What Happened to the Reprocessing of Single-Use Devices?—ThrowbackThursday

The journey continues with a brief stint over to my Editor’s Letter on Surgical Products (SP) magazine, a role that lasted almost two years. August 2000 marked the start of my editor-in-chief duties for SP alongside my established responsibilities on Medical Design Technology (MDT). So for the next several versions of this article (you can catch up on any of them by clicking here), I will go back and forth between Letters from both magazines.
 
My first Letter in SP was merely an introduction of myself, the obligations I had with MDT, and how there might be synergies realized from covering both the development and manufacture of medical devices as well as new surgical technologies that were available to surgeons and other staff using them. Information from one of the magazines may be relevant to the audience of the other magazine. It was a reasonable theory, but in reality, over the course of the almost two years I served in both roles, I don’t recall there being much information relevant enough that I felt the need to pass it along to the other brand’s audience.
 
On a personal note, that first Letter in SP was also where I announced the birth of my first child Sydney. I wrote about how my life changed in that instant and I couldn’t have been more correct.
 
For the sake of this entry, however, I elected not to share that Letter in full as the recap I just provided was all that was needed. No reason to see it spelled out in long form. Similarly, I’m also skipping my August 2000 Letter from MDT, which shared information about its redesigned website and the new features it provided. Nothing of any great interest there.
 
That brings me to the Letter I am focusing on—Sterilization Issues Concern Everyone—which was from SP’s September 2000 issue.
 
In each issue of Medical Design Technology, we run a column written by the founder of the Biomedical Market Newsletter, David G. Anast, updating readers on important issues in the medical marketplace. This month’s column was particularly disturbing and relevant to the readers of Surgical Products as well, so I thought you would be interested in hearing a synopsis.
 
Didn’t I just mention how over the course of two years on SP, I didn’t see much opportunity to share information across the brands? Clearly, my memory is not all that good of how much crossover there was. Hopefully, I continue to be wrong and more examples emerge as it is likely more relevant to this current audience.
 
Allegedly, an incident with failing sterilizers at a hospital in California resulted in at least 30 patients being exposed to a fair amount of bacteria. The hospital’s autoclave sterilization equipment is believed to have been faulty for approximately three months and had repeatedly failed bacteria tests. Further, even though the staff was aware of the problem, they failed to fix or replace the units and also failed to make surgeons utilizing the possibly unsterilized instruments aware of the problem.
 
Frankly, this is a nightmare. And it’s hardly the only time it has occurred. While I couldn’t find a link to the hospital involved in the original story, I did find another incident involving a healthcare center in Detroit as well as one for Chicago. Further, this was after a very simple search. Had I dug deeper, I would likely have found many more similar stories.
 
The fact staff was aware of the issue and failed to report it is horrific. This isn’t a case of reprocessed duodenoscopes where danger was “hidden” in the nooks and crannies of the devices. This was a clear and identified problem that wasn’t brought to the attention of the right people (or, if it was, they ignored it).
 
Mr. Anast also points out that several days following the announcement of the findings by a newspaper report, the FDA issued final guidance on the controversial practice of reusing single-use medical devices and instrumentation. Was this simply a coincidence or an attempt to cover such findings in the future? I don’t think one will be able to ever discover which is the case.
 
And here’s where we get into the interest area for device makers. This practice—reprocessing single-use devices—was a cost-saving measure that had no business taking place. Healthcare facilities were sticking devices intended for one-time use into sterilizers and then using them again. This clearly went against the instructions-for-use and still likely put many manufacturers in the line of sight of liability lawsuits regardless.
 
Another odd aspect of this case that Mr. Anast points out is the fact that following the report of the sterilization findings, the hospital took out a full-page advertisement in the same newspaper that published the article, announcing the fact that they received JCAHO (Joint Commission on Accreditation of Healthcare Organizations) quality accreditation. The surprising aspect is that this ad was run AFTER the sterilization catastrophe was made public. Which is more troublesome: the fact that this ad ran after the findings came out or that this hospital was ranked in the top 39% nationwide by JCAHO?
 
CYA at its finest, I suspect. “Hey, this independent organization said we were an excellent hospital and healthcare facility. Therefore, disregard anything you hear that speaks to the contrary.” Perhaps not, but seems certainly like the hospital was doing what it could to cover for themselves to show they weren’t the only ones who thought they were doing a great job.
 
While the fact of the matter is that a majority of the “sterilized” surgical instruments were not necessarily single-use products but rather the result of opened but unused packages, there was still a percentage of single-use products that had been supposedly sterilized for reuse. This does bring to the forefront one of the major concerns against reusing single-use instruments. While the hospital can save as much as 50% per unit by reusing these single-use devices following sterilization, is it really worth it when a patient’s health becomes at risk or at the expense of a possible lawsuit against a hospital for a similar occurrence to what happened in California?
 
For me, the clear answer to that question is no. Obviously, others don’t see it as black and white as me. While I can understand the sterilizing of devices that went unused but where the packaging was simply opened, if they are single-use devices, are they OK to be sterilized with the method the healthcare facility is using? Can the material be safely sterilized with steam if it was never intended to be sterilized at all? Does the hospital even know?
 
Fortunately, the FDA responded to this practice with guidance. In 2000, the agency issued guidance on “the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors.” Oddly, it seems the original information has been removed from the site. I’m not sure if it was repackaged in other guidance, but I did find a number of links that help tell the story. The FDA itself even used the Wayback Machine to provide some previous information.
 
In addition, the following is available from the agency on their actual website:
 
An FAQ on the practice of reusing and reprocessing single-use devices (2001)
A second FAQ with “three additional questions” (2003)
 
Then, in January 2008, the Government Accountability Office issued a report on “Reprocessed Single-Use Medical Devices.” Essentially, the findings were that the practice in 2007 did not represent an elevated health risk. The report noted the practice was believed to be much more widespread in 2000, but with additional FDA oversight and the passage of laws, the practice was greatly reduced.
 
In the Results in Brief section, the report stated, “According to FDA officials, as of July 2007, 11 establishments reported they were planning to market or actively marketing more than 100 types of reprocessed SUDs in the United States. The types of reprocessed SUDs ranged from compression sleeves used externally to maintain circulation during and after surgery to invasive devices used to lift and stabilize the heart during open-heart surgery. In terms of relative volume among the reprocessing establishments, 3 of the establishments account for about 90 percent of the SUD reprocessing business, according to AMDR [Association of Medical Device Reprocessors].”
 
There is no question that medical costs are consistently spiraling upwards and the practice of reuse is simply a method with which to attempt to combat it, however, when we are speaking about it being at the expense of a person’s health or possibly even their life, then we need to reevaluate the procedure. If the FDA has issued regulations regarding reuse, these instructions must be followed to the letter or we may have more instances like this one.
 
And apparently, those guidances seemingly eliminated the practice. I don’t hear about this occurring today, but greatly encourage anyone who has any information on this practice taking place to reach out and let me know about it.