Sterility and Tapeless

STERILITY AND TAPELESS

Occasionally the question of sterility and the use of Tapeless dressing holders is asked.  Obviously the nature of the wound and any special circumstances under which the product is to be used is important, but even with this question, Tapeless demonstrates its versatility with no compromise in clinical efficacy.  Most wounds by definition are “infected” by their very nature and concerns about secondary wound dressings are in practicality, secondary.

First, Tapeless dressing holders are categorized as secondary wound dressings.  By FDA standards this means that the dressing is not to be directly in contact with non-intact skin (the wound).  The only real FDA requirement is that the product is manufactured under certain specifications for a class I product of this type, i.e., in a “clean environment”.  This sets certain air filtration and personnel requirements.

Tapeless becomes versatile in that it may be sterilized if the use merits.  Since Tapeless is a laminate incorporating a polypropylene plastic, anything with excessive heat should be avoided.  The product may be sterilized with ethylene oxide or radiation.  This is rarely indicated.  It is not however unusual for the user to want to “clean” the product, either for cosmetic purposes or to reduce the level of contamination.  If there are any concerns, discard the product since the product by this time has most likely already been cost effective by means of its re usability.  Tapeless has studies that prove that it may be washed and reused, surprisingly even unaffected by boiling water or a substance as harsh as pure bleach.  Studies have proven that there is 100% memory in the material with repeated washings as long as the product is air dried.


There are methods to minimize possible contamination, such as more frequent dressing changes, or using a thicker layer of the primary dressing until drainage decreases.  The issue of sterility and the use of Tapeless should be determined  case by case and should not be “painted with a broad brush”.

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PLASTIC SURGERY AND TAPELESS

PLASTIC SURGERY AND TAPELESS 

Perhaps no surgical subspecialty has the potential to use as many Tapeless products as plastic surgery.  The reason is simply that plastic surgeons do various procedures ranging from hand surgery to complicated reconstruction.  Often the plastic surgeon is called upon as the final solution to deal with chronic or complicated wounds.  Wound healing is their forte, and consequently the smallest of details may make a significant difference in a result.  For this reason, great attention is paid to even secondary wound dressings since they often affect the ability to heal a wound and reduce the unwanted complications of scarring and tissue loss.

The success of Tapeless is related to the design of the product and the material used.  The design imparts its influence through the ability to support the tissues, keeping the primary dressing exactly where it is placed and intended for use, and, as in the case of the breast dressing holder, can actually be used to help contour the surgically operated breast and define anatomic features such as the infra mammary fold and symmetry with the opposite breast.

The material is equally as important since compression, while helping to reduce swelling, will also reduce blood supply.  The key to a successfully healing wound is to maintain a good blood supply.  Tapeless is slightly compressive allowing for changes in swelling, up or down, that is accommodated for by the material without a need to reapply or adjust the degree of compression.  Because the material is “forgiving” in this manner, at the same time, the blood supply will not be compromised or significantly reduced.

These Tapeless qualities in of themselves make Tapeless the ideal secondary dressing for most plastic surgical procedures, and when added to the qualities not discussed, like cost effectiveness, increased patient compliance, no adhesives, latex free and no bulk, further enhance the clinical efficacy of Tapeless.

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CE MARKING AND TAPELESS

CE MARKING AND TAPELESS

Obtaining a “CE” mark means more than having the ability to sell or market one’s products within the European community.  These communities, 27 member states of the EU, Iceland, Norway, Lichtenstein, Turkey, Croatia, Macedonia, Albania, Serbia and Montenegro, require a conformity of one’s products whose purpose is to protect the safety, public health and consumer from non-conforming products.

This CE marking process is extensive and thorough.  Each manufacturer is required to compile a technical file that demonstrates approved safety and regulatory standards along with detailed manufacturing, packaging and quality control procedures.  The CE mark must be displayed on the package when used in that market, providing an assurance to the consumer that the product has met the combined conformity and standards of the member nations.

To highlight the depth to which a product must conform, an outline of the manufacturer’s responsibilities include:

1.      ensure compliance product design and manufacture

2.      caring out conformity assessments

3.      draw up the technical documents

4.      draw up the EU declaration of conformity (D of C).

5.      affix the conformity marking ( CE marking)

6.      keep the technical file and D of C

7.      ensure continued conformity by reviewing on a several year cycle

8.      take into account changes in the standards or technological specifications which are stated for their product’s compliance requirements

9.      secure the type/serial/batch numbers to the product

10.  take corrective actions or withdraw/recall the products from the market when there is a reason to assume non-conformity

11.  in such cases, inform the appropriate authorities

12.  indicate name and contact address of manufacturer on the product

13.  on request, provide information/documentation to authorities and cooperate with them

Each product must have achieved the same degree of conformity so not only has Tapeless achieved a high level of efficacy and usefulness clinically, it has achieved a high level of excellence not apparent by simply looking at the product.

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