The surgeon, the scrub nurse and the product assistant. Who’s that third party in the operating theatre?
Who knew the operating theatre can be a hi-tech minefield in 21st-century medicine? Here’s how your surgeon copes.
You’re out to it on the slab, ready for your hip or knee replacement, or pacemaker. You know you’re in good hands with your specialist surgeon, the anaesthetist and the nursing team. What you may not know is that there’s a non-medical person in the room – a representative of the company that makes or sells your implant. So, what on earth are they doing there?
In the past, some private health insurers have criticised the presence of product assistants, arguing they add to costs.
We sought some answers from a group of experts: leading Sydney orthopaedic surgeon Dr Michael Solomon; Dr Kerin Fielding, an orthopaedic surgeon based in Wagga Wagga and the immediate past president of the Royal Australasian College of Surgeons; Associate Professor Claudia Di Bella, orthopaedic surgeon, at St Vincent’s Hospital, Melbourne; Ian Burgess, CEO, Medical Technology Association of Australia; product specialist Bronwyn Steele, who works with surgical products wholesaler Medacta, and; spine surgeon Dr Angus Gray.
What does a product assistant do?
A product assistant is paid by the device manufacturer or distributor to provide technical advice and support to the surgeon and nursing staff during an operation involving medical devices or prostheses such as hip implants and pacemakers. They oversee the inventory of products on site and manage supplies in the lead-up to an operation. The manufacturers call them in-theatre technicians or orthopaedic medtech company representatives, and they are trained by the companies to know the details of their products. Associate Professor Claudia Di Bella says they ensure each implant is used safely and effectively. They can troubleshoot when things go wrong. Ian Burgess says the technicians are “highly trained professionals and experts in the complex technologies they support”.
Are they allowed to touch a patient?
No. They wear gowns and masks but are not part of the medical team. Sometimes they use a laser to point to a section of the patient, and they routinely hand tools and other instruments to the nursing staff. The techs work under operating theatre protocols, including those developed by the Australian College of Perioperative Nurses, and Burgess says MTAA members must complete training every two years and provide evidence of that training to the relevant hospital. They have a range of backgrounds. Product specialist Bronwyn Steele, who works with surgeon Michael Solomon, is a physiotherapist who switched jobs nine years ago. She says the job suits physios because they have a good understanding of anatomy.
Are they present in all operating theatres?
They are a regular part of most theatre teams except for very straightforward procedures using basic implants. Michael Solomon says they are not only common, but critically important. From Wagga Wagga, where she is one of 10 local orthopaedic surgeons, Kerin Fielding says: “I could not work without them.” Spine surgeon Angus Gray says his long, complicated operations almost always involve implanting “metal, titanium and chrome cobalt, and rods and screws” and there are multiple options on the “trays and trays” of material. “It’s a bit like Bunnings! There are different shelves for different instruments and tools and implants, and what I use depends on what’s before me. So screw sizes change in diameter and length, and I’ll pick one depending on the size of the bone I’m dealing with. So there’s lots of choices, and having someone in the theatre who knows the implants, knows the trays, is critical. If I’ve just asked for a five-by-35 pedicle screw with a polyaxial head, they’ll know what tray that’s in. If I didn’t have a rep in theatre, even with experienced scrub staff, it would increase the operative time, it would increase the hassle factor. It’s not safe.”
Why are they so essential?
Product specialists ensure there is always a supply of the right devices and tools on the shelves. Fielding says regional hospitals in particular do not have enough nursing or administrative staff to manage inventory. Says Solomon: “The rep makes sure that all the equipment is there, that all the implants are there. My rep comes in the day before and double-checks everything. So then on the day, it goes absolutely smoothly.”
Steele sees herself as the so-called “glue” of the team; “I make sure everything Michael needs for that operation to go perfectly is there. He doesn’t have time to think about it. So I liaise with his PAs and secretaries to get the bookings, I give the bookings to our customer service team, I liaise with the warehouse team to make sure I’ve got the right instruments for that patient on the right day at the right hospital. We need to have incredible knowledge of our products, of our instruments, how to use them, because a lot of the nurses have never seen them before. So we have to be able to communicate to the nurses how to put instruments together.”
While many private hospitals deal directly with major multinational manufacturers, others, such as those in Wagga Wagga, deal with a “middle man” – a company that sources products from different makers – and employs three local product specialists for the 10 orthopaedic surgeons in the town. Di Bella says that outside the theatre technicians help nursing staff set up complex systems, and are often involved in post-operative discussions to identify areas for technical refinement. “Their presence helps safeguard against errors, ensures smoother procedures, and ultimately supports better patient outcomes,” she says.
Are they really needed once the operation begins?
