Managing the tool-care continuum

If only healthcare facilities operated under limitless budgets they could dispose of their reusable devices, equipment and tools after each use and simply buy new products for each patient.

That logic may work the first time (and perhaps under the glitziest and ritziest health plans) but the fiscal recovery after that may be a bit too bloody and painful, the operational mortality rate unbearably high.

So maintenance and repair of reusable endoscopic and standard medical/surgical instruments and equipment makes a bit more sense.

From there the decision centers on who should handle the maintenance and repairs? Typically, healthcare organizations choose between several options: Externally, the product’s original equipment manufacturer (OEM) or a third-party independent service organization (ISO), and internally the healthcare organization’s biomedical/clinical engineering department.

The first two involve issues of budget, customer service, quality assurance, warranty coverage, liability and access to parts and available loaners; the third involve all of those plus ongoing training and development of staff members.

Maintenance and repair strategies need not be centralized and singular under a series of OEMs; they could be decentralized and plural, relying on multiple ISOs or a mix of OEMs, ISOs and internal experts.

How does a healthcare organization determine the optimal strategy for its devices, equipment and tools? Namely, who should maintain and repair a facility’s devices, equipment and tools across the enterprise, based on internal evaluations of available choices?

Among the options healthcare organizations typically choose, what’s noteworthy is that none is mutually exclusive, which means a healthcare organization tends not to standardize on a single option across the board. In fact, many adjust their options to fit particular financial and operational needs or products. Perhaps that qualifies as yet one more option.

Maintaining and repairing devices, equipment and tools remains as important as selecting them the first time. Healthcare Purchasing News reached out to a number of device OEM and ISO executives for insights on the pros and cons of available options.

“When a new device model or series is released to the market, it is unlikely that an independent service provider will have a comprehensive repair program in place for that device,” said Matt Ofenloch, CSPDT, Device Implementation and Business Development Manager, STERIS Instrument Management Services, Birmingham, AL, in support of OEMs. “Medical devices can be complex instruments, and it takes service providers time to do the research, engineering, development and component sourcing or manufacturing to be able to repair the device to the OEM standard. Once the company can demonstrate that it has achieved this, and assuming they offer cost savings and excellent service, it is time for the healthcare organization to consider using the service provider.”

But ISOs have their value, too, Ofenloch continued.

“There are many devices in the marketplace that are no longer serviced by the OEM,” he said. “For these devices, independent service providers have typically built the associated service program years earlier. The healthcare provider can then choose to upgrade the items or have them maintained via their only option, the independent service organization.”

Pros: Consistent repair quality, the device meets the OEM’s designed standards, the device will function as the OEM intended it to.

Cons: Higher cost of repair, lack of solutions when the OEM discontinues service on a model or series of device, managing multiple repair vendors when you have devices from different OEMs.

“It makes the most sense to maintain equipment through OEMs when the equipment is new, involves new technology or it is subject to mandatory recalls,” asserted Melissa Kubach, Educator, Mobile Instrument Service & Repair, Inc., Bellefontaine, OH. “New equipment is covered under a warranty against defects in materials and workmanship. There is a brief period of use when any defects would become evident and after that time it is more likely that damage will be the result of use and not a defect.

“Using an OEM for service is not synonymous with buying an OEM service agreement,” she continued. “OEMs often seek one-year service agreements for brand-new equipment, which is far too long for the warranty to have any value. We recommend using the OEM for repairs for 90 days and then looking at sources for high-quality and cost-effective repair and maintenance services.”

Pros: Maintaining equipment with the OEM is always optimal under the following conditions:

• Equipment is under purchase warranty — The purchase warranty time frame has been established to protect the consumer from premature failure due to design or workmanship. Occasionally, issues of component longevity or function are not realized until the product experiences real time, repetitive patient use.
• Equipment is under recall or corrective action requiring return to the OEM — All notifications that require the item(s) to be sent back to the OEM should be followed. Much of this is under the scrutiny of the FDA and failure to comply may leave facilities open to increased risk of liability should the item fail during patient use.
• Equipment has newly emerging design or technology — This once again supports observing the purchase warranty time frame. It usually takes about a year for components to be reverse-engineered and cleared for Independent Service Organizations and internal facility repair support, thus limiting repair to the manufacturer.

