Trudy Triumph's Neurogenic Bladder Blog

Put Your Trust in your Medical/Healthcare Device Supplier – Your Life May Depend on it

My Back Story

Using a trustworthy medical supplier is as important as choosing your doctor. Let’s discuss issues to consider when buying medical devices online. Aeroflow is one option to consider when selecting a medical device supplier. 

Recently, I had a very big, healthy-life threatening, day-spoiling situation. I ran out the door for a fun day off. I grabbed some of my female compact Clean Intermittent Catheters (CIC) to put in my pocket. When I fly off for a full day, I don’t usually even think about having body parts that are paralyzed or ineffective due to my neurogenic bladder. Because of modern medicine, I live a relatively carefree lifestyle and not a soul even knows that I depend on these devices, except those I have chosen to include in my inner circle. These catheters keep my kidneys healthy by helping me to completely empty my bladder, on regular intervals that I set.

My day can get ruined pretty fast, though, if I do not have a safe catheter. I cannot pee easily without their support. Left to pee on my own, my bladder blows up like a balloon, even if I try to press my urine out, because there is so much residual urine building up in my bladder. “Pressing my urine out” which I did do before my diagnosis, is a totally inadequate option because my bladder never completely empties.

On that fateful day, only too late, I sadly discovered and unfortunately while away from home, that they were faulty. All the catheters I had brought were compromised! The lubricant was discolored, old, thick and gummy, and that I only discovered once I had opened the seal. I unwrapped my sterile compact disposable catheter and noticed that the lubricant that helps guide the catheter into my urethra was gummy/thickened and unusable (see below). [Only once I examined them further, much later, did I find No lot number and No expiration date stamped on them.]

Disappointed, I finally made the decision to leave, because life without the devices I rely upon, is too dangerous and extremely uncomfortable. I was not willing to take a risk and compromise the current health I have been enjoying. After discovering that I did not have what I needed, I just sulked home.

We need Safe Devices

Have you ever pondered upon the integrity of the thin layer of packaging that protects these devices we keep on hand and depend upon, before they’ve been opened?

  • After they are opened, we trust our very lives that the product inside provides a safe and effective result – these tools that we use and hardly consider, after they are part of our life routine . . . especially after years of use.
  • We allow these little devices to prod and poke into areas of our body that are not meant to contain or have foreign objects introduced into them.
  • Because of circumstances beyond our control, they are a necessary & nearly a rote part of daily living.

 

Here are pictures of intact catheters, individually stamped with the lot # and Date of Expiration!

               

Here are some of the defective catheters I found in my shipment – the lot # and Use-by Dates are missing! The lubricant was thick, discolored and did not coat the tip of the catheter as it should, once extended.

       

 

Device Questions To Ask Yourself

  • How old are they?
  • Are the seals intact?
  • Do they look different (have a different color than usual/discolored)?

What to do if there are Concerns

  • Contact your medical-supply distributor
  • Contact the Manufacturer
  • Consider contacting the FDA

 

The FDA

There are regulations in place to keep food and drugs safe. The Food and Drug Administration (FDA) – is the US agency that ensures our health is protected. The FDA regulates ingredients in food and drug products sold in the US (products ingested), but also Medical Devices/Equipment, including catheters. They keep us safe. Did you know that? Have you ever wondered why products in the US sometimes cost more than they do in other less regulated countries? Their mission is to [protect] “the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”

Our Responsibility: To Help Ensure Public Safety

If you have a problem with a device, take the time to report it. You can contact the manufacturer directly and provide the details for a “case study”. The manufacturer can determine many things from the lot number stamped on your device, including:

  • the place of manufacture
  • the day it was produced
  • the machine operator
  • even the time of day it was manufactured

This allows the manufacturer to follow-up and helps them determine if there are ongoing problems that need to be corrected and/or if necessary, issue a recall on specific lots. In addition, the FDA can be contacted and brought into play. Part of their role is to serve as enforcers of safety. Contact the reporting end of the FDA – known as “MedWatch,” if you experience an adverse event due to your medical device. You can reach them by phone at 800-332-1088 or submit a report through the online reporting tool at www.fda.gov/medwatch


Going Forward/Staying Vigilant


What have I learned?

