Revised: 17 April 2012
Safety Information
Medical Devices
| 17 April 2012 | Management of Patients with Metal on Metal Hip Implants |
| 9 June 2010 | Medsafe Statement - Graseby MS-Series Syringe Drivers - Further Extension of Deadline |
| 1 December 2009 | Medsafe Statement - Graseby MS-Series Syringe Drivers - Extension of Deadline |
| 2 March 2009 | Medsafe Statement - Graseby MS-Series Syringe Drivers |
| 30 January 2008 | Syringe Driver Advisory Group (SDA) |
| 23 November 2007 | Discontinuation of supply of Graseby MS16A and MS26 Syringe Drivers |
Archived Medical Device Issues
Management of Patients with Metal on Metal Hip Implants.
Medsafe and the New Zealand Orthopaedic Association (NZOA) (www.NZOA.org.nz) support the advice to healthcare professionals issued by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on the management of patients implanted with metal on metal hip replacements.
Issue
The majority of patients who receive a metal on metal hip replacement do well with the implant and are thought to be at low risk of developing serious problems. A small number of patients implanted with metal on metal hip replacements may develop a metal debris problem that can lead to a progressive soft tissue reaction in proximity to the joint. The metal debris problem does not occur in every patient but in some patients it occurs through the build-up of microscopic metal debris through wear at the articular surface of the joint. The issue may be monitored through a heightened level of trace amounts of the metals cobalt and chromium in the blood of a patient. Early revision surgery of poorly performing hip replacements is likely to lead to a better outcome of revision surgery.
Action
The attached table developed by the MHRA details the management of patients with implanted metal on metal hip replacements. This management plan is supported by both Medsafe and NZOA and can be used as a set of guidelines or a protocol on how to manage patients with metal on metal implants. Where appropriate a revision of the implant should be completed as early as possible.
The types of replacement are divided into four groups:
- MoM hip resurfacing implants
- MoM total hip replacements with head diameter <36mm
- MoM total hip replacements with head diameter ≥36mm
- DePuy ASR™ hip replacements comprising:
- - ASR™ acetabular cups for hip resurfacing arthroplasty or total hip replacement
- - ASR™ surface replacement heads for hip resurfacing arthroplasty
- - ASR™ XL femoral heads for total hip replacement.
The table has recommendations for patients who are symptomatic and also those who are asymptomatic.
Importantly all patients with implanted with a metal on metal implant that has a large diameter head (36 mm or greater) will require annual follow-up for the life of the implant.
Medsafe and the NZOA are providing this advice to you so that healthcare professionals can provide consistent advice to patients that seek consultations regarding their implanted hip replacement.
Table was updated on 27 August 2012
Table footnotes:
- Blood metal ion testing to be in whole blood
- 7 parts per billion (ppb) equals 119 nmol/L cobalt or 134.5 nmol/L chromium
Guidance notes
- On the basis of current knowledge, this chart has been produced as a guide to the management of these patients. It will not necessarily
- cover all clinical situations and each patient must be judged individually.
- MARS MRI scans (or ultrasound scans) should carry more weight in decision making than blood ion levels alone.
- Patients with muscle or bone damage on MARS MRI are those of most concern. A fluid collection alone around the joint in an asymptomatic patient, unless it is very large can be safely observed with interval scanning.
- Local symptoms include pain and limping.
Graseby MS-Series Syringe Drivers – Further Extension to Deadline
Medsafe has extended its target date for the removal of Graseby MS-Series Syringe Drivers from clinical use to 30 June 2011. This change has been made in consultation with both DHBNZ and CareFusion, suppliers of the recommended replacement device.
Current Situation
Following customer feedback regarding a nuisance alarm CareFusion temporarily halted deliveries on the Alaris AD syringe driver while this issue was resolved. The upgrade to address the cause of this alarm is still undergoing development but is expected to be available shortly. To reduce inconvenience to healthcare professionals caused by stock shortages due to the removal of Graseby devices before the replacement pumps are readily available Medsafe has agreed to a twelve month extension of the deadline for the removal of Graseby MS-series syringe drivers from clinical use.