Cons:

• Maintaining equipment with the OEM under these three situations limits your choice only to the manufacturer and there may be increased associated cost for repair and maintenance that is unavoidable.
• Some of the manufacturers only offer repair exchange scenarios that can quickly become financially overbearing for budget control. This can also lead to less emphasis and support for identifying and correcting associated causation.

Christian Berling , Vice President of Sales and Marketing, Heine USA, stresses the inherent reliability on part of the OEM, but acknowledges that costs and timing can be factors.

Pros:

• Ensures your equipment is cared for by a factory-trained technician. They can typically bring your product back to a like-new/refurbished state.
• Using imitations of medical devices or parts can pose a risk of injury to both the user and the patient. In such cases, liability may pass to the party who installed the third-party product. Even something as simple as using a non-authentic replacement bulb or battery could cause damage or lead to the high-quality instrument becoming totally defective. You should partner with OEMs to receive original parts to ensure that product guarantees and the CE Declaration of Conformity are maintained.
• OEMs will understand what warranties are available with the product and have the potential to save you money on repairs.
• Manufacturers might offer product loaner programs to ensure you still have the tools you need for proper patient care while your equipment is being repaired.
• Simple way to partner with a manufacturer to build rapport, and find out how they can help your facility to achieve its goals.

Cons:

• Some manufacturers will charge for their services.
• A facility will likely be required to ship the products out for repair. Overall, this could result in longer wait times.

Jamie Molina, Manager of Product, Service& Repair Marketing, Olympus Corporation of the Americas, emphasizes that using the OEM for the repair process of your flexible endoscope ensures the scope is brought back to its original specifications, which will “help maximize the performance of your scope and preserve its original high-quality imaging and handling, [and] also will ensure that the endoscope remains validated for reprocessing.

“Medical device manufacturers validate the reprocessing instructions for their endoscopes in order to prove that, when followed, the instructions result in a device that has been disinfected effectively and is ready for use on subsequent patients,” Molina continued. “The validated reprocessing protocol typically includes cleaning, disinfection and/or sterilization in order to remove soils and inactivate microorganisms.

“Unlike third-party vendors, medical device manufacturers are regulated by the U.S. Food and Drug Administration (FDA), which requires reprocessing validation data to be submitted by the OEM as part of the 510(k) premarket notification process in order to demonstrate that a device is safe and effective for clinical use. Repairs performed by the OEM return the device to its original factory specifications, ensuring the device is still validated for reprocessing.

“To keep facilities up and running with minimal disruption and maximum uptime, look for an OEM that offers fast repair turnaround time and a large selection of temporary loaner equipment, covering all models,” she said. “The OEM also may offer on-site loaners that stay at your facility throughout your contract term and can be used when your scopes are sent out for repair.”

ISOs

“Choosing an ISO for your maintenance and repair service makes sense in other ways,” assured Healthmark’s Hendee. “If a facility’s repair budget is limited, when a service contract has expired, or the OEM says the equipment is no longer supported, but it is still in good working order, a qualified ISO is a great option to keep that equipment functioning properly.”

Pro:Good for the budget. ISO services in most cases cost less than a comparable repair when provided by an OEM.

Pro:Fast field service. ISO repair companies deliver fast initial response. Many ISOs can have someone in and out of the department the same day.

Pro:Picking up where the warranty left off. A service agreement with an ISO ensures your equipment is still being regularly serviced by a professional.

Con: Use of equivalent parts. To be fair, some equivalent parts perform just as well and cost less than their OEM counterpart, but some do not. If equivalent parts are used look for parts that don’t perform as well, or last as long as the original. Replacing a cheaper part more often doesn’t save money in the end.

“The key is to choose an independent service organization with a long history of investing in and performing the necessary research, engineering, development and component sourcing or manufacturing required to repair the devices they service to the OEM standard,” said STERIS IMS’ Ofenloch. “And they need to offer cost savings over the OEM as well as excellent service. But there are companies that, with the promise of lowering your costs, take short cuts on device repair and don’t offer sufficiently developed support programs. So it is important that the healthcare provider make every effort to thoroughly validate the expertise of the independent service organization.”

Ofenloch offered several tips for sourcing and validating ISOs.

