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KSR Publishing, Inc.
Copyright © 2008

People, Places, Processes & Products that Influence the Supply Chain

INSIDE THE CURRENT ISSUE

July 2007

Central Services

Pinpointing common problems

Virtually any surgical instrument can suffer from premature failure or chronic malfunctioning. Even so, instrument maintenance and repair experts do see their fair share of repeat offenders; that is, preventable problems that commonly crop up on certain types of devices. What follows is a brief rundown, from the vendors themselves, along with some tips for preventing the damage:

"Rongeurs continue to be an instrument that must be maintained correctly. Often, these instruments are sharpened quickly by grinding the outer surface of the cutting edge. This can create a problem in two ways: the rongeur cup size can be compromised, resulting in an incorrect instrument, and the inner track of the instrument must be cleaned, running surfaces trued and any debris removed. If not, there poses a risk of infection, improper function and decrease in instrument longevity."

--David Cabral, principal,
Five Star Surgical

"We see endoscopes with fluid invasion. In many instances, this problem can be averted by proactively leak testing the scopes, ensuring that the leak testing equipment is in good working order, and that the storage of the scopes is according to manufacturer guidelines."

--Eddie Garces, vice president,
Medical Production Repair Group,
Olympus Medical Equipment Services America Inc.

"Items that tend to pose the most problems are the bigger ticket items, such as flexible and rigid endoscopes, powered surgical instruments, laparoscopic instruments, and other expensive specialty items. The reason is that because they are so expensive facilities cannot afford to have back-up inventory, which forces items to get over-used. This causes them to break down quickly, which drives up the repair budget."

--Alex Vrancich,
general manager,
Spectrum Surgical Instruments

"[With laparoscopic instruments], insulated electrodes should be tested for insulation integrity to check for pinholes or other insulation damage that can cause serious patient burns, post-op complications and even death. Additionally, it’s extremely common for bioburden to become trapped underneath the insulation, causing rusting, pitting and patient-to-patient cross-contamination risks. This insulation should be periodically replaced and the inner instrument mechanisms cleaned and refurbished, even if no pinholes are present."

--Ann Purtell, director of business development,
Mobile Instrument Service & Repair Inc.

"There are common complaints on basic instrumentation that can be addressed through routine inspection where a trained instrument specialist tests the instruments for proper functionality. Some examples: dull scissors – tested for sharpness using material to simulate tissue; needleholders – tested for proper grip. if they do not grip firmly as designed, the inserts are replaced; missing parts, such as screws, pins, locking collars and springs; cracked instruments – often, cracks and damage can be difficult to see with the naked eye. Having a magnifying light and other specialty equipment to assist with visualization is important; lack of lubrication – this makes the instrument ‘sticky’ and not smooth-functioning; improper assembly – bookwalter retractors, sheaths, take-apart laparoscopic instruments and kleppingers can be more complicated to assemble. Training and ongoing education is key to resolving this complaint."

--Susan Williams,
market manager,
OnSite Services, Cardinal Health

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Proactive instrument care a win-win proposition

by Julie E. Williamson

An Olympus technician examines an endoscope

Considering the costs and headaches associated with improperly maintained medical instrumentation, it becomes clear that the adage, "an ounce of prevention is worth a pound of cure," is aptly suited.

If angry surgeons berating the Central Service department over broken, damaged and poorly functioning devices isn’t enough
to make facilities open their eyes to the importance of a well-implemented preventive maintenance program, then consider the risks that malfunctioning devices pose to patients at the receiving end of the instrument. Still not convinced of the benefits? Failing to properly maintain devices can cost a bundle by delaying surgical procedures, increasing the need for costly, preventable repairs, and prompting the premature purchase of replacement devices.

"It is the costly repairs and malfunctions that result in the need for a pound of cure," pointed out Susan Williams, market manager for Cardinal Health’s OnSite Services, which offers maintenance and repair services for surgical instruments, scopes and power equipment, cameras and other accessories.

So why, despite the ongoing challenges and plentiful data highlighting the value of preventive maintenance, are some hospitals still falling short? For starters, one industry expert cites budgetary pressures and the seemingly ongoing push to cut expenses as a major contributor to the problem.

"The simple reason is that in order to implement proactive maintenance programs, you will pay more upfront and see savings further down the line," explained Alex Vrancich, general manager, Spectrum Surgical Instruments Corp., Stow, OH. "It takes vision and sometimes a leap of faith to put an instrument maintenance program in place, but patience and proper management will result in substantial savings."