This extension will enable CareFusion to upgrade its quarantined stock to supply all orders. Current users of the Alaris AD will receive the alarm fix as a free of charge upgrade as soon as this is available. CareFusion will be in contact with users to advise them of the upgrade process in the near future.
Medsafe will continue to monitor the progress of the transition program.
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and is a business unit of the Ministry of Health.
Inquiries about this matter should be sent to Robert Jelas, Senior Advisor Medical Devices, via email (robert_jelas@health.govt.nz), telephone (04-819-6881) or fax (04-819-6806).
Graseby MS-Series Syringe Drivers – Extension of Deadline
Medsafe has extended its target date for the removal of Graseby MS-Series Syringe Drivers from clinical use to 30 June 2010. This change has been made at the request of CareFusion, suppliers of the DHBNZ recommended replacement device.
Current Situation
Most of the DHBs and hospices have already transitioned to the DHBNZ recommended replacement device, but some organisations still need to make the change from the Graseby to the new device. In the interests of patient safety Medsafe has extended the target date for the removal of the Graseby devices to ensure that there are sufficient syringe drivers available for patient care during the transition phase. The six month extension of the deadline should provide adequate time for the remaining organisations to transition from the Graseby devices.
Medsafe will continue to monitor the progress of the transition program.
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and is a business unit of the Ministry of Health.
Inquiries about this matter should be sent to Robert Jelas, Senior Advisor Medical Devices, via email (robert_jelas@health.govt.nz), telephone (04-819-6881) or fax (04-819-6806).
Attention
Chief Executives
Risk Managers
Materials Management
Medsafe Statement - Graseby MS-Series Syringe Drivers
Medsafe expects that Graseby MS-Series syringe drivers will be removed from clinical use by 31 December 2009. However should there be exceptional circumstances caused by delays in availability, supply, training, or other issues relating to the replacement pump recommended by DHBNZ - the Alaris AD Syringe Driver - this date may be revised.
Background
In 2007 Medsafe raised safety concerns about the Graseby MS-Series syringe devices with Smiths Medical New Zealand, the supplier of the devices. Subsequent to this Smiths Medical ceased supply of the MS-Series syringe drivers in both New Zealand and Australia in October 2007.
The Syringe Driver Advisory (SDA) Group was formed in January 2008 to facilitate the safe and smooth transition from the Graseby MS-series syringe drivers to alternative syringe drivers. District Health Boards New Zealand (DHBNZ) conducted an evaluation process to determine a suitable replacement for the MS-series syringe driver. At the end of this process the Alaris AD Syringe Driver was identified as a suitable replacement device.
Cardinal Healthcare, suppliers of the Alaris device, have committed to a nationwide roll-out of the new syringe driver.
Current Situation
Now that there are alternatives to the Graseby MS-Series syringe driver which incorporates safety features consistent with modern medical device design, Medsafe recommends that all users of these devices transition to the Alaris syringe driver or an equivalent alternative syringe driver as soon as possible.
To provide clarity for the transition Medsafe has set a date of 31 December 2009 by which time all Graseby MS-Series syringe drivers should be removed from clinical use and replaced. Medsafe will expect users to recall any Graseby MS-Series syringe drivers still in use at this time.
The final date for the transition will only be influenced by delays in availability, supply, training, or other issues relating to the Alaris AD syringe driver. Should any issues arise Medsafe may revise this date.
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and is a business unit of the Ministry of Health.
Inquiries about this matter should be sent to Robert Jelas, Senior Advisor Medical Devices, via email (robert_jelas@health.govt.nz), telephone (04-819-6881) or fax (04-819-6806).
Syringe Driver Advisory Group (SDA)
An advisory group, the Syringe Driver Advisory Group (SDA), has been established to facilitate the safe and smooth transition from the use of Graseby syringe drivers to alternative device(s).