  • All catheters I order and use need to come in date-stamped boxes that include the lot number.
  • I will inspect all the boxes I buy to make sure they are clearly dated and there is reasonable time before their expiration.
  • If I receive product that does not meet my criteria, I will contact the supply company immediately.
  • I will store my devices properly.
  • I will store my supplies such that I can easily determine expiration dates/not pass the Use-By date.
  • I will select devices from different lot numbers when I leave for the day. Then, if I get a bad catheter, I will be sure to have back-up. I can’t afford to become complacent.

 

The mission of Aeroflow encompasses more than selling the medical devices that fill their warehouses.

https://aeroflowurology.com/

You might wonder how I came to know Aeroflow in the first place, if they are not the supplier I have used. The answer is simple. In 2016, I wrote the book, Beyond Embarrassment: reclaiming your life with neurogenic bladder and bowel, with Julia Parker, MS, MLIS. I have found that writing a book is much easier than selling a book or making sure that the audience that actually needs the book discovers that they are not alone – an inspiring/encouraging resource is available. Early on, one of my marketing ideas was to contact medical device suppliers and ask them to add my book to their catalog since their customers are the people who could most benefit from reading my story. I contacted a huge number of medical device dealers. However, finding the right CEO who would take time out to listen or even ensuring your request reaches a real person is hard and arduous. I was, however, able to find the right person to talk to at Aeroflow.

  • They are in business to serve and nurture the spirit of those to whom they provide service — those living with serious medical conditions. I thank them for that. They happily put my book in their catalog, as a resource to those living with bladders that require assistance to work properly.
  • One of the ways they do this is by making real people with real medical situations part of “peer support”. They offer real life stories from their patients to encourage others. They know that our condition is not easily shared and support is key!
  • Medical suppliers are a part of my health team. I need to use a medical supply company in which I am confident they take my best interests seriously.
  • Aeroflow Healthcare is a good option in obtaining safe medical devices.
  • It offers free shipping to your door.
  • Can be paid through your insurance.

 

What do you think of your device distributor and the manufacturer?  Do you have comments/suggestions that might help them provide you with better service?

 

Additional Reading

Code of Federal Regulations (CFR) – are the books that spell out US law. The legal authority specifically which regulates catheters in the US is contained in CFR Title 21 Sec. 876.5130

TITLE 21–FOOD AND DRUGS
SUBCHAPTER H–MEDICAL DEVICES | Subpart F–Therapeutic Devices
GASTROENTEROLOGY-UROLOGY DEVICES (PART 876)
Sec. 876.5130 Urological catheter and accessories

Part of FDA regulations require that manufacturers with new invention designs meet safety requirements & efficacious product approval guidelines, that must be applied for and reviewed by the FDA, before they go on the market.

But it doesn’t stop there. After approval, manufacturers must continue to prove they are manufacturing safe products, under controlled conditions and maintain Good Manufacturing Practices (GMP). They must pass audits and maintain their approval by submitting the requisite annual registration user fees. Manufacturers develop compliance programs to reduce risk to their patient-base and build a relationship of trust.

Medical Device Information for Consumers – the FDA ensures that you have access to the information you need to understand the science and medical reasoning behind the devices it regulates so you can make informed health decisions. So, not only does the FDA regulate manufacturers, but they serve to interact and educate the public, “the consumers” who use them: both you and I!

“This post (published 3/14/18) was sponsored by Aeroflow, as part of the ‘Chronic Illness Bloggers Network'”

One Response to “Put Your Trust in your Medical/Healthcare Device Supplier – Your Life May Depend on it”

  1. Reply Susan Bilsky

    Hello Trudy,
    I truly admire your confidence and go about and enjoy life attitude despite this debilitating condition that we share. I have yet to venture out for an all day affair with just a few catheters in my pocket or purse. I still use the unlubricated single use type and yes some are much better than others I have found. Your post prompted me to check my supplies Lot Numbers and
    expiration dates etc., all is good. Lubricant should be checked too as that can go bad. My pocket is rather a big one as it also packs the other supplies needed to complete this operation. Wipes, hand sanitizer and the like are also included in my kit. I have been able to reduce it down to a makeup bag to contain all the stuff. Thank you for your post, I have been graciously reminded to add to my gratitude list, the luxury and convenience of buying my products locally and being able to inspect on sight the status of my catheters. Also on my gratitude list is the fact that I can get insurance to cover a portion of my catheters. No we cannot afford to become complacent.
    God Bless you Trudy

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