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The use of vaginal specula in improving infection control

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VOL: 102, ISSUE: 09, PAGE NO: 53

Sarah Tattersall, RGN, DipHE, is infection control nurse, Salford Primary Care Trust

Adherence to infection control guidelines on the use and decontamination of medical and surgical devices and instru...

Adherence to infection control guidelines on the use and decontamination of medical and surgical devices and instruments is essential in minimising the risk of transmission of infectious agents. Failure to do so can put patients at risk of cross-infection, health care providers at risk of litigation and individual practitioners at risk of being reported to their professional regulator for disciplinary proceedings. The latter could result in practitioners being removed from their professional register and unable to practise in the future.

A local audit undertaken in several GP practices found that many were failing to follow current national guidelines on the decontamination of minor and general surgical instruments and other equipment, including vaginal specula. This included both the reuse of instruments designed for single use only and inadequate decontamination of reusable items. Much of this type of poor practice could be reduced by investing in improved reprocessing systems, such as contracting out the reprocessing, or using disposable instruments. Costs could also be reduced by using disposable instruments correctly, in this case, vaginal specula.

As a result of the audit, an initiative was taken by Salford PCT that aimed to persuade local GP practices to use disposable rather than reusable vaginal specula, and to do so appropriately.

Literature review

In 2000 the deputy director of the Surgical Material Testing Laboratory (SMTL) produced a report for a leading manufacturer of disposable vaginal specula on the issues relating to disposable and reusable vaginal specula (Phillips, 2000). While many company-produced reports may be biased, this one focused on the issues surrounding poor practice in GP surgeries. It found, also, that some GP practices would have to make significant investments in training, testing, equipment and maintenance to comply with best practice. It was suggested that some GPs were willing to accept the costs of purchasing single-use specula, in order to bring reprocessing in line with best-practice guidelines.

Clark (2004) examined the pattern of health care provision in primary care and assessed whether guidance such as Controls Assurance in Infection Control and Decontamination of Medical Devices was known, understood or implemented in four primary care trusts. The findings demonstrated deficits in knowledge and practice, and the author suggested these probably reflected practice in other PCTs.

Houghton et al (2004) carried out a patient evaluation of a recall programme based on occurrences at Blackburn with Darwin PCT between 1991 and 2003, where hundreds of women from a local GP surgery had to be recalled after it was found that a practice nurse had been washing vaginal specula - most commonly used for smear tests - in disinfectant, instead of sterilising them. They found that, in such situations, consulting patients regarding their care benefits both the organisation and the individual.

The incident at Blackburn with Darwin PCT brought decontamination to the attention of all PCTs, and particularly to infection control nurses, who began to audit their own GP practices to assess standards of decontamination. When I audited several practices, it became apparent that some GPs and practice nurses were unaware of the strict processes to be followed when decontaminating vaginal specula, despite a rolling programme of training, the availability of policy guidance and a supportive in-house health protection team.

The Medicines and Healthcare products Regulation Agency (MHRA) bulletin on single-use medical devices (MHRA, 2000) discusses the legal implications, risks and concerns in the reuse of single-use items. The agency has also issued guidance on periodic testing, legal issues and maintenance schedules of benchtop steam sterilisers (MHRA, 1996).

Despite a paucity of evidence it appears that as the profile of infection control in the community increases, so do the number of studies demonstrating that some GPs are compromising patient care by carrying out ineffective decontamination.

Morgan et al (1990) used a survey sent to 600 GPs to investigate disinfection procedures. Their findings indicated that, from a 65 per cent response rate, up to 22 per cent of instruments used in high-risk procedures were inadequately decontaminated.

Allen et al (1997) found that the concept of sterilisation was not fully understood in general practice, which raises the question of patient safety. If practitioners do not understand how to use equipment correctly their patients are clearly at risk.

Smythe (1999) found that when asked to define sterilisation, only 25 per cent of GP respondents did so correctly, while 34 per cent defined disinfection, which clearly indicated a strong need for education. One solution to this problem would be for PCTs to provide training targeted at practices carrying out in-house reprocessing.

However, it could be argued that it is the purchaser's responsibility to ensure all medical devices are used only by those trained to do so. This is supported by the MHRA, which has clearly stated in a number of bulletins that practitioners must use medical equipment only when they are deemed competent following training and assessment.

Decontamination

Decontamination is the process by which reusable medical devices are made safe for further use by minimising the risk of transmission of infectious agents. It involves a combination of cleaning, disinfection and sterilisation. However, evidence suggests that primary care professionals often fail to decontaminate their medical devices properly, citing economic reasons for this failure. According to the MHRA (2000), reprocessing of single-use medical devices - usually for economic reasons - is a common practice despite the fact that it increases infection risk to patients. However, Phillips (2000) found that some GPs were willing to put aside cost implications for the greater good of adhering to safe practice, and demonstrated that it is more cost-effective to purchase single-use vaginal specula than to reprocess reusable versions.

Benchtop steam sterilisers

Health care provision over the past decade has increasingly moved from a hospital-centred to a community-based approach, which has resulted in GPs offering an extended range of services (Health Service Guidance, 1993) including cervical cytology and some minor surgical procedures.

In order to provide these services, increasing numbers of GPs need benchtop steam sterilisers (BTSS) to decontaminate equipment. Fuller (1992) conducted a study of sterilisation practices in GP surgeries and described the best practices that should be followed when reprocessing medical devices. This included regular servicing, weekly checks and careful documentation. However, the study showed that only a minority of surgeries adhered to best practice.

