A bit of a problem in surgery

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Medical administration is a rewarding profession, but it comes with challenges. So what is it like and what should you do if confronted with a monumental administrative difficulty? This is the podcast that takes unfortunate scenarios and explores the essentials of clinical governance to find solutions. I'm Dr. David Rankin. A very experienced medical administrator and lead fellow with the Royal Australasian College of Medical Administrators. And this is Safeguarding. The essentials of clearing.

Today, a bit of a problem in surgery. I think there are obvious medico-legal issues with this. That's Dr. Brett Gardner, the project director, Medical Work for Strategy and Planning with Western Sydney Local Health District. He has over 30 years experience as a medical administrator and I'm presenting him with a difficult scenario. The surgeon has a responsibility ultimately for

the care of the patient. In today's scenario, during an operation on a knee, the drill begins to shake and then stops working. When the surgeon withdraws the drill from the bone, it appears the end has broken off. An X-ray confirms that the tip of the drill has broken and is now sitting deep in the bone. The surgeon believes it will be very challenging to remove the broken drill bit and that it will be fine to leave it in place as the risk of infection is extremely low.

However, it may make the knee ache when it is very cold and cause arthritis later in life. There is a possibility that the metal will set off the airport security scanner whenever the patient travels.

I started by asking Brett what big issues are raised by this scenario. There's a number of issues. I think primarily this is a patient safety issue. This is both the organisational level and also for individuals within that organisation. I think there are obvious medico legal issues with this. who is responsible for this, what the reporting aspects of this are both initially and into the system, and also what can be done to prevent these sort of events into the future.

So there's many different aspects to this, also including whether the organization's a public or a private organization. So who's responsible for maintaining the equipment used in the hospital? We've got a number of scenarios. The the equipment might be leased, it might be owned, it might be borrowed. might be part of a prosthesis set that comes in a suitcase just for that procedure. So who who's responsible for making sure the equipment is maintained?

The major responsibility here is on the organization and also on the people who manage and run the theatre itself. So, you know, from an overall organizational point of view, It's important to have all the policies, procedures, accreditation, making sure we have systems to make sure the people are educated and trained that we do have the appropriate incident management systems and staff.

But at the whole face to make sure the theatres are safe, this responsibility is that of the theatre manager, the various people who maintain or clean or order the particular instruments. and also the, you know, people there, you know, attending a theatre on that event. There's also a number of things with this that could be important, including who's taken consent. It's always a complicated matter of different things that come together to say who is responsible.

The surgeon's the one that had it in their hand at the time up the drill broke. How much responsibility is it of the surgeons versus the hospital and the theatre staff?

Yes, well the surgeon does have a number of responsibilities. Often the surgeon will assume or understand or rely on the staff to make sure that the equipment is in working order.

is available, has been managed to instructions. But the surgeon has a responsibility ultimately for the care of the patient and, you know, there are various safeguards that the surgeon needs to do with this, including you know, there are specific timeouts that are put into place or safety checklists that prior to operating the surgeon certainly needs to be assured that the equipment is safe. There are a number of other safeguards that could be put into place with this.

make sure that the drill bit is attached to the drill. It's the right whether or not it's a single use or multiple use. actually running the drill to see if it wobbles all that beforehand. Certainly the surgeons also got responsibility that there has been issues before with any pieces of equipment or problems of that type. They certainly need to make sure that those are appropriately documented and escalated to reduce further problems.

So certainly the surgeon's got responsibility for the safety of the patient there. The surgeon does need to go through a checklist and assure themselves that things are right for them to proceed. Surgery doesn't always go the way it's expected, and sometimes surgeons do some unusual things with the tools that they have at hand. Does it make a difference if the surgeon's been using the drill in a way that it wasn't manufactured to be used?

each individual has a duty of care and part of that extends to using the equipment in the way that it was actually intended to be used. Each of the manufacturers do actually have a whole lot of standards and guidelines. There are policies and procedures to make sure that the appropriate setup is done and on each occasion that patient's going to be operated upon. If the surgeon isn't using the equipment in the way that it was intended to do.

It's also incumbent on other members of that operating theatre staff to actually identify and notify that. Some of these pieces of equipment can be really quite complicated and The surgeon or the people in the theater may not have the competence to determine whether or not the equipment's back and functioning properly. How do you go about making sure that the equipment is functioning properly before you reintroduce it into theatre again.

