Ensuring optimum protection in theatre

The correct use of surgical drapes and gowns is a vital issue for many thousands of healthcare professionals – not only for the surgeons and perioperative staff working in operating theatres, but also procurement and supply managers employed by acute NHS Trusts and independently-managed hospitals. In addition to protecting patients from the possibility of cross-infection, it is also vital to protect healthcare professionals from the risk of contracting a blood-borne virus from the patient.

Although it can be argued that the risks of infection in the operating theatre are multifactorial, it is clear that there is a higher potential for the transmission of infectious microorganisms via permeable cotton through which blood and other bodily fluids can penetrate. Single-use surgical drapes and gowns represent a safe, reliable, validated option for protecting both patients and operating theatre staff. In order to meet these objectives, we need drapes and gowns that will provide a bacteriostatic, sterile operating field. Single-use materials provide a validated means of achieving these goals.

Not only are the consequences of blood-borne viruses and wound infections potentially devastating for both patients and healthcare professionals, the financial implications for NHS Trusts and independent hospitals can be disastrous. The cost, for example, of having to replace an infected joint could be as high as £50,000.

In 2006, a new series of European Standards (EN13795) was published, setting out the essential requirements and performance criteria of surgical drapes and gowns. Despite the potential legal consequences of failing to use products that comply with this standard, knowledge of this important standard is not widespread in the healthcare community.

Legal implications

From 31 January 2007, the third and final part of the European standard EN13795 was ratified by the British Standards Institute – making the legal requirements facing both NHS Trusts, independentlymanaged hospitals and the individual staff working for those organisations much clearer.

Compliance with EN13795 is not mandatory, but under the UK’s Consumer Protection Act, legal action could be taken against individuals and organisations if they are found to have breached the duty of care towards patients. Therefore, if a decision is made to use drapes or gowns that do not comply with EN13795, that duty of care will almost certainly have been breached. From a legal point of view, there are theories under which a healthcare institution that continues to use non-CE marked drapes and gowns could risk several forms of liability. Failure to use drapes and gowns that conform to the EN13795 standard could in theory leave open a window of opportunity for a legal case. Organisations could have considerable difficulty in resisting any claim for damages brought by a patient injured or infected as a consequence of the use of materials that do not meet EN13795 requirements.

Therefore, healthcare organisations and individual staff should ask:

• Does the medical device you are proposing to use have a CE mark?
• Do your drapes and gowns meet the EN13795 standard?
• Can you use a re-usable drape or gown and still meet the EN13795 standard?

In terms of surgical drapes and gowns, the following EN13795 criteria must be met:

• Resistance to wet and dry microbial penetration.
• Cleanliness (microbial and particulate matter).
• Resistance to liquid penetration.
• Wet and dry bursting strength.
• Wet and dry tensile strength.

Compliance with EN13795 criteria is recommended before use and, in the case of re-usable drapes and gowns, before each and every use which will mean after each reprocessing. Systems must be in place to document the testing undertaken in order to meet this standard and ensure the traceability of such materials (especially where proof is required to show they have been re-processed to a standard that complies with EN13795).

Duty of care

Ratification of EN13795 reinforces the duty of care that all healthcare professionals owe to their patients. Before using a CE-marked product, the practitioner should weigh up the potential benefits of using that product against the potential risks. Again there are questions to be asked:

• What level of competency/expertise is expected of individual healthcare professionals?
• Has their competency been assessed? If so, has it been documented?
• Have they received appropriate/ accredited training?

Duty of care In essence, a duty of care is expected of everyone involved in the chain of events leading from the supply of a CE-marked medical device, to its subsequent use and disposal. If practitioners use drapes and gowns that do not comply with current EU legislation, they may be deemed as failing to comply with the duty of care they owe their patients – one of the essential components of any case of negligence that may be brought against them.

By complying with EN13795, using CE-marked drapes and gowns that meet the current EU standard will encourage best practice in the operating theatre and increase confidence in the use of surgical drapes and gowns.

This involves reducing infection risk by improving the standard of barrier protection between theatre staff and patients, and following agreed risk management procedures in order to minimise the likelihood of subsequent litigation.

The onus is on healthcare organisations to prove that they have safe systems in the operating theatre. If challenged, it would be difficult to establish that the “in-house” reprocessing of re-usable materials meets the strict criteria required by EN13795.

It is impossible to predict which patients or which members of staff may acquire an infection – or what role, if any, a particular type of drape or gown might play in contributing to such an infection. The complexities of the reprocessing of reusable drapes and gowns make it very difficult to ensure (and importantly demonstrate) that the devices are safe at each use. By converting to effective, single-use materials, it is a risk that can be taken out of the equation. In other words, if there is an infection, the potential for failure in a reprocessing system and therefore the part played by drapes and gowns can be ruled out.

Healthcare-associated infections carry significant consequences for the patient, the surgeon and the organisation. Minimising risks carries significant benefit for the healthcare provider in terms of savings, efficiencies and maintenance of a positive reputation in addition to reducing the potential for a successful legal action against the organisation.