I’ll respectfully bow out on debates over those first two questions. My answer to that third query is yet another, larger question: How can we hold hospitals accountable without comprehensive criteria established by a major regulatory agency to determine what qualifies as a clean instrument?
As a professional in the medical device development industry, that last issue keeps me up later at night than the fear of virulent new bacteria lurking in hospital halls. So, I take great comfort in the fact that my colleague Don Tumminelli is working on changing that. As senior technical manager of Client Services for HIGHPOWER Validation Testing & Lab Services, Tumminelli is part of a core group of professionals working on standards that will eventually be blessed by the U.S. Food and Drug Administration (FDA) and the Association for Advancement of Medical Instrumentation (AAMI).
“Cleaning is huge right now,” he said. “Here at HIGHPOWER, we sit on about 20 different committees for standards, so we help develop them and get the right validation methods in there. It’s been many years in the making. We’ve been talking about this for at least five years, probably longer.”
Sterilization standards have been well vetted and set since about 2005. Low-temperature and steam sterilization processes have proven their effectiveness and manufacturers, designers, and device developers all know what markers of accountability they’re held to.
“There are parameters that you need to claim,” Tumminelli said. “The FDA now has what they consider to be traditional sterilization cycles. So everyone knows what they’re working toward.”
But errors occur even with those relatively new sterilization standards. Tumminelli has seen some clients default to instructions for a similar device rather than developing processes specific to their new project.
“I think some people, one of the biggest mistakes they make, they will go back and look at a competitor’s instructions and cut and paste,” he said. “A lot of these competitors’ products have been around 20 to 30 years, so just copying and pasting what they did years ago doesn’t work. There used to be no sterilization standards, so (that older device) might’ve been grandfathered in.”
When it comes to cleaning standards, Tumminelli and his crew are starting from scratch. It’s a daunting undertaking given the range of reusable devices. To put that in perspective, consider how many devices a single hospital might reuse—instruments, scopes, storage, among many others. Each item likely has separate and differing requirements for cleaning, he said.
“If you’re a hospital and you have 1,000 different surgical devices and each surgical device has a different set of cleaning instructions, logistically, you can imagine what goes into that,” he said. “It’s like washing dishes—you have 20 plates, 20 pieces of silverware, and each piece of silverware has to be washed differently.”
So, Tumminelli and his colleagues are working closely with the AAMI to come up with standards that will work for a very broad user base.
“It’s been the wild, wild west of cleaning,” he said. “We just started the process. It’s at least a year out. When that’s done, it will allow everyone to be on the same page when it comes to evaluating your device for cleaning.”
Though we appreciate that sterilization and validation standards are already in place, that can essentially create a false sense of security, he explained. Yes, you can sterilize instruments to those standards, but without a baseline for cleanliness, it raises questions about how safe the instrument or reusable device actually is. How does it affect patient health if a device or instrument is sterilized, but debris remains?
“Nobody really knew where to start—there was a lot of fear and confusion out there,” Tumminelli said. “Because there are so many different types of devices on the market, some do require different ways to clean.”
Simpler pieces can be cleaned fairly easily, but more complex devices pose greater challenges, he said.
“You get these really complicated things like a colonoscope,” Tumminelli said. “These things will have multiple channels that are a millimeter in diameter and six, seven feet long with biopsy ports. If you leave debris in the channel, sterilization won’t do its job.”
Tumminelli has seen that first-hand in his lab, and that experience plays into the work he and his team are putting into developing cleaning standards. Each instrument or device that receives clearance to market must have a set of instructions for cleaning and sterilization. For clients, Tumminelli’s review of those instructions includes simulating the type and location of soil most likely to occur as the device is used. For items such as bronchial scopes, the test soil is mucus. For intravenous devices, it’s blood. Orthopedics are evaluated with bone chips.
“What we do is we soil the devices as clinically close as possible,” he said. “Once we soil the device the way it’s used clinically, then we have to clean it. We clean it with those factory instructions. When we’re done cleaning it, then we extract the device and we look for residual soil.”
The acceptable level of residual soil varies with the instrument and use, he said, so it’s a painstaking process to establish criteria that will apply to the industry as a whole, perhaps even more so than when sterilization standards were established.
“We’re working to bring order,” Tumminelli said. “Manufacturers are confused—there’s not a lot of guidance out there. It’s more of a learned thing. We’re just trying to get everyone on the same page.”
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.