1. Ask around. Talk to other healthcare providers and learn about their experience with the independent service organization.
2. Ask for proof. Find out how the independent service organization develops their repair capabilities. Visit them and see for yourself.
   • Do they have engineering and manufacturing capabilities to source and develop components that meet the OEM standards?
   • Can they show you their document library, which should include a model specific bill of materials and all related technical part and component drawings?
   • Are they using components and parts that will not compromise how the device was designed to function?
   • Can they provide documentation of material compatibility and sterile efficacy testing?

Pros: Choosing a third-party ISO with the engineering and manufacturing capabilities can lead to using one vendor to handle all repairs, can extend the life of a device after an OEM discontinues service and support, provide a cost savings solution versus using the OEM, receive vendor neutral support and service, consistent repair quality, the device meets the OEM’s designed standards and functions as the OEM intended.

Cons: Choosing a third-party ISO without the engineering and manufacturing capabilities can lead to devices not meeting the OEM-designed standard and causing the device to not function as the OEM intended, higher repair frequencies due to inferior parts and components, surgeon and staff dissatisfaction when the device malfunctions, patient safety if the device were to fail during surgery.

“ISOs will help you reduce your spend on repairs and maintenance and elevate the level of service you receive,” noted Mobile Instrument’s Kubach. “They are a natural choice when your inventory is well-suited to ISO service. Because they service multiple OEMs equipment, you will find ISOs to be well-equipped to address broader inventory management challenges and they can be more responsive to systemic training and education that impacts multiple brands of products. For example, you probably have rigid endoscopes from multiple OEMs. The principles of good care and handling are largely the same across OEMs so it only makes sense to have an integrated education program and to manage the inventory as a whole.”

Pros: Repair and maintenance of equipment with ISOs can have a positive impact in multiple areas as follows:

• ISO organizations can greatly reduce repair cost while effectively servicing equipment. This is even more emphasized as inventories age. OEM contracts are not as lucrative for healthcare systems that keep their equipment longer than the expected purchase cycle of new equipment platforms. Additionally, older models may lose OEM support completely.
• Skilled third-party companies often provide personal and interactive service such as personal pick-up/delivery of repair items that cannot be repaired in the hospital setting.
• While all established repair sources offer varying degrees of educational/training support, often third-party companies will assist with preventative maintenance inspections, ongoing continuing educational support and on-site troubleshooting at no charge. Many of the manufacturers will charge for these services after initial install, especially if the facility is not under an associated contract.
• ISO vendors, in general, are more flexible and open to working as an ROI “partner.” Much of this has transpired out of need to complete with the OEM, set themselves apart, and bring greater value to the healthcare industry.

Cons:

• All third-party organizations are not equal in skill, quality system, national support or employee training. Vetting and trialing should be used when choosing an ISO partner.
• While there are many great companies that supply components, not all parts are available for every item in service, and most OEMs do not supply components to independent service organizations.

Third-party service companies may be a useful resource to certain facilities, according to Heine USA’s Berling.

Pros:

• Smaller facilities might not have an internal team to care for their products. They could utilize this resource to ensure their products will be maintained.
• They might offer preventive maintenance contracts and proactively come and service your equipment.

Cons:

• This is not a free service. It will likely end up being the highest price option for service.
• You must do your research and ensure that the ISO is trained on the repair of your product. You do not want to pay to have them do more harm than good.

Olympus’ Molina stands behind OEMs for device maintenance and repair over ISOs.

“If an endoscope is repaired by a third-party vendor, the OEM can no longer be certain that the reprocessing validation studies that were performed on the original device are still applicable, even when the instrument’s instructions for use (IFU) are followed,” Molina noted. “This is because the use of aftermarket (non-OEM) parts and materials for device repairs may affect the device’s compatibility with reprocessing protocols and chemicals.

“An OEM has no oversight of third-party repairs – which are not regulated by the FDA – nor knowledge of the repair parts and materials used by various third-party vendors,” she continued. “Once a device has been modified by a third-party vendor during the repair process, the OEM can no longer guarantee that the validated reprocessing instructions provided in the manual are still effective.”

Biomedical/Clinical Engineering

“Choosing your internal biomed/clinical engineering team for your maintenance services has advantages also,” Hendee indicated. “Internal Biomed provides a speedy response when issues occur. Like ISOs, they also do an excellent job of extending the life of instruments/equipment, even if the OEM has stopped supporting it.”