Members of the group include representatives from;
- Palliative Care Working Party
- Palliative Care Nurses NZ
- Hospice NZ
- Healthcare Providers NZ
- Paediatric Intensive Care
- Medsafe
- District Health Boards NZ
- Ministry of Health
The SDA wishes to ensure that all current users of Graseby syringe drivers are aware of the discontinuation of supply and therefore, the need to plan for changing over to a different device. Current users are providing generalist or specialist palliative care in a variety of settings, or within a variety of paediatric and neonatal healthcare settings. This has practical, financial and educational implications. The SDA wishes to provide a supportive, rather than a directive role.
For further information about SDA please contact Emma Murray, MoH, (emma_murray@health.govt.nz, or phone 04-816-2978), Nancy Harp, MoH, (nancy_harp@health.govt.nz or phone 04-816-2983) or Anne MacLennan (Anne.MacLennan@ccdhb.org.nz)
Discontinuation of supply of Graseby MS16A and MS26 syringe drivers
Wellington
23 November 2007
Ref - TT05-16-2-6
Discontinuation of supply of Graseby MS16A and MS26 syringe drivers
Earlier this year Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, raised concerns with Smiths Medical about the safety of the Graseby MS-Series Syringe Driver. These syringe drivers are commonly used in palliative care and other situations to provide continuous ambulatory infusion of medicines. As a consequence of Medsafe's action Smiths Medical decided to cease supply of the Graseby MS-Series Syringe Driver to the market with effect from 4 October 2007.
This document briefs you on the situation, the reasons for Medsafe's action and the action that will need to be taken by users of these devices.
Background
Regulators in several countries, including Australia and the UK, have previously issued safety alerts in relation to the Graseby MS-Series Syringe Driver and these have related to possibilities of over-infusion, tampering with the device and confusion between the different models of Graseby device.
Among the specific points noted by regulators were;
- The visually similar MS16A and MS26 models have a 24-fold difference in infusion rate. Confusing the two has resulted in multiple serious adverse events
- The device does not use standard measuring units requiring a calculation to set the flow rate, thus introducing the risk of error.
- The pump lacks a stop button.
- The rate can be changed while the pump is in operation.
- There is no protection against misloading of the syringe, air entrainment, tampering or siphoning.
- The occlusion response characteristics of this pump are very poor.
- The pump does not retain a record of operation
- Some models feature a "prime" button which provides maximum infusion rate when depressed. There is no limitation on the number of times this may be activated nor a record of activation. Serious adverse outcomes have resulted from inappropriate use.
Although available for some time it has become apparent that the safety features of the Graseby MS-Series devices have not been upgraded to comply with current minimum standards as recommended by internationally respected regulators.
In particular the Graseby MS-Series devices do not meet the Global Harmonisation Task Force for medical devices (GHTF) "Essential Principles of Safety and Performance of Medical Devices" guidelines. These guidelines reflect international minimum requirements for the safety and effectiveness of medical devices.
The "Essential Principles" may be downloaded from the GHTF website at;
http://www.ghtf.org/documents/sg1/sg1n41r92005.pdf
Smiths Medical and Medsafe agreed that the Graseby MS-Series devices did not meet these requirements and thus Smiths Medical decided to cease supply of the devices in New Zealand from 4 October 2007.
Current Situation
Supply of Graseby MS-Series devices in New Zealand ceased on 4 October 2007. Spare parts and service for existing devices continue to be available through Smiths Medical at this time.
Medsafe recognises the clinical implications of this situation and thus does not currently require existing devices to be recalled or withdrawn from clinical use when alternates are not available provided the manufacturer's instructions are carefully observed.
Medsafe also recognises the on-going risks associated with these devices and therefore advises users to give immediate consideration to sourcing alternative equipment which meets the "Essential Principles" for safety and efficacy.
The Next Steps
Medsafe has commenced consultation with healthcare professionals and stakeholder groups to determine a process and timeline for the removal of all existing Graseby MS-series devices from clinical use.
Users should consider how best to phase the use of these devices out and consider which device or devices may be used as a satisfactory replacement.
Medsafe does not undertake comparative evaluation of medical devices, nor is it appropriate for Medsafe to endorse any specific device. However Medsafe can assist users by providing information about the notification status of alternative devices on the Web Assisted Notification of Devices (WAND) database and by facilitating end-user group discussions.
Rob Allman
Acting Interim Manager
Medsafe