Another obstacle, according to Williams, is that some facilities struggle with how to determine which instrument sets to pull and how to minimize downtime during peak OR hours. "This is especially challenging for trauma facilities that cannot predict case loads," she noted.

Assessing – and addressing — the problem

Failing to make the connection as to what preventive maintenance actually means may also attribute to some facilities’ instrument management shortcomings.

As Gregg Agoston, sales manager for Karl Storz Endoscopy-America’s Protection 1 Services, pointed out, a broader interpretation of preventive maintenance is needed to get at the root cause of the damage. "Prevention should be viewed as any act that is used to actually prevent damage to devices."

By most accounts, making that connection requires adequate and ongoing education – and a willingness to take an honest look at instrument-related problems to pinpoint issues and determine the most effective solution. According to Agoston, the number one preventive measure that hospitals can take is to develop a system for monitoring and tracking damage, with an emphasis on educating staff on improved instrument care. "With such a system in place, the hospital can use this information to focus on the devices that are damaged most frequently, and cost the most to replace."

Fortunately, hospitals have many places to turn for education. "For hospitals, there is more information and available resources than ever before [that is] available through professional organizations, the Internet, manufacturers and repair vendors to help hospitals make solid and informed decisions about their instrument maintenance," said Ann Purtell, director of business development, Mobile Instrument Service & Repair, Bellefontaine, OH.

One instrument with breaks in two different locations, which are typical stress points.
There is bio-burden build-up on this instrument, which contributes to the breakdown /
weakening of the metal

Photos courtesy Mobile Instrument

Still, initial education often comes the hard way – with Central Service personnel fielding multiple complaints from OR staff about instruments, being burdened by a high number of tagged devices in disrepair, and in some cases, being forced into "emergency mode" by replacing malfunctioning devices with just-in-time
replacements. Such was the case for Mansfield, OH-based MedCentral Health System. Prior to implementing a preventive maintenance and instrument education program, the SPD was inundated with complaints from customers about various instrumentation-related issues, from lack of instrument sets to devices that were dull, bent and had missing parts.

Although the problems were frustrating, they gave the facility the nudge it needed to actively pursue a resolution. Spectrum Surgical was contacted to provide an on-location objective evaluation of the problems and help formulate an action plan to address customers’ needs. Following the evaluation, a detailed report was prepared and presented to all stakeholders. The evaluation shed light on several major issues that were contributing to the instrumentation problems. What first became apparent was the lack of knowledge, which was addressed by providing staff with mandatory education on instrument reprocessing, handling and inspection.

"During the evaluation, it was discovered that our customers did not understand their role in identifying worn instruments or the proper decontamination of used instruments," noted David Narance, RN, BSN, CRCST, MedCentral’s sterile reprocessing manager, adding that sets were often returned without wetting or pre-soaking, and others were returned soaking in damaging saline or betadine solutions. He went on to explain that on several occasions, customers failed to return the entire instrument sets because they thought the sets were disposable, and one unit routinely threw away dull scissors because they did not know they could be sharpened.

"Again, our losses became an opportunity to provide service excellence." Meetings were scheduled with the CS department’s customers during their monthly staff meetings, and training began to educate customers on proper pre-sorting and wetting of instruments, the identification and tagging of worn or damaged instruments, and the difference between surgical grade and floor grade instruments.

"Within a year, lost instrument replacement expenses were reduced by 78 percent, and we’re saving $10,000 annually," said Narance. Simple maintenance measures can garner substantial rewards. He explained that a Kerrison Rongeur may cost $7.50 to sharpen, but if it doesn’t undergo proper PM, it won’t cut properly and may be overtaxed by the surgeon, causing it to break. The result? A $500 invoice to replace the instrument.

MedCentral’s assessment also revealed an insufficient number of instrument sets, which was contributing to downtime, excessive reliance on flash sterilization, and over-use of the instruments that were available. "I discovered that with the dollars invested in the purchase of additional sets and on a PM program, our productivity rose and flash sterilization decreased."

Needle holder with finger rings has been
gold plated as part of full restoration program
by Five Star Surgical

Today, each instrument set at MedCentral must pass ten quality standards, which include inspection and testing of surgical devices.

