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.

Evidence:http://www.cqc.org.uk/newsandevents/newsstories.cfm?......nt_view_1&cit_id=35456

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/

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.

  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