1. Introduction

The Care Quality Commission (CQC) has stated that medical devices have the lowest rates of compliance when they carry out regulatory compliance audits. Next year, the CQC will further develop regulations to become more focussed. All trusts will need to register with the regulator to legally function.




2. Core standards with lowest rate of compliance
6 Core standards were reported by the CQC as having the lowest rates of compliance.  4 of those 6 standards, listed below impact on medical devices management (and therefore patient safety).

  • C11b - participation in mandatory training
  • C09 - systematic and planned approach to records management
  • C04c - reusable medical devices are properly decontaminated
  • C04b - minimise risks of medical devices


3. NHSLA Claims

The NHS Litigation Authority are reporting high rates of negligence claims. The total payouts in 2009/10 were £786 Million. There is an upwards trend as seen in the graph below.
Evidence: http://www.nhsla.com/Publications/

claims received

3.1 NHSLA Payments: Upwards trend



The clinical negligence payments have increased £321M from 2005 to 2010. This is a 97% increase in payment against clinical negligence. Many of these negligence claims involve the use of medical devices, and I am regularly involved in investigating these types of incidents. In my opinion, most incidents are avoidable, as they are usually a result of no/poor training.


3.2 NHSLA Assessments

During 2009/10, a total of 229 assessments were carried out: 141 (61%) at Level 1, 72 (31%) at Level 2 and 17 (8%) at Level 3. At the end of the year, 60% of acute trusts, 31% of mental health and learning disability trusts and 70% of maternity services had achieved Level 2 or 3, as illustrated in the chart below.


service levels


  Within each standard, there are ten equally weighted criteria or risk areas. Each risk area is addressed through an ongoing programme of assessment at three distinct, progressive levels:

  • Level 1 - documentation (policy)
  • Level 2 - implementation (practice)
  • Level 3 - monitoring and improvement (performance).


To achieve compliance, organisations must pass at least 40 out of the 50 criteria with no fewer than seven passes in any one standard. NHS trusts receive increasing discounts, ranging from 10% - 30%, on their contributions to the risk pooling schemes as they progress from Level 1 to Level 3.

  With regard to: NHS White Paper: 'Equity and excellence: Liberating the NHS' Gateway reference: 14541

Dear Mr Sandham
Thank you for your email.  Your comments on the NHS White Paper and the management of devices have been noted and will now be considered as part of the consultation process.

NHS White Paper Consultation team

"John Sandham" <This email address is being protected from spambots. You need JavaScript enabled to view it.>  16/09/2010 20:46 To NHS White Paper/OIS/DOH@DOH Subject RE: Deadline for comment in the new white papers is OCT 5th</This email address is being protected from spambots. You need JavaScript enabled to view it.>

In every NHS organisation I work with, they have similar problems around buying, maintaining, and training on medical devices. The CQC recognises this as an area where the NHS is weak. This leads to death / serious harm, and overspend that is well documented by various government agencies.  The average Trust spends 1.5% of its budget on medical devices. Implementing medical devices management processes aids Trusts to reduce risk, reduce downtime, and reduce costs by approximately 25% to 35% of their spend, and also improve efficiency. If an NHS Trust has a £200M budget, and spends £3M on medical devices (Equipment, consumables, training, and maintenance); There could be a recurrent annual saving of £1M by improving quality and patient safety.  


I would be pleased if you could raise this issue as a question to the house, raising awareness of the risks and opportunities. My suggested question would be: How can management of medical devices be facilitated and supported in NHS Trusts by responsible executives? In the past, many excellent guidelines have been issued and ignored. I am concerned that the CQC are not drilling down deep enough to instigate change at a suitable pace.

(Presented to Nadine Dorries MP, Health Select Committee, Oct 2010)


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