In a survey of 700 GPs across England and Wales, Coulter et al (2001) found that 82 per cent owned a BTSS. However, 39 practices did not autoclave instruments after use, even though the lifestyles of their patients often put them at increased risk of HIV or hepatitis B.

Despite the availability of national advice on decontamination, MHRA (1996) guidance on the purchase, operation and maintenance of BTSSs, and the employment by many PCTs of infection control practitioners, the question still arises of how to implement this guidance in general practice without additional resources.

The experience of Blackburn with Darwin PCT highlights the importance of employing infection control nurses and the significance of partnership working. Following the incident at the trust, a nurse was appointed to work proactively with practice staff and to provide expert advice and guidance on infection control and decontamination. The introduction of an infection control nurse much earlier might have prevented the stress and anxiety caused by the failures at the GP practice and averted the need to spend huge amounts of time and money on a rescreening programme.

Single-use devices

The MHRA (2000) emphasises that devices designated for single use must not be reused under any circumstances. The devices are not designed to be reprocessed, as doing so may cause a range of problems, such as material and substance alteration, or mechanical failure. It may also be that reprocessing will not clean them adequately. All these factors increase the risk of cross-infection. However, poor understanding of the consequences of repeated use of devices intended for single use only leads to many of them being reprocessed and reused, despite clear labels on the packaging and sometimes on the instruments themselves.

Local audit

An audit undertaken in local practices revealed unsafe infection control and associated decontamination procedures. Some GPs appeared, unwittingly, to be carrying out unsafe decontamination procedures by failing to comply with current national guidance.

Many GPs are independent providers of health care, and this can, in some cases, be problematic because they are not under the direct control of the NHS and therefore not as easily regulated as NHS facilities. However, GPs - and their practice nurses - are professionally accountable and have a responsibility continuously to improve the quality of services they provide (Gillam and Bradley, 2001). If they are to comply easily with infection control guidelines and policies it would seem sensible for practices to consider using single-use vaginal specula, particularly considering the costs of using BTSSs safely and effectively. Salford PCT therefore recommended that GPs, sexual health departments and practice nurses move to the routine purchase of single-use vaginal specula.

The recommendation was strongly influenced by the Blackburn with Darwin incident and recommendations drawn from the SMTL report (Phillips, 2000).

The change process

As an infection control/clinical equipment nurse specialist, it is part of my role to evaluate products and seek reputable companies to supply a range of medical devices and consumables to the PCT. It was my responsibility, therefore, to manage the change process in my PCT and oversee the purchasing and supply of the disposable vaginal specula. I worked in collaboration with an infection control nurse at the Health Protection Agency in Manchester, exchanging information on the necessary change processes. A letter detailing the reasons for, and benefits of, this change was mailed to all GPs throughout the trust. A simple form was also sent to the GPs to stimulate interest and to help them to estimate the number of specula their practices would need. Based on this information the GPs could easily calculate the costs to their practice of purchasing single-use specula.

Once the process had been explained, together with the rationale behind it, the majority of GPs were happy to give up local reprocessing where possible and use the recommended specula. Understandably, some GPs were unable completely to give up using their BTSSs, as an increasing number in Salford are being paid to carry out minor surgery and therefore need a steriliser to decontaminate their surgical instruments.

A company was contacted whose vaginal specula had shown good results in evaluation, and an agreement was reached to purchase these. They were bought in bulk by the PCT and stored at its headquarters before being supplied to GP practices. Once the GPs had agreed to purchase the specula they were sent an order form that was to be completed by them or the practice nurse, then returned to the PCT.

Almost a year on, uptake of the single-use specula programme has been extremely encouraging, with increasing numbers of GP practices taking advantage of it.

Now that more intense and rigid guidance on the use of BTSSs is being developed, GPs are facing pressure to find alternative sources of decontamination.

Central sterilisation store department (CSSD) contracts with a local hospital are an option for some practices, but for many GPs, this is too expensive and the turnaround of instruments can be too slow. Salford PCT is now applying the same assessment principles as were used for selecting specula to selecting common minor surgery instruments that can be offered to GPs for purchase for their practices.

Legal issues

Health care providers are responsible for ensuring the care they provide is as safe as possible. This is vital not only to protect patients, but also for financial reasons, as the cost of litigation resulting from accusations of unsafe practices grows with increasing expectations among patients and their awareness of their rights if healthcare falls below accepted standards. Furthermore, individual practitioners are accountable for their practice and may face disciplinary proceedings by their professional regulatory body if it is thought that their care is not safe.

In order to protect their patients, their finances and their practitioners, GPs must instigate a thorough review of the risks and costs inherent in their current reprocessing practices. They should compare these with the cost of entering into a litigation suit following non-compliance and take advice from bodies such as the DoH and the MHRA that serve to protect the patient.

Surgeries that fail to comply with best practice are putting their patients at risk. The MHRA (1996) emphasises that failure to follow its advice could compromise safety and have legal and insurance implications for the owner of the steriliser. However, many practices are still ignoring this advice.

The reasons cited for accepting these risks are mainly based on the economic implications of complying with guidelines, insufficient staff training and lack of product knowledge.

Conclusion

The GPs in Salford who are purchasing single-use specula through the PCT are reducing the risks of cross-infection among their patients. Furthermore, litigation from unsafe practice is being minimised. For safe practice it is essential that national guidelines on the use and decontamination of surgical instruments are adhered to. If benchtop sterilisers are used, it is essential that they are done so correctly; failure to do so has serious consequences.

KEY POINTS

- Healthcare providers are responsible for ensuring that the care they provide is safe

- Using single-use vaginal specula avoids the need for decontamination and the risks that are associated with this process

- Single-use items must not be re-used under any circumstances.

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