New surgical instruments: a question of quality

When hospitals purchase surgical instruments, most will assume that they are safe and reliable and that good manufacturing techniques have been used. There is also a reasonable expectation that these devices have been subjected to a rigorous quality control process.  

In 1998, the Clinical Physics Department at Barts and The London NHS Trust was asked by clinical colleagues to investigate the quality of surgical instruments being supplied to the Trust. We began a quality assurance study of new surgical instruments arriving in the Trust to determine whether they complied with British or International standards. This study found a large number of poor-quality instruments entering the Trust’s hospitals. These were frequently of such poor quality that they were discarded immediately, before being used. We also discovered that a large number of instrument manufacturers and suppliers had paper management systems but no formal product quality control process. 

In 2000, Barts and The London NHS Trust set up its own surgical instrument quality assurance section, because we had no confidence that new instruments were undergoing a real quality-control process. By 2010, the UK Medical and Healthcare Products Regulatory Agency (MHRA) was warning of possible surgical instrument problems, and in 2011 a BBC television programme (Panorama), entitled ‘Surgery’s Dirty Secrets’, investigated the surgical instrument industry and found evidence of lax quality control and poor manufacturing practices and conditions.

In 2008, the US Food and Drug Administration (FDA) published a Public Health Notification advising on serious events that arose from fragments of medical devices being left behind after surgical procedures. These fragments are known as unretrieved device fragments (UDFs). The FDA’s Center for Devices and Radiological Health receives around 1000 adverse event reports each year relating to UDFs.(1,2) One major source of UDFs is the failure of surgical instruments.(3) 

There are many risks from UDFs. The FDA states: “The adverse events reported include local tissue reaction, infection, perforation and obstruction of blood vessels, and death. Contributing factors may include biocompatibility of the device materials, location of fragment, potential migration of the fragment, and patient anatomy. During magnetic resonance imaging procedures, magnetic fields may cause fragments to migrate, and radiofrequency fields may cause them to heat, causing internal damage and/or burns.”(1)

If fragments of surgical instruments are left behind in the body, they have the potential to cause an embolism. A foreign body embolism occurs when an object travels through the bloodstream and obstructs a blood vessel in another part of the body. This restricts the flow of vital oxygen and nutrients to the tissue and can result in a number of clinical problems, including pulmonary embolism, stroke or death.(4,5) In addition, it has been known for foreign bodies to migrate through soft tissue into the venous system.(6)

Metallic implant material needs to be biocompatible; that is, not exhibiting any toxicity to the surrounding biological system.(7) Surgical instrument steel is not designed for implantation in the human body. Steel implants that are intended to be left in the patient are made out of austenitic stainless steel, which is biocompatible and highly corrosion-resistant. However, most surgical instruments are made of martensitic stainless steel, which is much less resistant to corrosion.

A foreign body granuloma is an inflammatory mass of tissue that accumulates around embedded fragments as the immune system attempts to engulf the foreign body.(8) If this enters the bloodstream, an embolism can occur, with serious consequences to the patient.(9) Even small particles have the potential to block critical vessels.

To give an idea of the consequences of instrument failure, the following are reports of patients in whom instruments have broken and fragments have been left behind: 

• A 56-year-old woman has had surgery on the temporomandibular joint. In the 10 years following surgery, she suffered pain, tinnitus and restricted mouth opening. A 4-mm metallic foreign body was subsequently removed, which was most probably the fractured tip of a surgical awl that had been left behind during the original surgery.(10)
• The jaw of laparoscopic grasping forceps became detached and fell into a patient’s abdominal cavity and could not be recovered.(11)
• A 4-year-old girl with recurrent respiratory papillomatosis had a laryngeal biopsy with straight cupped forceps. During the biopsy, the unhinged cup of the forceps broke free and was aspirated into the lower airway.(12)

The surgical instruments team at Barts and The London NHS Trust carried out a study of 4800 instruments between January and June 2004, and 15% were found to have problems.(13) Faults found included fractures, soldering faults, burrs and shredded serrations on forceps. In all these cases, the faults had the potential to cause material to become detached in the patient and provide niches in the instruments that could retain blood and tissue.(14) The most common fault was the lack of a manufacturer’s mark. The British Standard states: “The instrument shall be marked with the name or registered trade mark of the supplier.”(15) While this may seem a minor infringement, it is in fact very important. If an instrument fails in service, it is essential that the supplier and manufacturer can be notified, so that any wider problems can be rectified to ensure the safety of both patients and theatre staff. In addition, the traceability of instruments is important for reasons of liability and insurance.(13)

Many fine tissue forceps have guide pins to reinforce the accuracy of mating of the jaws. Again, the British Standard states that: “If present, the guide pin shall be tapered to facilitate entry into the locating hole and shall not protrude from the hole when jaws are closed.”(15) On visual inspection by the naked eye, we identified 34 guide pins that protruded on gentle, but complete, closure of the forceps jaws. This could be a source of glove puncture.(13) Artery forceps with deficient ratchets and scissors not cutting correctly were also identified, as well as deficient electrical insulation, corrosion and previously used and contaminated instruments.

Decontamination cases are supplied to hold particular instruments or instrument sets securely during sterilisation and transportation, which protect the instruments and maintain their sterility until use. It would be reasonable to expect that, when a decontamination case is opened in theatre,  the instruments are positioned in a logical manner, as when dispatched from the sterile service department (SSD). Decontamination cases for new sets of instruments were found that did not secure the instruments properly, allowing them to move out of position in transit causing unnecessary and expensive damage. We now require cases to be supplied with assembly diagrams etched onto the case. If this is not available from the supplier we request a laminated assembly photograph or diagram. This directs SSD staff to assemble the case correctly and is a visual check that all instruments have been included.

