The average wound is treated with at least 5 different wound dressing products (which may or may not make sense based on the wound characteristics recorded), and dressings are often layered into a “club sandwich” of competing products that ought to be served with a pickle on the side. This is a big topic with a lot of downstream implications. For the manufacturers of dressings, it makes meeting new European requirements harder. A new Medical Device Regulation (MDR 2017/745) was adopted by the European Union in 2017 and will become effective May 26, 2020. The regulations detail the requirements of device Post Marketing Clinical Follow Up (PMCF). Medical device manufacturers must implement processes to, “actively and systematically collect, record and analyze data on the safety, quality and performance of the device throughout its expected lifetime.” A lot of those devices are dressings.
I am just reading the regulations. According to what I read, the companies must produce Periodic Safety Update Reports which records “non-serious incidents,” data on any “undesirable side-effects,” interaction with other medical products, “emergent risks,” and possible systematic misuse or off-label use of the device, particularly in “high-risk target populations” (e.g., children, elderly).
The dressing manufacturers will also need to address whether their existing product claims are still justified and whether any new claims the manufacturer intends to use are justified. Listen to this
“Positive impacts of a device on the health of an individual should be meaningful (relevant for the patient) and measurable… Benefits may include… positive impact on clinical outcome (such as reduced probability of adverse outcomes, e.g. mortality, morbidity; or improvement of impaired body function).”
If the manufacturer can’t conform to the “Essential Requirements”, the manufacturer must stop selling the devices (e.g. dressings) until they can.
Wow. Those are sweeping requirements. Thankfully, the US Wound Registry (USWR) was designed to harvest data on every dressing and combination of dressing at the brand level, as well as the response to the dressing(s) and outcome. As part of our data preparation process to help manufacturers meet these requirements, we noted some things that everyone might find interesting.
- Thanks to USWR quality measures, venous leg ulcers (VLUs) seen in USWR participating clinics are getting compression bandaging most of the time. That’s a change from 2010 when most of the time, VLUs were NOT put in compression.
- Patients nearly always have more than one wound.
- More than 50% of patients have a tobacco history (or current use) and 50% are obese.
- Clinics that don’t record patient co-morbid conditions like diabetes or arterial disease have trouble diagnosing diabetic foot ulcers or arterial ulcers. (If you don’t know what diseases the patient has, you probably don’t get the wound diagnosis correct.)
- The clinics with the highest patient volume do the worst job of recording co-morbid conditions and medications (it is possible to see patients very quickly, but not possible to see a lot of patients quickly and document properly).
- Wound patients get a lot of systemic antibiotics (half of the top 10 medications used by patients in the wound center are antibiotics).
- Wounds get a lot of different dressings, sometimes at the same time.
There are a lot of other take-home messages from more than a million and half dressing changes. I don’t know if the new European device safety monitoring standards will make wound patients safer. I mean, dressings are pretty safe “devices” already. But I can tell you that:
- We don’t use dressings very well
- We use a lot of them in weird combinations
- We don’t stick with any specific product very long, and…
- We don’t even attempt to determine whether the dressings support the claims made about them (assuming we could figure that out given the way we use them).
We do spend a lot of money on dressings, and no one seems very interested in what we get for the money except the manufacturers themselves. And maybe the European Union.
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/channel/UCbxBv_PCAYkbUCvnCjTzW0A/videos