal

Page 22: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Appendix 3: Product images 22

CEP 07020: December 2007

Intelligent Discard Pad &

Pennine AP1000 J&J Discard-a-Pad

Medasil DP1 Medasil DP2

Nipro Disgard &

UHS Disgard P3 Medical Disposafe

P3 Medical Disposafe Plus UHS Protectapad

Page 23: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Appendix 3: Product images 23

CEP 07020: December 2007

ASM 70424 ASM 70119

ASM 70730 ASM 70411

ASM 70361 ASM 70362

ASM 70110 Covidien 1105

Page 24: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Appendix 3: Product images 24

CEP 07020: December 2007

Covidien 1530 Covidien 1110

Covidien 1260 Covidien 1200

Covidien 1560 Covidien 1615

Covidien 1940 Covidien 1942

Page 25: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Appendix 3: Product images 25

CEP 07020: December 2007

Covidien 1922 Covidien 1920

Covidien 1630 Covidien 1660

Covidien NC1925 Covidien NC1535

Covidien NC 1635 Covidien 1910

Page 26: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Appendix 3: Product images 26

CEP 07020: December 2007

Covidien 1100 J&J Disarmer

P3 Medical NB-100 UHS Sharps Safety Box

Page 27: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Appendix 4: Supplier & product details 27

CEP 07020: December 2007

Supplier Product Order code

ASM Ltd 69 Bishops Road Hayes Middlesex UB3 2TG Tel: 07740 406996 www.asm-group.com

Sharps box Sharps box Sharps box Sharps box Sharps box Sharps box Sharps box

70424 70119 70730 70411 70361 70362 70110

Covidien (formerly Tyco Healthcare UK) 154 Fareham Road Fareham Hampshire PO13 0AS Tel: 01329 224000 www.covidien.com

1530 1110 1260 1200 1560 1615 1940 1942 1922 1920 1630 1660

NC 1925 NC 1535 NC 1635

1910 1100 1105

31142113 31142139 31142154 31142196 31142246 31142329 31142337 31142345 31142360 31142386 31142451 31142477 31181459 31181467 31313425 31142394 31142410 31142212

Intelligent Medical Supplies Ltd The Poplars Landican Lane Upton, Wirral CH49 5LJ Tel: 0151 648 0955

Discard pad

Johnson & Johnson Medical Ltd The Braccans London Road Bracknell Berkshire RG12 2AT Tel: 01344 864000 www.jnjgateway.com

Discard a pad

Disarmer

S4305 S4311

Page 28: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Appendix 4: Supplier & product details 28

CEP 07020: December 2007

Supplier Product Order code

Medasil (Surgical) Ltd Medasil House Hunslet Road Leeds LS10 1AU Tel: 0113 243 3491 www.medasil.com

Sharps pad Sharps pad

DP1 DP2

Nipro Europe Ground Floor Unit 7 Minerva Business Park Peterborough PE2 6FT Tel: 01733 234300 www.nipro-europe.com

Disgard

10101

P3 Medical Ltd (formerly Amba) 1 Newbridge Close Bristol BS4 4AX Tel: 0117 972 8888 www.ambamedical.co.uk

Needle box Disposafe

Disposafe plus

NB-100 DS599 QF1001

Pennine Healthcare Ltd City Gate London Road Derby DE24 8WY Tel: 01332 794880 www.penninehealthcare.com

AP1000

Universal Hospital Supplies Ltd George House Unit 6 Delta Park Industrial Estate Millmarsh Lane Enfield London EN3 7QY Tel: 0845 082 0182 www.uhs.co.uk

Protectapad

Disgard Sharps safety box

UN210 10101 510050

Page 29: CEP 07020 Buyers’ guide: Sharps pads & boxes - Cedar Sharps... · CEP 07020: December 2007 ... With good product design and careful use, sharps should not penetrate the container

Author and report information 29

CEP 07020: December 2007

Buyers’ guide: Sharps pads & boxes Megan Dale, Jonathan Lane, Diane Crawford Clinical Engineering Device Assessment and Reporting (CEDAR) Cardiff Medicentre Cardiff CF14 4UJ Tel: 029 2068 2120 Fax: 029 2075 0239 Email: [email protected] For more information on CEDAR and our earlier reports visit www.cedar.wales.nhs.uk About CEP The Centre for Evidence-based Purchasing (CEP) is part of the Policy and Innovation Directorate of the NHS Purchasing and Supply Agency. We underpin purchasing decisions by providing objective evidence to support the uptake of useful, safe and innovative products and related procedures in health and social care.

We are here to help you make informed purchasing decisions by gathering evidence globally to support the use of innovative technologies, assess value and cost effectiveness of products, and develop nationally agreed protocols.

Sign up to our email alert service All our publications since 2002 are available in full colour to download from our website. To sign up to our email alert service and receive new publications straight to your mailbox contact:

Centre for Evidence-based Purchasing Room 152C, Skipton House 80 London Road SE1 6HL Tel: 020 7972 6080 Fax: 020 7975 5795 Email: [email protected] www.pasa.nhs.uk/cep © Crown Copyright 2007