Quality assurance procedures 

At Barts and The London NHS Trust, we have instigated our own quality assurance (QA) procedures that include inspection of instruments to British and International standards.

Instruments are inspected by normal vision under illumination but without magnification. Devices that include teeth, serrations and prongs are additionally inspected with the aid of an eyeglass to a magnification of x15, to ensure sharp edges, burrs and manufacturing debris have been removed. If any problems are discovered, further evaluation may be required using a microscope up to a magnification of x60. Any medical device that could pose a risk to patient safety must comply with these requirements. Instruments that include tungsten carbide inserts are inspected using a microscope with a magnification up to x60 to ensure that the inserts are soldered correctly and are free from fractures.

These QA checks have been carried out on newly purchased surgical instruments for a number of years and a significant proportion of instruments still fail to meet the appropriate standards.  We immediately remove these faulty instruments before they can be delivered to a clinical environment and report their failure to meet standards to the supplier and the MHRA. The failure rates of new instruments have remained roughly constant since these inspections started, for example 13% in 2001, 16% in 2003, 14% in 2005 and 17% in 2010.

The surgical instruments’ QA service has been running since January 2000, augmented in 2003 with high-resolution digital photography of faulty or poor- quality instruments. The provision of photographic evidence has helped to persuade the sometimes-sceptical suppliers of the reasons for rejecting devices, minimising the likelihood of devices being returned with faults unrectified. These images also play an important role in educating theatre staff and procurement managers as to the nature of the faults commonly seen and thereby reduce the chances of substandard instruments entering or remaining in service. All inspection records are now stored on a purpose-built database, with archives from the start of the service in 2000, which allows statistical analysis of the failure data and comparison between the various types and sources of device.

Not long after beginning our own QA service, it became apparent that many suppliers were not aware of the relevant British or International standards governing surgical instruments. Even after several meetings advising them of our reasons for rejecting such a high proportion of new devices, many suppliers were still reluctant to address the issues we had highlighted.

How organisations go about resolving defects can give hospitals and their staff the confidence to continue the procurement relationship with the supplier. Conversely, a reluctance to address these issues in an open and cooperative manner will lead them to seek alternative suppliers.

NHS Supply Chain and Barts and The London NHS Trust are now working together to improve the quality of surgical instruments across the NHS. In 2010, QA inspections were carried out on instruments from twelve suppliers who previously held single-use instrument pack contracts. Six suppliers who passed the relevant standards set by NHS Supply Chain were awarded contracts to be added to the NHS Supply Chain Framework Agreement. By collaborating in this way and using robust and independent instrument quality data in procurement decisions, we can ensure that manufacturers and suppliers address shortcomings in their own quality procedures. This will result in  improved safety for patients and staff, reduced potential litigation and substantial cost benefits for the NHS.  

Every year serious incidents arise as a result of fragments of medical devices being left in patients’ bodies after surgical procedures. Foreign body fragments entering the patient expose them to a number of clinical risks, including foreign body granuloma or embolism, which could be fatal. In addition, instrument defects can trap human tissue. Sterilisation procedures cannot be relied upon to render such debris inert.

Not all manufacturers currently provide good quality instruments. Manufacturers need to ensure that the instruments they sell meet British and International standards and do not needlessly endanger patients. The US Food and Drug Administration recommends inspection of devices prior to use. However, to our knowledge, most trusts do not employ a formal quality assurance process.

The implementation of our QA  service has prevented potentially dangerous and faulty instruments from being accepted, ensuring instruments are fit for purpose and preventing valuable resources being wasted on unnecessary replacements.

Dialogue with suppliers and manufacturers, together with recent publicity, is beginning to focus attention on improving the quality of the surgical instruments used both in the NHS and the private sector.

1. FDA Public Health Notification: Unretrieved Device Fragment. 2008 (www.fda.gov/medicaldevices). 
2. Fischer  R. Danger: beware of unretrieved device fragments. Nursing 2007;37:17. 
3. Top 10 Technology Hazards. Health Device November 2010 (www.ecri.org).
4. Callegari L et al. Ultrasound-guided removal of foreign bodies: personal experience. Eur Radiol 2009;19(5):1273–79.
5. Caplan L. Embolic materials brain embolism. Caplan L (ed). Informa Healthcare USA 2006;259–88. 
6. Kones R, Philips J. Foreign body of the heart complicated by papillary muscle necrosis located echocardiology. Chest 1972;52–57. 
7. Hansen D. Metal Corrosion in the human body: the ultimate bio-corrosion scenario. The Electrochemical Society Interface. Summer 2008:31–34. 
8. Truscott W. Patients, particles, pathology and pathogens: the infection connection. Manag Infect Control March 2009: 94–97. 
9. Truscott W. Lint and particle contamination during diagnostic and interventional procedures in the cardiac catheterization lab. Cath Lab Digest 2006;14:10–19.
10. Persson S et al. Metal fragment in the temporomandibular joint: a case report. Int J Oral Maxillofac Surg 2003;32:653–55. 
11. Australian Therapeutic Device Bulletin, No 29, April 2006;8. 
12. Monteiro E, Campisi P. Foreign-body aspiration during microlaryngoscopy: an unusual case of instrument failure. J Pediatr Surg 2007;42:E13–14.
13. Brophy T et al. Quality of surgical instruments. Ann R Coll Surg Engl 2006;88:390–93.
14. Daly PM et al. Unretrieved device fragments – the clinical risk of using poor quality surgical instruments. Med Device Decontam 2010;14:18–22.  
15. The British Standards. BS 5195, 1985, parts 1–4.