The Medicines and Healthcare products Regulatory Agency (MHRA) has revealed that it has received a number of complaints from users stating that the quality of some surgical instruments is unsatisfactory.
It has therefore issued a warning that care should be taken when new instruments, and all other devices, are initially purchased to check that they are fit for purpose. This is a reiteration of advice given regarding care of devices given in the MHRA Device Bulletin 2006(05) “Managing Medical Devices”.
All medical devices, including surgical instruments, sold in the UK, have to comply with certain quality measures brought together under the CE marking scheme. This is a risk based system and devices believed to be low risk, including many surgical instruments, are categorised as Class 1 devices.
Manufacturers of these Class 1 devices undertake self-certification that they comply with the required quality systems for their devices before placing them on the market.
The MHRA stated that “questions should be raised in relation to devices offered at below the current market price”, commenting that this may indicate counterfeit instruments or products of substandard quality assurance. It warned that such devices may superficially appear the same, but, when tested, they may not meet the essential requirements of the directives.
The MHRA said that it would like to work with manufacturers and users to increase the quality of these devices and would welcome details of any specific problems, via the MHRA Adverse Incident Reporting system.
The warning follows a campaign by Phil Daly and Tom Brophy, from the department of clinical physics, Barts and The London NHS Trust, to raise awareness of such quality issues, following a major study carried out by the Trust. The study, which included an evaluation of 4,800 instruments, found problems with 15% of instruments – with failure rates as high as 35% for individual manufacturers.
Speaking to The Clinical Services Journal, earlier this year, Tom Brophy urged other Trusts to follow the example of Barts and The London NHS Trust by implementing stringent quality control protocols, with a view to forcing suppliers that fail inspections to “up their game”. Key findings of inspections performed by the Trust, on newly purchased devices, featured in the October 2010 issue of The Clinical Services Journal. Click here to view the story.
