The recent Panorama programme on surgical instruments highlighted the fact that to achieve the CE mark, you can effectively self-certificate. By registering in the UK with the MHRA, you can be given a registration number and start CE marking. When purchasing from companies who CE mark their instruments, they should still have a series of technical documents, known as technical
How do we know where a piece of steel began its life? Every pieced of stainless steel that is used to manufacture a surgical instrument, should have a mill or certificate of conformity (manufacturers version of this). As a buyer, this may tell you where the steel came from, to what grade it is, its exact composition but ultimately the
Companies that are selling instruments CE marked, should certainly have the CE mark appearing on the device. In addition to this, a LOT number and manufacturer name should also appear.
Any instruments that are being used on trays, which do not have this basic traceable information, will not have any way they can be tracked or traced. How many times
GS1 marking has become very relevant in the past year, with high risk trays such as neurology needing to be tracked, so if necessary, steels can be traced back to their source. GS1 marking is the standard the department of health has proposed to go ahead with and this presents itself in the form of a 2D matrix mark, as
Different chemical compositions are suitable for different instruments. BS 5194 : Part 1:1991 gives a more in depth breakdown for the uses, but as a basic guide, instruments should be manufactured from the following (a few examples are shown below):
Non-Hardenable (Austenitic) Stainless Steel, High Chromium. Austenitic Steels are non-magnetic and cannot be hardened
AISI 303 for Machining/turned parts
Although companies monitored by notified bodies, such as SGS (www.sgs.com), ultimately, the government monitor all medical devices in the field. Their role is as follows:
The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
The MHRA do not see any medical
There are no harmonised standards in place that Surgical Instruments can be assessed against to prove quality, specific to their functionality. Standards such as ISO 9001 and 13485 may be referenced, but they do not demonstrate quality, they signify a formalised quality system. The BS 5194 standards document guidelines for each group of surgical
instruments, specification covered are:
Like all industries, the selling of Medical Devices is subject to legislation and monitoring. The law that we have to comply with, in order to sell Medical Devices is the European Communities Council Directive 93/42/EEC.
The Medical Devices that we sell fall into 2 categories, which are defined by the Directive. Class I re-useable surgical instruments and Class II
Each medical Device placed on the market, falls under a classification in the Medical Device Directive, which is determined by its function, use and period of use.
The main principle to understand is that the higher the Classification, more measures have to be taken to reduce this risk. As a general rule, all medical devices have to meet the essential