Supplying surgeons with the instruments they need to do their job can
be challenging at best. To help guide your decision making and help you
select the best quality instruments at the best price, Healthcare Purchasing News presents its annual Surgical Instruments Guide. It’s full
of useful tips from industry experts for evaluating instrument purchases, and it includes a comprehensive listing of surgical instrument suppliers - CLICK HERE.
 

Whether you are purchasing a new surgical instrument, or merely evaluating the condition of ones you already own, your evaluation criteria will be highly dependent on the product and its functionality. The criteria for evaluating rigid and flexible endoscopes does not necessarily make sense for evaluating hand-instruments, energy, suction and irrigation probes and blades.

• Smooth surfaces: Surfaces and mechanical joints should be clean, smooth and free from cracks and porous materials unless specifically required for the functionality of the instrument.

• High-quality materials: Look for superior quality materials such as stainless steel, titanium, sapphire and PEEK (high quality, light weight material) where appropriate.

• User-friendly design: Instruments with intuitive functionality and an ergonomical design make them easier to use and maintain.

• In-service training: In-service visits that come with the new product purchase are helpful for understanding the instrument’s full potential. They also help clarify the manufacturer’s recommended handling procedures, designed to protect the safety of the instrument and maximize the duration of its useable life.

• The instrument functions like it is supposed too.

• With normal care, the instrument does not rust.

• The instrument you bought today functions the same as the one you bought 10 years ago.

• Your repair/replacement budget for instruments is not out of control.

• The instrument holds up over time.

• The company you work with stands behind its instruments with lifetime warranties, lives up to them and can provide instrumentation repair services.

• Pattern consistency

• Finish

• Feel (how smoothly it operates)

• Quality of metal

• Metals used, stainless steel usually the optimal one

• Understand the process used to manufacture

• Examine instrument for potential flaws

When evaluating the quality of your current instruments,
remember:

• Before inspecting an endoscope, make sure all optical surfaces are cleaned to avoid errors in the evaluation of its optical quality.

When inspecting a rigid telescope, start with the distal tip, then proceed with to the outer tube, the light guide fibers, and then the proximal eyepiece. This will rule out damage to any of these external components before you proceed to evaluation of the scope’s interior and optical quality.

• Visually check the distal tip for scratches, cracks and burns that may have been caused by a shaver, HF device or other instruments.

• Inspect the telescope’s outer tube using a magnifier and manually feel the tube with your hands. Rigid endoscopes are fragile devices. While the presence of dents might not impact its optical quality, the dents are a good indicator of how much care is given to proper handling in your facility.

• Inspect the telescope’s optical system by assessing the quality of the projected image in terms of its clarity, contrast, color and brightness. A useful tool is the telescope test chart provided by Olympus Surgical America Inc. Look through the telescope while placing it approximately 5 cm in front of the test chart. Then move the telescope slowly closer to the test chart to about 1 cm. The image should stay sharp with minimal distortion. If the image is not acceptable, send the telescope in for service.

• Simulate the surgical instrument’s functionality to identify any movement related issues. Make sure that broken and worn parts are replaced or repaired immediately, using factory-certified parts.

• Carefully monitor the instrument’s functionality parameters and repair data over time and have it serviced when these parameters begin to deteriorate. This protects the instrument’s ongoing safety, reliablity and performance.

• Purchasing a high-quality instrument to begin with and then rigourously perserving it to original manufacturing specification, will help maximize the instrument’s usable life and its cost efficiency.

• Evaluate the service levels provided by your instrument vendor. There are three key factors when purchasing surgical instruments, price, quality and service. It’s difficult for any vendor to provide all three of these key elements. Make sure that your service is up to par, as we have found that this is the one key factor that is most lacking. Does your representative know the products they represent, or possess the clinical know-how to help you in the decision-making process? Also, what type of education does your instrument vendor provide? Most instrument companies have care and handling procedures listed in their catalogue, but that’s not nearly as effective as CE-approved educational programs, and hands-on training.

• Warranty, warranty, warranty! When evaluating a surgical instrument vendor, make sure to press the issue of warranty. Most companies say they have a lifetime warranty on their German surgical grade instruments, but when presented with a cracked hemostat for instance, they may balk at replacing the instrument. The instrument should be replaced, no questions asked.

• Breadth of product line

• Service

• Inventories

• Warehousing

• Fill-rate

• Company history

• Reliability of inventory in the country

• Customer service of the local representative

• Consideration of group purchasing contracts for best pricing

• Personal history with instrument companies you or your colleagues have dealt with previously.

• Choose a company with an established reputation for both quality and leadership in the endoscopy instrument field.

• The company should have product lines that offer superior breadth and depth to allow standardization with a single provider.

• The company should promote innovation that ensures that products evolve to meet changing clinical needs and support new procedures.

• Service and support program should maximize uptime through quality service and repairs, availability of loaner equipment, on-site repair by manufacturer-trained technicians, and warranties that provide extended protection.

• A commitment to training, education and ongoing exchanges of professional knowledge, including continuing education programs and support of innovative programs that allow surgeons to share clinical insights.

It’s a great idea to tour a vendor’s plant. Not only will this show you that the vendor you are working with is a manufacturer, but it will give you a sense of the quality that goes into their manufacturing. Making surgical instruments is not only a science but it is truly an art.

