September 7, 2022

Tools that break during surgery can lead to significant patient harm.

Surgical instruments that are of poor quality or improperly maintained can fail during procedures, an alarming occurrence that jeopardizes outcomes and the well-being of patients, according to research published in the Cureus Journal of Medical Science.

The study analyzed 161 patient safety incidents involving broken surgical tools that occurred between August 2004 and December 2010. Burrs, retractors, snares, clamps, suction catheters and saws were among the most frequently broken items recorded in the database.

Of the 161 incidents, metal was left in 77 patients. Broken fragments were removed in only 57 cases, and 27 reports did not state whether instrument pieces had been removed. Among the incidents, five resulted in reoperations to remove device fragments, six caused moderate patient harm, 35 caused low harm and 119 resulted in no harm.

Surgeons and surgical teams assume instruments purchased from reputable suppliers will perform to the highest standard, but tools sometimes don't live up to those expectations. "Poor-quality instruments fail and break and, when used in an operation, the consequences to the patient can be disastrous," write the researchers, who note the FDA published an alert about 1,000 incidents of retained pieces of broken instruments occurring annually that led to tissue reactions, infections, disability and even death.

"The results of our report are likely to only be the tip of the iceberg," say the researchers. "Poor reporting of patient safety incidents means there may be as many as 1,500 incidents a year of poor-quality surgical instruments causing harm."

Moving sterile processing offsite can help facilities gain space to boost patient volume or introduce new service lines.

As more procedures move to the outpatient setting, concerns over the instrument care necessary to keep case volumes running smoothly and efficiently is causing many facility leaders to look for outside-the-box solutions to the logistical problems inherent in sterile processing — or more accurately, outside-the-facility solutions.

Offsite and third-party instrument care facilities are gaining traction throughout the country, and even more ASCs and HOPDs are expected to give the concept a try in the near future. Why are more facilities choosing to outsource or create their own offsite location for their sterile processing and instrument maintenance needs rather than keeping the service line in-house where it traditionally resides?

One huge benefit is the extra space offsite reprocessing provides. Penn Medicine in Philadelphia provides an eye-opening example. It recently opened the Interventional Support Center (ISC), one of the largest instrument reprocessing facilities in the country, with 80 reprocessing techs working in a 110,000-square-foot space to sterilize thousands of instruments each day. Back at the hospital, there is now more space to expand clinical services. "Sending instruments to a centralized facility provides the breathing room hospital departments need to expand their services," says Chris Pastore, managing director of the ISC.

Most facilities, particularly smaller freestanding ASCs, don't have the resources to create a top-of-the-line, offsite sterile processing facility of their own. To serve smaller centers, third-party vendors offer offsite reprocessing options. For example, OrthoIllinois Surgery Center in Rockford, Ill., recently partnered with an offsite reprocessing service and, as a direct result of the move, the ortho center increased its surgical capacity and reduced instrument backlogs for total joint replacements. "We had reached capacity in our sterile processing department and needed to get creative if we were going to process instrument trays quickly enough to accommodate more cases," says Leanne Brennan, the center's business manager.

Facilities that are interested in such an arrangement should first perform a thorough analysis of the pros and cons, as well as confirm that any third-party vendor they use is also capable of handling the regular maintenance and repair services of the instruments it reprocesses.

A PM program can identify instrument issues before they affect patient care and outcomes.

Preventive maintenance on KARL STORZ rigid endoscope.

The cost of healthcare has skyrocketed in the past decade and is increased by each surgical case that has an adverse outcome because of a broken, non-functioning or dirty instrument. The National Center for Biotechnology Information reports, "There may be as many as 1,500 incidents a year of poor-quality surgical instruments causing harm."¹ In 2008, the FDA published an alert that stated, "Nearly 1,000 incidents of retained pieces of broken instruments (unretrieved device fragments) occur each year, leading to a range of problems including local tissue reactions, infections, disability, and even death."²

Maintaining your instruments is critical for the safety of your patients and staff and should be a regular part of your workflow. Medical equipment maintenance is a set of activities conducted to keep a medical device in good working condition. It consists of inspection, preventative maintenance and corrective maintenance and involves regular routine testing, calibrating and adjusting of equipment. These activities help identify wear and tear and eventually may lead to replacement of components or the product to avoid breakdown.

Surgical Services typically account for 40% of a hospital's operating expenses and generate about 70% of its revenue.³ A significant portion of an operating room budget is allocated to cleaning, maintaining and repairing surgical instruments. To keep ORs running efficiently, it is important to have a plan for ensuring that all surgical instrumentation is functioning safely and effectively and is procedure-ready.

There are direct and in-direct costs associated with instrument maintenance. Not having functioning equipment ready for surgical procedures can result in delayed starts and cancellations, thus directly affecting costs. Indirectly, using non-functioning, broken or improperly cleaned instruments can lead to surgical site infections and other adverse patient events. Patient safety is the priority and removing these risks and costs must also be a primary goal.

A Preventive Maintenance (PM) program can identify instrument issues before they affect patient care and outcomes. Functionality of surgical instruments is a critical factor in ensuring the highest standards and best patient outcomes. By establishing a comprehensive, thorough PM routine, a hospital or outpatient surgery center can mitigate much of the risk of adverse events related to broken devices or retained bioburden. Additionally, such a program will increase the lifespan of the instrumentation, lead to a higher level of surgeon and staff satisfaction and eliminate costly weekly visits from the instrument repair company.

KARL STORZ recognizes that your staff is caring for patients in a new and increasingly challenging environment. Let us lift your team by doing the heavy lifting in managing your equipment needs. Our On-Site Endoscopic Specialist (OES) is a dedicated, full-time resource to your team, providing daily face-to-face support in the perioperative space. The OES keeps your equipment functioning like new and provides expert troubleshooting, education and problem prevention.

Our OES program helps you ensure safety and compliance with the support of full-time subject matter experts, save time with right and ready equipment for your MIS procedures, and save dollars by maximizing the life of your equipment and minimizing repairs. Overall, you will increase the satisfaction of your clinicians and staff as they focus on patient care. The On-Site Endoscopic Specialist program has been shown to have significant clinical, operational and financial benefits such as increased overall satisfaction, decreased downtime and reduced costs.

References:

1. Dominguez E, Rocos B. Patient safety incidents caused by poor quality surgical instruments. Cureus 2019 11(6): e4877. doi:10.7759/cureus.4877

2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6687421/

3. Open Anesthesia. OR Costs: Labor vs Materials, Open Anesthesia. https://www.openanesthesia.org/or_costs_labor_vs_materials

For more information please go to: https://www.karlstorznetwork1.com/flexpaper/stayready