"I can’t stress enough how important routine inspection is. In our teachings, we recommend that departments implement scissor sharpness testing protocols, laparoscopic insulation testing, and offer tips for finding cracked and damaged instruments," Spectrum’s Vrancich explained. He pointed out that the OR can play an important role in the PM process by communicating to the SPD in a consistent manner. "We have seen instruments that require sharpening or repair with tape on them or wrapped in suture material. The SPD is somehow supposed to know what this means." To eliminate confusion, he recommends using autoclaveable sharpen/repair tags that can be placed in each set.

Another piece of valuable advice that can go a long way toward increasing instrument longevity and preventing common problems, according to Narance, is to always check with the OEM on how to clean, inspect, test, and sterilize their instruments.

"The potential exists for damage and premature wear to any instrument that has been improperly cleaned and sterilized due to inadequate training." MedCentral’s SPD makes manufacturer instructions easily accessible by placing a comprehensive three-ring binder at each workstation.

PM partners raise the bar

MedCentral’s experience is a good example of the value that can be driven by teaming up with a quality partner – whether it’s the original equipment manufacturer, third party repair vendor, or both – for instrument-related education and PM services.

These partners are doing more than ever to provide hospitals with the most value for their preventive maintenance dollar. Olympus, for example, is supporting its customers with several educational programs, such as Olympus University, which offers courses in endoscope care and maintenance, and reprocessing techniques. Also, the OEM has 45 Endoscopy Support Specialists throughout the U.S. whose main focus is to assist and educate customers in repair reduction and proper care and maintenance of endoscopy equipment. If a scope, for example, is received for service, it is immediately inspected and the instrument history reviewed to determine if there is a pattern of repairs or any emerging trend. If the technician sees that the repair is one that may have been prevented, and there is a pattern of such repairs on the account, Olympus technicians will contact the customer or call the local Endoscopy Support Specialist to arrange an on-site visit to provide support to that customer and help prevent those repairs in the future. "In some instances, we will also dispatch our specialized factory engineers, resident in the United States, to assist biomedical engineering staff in troubleshooting and solving problems on-site," noted Eddie Garces, vice president, Medical Production Repair Group, Olympus Medical Equipment Services America Inc.


Photo courtesy of Karl Storz

Mobile on-site technical support provided by endoscopy companies can perform preventive maintenance checks, inspections and minor repairs to help ensure that facilities obtain the most from their instrumentation.

And Olympus isn’t alone in its extensive, hands-on service offerings. Karl Storz offers free training to all perioperative personnel in the use, inspection and maintenance of KSEA equipment, and Field Service Technicians are available in most major markets to provide on-site inspection services at no cost, as well as in-service staff education. Additionally, Karl Storz now offers Comprehensive Asset Management, which provides an On-Site Endoscopic Specialist who works 40 hours per week at client hospitals to manage Karl Storz inventory and prevent instrument damage. "This approach has proven very successful for our customers in maintaining their investment in our equipment," said Agoston. "Special assistance is also provided to those hospitals that are actively trying to build a [preventive maintenance] program."

Through Cardinal Health’s OnSite Services, facilities can have their instruments managed and maintained by an expert who works on location within the Central Service Department. "This service can provide capital relief for new instrument purchases as well as extend the life of current assets through daily inspection and expert care," said Williams, noting that one facility saved more than $70,000 the first year.

Intergrated Medical Systems International Inc., Birmingham, AL, focuses on the use cycle of a device and the many points of impact, beyond the clinical end user. IMS can provide on-location technicians that focus on instrument issues associated with minimally invasive surgery, for example, enabling the clinical team to focus on the procedure. For facilities needing a bridge between the OR and Central Service, an IMS management and coaching team can be employed to create a true CS center of excellence. One IMS Central Sterile Process Management team at the University of Alabama at Birmingham helped the hospital increase surgical volume by 14.4 percent, according to IMS president and CEO Gene Robinson. The goal, he noted, is to focus on process improvement, not just repairs.

"An IMS representative will follow instrumentation through the entire cycle to develop a process improvement plan to reduce future repairs. For instance, with flexible scopes, they may see that sinks are too small for decontamination or the scopes are coiled too tightly at some point in the cycle," explained Robinson. "With rigid scopes, they may find that the scopes are not isolated or immobilized during transport and are easily damaged. For power equipment, they may find that accidental fluid immersion during cleaning or flash sterilization is drastically reducing equipment life."

Enhanced tracking capabilities are another benefit hospitals can – and should – expect from their instrument partners, and should be preceded by a complete inventory assessment to determine which items require more frequent maintenance, which devices may be exposed to overuse or misuse, and whether the facility’s current inventory is sufficient.

