All Wales Lymphoedema Contract 2014
Gavin Hughes, Louise Barry (Surgical Materials Testing Laboratory, Bridgend)
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. This was the first time that NWSSP PS had tendered an All-Wales Lymphoedema 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garments using a method based on the British Standard BS 6612 for graduated compression hosiery (BS 6612 has since been superseded by BS 661210), and SMTL and NWSSP PS could publish the results of testing and assessments without restriction.
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 test apparatus (Hatra Mark 2 - see image).
The sample requirements, test methodology and performance requirements of compression garments are outlined in AWC Lymphoedema Testing Specification 14/4431/1 (Report-14-4431-1)
Testing performed by SMTL identified that only 71% of garments passed the pressure requirements claimed by the manufacturers. Of note were a number of garments that produced negative pressure gradients which could potentially cause patient harm.
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.
The results of the SMTL laboratory testing are presented in the following reports.
Lot 1a Armsleeves Circular Knit (Report No: 14/4431/2)
This document (Report-14-4431-2) presents the results of testing Class 1 and Class 2 Upper Limb Circular Knit Armsleeves. The results show that 3 of the 4 garments tendered did not comply with the pressure requirements.
Medi Class 1 & 2 garments were found to exert higher pressures than were specified, but on investigation it was noted that they had provided the wrong size samples which were intended to fit a smaller limb than the one specified in the contract documents.
Test results indicated that the class 1 Sigvaris Advanced garment produced a negative pressure gradient with higher pressures at the bicep compared to the wrist.
Lot 6b Armsleeves Made To Measure Flat Knit (Report No: 14/4431/3)
This document (Report-14-4431-3) presents the results of testing Class 2 Upper Limb Made To Measure Flat Knit Armsleeves. The test results show that 3 of the 4 garments tendered complied with the pressure requirements. One garment (BSN/JOBST Elvarex) produced a negative pressure gradient with higher pressures at the bicep compared to the wrist.
Lot 3a, Lower Limb, Thigh Length, Circular Knit, Light Sheer (Report No: 14/4431/4)
This document (Report-14-4431-4) presents the results of testing Class 1 and Class 2 Lower Limb, Circular Knit, Light Sheer, Leg Garments. The test results show that all class 1 and 2 garments tendered complied with the pressure requirements.
Lot 3b, Lower Limb, Thigh Length, Circular Knit, Firmer Denser – Report No: 14/4431/5
This document (Report-14-4431-5) presents the results of testing Class 2 and Class 3 Lower Limb Circular Knit, Firmer Denser, Leg Garments. The test results show that 5 of the 6 garments tendered complied with pressure requirements. The Sigvaris Traditional class 3 garment did not comply with the pressure requirements with ankle pressures lower than the specified limit.
Lot 4, Lower limb, Below Knee, Flat Knit (Report No: 14/4431/6)
This document (Report-14-4431-6) presents the results of testing Class 1, Class 2 and Class 3 Lower Limb Flat Knit, Leg Garments.
On receipt of samples it was evident that Haddenham had sent different sized samples for the specified patient limb. The test results show that all 3 garments tendered did not comply with pressure requirements with ankle pressure lower than the specified limit.
Lot 5b, Lower Limb, Thigh Length, Made To Measure, Flat Knit (Report No: 14/4431/7)
This document [Report-14-4431-7] presents the results of testing Class 2 Lower Limb, Made To Measure, Flat Knit, Leg Garments. The test results show that 3 of the 4 garments tendered complied with the pressure requirements. One of the garments (Haddenham Goldpunkt garment) exerted a negative pressure gradient with lower pressures than specified.
All of the test reports are available for download as PDF files:
- AWC Lymphoedema Testing Specification (Report-14-4431-1)
- Lot 1a Armsleeves Circular Knit (Report-14-4431-2)
- Lot 6b Armsleeves Made To Measure Flat Knit (Report-14-4431-3)
- Lot 3a, Lower Limb, Thigh Length, Circular Knit, Light Sheer (Report-14-4431-4)
- Lot 3b, Lower Limb, Thigh Length, Circular Knit, Firmer Denser (Report-14-4431-5)
- Lot 4, Lower limb, Below Knee, Flat Knit (Report-14-4431-6)
- Lot 5b, Lower Limb, Thigh Length, Made To Measure, Flat Knit (Report-14-4431-7)