Yes. That is certainly a responsibility of the organisation, which is vested in a range of individuals. Look, there are a number of things the organisation needs to do. One is to make sure that all the equipment that is being used is TGA approved. That's number one. There are certainly instances where we know that people have brought equipment hint theatres that hasn't gone through the right channels. Second there's the whole credentialing side of things in terms of the individual surgeons.

Certainly all the equipment if we're going through a hospital system that there may well be a statewide purchasing list which actually has number of items of equipment. I think the biggest issues that we do have is when we're looking at doing if you like, low volume of orthopaedic surgery in a particular facility. There obviously if if the team is only doing some orthopedics once a week or something like that.

That's from an overall prevention point of view and and training point of view and knowing how to use the equipment, that is not the best scenario at all. you're better off in a high volume environment where the staff are actually familiar with the various pieces of equipment. I should say also that standardization of the equipment is quite important in terms of not necessarily offering too many choices. We do know that one way or the other surgeons have their

Preferences for particular pieces of equipment. This probably happens a bit more in the uh private sector with people's particular cards. to in the public sector we try to standardise things a little bit more in terms of not having as wider range of equipment.

to actually utilise the loan equipment is always an issue as well with this in terms of you can have a number of different loan kits that are actually provided That raises a whole new area, and that's the tinkerer surgeon, who bends equipment in a special way so that he can get into different cavities or at the extreme prints up something on a three D printer at home and brings it in so that he can use it in his procedures.

How does a hospital go about making sure that these tinkerer surgeons are providing safe care? Yes. Unfortunately there are a few tinker resurgents that we've experienced at different different times. And people do things for what they consider unnecessarily some of the right reasons, but It's incumbent on the hospital to know what we are actually using and what the surgeon and the team are doing.

You know, we do go into credentialing individual surgeons. We do have now a lot better scope of practice definitions in terms of what we allow individuals to actually do or not do. These things are also site specific in terms of whether, you know, even though somebody's got the skill, whether they can be done in a a small facility, say, versus a larger facility, because the team and the backup is is quite important.

When it comes to special skills or new equipment and so forth, we go through other processes in terms of making sure that we evaluate the safety, the efficacy of the equipment, the training of the individuals, whether we need further training or or proctors to help get things up to speed. who we need to train and how much of that extends to not just the individual surgeon but the wider team if we're doing, you know, some new innovative things.

The responsibility then also lies on the theatre staff, not just the nursing staff, it could be the anaesthetist or anybody in that. I think you t do be able to raise issues and sometimes people do have issues in raising issues, but this gets down to not just the processes there but also the culture within that operating theatre team and being able to

yeah, escalate if there's any issues. Yeah, we also have formal uh ways of doing things through incident reporting systems and being able to oversee that we are actually recording what is happening. Yeah, for instance in this case scenario we've got a drill that appears to be malfunctioning. It's actually important if that has happened before or not.

and what has been escalated documented and you know what work has actually been done. Also with any of these it's also we need to have actual formal maintenance schedules of things into life of equipment and so on. So it's quite a big business. in our theatres and everybody's got a lot of responsibility here in terms of m making sure things are safe for the patient undergoing the procedure. Yeah.

Let's turn to the patient and a piece of equipment has been unintentionally left in the patient's knee. Is this harm? And how would you classify this incident in a reporting structure? Yes. As far as harm is concerned, and it does get down to how we actually define harm, we do know that there are a number of retained products such as sponges and the like, you know, which are serious incidences that can cause problems into the future. The drill bits and it's not necessarily an uncommon

problem with some retention of drill bits. I think some studies have shown that the rate is about point three percent. Now these retained drill bits don't always cause any harm at all. And harm can be defined as either physical and also psychological harm to the individual if we're going down a legal process into the future.

In this scenario we do have a case whereby we knew at the time there was a drill bit actually left in the patient. Sometimes we don't know if there's a bit retained. It gets down to where it is and when we look at this, what is the foreseeable harm that could be possibly incurred by this patient.