Pro:Rapid response. An onsite biomedical engineering lab can dispatch someone immediately to assess and begin the repair process.

Pro:Adds life after warranty. If taken care of, equipment and instruments can last for years. If the biomed team has the manual and access to a supply of compatible parts equipment can function properly for many years.

Con: May be unable to perform repair service even if you want them to. Biomedical departments can find it difficult to gain access to part, diagnostic and service info like manuals and parts catalogs.

“Healthcare organizations are increasingly relying on biomedical departments to handle device maintenance and repair,” Ofenloch insisted. “A good biomedical team will implement a comprehensive approach that focuses on preventive maintenance, reducing device damage and ultimately lowering costs. Preventive maintenance is especially important as it promotes patient safety and reduces the opportunity for device failure during surgery. Further, properly implementing a maintenance strategy for devices satisfies the Centers for Medicare and Medicaid Services (CMS) and other accrediting agencies’ requirements.

“However, biomedical departments are often faced with budgetary restrictions that may lead them to seek the lowest cost repair solution for their devices,” Ofenloch countered. “A low-cost repair solution doesn’t guarantee a quality repair and will likely result in increased costs and more device downtime. This can lead to more work for the biomedical team, as well as to frustrated clinical staff. The chosen repair solution should not only consider cost management, it should focus on uptime, life-cycle management, value added services, quality of repair, and most importantly, patient safety.”

Pros: Relying on the healthcare organizations internal biomedical/clinical engineering team can lead to implementing a maintenance strategy around devices to ensure that they meet the level of safety and quality for patients, comprehensive approach to reduce repair expenses, managing and maintaining an accurate inventory.

Cons: There can be a communication gap between biomed, clinical staff and surgeons that may cause frustration. Biomedical departments may choose a lower cost repair solution that can impact the quality and functionality of the device and increase device downtime.

“Practically speaking, most biomedical/clinical engineering teams do not have the training to service most surgical equipment,” Kubach said. “Even when trained, they need specialized tools, testing equipment and access to thousands of components to provide effective service. Yet biomed teams can provide vital value-added services to the overall repair and maintenance program for surgical equipment. Because they are trained to think about preventive maintenance in addition to repairs, they bring processes and disciplined thinking to the maintenance and repair service. They can often more effectively assess service providers for their capabilities and quality than a clinical value analysis team can, given their technical background.”

Pros:

• Overall, internal biomedical/clinical engineering teams provide excellent service, repair, and maintenance for countless items within their facilities every day.
• Items that can be repaired internally incur only time and material cost and repair tracking/history can be maintained on the established internal system.
• Biomedical/clinical engineering employees have required procedures and policies standardizing maintenance for the applicable equipment under their purview.

Cons:

• Many items that require maintenance and repair such as surgical instrumentation, flexible/rigid endoscopes, power, and video equipment are not typically completed by hospital employees. This is mostly due to the training, componentry, and support equipment needed to complete these repairs. The time and investment required is too great for effectively keeping this in-house.
• Internal biomedical/clinical engineering staff has so many items to maintain, especially those that are considered life sustaining or emergency based, that repair for all types of equipment is not reasonable or realistic.
• Many manufacturers will not supply parts or train internal hospital employees to complete these types of repair.

An internal team offers a degree of convenience, according to Berling.

Pros:

• They are part of the operating budget and not an extra cost to a department or facility.
• In theory, there is the possibility for shorter repair times if they are on site.

Cons:

• Yet, we often hear facilities complain about incredibly long wait times to get help, even if it is something as simple as getting a replacement bulb for a piecae of equipment.
• Additionally, you have to ensure there is a solid training program in place, and that the biomed team understands how to handle repairs and maintenance.

Molina sees little-to-no difference between any option outside of the OEM.

“While keeping your equipment ‘close to home’ may seem like a time- or cost-saving measure, the same drawbacks exist with this strategy as with using an ISO,” Molina said. “If the biomed/clinical engineering team is repairing endoscopes, Olympus considers an organization’s internal biomedical/clinical engineering team to be equivalent to a third-party repair service.”

Visit www.hpnonline.com/how-might-single-use-be-reliable-option/ for related sidebar