Details

All Wales Lymphoedema Contract 2018

Gavin Hughes, Louise Barry (Surgical Materials Testing Laboratory, Bridgend)

Dec 2019

Introduction

As part of SMTL's role in providing testing and technical advice on medical devices for the NHS in Wales, SMTL embarked on a test programme for NHS Wales Shared Services Partnership - Procurement Services (NWSSP PS) to test the performance of compression garments for the All-Wales Lymphoedema Garment Contract.

The terms of the contract were that by participating in the procurement process, SMTL would test the compression profiles of tendered garments using a method based on the British Standard BS 6612 for graduated compression hosiery (BS 6612 has since been superseded by BS 661210), and SMTL and NWSSP PS could publish the results of testing and assessments without restriction or censure.

This is the second time NWSSP PS have run an All-Wales Lymphoedema Contract exercise. Originally testing performed by SMTL in 2014 identified that only 71% of garments passed the pressure requirements claimed by the manufacturers.  In this second testing exercise only 58% of garments met the pressure specifications.  Of note, were the made to measure lower limb garments where obvious differences in the garments sizes were evident, and test results identified that the majority of the garments tendered did not produce pressures claimed by the manufacturers, with one garment producing a negative pressure gradient which could potentially cause patient harm.

 

Sample selection and submission

It was not feasible to test every garment tendered for the contract, and therefore based on clinical advice from the lymphoedema practitioners on the working group, a selection of lower limb and upper limb garment categories were selected for testing.  Tendering companies were asked to provide appropriate sized garments to fit standard patient lower or upper limb, with the intention that the submitted garments would apply the required pressure profile for the various limb sizes detailed in the specification document.  The limb sizes were selected by practitioners as this is a common patient size seen in Wales lymphoedema clinics, and the dimensions correspond with those of specific settings on the Hatra Mark 2 test apparatus.

The sample requirements, test methodology and performance requirements of compression garments are outlined in the Contract Testing Methodology Lymphoedema Garments 18/5547/0 (Report-18-5547-0).

 

Testing results

All results were generated using the Mark II Hatra, as specified in the contract documentation.  All manufacturers were informed prior to bidding for the contract which test method was to be utilised and no manufacturer objected to the method which has been used by the Welsh NHS to assess the compression profile of compression garments for over 30 years.  SMTL are aware that there are other tests and specifications available for compression garments, but the results from the tests detailed here should not be used to assess compliance or otherwise with these other specifications.

A selection of the SMTL laboratory testing results are presented in the following reports.  The garments tendered have been listed, however the results have been anonymised on the request of the client.

 

Lymphoedema Arm Sleeve Test Report - Lot 1 - Report No. 19/5547/11 (Report-19-5547-11)

This report details the results of Upper Limb, Circular Knit, C-G, Grip Top, Class 2 compression garments.  Results show that 2 of the 4 garments tendered did not comply with the pressure requirements with wrist pressures lower than the specified limit.

Lymphoedema Lower Limb Test Report - Lot 8 - Report No. 19/5547/12 (Report-19-5547-12)

This report details the results of Lower Limb, Circular Knit, Below Knee, Light Sheer Fabric, Class 1 compression garments. Results show that 1 of the 6 garments tendered did not comply with the pressure requirements with ankle pressures lower than the specified limit.

Lymphoedema Lower Limb Test Report - Lot 20 - Report No. 19/5547/13 (Report-19-5547-13)

This report details the results of Lower Limb, Made To Measure, Below Knee, Flat Knit, Class 1, compression garments. Five companies tendered product for this category and on receipt of samples noticeable differences in the sizes submitted were evident (see Figure 1).

 

Figure 1

IMG 0177

Testing of the garments showed that 4 of the 5 garments tendered did not comply with the pressure requirements, with the following anomalies noted:

  • Manufacturer A garment had a negative gradient compression profile with lower pressures than specified.

  • Manufacturer B garments had lower ankle pressures than specified

  • Manufacturer C garments had higher ankle pressures than specified.

  • Manufacturer D garments had higher ankle pressures than specified. On review of the sample it was evident that Manufacturer D had submitted a class 2 garment rather than the class 1 requested.

  • Manufacturer E passed the testing with ankle and calf pressures within the specified limit.

 

Lymphoedema Lower Limb Test Report - Lot 29 - Report No. 19/5547/14 (Report-19-5547-14)

This report details the results of Lower Limb, Below Knee, Mens Garments, Class 1, compression garments. Tendered garments were either tested on the lymphoedema patient leg specified in 17/5547/0, or on a longer lymphoedema patient leg size if requested. Results show that 1 of the 3 garments tendered did not comply with the pressure requirements with ankle pressures lower than the specified limit.

Lymphoedema Lower Limb Test Report - Lot 30 - Report No. 19/5547/15 (Report-19-5547-15)

This report details the results of Lower Limb, Below Knee, Mens Garments, Class 2, compression garments. Tendered garments were either tested on the lymphoedema patient leg specified in 17/5547/0, or on a longer lymphoedema patient leg size if requested. Results show that 1 of the 4 garments tendered did not comply with the pressure requirements with ankle pressures lower than the specified limit.

 

Resource List

All of the test reports are available for download as PDF files:

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