They might have some ache in the knee in the future or possible low risk of infection and problems when going through, you know, airport's uh security thing and going off and people can react in that in different ways. So in itself at the time this isn't going to be serious harm. It is certainly something that can be foreseeable. And if the situation is such that the surgeon

cannot safely or unable to remove the broken drill bit and decides to leave it there. Certainly the all the circumstances will need to be recorded in the notes and the patient informs. people would argue about how foreseeable this is in terms of a serious harm to that individual patient. How much do you tell the patient? Look, this would require an open disclosure to the patient. The patient needs to know.

that a drill bit has been left in their body, you have to tell the patient what has occurred. In general circumstances under an initial open disclosure, you would tell the person this is what has occurred, you've got a broken drill bit and we're doing a formal investigation into what has occurred and we will meet with you again after we've done that investigation.

So tell us about the investigation that you'd undertake. What happened? Why? Was it preventable? What sort of investigation are you going to run? Well the investigation would consider a number of factors. So I would get a group together to actually get the facts of the situation. So you would assemble a team, an incident report would be done, you would take things into consideration and it may well be a SAC two or significant incident to investigate.

Particularly if we're looking at a faulty drill because what we'd have to do is to go through and see how that actually came into the theatre in the first place to look at responsibilities and to look at how we can actually mitigate this into the future. So an investigation would do that. through the jurisdictional incident management processes.

we would do this under a recourse analysis side of things. That would be my recommendation with this because there's there's a number of things that we do need to keep confidential and private in terms of our discussions with people. I would get independent people on that investigation team. and take it from there essentially. Would you follow the patient up? I mean, worst case scenario is the piece of metal migrates out and gets into the joint and causes quite significant disruption and harm.

So would you contact the patient every six months just to check how they were going, or would you wait for them to call you? No, what I would do would be after we've done the investigation, I'd certainly meet with the patient and their family at that time to go through the results of their investigation. A lot of people would like to see that this incident isn't going to happen to anybody else.

I think the other thing is that this would be certainly something we'd notify in our insurers about. We would also make sure we'd ensure that the medical doctor involved would also notify uh their insurers because If we're looking at future harm we would be looking at apportionment of the responsibilities with this But in terms of the patient.

if there's likely to be no problem for a long period of time what we would do would be to say and they may not have any problems in six months time when we do this at all. So what we'd do would be to you know, perhaps have a contact number for them to actually be able to get in touch with us. But it's always a balance here about what does the patient want to do. So Yeah, they can always go through other mechanisms, through healthcare complaints, or go through a legal process themselves.

Now if the person does have something we can potentially do, like some psychological issues. it may well be prudent for us to provide some psychological counselling and support to actually help that person through what has actually happened. But each of the circumstances are individual here and all you can do is make sure you follow up the patient after the investigation.

see where they're at, see what they need, see if they've got harm at that time or what support they need and you know, provide an avenue for recontact in the future as necessary.

Thanks, Ben. That's been a Great discussion. Any final thoughts on this scenario and how you would manage it as a medical administrator? Yeah, well I think anytime these things happen, y you always swallow and think, uh, gee what's happening here.

Because I think oftentimes it's always a reminder to be quite proactive to look at what your systems and processes are and this is multi level right across the organization and you know there are standard basic things that are always essential that you need to do in terms of your Processes, policies, guidelines, training support, your escalation procedures, your incident management systems.

And you need to make sure that any of the standard reporting that you have is actually operational and functional, that these things are actually being escalated and identified and looked at in terms of an organizational risk. And I think the other thing of course is the culture of the organisation in terms of the reporting structures, how the operating theaters are going and what's happening with you know individual people within that. So it's always a dynamic situation.

And as a medical administrator you gauge the pulse of the organization or you gauge the processes. through multiple mechanisms, your formal mechanisms, your medical staff council, your theatre meetings. in the one off discussions with various people and, you know, your senior people in the organisation and what the importance it is to maintain the health and maintain the safety of the community because ultimately

people come into hospital expecting to receive safe care. That is one of our major responsibilities and we must never forget that and should always strive to have that as our number one thing that we do. A real challenge, particularly in a modern hospital that can have thousands of pieces of equipment all needing to be maintained. Some of them may not be used very frequently and increases the risk. So yeah, a real important call out.

that we need to be on top of our preventative maintenance, particularly in patient care related equipment. Thanks very much, Britt, for a great discussion on an unfortunate outcome. Thanks very much, David. That was doctor Brett Gardner, the Project Director Medical Workforce Strauss. and planning with the Western Sydney Local Health District. And that brings us to the end of this episode of Safeguarding Home. Kier, I'm Dr. David Rainkin.

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