EXECUTIVE SUMMARY

Surgery centers can improve safety by prioritizing efforts to reduce some of the more common and troublesome hazards.

  • Surgical staplers and inadequate cleaning of reusable instruments are some of the more common hazards.
  • Centers also could have safety problems caused by their failure to update equipment software.
  • There’s a less well-known problem with some cleaning agents causing equipment to degrade and crack.

With the ringing in of the New Year, many surgery centers will resolve to improve safety and enhance hazard and infection prevention efforts. They can prioritize their initiatives by looking to the past: What were the big problems last year and how can surgery sites prevent these from recurring?

For example, inadequate cleaning of reusable instruments and surgical stapler misuse were some of the more predictable health technology challenges outlined in the latest report by ECRI Institute and Health Devices.1

But there also are some unexpected hazards, including surgery centers failing to update software and using the wrong cleaning product with certain plastic devices. (For more information, see top 10 hazards list in this issue.)

“One of the things that struck me with the topics on this year’s list — more than in some other years — is these topics show that while doctors and nurses play an important role in the care of a patient, so do the people who help manage healthcare technologies,” says Rob Schluth, senior project officer at ECRI Institute’s Health Devices Group in Plymouth Meeting, PA.

“The people involved in purchasing or installing or servicing or cleaning medical devices need to be thought of as members of the care team because they have an impact on how well the patient will be handled within the hospital environment,” Schluth says.

Staff education is very important to preventing hazards, he notes.

For example, it’s difficult to clean certain instruments such as duodenoscopes, says Chris Lavanchy, engineering director of the ECRI Health Devices Group.

“When they’re not designed to be effectively cleaned, this presents a problem,” Lavanchy says. “What we’re trying to do is ask what steps you can take to assure instruments are properly being cleaned after each use.”

Lavanchy and Schluth describe the challenges surgery centers face with some of the top health technology hazards, including the following:

Inadequate cleaning of complex reusable instruments. Complex instruments, such as cannulated drills and endoscopes, have various features that are difficult to access for cleaning, Lavanchy says.

“They’re likely to be more prone to this issue of inadequate cleaning,” he says.

Hospitals sometimes seek professional help in resolving the problem, Schluth says. “The issue of reprocessing medical equipment has come up a number of times, and we’ve done investigations about it for medical facilities.”

Inadequate cleaning of instruments is a perennial issue, and it has been known to lead to infections, such as the well-publicized carbapenem-resistant Enterobacteriaceae (CRE) infections, Lavanchy says.2

The report cites outbreaks associated with the use of contaminated duodenoscopes as one example of the problem. Other instruments, including endoscopes, cannulated drills, and arthroscopic shavers, also are difficult to clean, disinfect, and sterilize between uses.1

“We get reports of failed reprocessing on a fairly regular basis from hospitals,” he says. “Once you start digging down, you often find that instruments are of more complex design and the degree of cleaning is not adequate, so that’s what brought it to this year’s top 10 hazards.”

Both visual inspections and manual cleaning of such instruments are big challenges.

“The problem is in reprocessing them because they have features and mechanisms that are extremely difficult to visualize and inspect,” Lavanchy explains. “They’re tiny and difficult to clean.”

The prime solution is education, Schluth suggests.

“You need cooperation between different members of facilities,” he says. “So when cleaning complex instruments and reprocessing, part needs to be done by clinical staff and part by reprocessing staff in another location.”

When both groups understand what the other group is doing and what each group’s pressures are, it can lead to better understanding, cooperation, and more effective performance, Schluth adds.

Software management gaps put patients and data at risk. “So many medical devices these days are software-driven,” Schluth says. “Just like a laptop at home, these may need updates that the manufacturer puts out to improve functionality.”

Medical device manufacturers might issue updates to correct issues related to patient harm, and surgery centers’ patients could be at risk of harm if the center doesn’t install appropriate updates.

“Medical facilities need to know these updates exist, or that there’s a recall out there or some kind of safety problem,” Schluth says. “The problem may be specific to a software version, so the question is, ‘Can I easily find out what software is running on the equipment?’”

Healthcare facilities should have answers to that question in an inventory database, he adds. “Different facilities do things in different ways; it’s important to make sure you have a process for managing that kind of information.”