Upon taking complete inventory, Mobile Instrument’s Purtell said trays should be logged or maintained in either a manual log or computerized service record, and a regular maintenance schedule set up based upon the type of instruments, their condition, and their use frequency.

"Instrument tracking is important to ensure that instruments are not being under-serviced throughout the course of the year," she explained. "Likewise, it’s just as important to make sure that your instruments are not being over-serviced. Too frequent sharpening of scissors, for example, will cause excessive metal loss and the need for premature replacement."

As a general rule, Purtell recommends that every tray be serviced at least once a year, with general and specialty trays being serviced every month to six months. "Following repair, the next step is to record the service information in a log and label the tray with a service date."

A Spectrum Surgical technician repairs an instrument

Five Star Surgical Inc., New Bedford, MA, counts and documents the hospital’s inventory and provides a scheduled maintenance program based on the number of trays available and the number of times they will need them maintained throughout the year. "This is usually once or maybe twice for heavily used instruments, and [depends upon] how well the instruments were previously maintained," said Five Star Surgical’s principal David Cabral. The company etches a date code on each instrument serviced, allowing the customer to know when the device was last maintained. "They can then track them electronically via the many software systems readily available in the industry." Although Five Star Surgical is not directly affiliated with a software tracking company, the firm believes that individual device tracking is more beneficial than tray tracking.

IMS’ services are supported by a View at a Click system that is driven by an Oracle database, allowing facilities to immediately track inventory repair history and status online. "The system also allows facilities to plan ahead for budgets and inventory investment," stressed Robinson. Beyond that, IMS’ ReadyTracker tray software system provides another solution for managing surgical inventory, using barcode technology and a web-based system to carefully track surgical trays and instruments throughout the usage cycle.

Olympus’ newly launched 24/7 Service portal promises added efficiency by giving customers faster repair turnaround times and insight into the complete service and repair experience with repair history and tracking, equipment inventory, service order approval, loaner instrument requests, and other functions. "This will allow hospital administrators, as well as nurse managers and other key personnel, to track the status of their service and repairs from Olympus," noted Alec Weiss, product manager, Endoscopy Service, Olympus America Inc.

While software solutions are undoubtedly helpful for ensuring an efficient PM program, it in no way can replace the expertise and hands-on service of a skilled instrument repair specialist, stressed Williams of Cardinal’s OnSite Services. "Instrument management and repair software can provide appropriate scheduling of the instrument sets. However, as a hospital is switching to scheduled maintenance, it may still run across some sets that have not been on routine maintenance in the past. A skilled instrument repair specialist with the right tools can refurbish those instruments and make qualified recommendations about instruments that should be replaced for patient safety purposes," explained Williams. She referred to one incident where a hospital’s Ophthalmology Retina instrument set, which the facility believed was unsalvageable, was effectively refurbished for less than 10 percent of the replacement cost.


Photo courtesy Mobile Instrument

Arthropunch with damage
due to abuse or mishandling

Focus on quality, flexibility

Despite the more advanced services being provided by repair companies, sources agreed that customers need to do their due diligence before entering into an instrument maintenance partnership.

Teaming with a flexible service partner is one important piece of advice. "Too often we see facilities that have to work around the repair vendor’s schedule," said Vrancich. "Scheduling is important because you want to be able to access the trays that require service most."

Flexible scheduling is also necessary to accommodate inevitable circumstances where changes to the schedule will be required, added Purtell. "There should be continuous dialogue between the repair vendor and CS and OR department personnel regarding instrument performance, complaints, or changes to usage frequency."

Of course, choosing a reputable, quality-driven PM partner should be a hospital’s top priority. Sources recommend seeking only an experienced repair vendor with accredited training, and one that is willing to provide references. They should also be willing to stand behind their work if a warranty issue or problem arises, charge a fair price for the work being performed, have the modern technology and equipment to effectively and efficiently perform a range of instrument services (and the ability to invest in new technology), and have the means of tracking repairs to ensure that the right service is being provided on the right instruments and the right time. Partnering with a vendor that sends multiple technicians to the hospital is another plus because it allows a facility to tackle more repairs and service in one visit, therefore, reducing downtime, according to Vrancich.

Williams stressed that with tens of thousands of instrument patterns available in the market, experience is essential. She urges hospitals to ask important questions, including how long the company has been in business and whether they understand the entire instrument cycle, as opposed to just the repair portion. "Quality is a result of technical expertise and commitment," she said."Open, frequent communication is required. The repair company should be part of your team."