Safer sharps - Scalpel and Suture needles

Joanna Ford and Pete Phillips, SMTL

Originally published October 2008. Updated in April 2014

Introduction

Sharps injuries are a common occupational hazard for health care workers in the NHS. An injury sustained from a sharp contaminated with blood can put staff  at risk of bloodborne viruses such as Hepatitis B and C and HIV. As a result of this, a range of sharp devices exist with features designed to reduce the risk of injury.  This report summarises 'safety' scalpels, sutures and associated products.

Device Evaluations

The five key factors in designing a sharps safety instrument are as follows (FDA, 1995):

• The safety feature should allow or require the workers' hand to remain behind the sharp
• The safety feature should be an integral part of the device and not an accessory
• The safety feature should remain activated during assembly and disposal
• The safety feature should be simple and self-evident to operate, and require little or no user action or training
• The safety features should have no impact on the delivery of patient care

The following section lists the safety devices currently on the UK market. The devices included here have not been evaluated by ECRI as of the date of publication.

Scalpels

Description and Use

Traditional scalpels are small, very sharp knives, used in most surgical operations, as well as in many other areas (for example, chiropody). Blades are made from stainless steel or carbon steel -- carbon steel is sharper, but is also more brittle and blunts and rusts more easily than stainless steel.

Injury Risk

Injuries can occur during use (where the surgeon can injure themselves), whilst passing the scalpel from one person to another, and when disposing of the whole scalpel (on a disposable) or the blade (on a reusable).
Reusable scalpels pose the extra risk of an injury while attaching and removing the blade.

Safer Alternatives

Safer designs include mechanisms with retractable blades or blade covers. The alternative devices resemble traditional disposable scalpels, but with an added mechanism which retracts or covers the blade before and after use. Some models offer two levels of safety activation - one which offers protection during handling, but still allows use of the scalpel, and the second level which locks the scalpel ready for disposal.

 In addition, a range of related disposal products exist that are designed to safely remove and dispose of blades from conventional scalpels. Some of these are shown in the table below:

Sharps injury in chiropody

There is very little information in the literature concerning chiropodists and sharps injuries, even though this group of health professionals is fairly high risk due to the number of sharps intsruments used within their job.  The Health Protection Agency have produced infection control guidelines for chiropodists and podiatrists (HPA 2007) which describes what to do in the event of a sharps injury and encourages safe disposal of sharps. However, it does not discuss any  'safety' engineered devices. The authors of this report did not come across 'safety' scalpels marketed specifically for chiropodists or podiatrists although it is possible that some of the generic 'safety' engineered scalpels on the market may be suitable for this group to use.

Suture needles

Description and Use

Traditional suture needles are sharp, usually curved, and used to thread sutures through the patient's skin or other tissues to close wounds. They come in a variety of designs, including those with cutting tips, or those with tapered non-cutting tips.

Injury Risk.

Injuries can occur before use (when preparing the needle in the needle holder, passing between staff), during use (it is quite common for surgeons to pierce their own fingers whilst suturing), and after use/during disposal.

Alternatives

The protective alternatives are based on the  traditional curved designs, but with tips which are blunter than usual.  The needles can still penetrate tissue, but the blunt ends make it less likely that they will penetrate skin accidentally.

Review of literature

A number of studies have evaluated the blunt-tipped needles for closure of tissue during operations (Hartley et al., 1996, Mendelson et al., 1997)). The suture needle is designed to penetrate tissues other than skin. Both of the studies reviewed reported a significantly lower glove penetration rate when using a tapered needle and no needlestick injuries were sustained whilst using the tapered needles. However, in one of the studies, some issues were reported when blunt sutures were used which included tissue tearing and bleeding although these were not considered to be clinically important (Mendelson et al., 1997).  Both studies concluded that the safety suture needle was successful and required only the minimum change to technique. Neither of the studies addressed issues of differences in tissue damage, bleeding, and quality of closure whilst using the safety suture needle. A more recent Cochrane review of studies investigating blunt suture needles concluded that they reduced the incidence of percutaneous injury during surgery (Cochrane report, 2011).

A more recent paper reviewed the evidence surrounding sharp safety in surgery and included the use of safety scalpels, safety suture needles and the practice of double gloving (De Girolamo et al., 2013). They concluded that double gloving and the use of blunt suture needles had a protective effect but could find no evidence for or against the use of safety scalpels. However, they reported anecdotal evidence suggesting that users often preferred conventional scalpels to safety versions. 

Bibliography

Cochrane Database Syst Rev.  Parantainen A, Verbeek J, Lavole M, Pahwa M. Blunt versus sharp suture needles for preventing percutaneous exposure incidents in surgical staff. 2011 Nov 9.

DeGirolamo K, Courtemanche D, Hill W, Kennedy A and  Skarsgard E. Use of safety scalpels and other safety practices to reduce sharps injury in the operating room:What is the evidence? Canadian Journal of Surgery. 2013: 56(4); 263-269

FDA Safety Alert, April 16, 1992. Draft Supplementary Guidance on the content of premarket notification 510 (K) Submissions for Medical Devices with sharps injury prevention features. March 1995

Hartley J, Ahmed S, Milkins R, Naylor G, Monson J, Lee P. Randomized trial of blunt-tipped versus cutting needles to reduce glove puncture during mass closure of the abdomen. British Journal of Surgery. 1996 ;83:1156-1157

Health Protection Agency. Chiropody and Podiatry infection control guidelines. December 2007.

Mendelson M, Sperling R, Brodman M, Dottino P, Morrow J Solomon J et al. Evaluation of blunt suture needles in preventing percutaneous injuries among health-care workers during gynecologic surgical procedures. MMWR. 1997: 46 (2):25-29