Sterility Considerations for Vaginal Speculums: Navigating Medical Standards, Environmental Responsibility, and Common Misconceptions with Bridea Medical's Orchid Spec.
Introduction
The sterility of medical instruments is a vital consideration in healthcare. Within gynaecology, the question of whether vaginal speculums need to be sterile is often debated. This article explores specific requirements, prevalent misconceptions, and environmental considerations, highlighting Bridea Medical's offerings.
The Vagina: A Non-Sterile Environment
The vagina is inherently a non-sterile environment. Thus, a speculum used in many standard gynaecological procedures does not need to be sterile, as it will become non-sterile upon contact with the vagina.
Classification and Suitability for Regular Procedures: Spaulding's Approach
More than 30 years ago, Earle H. Spaulding devised a rational approach to disinfection and sterilisation of patient-care items and equipment. His clear and logical classification scheme has been retained and refined, used successfully by infection control professionals.
According to Spaulding's classification, vaginal speculums are categorised as semi-critical devices. This means the instruments should be free from microorganisms, though small numbers of bacterial spores are permissible. Intact mucous membranes, like those in the vagina, are typically resistant to common bacterial spores, making non-sterilised speculums suitable for regular procedures.
Our sterile speculum line is reserved for gynaecological procedures within a sterile field, such as during surgical operations or trauma. However, fewer than 5% of all gynaecological procedures require such a product. Though these scenarios occur, the vast majority can confidently utilise our non-sterile line.
Understanding Sterility
Sterility refers to the absence of all microorganisms. Whilst essential in particular medical contexts, it's crucial to distinguish between the need for sterility in specific scenarios and general clinical cleanliness.
Non-Sterile and Sterile Speculums: Bridea Medical's Offerings
We, Bridea Medical, offer speculums that are both sterile and non-sterile. Our non-sterile speculums are manufactured and packaged to ensure clinical cleanliness, whilst our sterile speculums are available for specialised cases.
Common Misconceptions About Sterilisation
A common misconception is that reusable metal speculums must be sterile before each use. Whilst they must be cleaned by sterilisation before reuse, sterility at the time of use isn't necessary. For a single-use speculum, they do not need to be sterile in most cases, nor do they need to be sterilised after use, as they are single-use items and can be disposed of. Our single-use speculums are injection-moulded at extremely high temperatures and directly packaged in a clean room facility to maintain clinical cleanliness.
Environmental and Health Considerations and Our Approach
Sterilising speculums have a significant environmental impact, often involving harmful ETO gas and extensive energy consumption. ETO's main drawbacks include lengthy cycle time, considerable cost, serious health risks, and environmental concerns. Acute and chronic exposure to ETO can lead to various health problems, from irritation to cancer. Residual ETO can cause injuries to patients.
Global Reach and Assurance
Bridea Medical sells speculums to 22 different countries, mainly in Europe and North America. The vast majority of the millions of speculums sold are from our non-sterile, clinically clean product line. Our belief is that using a sterilised disposable, single-use speculum is a potential waste of public funds and an unnecessary strain on the environment.
Conclusion
Choosing between sterile and non-sterile speculums is about more than medical protocol; it's also about environmental stewardship and understanding the specific needs of each procedure. Bridea Medical's offerings, adhering to clinical standards whilst promoting responsible choices, exemplify a dedication to excellence in both healthcare demands and environmental sustainability.