Quality of Surgical Instruments

Abstract

INTRODUCTION

Most of the surgeons will have encountered scissors that would not cut, but it would be good to assume that new instruments should be of good quality. This article reports the surprising results of local quality control for new instruments supplied to a single place.

METHODS AND MATERIALS

From January 2004 to June 2004, all surgeons of new general surgery instruments ordered by the Central Sterile Supplies Department of St Bartholomew’s and the Royal London Hospitals were assessed by three clinical engineers, concerning British Standards (BS) requirements.

RESULTS

In total, over seven hundred (15%) instruments failed the inspection.

It also shows 33 views of the jaws of vascular clamps: a well-finished instrument, an instrument with machining burrs in the teeth. It also shows a crack in the securing screw of scissors, a crack through the end of the jaws of a needle holder, and a major soldering fault in the surface of a wire bending forceps.

Discussion

The commonest fault identified was the lack of a maker’s mark. BS states that ”the instrument shall be marked with the name or registered trademark of the supplier. This may seem like a small infringement, but in fact, it is more important. If any instrument fails in services, it is essential that the supplier and manufacturer can be notified so that any potential problem can be rectified to ensure the safety of the patient and theatre staff. In addition, there is the question of liability and insurance.

The stainless steel alloy from which modern instruments are made must also conform to BS. Procedures are described to test corrosion resistance, but it surprised us to find visible corrosion on new instruments.

Conclusions

This study demonstrates the value of local quality control for new surgical instruments. We have found a significant number of cases where new instruments did not appear to meet appropriate standards and have discussed the potential problems that may result. It must be stressed that we have not shown any specific instance of harm to a patient or staff through these defects. Suppliers were informed, and remedial action was taken. All defective instruments were replaced and reexamined before entering service.