Software that is out of date can cause unanticipated downtime in medical devices and raise safety concerns. Mismanagement of these updates also can increase cybersecurity vulnerabilities.1

Another issue to consider is whether the software is operating on a network, Lavanchy says.

“Any facility that has an electronic medical record [EMR] might use that device to automatically forward data into the EMR, so when there’s a problem with the device or its software, it could have a ripple effect,” Lavanchy explains. “So facilities need good control of software and to manage it appropriately and make it secure.”

Recent headlines have brought attention to cybersecurity breaches in household devices, a problem that highlights the potential harm of someone hacking into a medical device.

“We don’t know of any hacking instances, but it’s more than a theoretical problem now,” Lavanchy says. “With the amount of cybercrime that goes on and with hacking, it’s inevitable that we’ll see an event of this sort.”

Surgical stapler misuse and malfunctions. “This is the kind of issue we consistently receive reports about, and we’ve investigated a number of issues where patient care was affected,” Schluth says. “Surgical staplers require meticulous technique to operate, and it’s not uncommon to have problems.”

For instance, there are FDA reports that 8,000-9,000 adverse events related to staplers are filed each year, Schluth says.

Surgical stapler problems can include intraoperative hemorrhaging, tissue damage, unexpected postoperative bleeding, failed anastomoses, and other harm.1

Surgical staplers typically are used for minimally invasive procedures, so surgeons do not have direct visual access and might be working somewhat blindly, Lavanchy says.

“The surgeon has the camera and views the operative field, but it’s more difficult to have the same visual context, and that’s one of the challenges,” he says. “The other thing is that these staplers are, in general, tricky to use.”

For instance, one common mistake is that the surgeon grabs too much tissue and the staple will not form properly, Lavanchy says.

“It’s like if you are stapling paper and have too many papers — it won’t go through,” he says. “So surgeons may think they’ve stapled the tissue and closed up the patient, but later realize they have not adequately closed off the tissue.”

Surgical stapler problems are reported regularly.

“We have investigated fatalities and other harm that has occurred because of the misuse of staplers,” Schluth explains. “It’s not common to have such severe harm, but incidents do occur.”

A stapler that is directed to the wrong place could harm a patient’s body. Also, a staple line that does not fully close the gap between patient tissues can lead to internal bleeding, Schluth says.

Device failures caused by cleaning products and practices. A new topic on the hazard list, this refers to a particularly tricky and perilous risk: equipment weakened by particular cleaning agents.

“This is the type of thing that doesn’t come to the front of mind, but it can have a significant effect on how technology is used, patient safety, and cost in a healthcare facility,” Schluth says. “This gets into the issue of cleaning wipes used to clean off the surface of medical devices.”

There have been incidents in which hospitals have problems with devices breaking down. Investigations would find that the cleaning process caused the problems. “Cleaning wipes degraded plastic components of the product, leading to cracking that may not be visible to the naked eye, but which weakened the device to where it failed,” Schluth explains.

The most common event is when the cleaning agent is incompatible with plastic on certain devices, Lavanchy says.

For example, an infusion pump could work with some cleaning agents and not with others. Manufacturers might list which agents work well, but a surgery center could own standardized cleaning agents for the sake of efficiency and cost.

“A lot of different chemical agents are used in cleaning products and some might not be compatible with different plastics,” Schluth says. “There is no one cleaning product that is compatible with all devices within a healthcare facility, so it’s tricky to find out which ones are compatible and get that information to the facility.”

This type of problem can be difficult to identify and expensive to solve. A surgery center might not even realize there’s a problem until after several months of the plastic breaking down and creating risk, Lavanchy notes.

“You may wipe the infusion pump every day for three or four months, and then all of a sudden you notice a piece of it is cracking and you don’t know why,” he says. “If damage is being done and is not visible, it may be a while before someone determines something is wrong with it, and, meantime, patient safety may be at risk.”

REFERENCES

  1. Executive Brief: Top 10 Health Technology Hazards for 2017. A report from Health Devices/ECRI Institute; November 2016.
  2. O’Horo JC, Farrell A, Sohail MR, et al. Carbapenem-resistant Enterobacteriaceae and endoscopy: An evolving threat. Am J Infect Contro 2016;44:1032-1036.