There are a variety of hip implants used by different surgeons, for example, and theatre nurses may not have up-to-date knowledge. This is particularly the case in trauma surgery. “There are lots of newer trauma products that are highly specialised in terms of the parts of the body they go into, and both the surgeon and the scrub sister need the input of the rep, who knows the product really well,” Solomon says. “They’re not guiding the operation, they’re not saying how to fix the fracture or where to make a cut, but what they’re saying is ‘here’s this piece of equipment that the surgeon has chosen to use, and this is how we assemble this piece of equipment, and this is how we assemble the tools to allow that piece of equipment to be put in’.” Burgess says that even relatively “straightforward” joint replacements can require more than 20 instrument trays, with hundreds of individual pieces tailored to the patient and procedure.
Why don’t the nurses know all this?
Shortages of skilled and experienced nursing staff can be a problem in many hospitals, and Burgess says the techs are important in a health system where there is a “significant shortage of theatre nurses”. Fielding says that in regional hospitals, many nurses are from India or The Philippines, where they see very few hip and knee replacements. Solomon says in trauma surgery the skill level of theatre staff can vary, especially after hours.
“If it’s a broken bone that just needs a plate and a couple of screws, you don’t need a product assistant because it’s very basic orthopaedics, where any scrub sister will be able to manage (to assist the surgeon),” he says. “When it’s more complicated, some nursing staff will know and others won’t.”
Di Bella says surgeons and nurses work with implants from multiple companies, each with its own design, instrumentation and specifications. “The rapid advancement and complexity of implant technology make it unrealistic – and potentially unsafe – for any one clinician to retain an in-depth understanding of every product on the market,” she says.
Are they really needed in elective surgery?
Solomon says hip replacements are now “very standard” operations for most patients. “But depending on the level of knowledge and skill that the nursing staff have, they need assistance because there’s a lot of tools that go with a hip replacement, or a knee replacement, for that matter, that prepare the bone to allow the implant to be put in,” he says.
Angus Gray says that while some operations are “quite simple” with implants “you can grab yourself or point to”, medical technology has become more complex.
“When I started spinal surgery 25 years ago, there was a couple of systems around, and you had a few choices in those trays, and there wasn’t really much to choose from,” he says. “Now there are multiple companies (producing products) and I use a number of them, and there are multiple options for each patient.”
What about the ‘troubleshooting’ role?
Even experienced surgeons can encounter unexpected issues during a procedure, and a product specialist can quickly diagnose problems related to the device. And while opening a box containing a prostheses might seem like a simple task, it’s one best handled by a company employee who unpacks according to the manufacturer’s instructions. That’s sometimes important for liability and compliance, and it reduces the risk of a nurse unpacking the wrong product that then can’t be repacked or used.
So how does it work out in practice?
Says Solomon: “The way the operation works is that for any major orthopaedic operation, like a hip or a knee or a shoulder replacement or ankle replacement, you’ve got to prepare the bone. You then put in a trial implant to make sure it’s the right fit, and then if you’re happy you say, ‘right, I’m happy with this, open box A’ … a lot of instruments are needed to prepare the bone and the instruments often have to be pointed out to some staff.” That is particularly the case now that precision robotic technology is being used in knee operations, for example. “There’s absolutely no ways you can run a robotic system and all these newer technologies without a rep around,” says Solomon. “It’s impossible.”
Surely the surgeon knows what tools are needed?
Yes, says Solomon: “I know what to do, because I’ve done it so many times, I know what equipment I need for the straightforward stuff. But I’m concentrating on the operation, I’m putting my hand out and saying, ‘okay, give me the number five broach’. Without a product specialist, I would have to stop the operation, go to the back table, pick up the number five broach – because the theatre sister doesn’t know what the number five broach looks like – and then go back to the operation.”
Some critics say the product specialists are ‘upselling’ in the theatre
“That’s ridiculous,” says Fielding, who rejects claims the product specialists encourage excessive use of products such as glue or filler. Says Solomon: “There’s a definite misconception about their presence; they are there as assistants, making sure the operation runs smoothly. If a rep’s got a new product, they’ll make a time to see me in the office or after theatre, and say, ‘look, I want to show you something’. That’s a totally different story from their presence in the operating theatre.”
Di Bella says the “in-theatre technician” has no sales role in the operating theatre: “Their presence is purely to provide technical and logistical support during surgery. In many procedures, multiple technicians from different companies may be present – each responsible for their specific implant systems. Their role is to ensure the right equipment is available, functions correctly and is used appropriately – not to influence clinical decision-making or sales outcomes.”
Burgess says: “False claims that these professionals are in theatre to ‘sell’ are disrespectful to surgeons, nurses and the technical staff themselves. Decisions about who is in an operating room and the devices used, rest exclusively with the surgeon.” Angus Gray also dismisses that claim and says: “The reps we have in theatre, they’re part of the team. It’s not like there is some blow-in trying to unload a whole bunch of implants.”
What happens without them?
A surgeon’s nightmare is to discover mid-operation that a vital piece of equipment is missing. Says Solomon: “What now? You have to actually down tools and wait until that piece of equipment turns up.” A product specialist in charge of inventory means those dramas are few and far between.
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