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The Ostomy Files: A Historical Review of Wear Time: Is It Still Relevant?

November 2005

    “I can only get 3-days’ wear time from my pouching system. What am I doing wrong?”

    How many times have ostomy specialists heard this complaint? Occasionally, we must step back from what we know is “tried and true” and ask ourselves if what we have been championing for so many years is still relevant. As ostomy pouching systems continue to evolve and improve, is the 7-day wear time gold standard still relevant? Where did it come from? Why do people with an ostomy question themselves and their techniques if they achieve “only” a 2- or 3-day wear time?

The History of Wear Time

    Seven-day wear-time was promoted in the 1950s to 1960s era of expanded research on the technology of ostomy products and improvement in surgical techniques that emerged from the Cleveland Clinic Foundation.1 Moving forward into the late 1980s and early 1990s, the Wound Ostomy and Continence Nurses Society (formerly IAET) Standards of Care Series2-5 stated that an “average” wear time is approximately 5 days, with appliance changes “approximately one to two times a week,” and “generally every 5 to 7 days or according to the manufacturer’s recommendations.”

    Despite confusion about wear time, the origin of 7-day wear may be associated with “manufacturer’s recommendations.” Ostomy supply manufacturers test their products for material durability, ease of use, odor control, comfort, and a myriad other metrics. Package inserts include instructions based on the findings of pre-market research as well as product claims permitted by the US Food and Drug Administration. Let’s say, for example, that during pre-launch studies, a skin barrier was able to sufficiently provide peristomal skin protection for 7 days without melting or eroding away but began to lose effectiveness on the eighth day. Through repeated tests, the manufacturer can reasonably ensure the skin barrier will remain effective for up to 7 days. Therefore, that claim is legitimate and can be included in the package insert. This does not mean that the pouching system must be worn for 7 days; it simply means that it has been proven to remain effective for 7 days. The claim does not take into account body temperature, abdominal topography, allergies or other medical conditions, activities of daily living, tropical climates, functional limitations, or personal choice — it merely states the product is effective for up to 7 days.

    Also pertinent to pouch wear time is reimbursement. Medicare uses available manufacturer data to establish coverage and payment policies. If a package insert states wear time up is to 7 days, it literally could be taken to mean that every person with a stoma should be able to wear that pouching system for a week. Recalling previous Medicare coverage policies for ostomy supplies, it is clear that this was the policymakers’ assumption. Beneficiaries continued to voice their concerns to policymakers that using one pouch and one wafer per week was simply not adequate to maintain a semblance of normalcy in their lives. After many years, Medicare utilization limits were changed to reflect a more realistic wear time and offer more options and access to a variety of pouches for beneficiaries living the ostomy experience.

    We have evolved from the “postoperative pouches”6 to “permanent reusable pouches”6 of 50 years ago to today’s lightweight, flexible, completely disposable pouching systems. People with an ostomy now have more options for stoma management than at any other time in history. Choices regarding such a private and intimate aspect of human function — ie, elimination of bodily waste — should be up to the individual. Policy or clinicians should not mandate wear time.

    The financial status of person with a stoma also should be considered.7 The fact that an individual may be a Medicare beneficiary or live on a fixed income should not determine ostomy management system choice, especially if a more costly alternative or shorter wear times dramatically improve quality of life. Individuals should be allowed to choose how they spend their money and many have reported it is worth the investment to feel secure, clean, or more comfortable in their clothes. Quality-of-life issues, especially for the person with a stoma, have emerged as a crucial aspect of living the ostomy experience.

    Clinicians who care for people with a stoma are responsible for ensuring that a pouching system meets the clinical needs of the individual. It is up to the individual to determine what pouching system is the right system, how frequently they wish to change pouching systems, and how the ostomy fits into their life. Seven days of wear time is no longer the gold standard. Today, clinicians must more intimately involve the patient in important lifestyle decisions.

    The Ostomy Files is made possible through the support of ConvaTec, a Bristol-Myers Squibb Company, Princeton, NJ.

 

1. Turnbull GB, Turnbull RW. The history and current status of paramedical support for the ostomy patient. Sem in Colon Rectal Surgery. 1991;2(2):131–140.

2. Standards of Care: Patient with Urinary Diversion. Wound Ostomy and Continence Nurses Society (formerly IAET);1991.*

3. Standards of Care: Patient with Ileostomy. Standards of Care: Patient with Urinary Diversion. Wound Ostomy and Continence Nurses Society (formerly IAET);1991.*

4. Standards of Care: Patient with Colostomy. Wound Ostomy and Continence Nurses Society (formerly IAET);1989.*

5. Guidelines for Management: Caring for a Patient with an Ostomy. Wound Ostomy and Continence Nurses Society (formerly IAET);1998.*

6. Broadwell DC, Jackson BS. Principles of Ostomy Care. St. Louis, Mo.: CV Mosby Company;1982.

7. Turnbull GB. The ostomy assessment inventory: a data-gathering process to enhance appropriate pouching system selection. Ostomy Wound Manage. 1998;44(2):28–37. *Author’s note: These standards are cited for referencing purposes only. They are no longer available and have not been replaced.

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