The reasons to go on a vendor plant tour are numerous, but most significant is to meet the people who are managing and operating the manufacturing facility. Identifying the horsepower behind the sales process is imperative in understanding the value you are receiving from the company and its products. Other important factors are quality systems, metrics, cleanliness, organization, service offering, receiving and distribution.

• How long has the surgical manufacturer been established? A longer history of surgical instrument manufacturing can indicate a level of commitment to the industry and an accumulation of expertise in the use, design and manufacturing processes of these highly innovative instruments.

• Are the quality controls used for manufacturing, packing, storage, and installation in conformance with the Quality System/Good Manufacturing Practice (QS/GMP) for Medical Devices Regulations? Surgical OEMs are required to meet these standards. Look for OEMs that go one step further with ISO 9001 certification, which underlines their commitment to quality control and continuous improvement.

• What system does the OEM have in place for handling faulty or otherwise unsatisfactory products? This question provides insight on how efficiently the OEM handles customer satisfaction issues. Have they established a formal customer care unit? What sort of product support do they have in place? What is their policy on product returns, and how do they handle that process?

• Does the manufacturer offer extended warranties for their surgical instruments? While not critical, extended warranties help protect your asset for a longer period. If an OEM offers an extended warranty, it also demonstrates a level of confidence in their product and its useful life. For example, Olympus offers a five-year warranty against autoclave damage on its rigid Goldtip telescopes.

• What percentage of the parts used in manufacturing the instrument are provided by outside suppliers? What system does the OEM have in place for quality control on these supplied parts and finished goods? A quality-oriented manufacturing organization will have a clear understanding of their vendors and their vendor’s quality system. The OEM should have an established system for inspecting incoming parts as well as the quality of the finished product.

• When considering a service/repair vendor, ask if the company uses the original manufacturer’s parts and protocols in their repair processes. Parts and protocols used in the repair process that do not conform to the instrument’s original design and intended use may jeopardize its safety and functionality.To protect the integrity of your equipment, make sure that broken and worn parts are replaced or repaired immediately using only factory-certified parts and processes.

• Does the company encourage ongoing training for their employees? An organization’s investment in ongoing training for their employees demonstrates its commitment to quality. Formal training programs for employees can contribute greatly to the product’s overall superiority.

• Do employee workstations provide clear documentation of the-required tasks? Is the work environment clean and organized? Concise instructions clearly delineate expectations, leaving no room for guesswork. An uncluttered environment helps further improve efficiency and minimize mistakes.

• How is waste handled? Does the company have specific enviromental protection standards and policies in place? Environmental standards help to reduce consumption and control hazardous chemical substances used in the product’s manufacturing process. They also promote efficiency and recycling, resulting in better cost management.

• In general, during site visits try to get a sense of the company’s corporate culture. Are employees motivated? Professional? Realatively happy? Ultimately, these attributes can have a huge impact on pride of workmanship and overall product qualtity.

• How many instruments are made in this facility?

• How long have you been manufacturing instruments?

• What is the average tenure of your instrument craftsmen?

• Do you control the entire manufacturing process at this facility?

• Can I see how you control quality?

• What is the average time it takes to manufacture an instrument?

• How do you passivate your instruments to control rusting?

• How many instruments do you produce in a year at this facility?

• Percent of on-time delivery for the past six months?

• Do you have a product planning or project management process?

• Is your facility ISO certified?

• Is your facility FDA certified?

• How does your company do capacity planning?

• How does your company manage inventory (system used, method, how often is inventory taken, are cycle done, how often, etc.)

• What is the typical response time for a formal customer response?

• Describe some of your company’s metrics.

• Do you have an internal audit system? How often is it reviewed, is it documented and is there corrective action taken?

• Selectively invest in quality. Certain instruments, such as needle holders and scissors, are more likely to breed surgeon contention than others if quality or maintenance is sub par. Purchase the highest grade of these and similar instruments, and your surgeon and staff satisfaction will rise.

• Evaluate the best contenders for cost-cutting. Economizing on handheld retractors, sponge forceps, towel clips, dressing, tissue forceps and basic hemostats will likely not impact surgeon satisfaction. 

• If it sounds cheap, it is cheap. Any item priced at the $5.00 level is sub-standard, no matter what the vendor says. Basement-bottom pricing is an indicator of poor quality.

• Streamline purchasing. You’ll save thousands by focusing only on the instruments you need. Sets are often designed by instrument companies and include unnecessary parts.  E.g., when buying a Bookwalter-type ring, purchase only the essential components and avoid complete sets.

• Maintain accurate expectations of instrument utilization. If you hear of new surgeons or new procedures coming to your facility, confirm that you’ll get a strong ROI before fulfilling an instrument "wish list." 

• Keep contracts in order. They must be current and in effect, with proper discount grading levels. All paper work must be completed by you and filed by your vendor before purchasing. Even after paperwork has been filed, pricing must still be loaded against your account. All of the above must occur to ensure savings, or you may be overpaying. 

• Compare pricing on discontinued items. Companies often discontinue items as a cost-cutting measure. Some remain available via special order at a significant premium. Seek out other vendors, who may carry the same manufacturers and offer the items without the premium.   

• Investigate repair options. Evaluate reputable repair companies before resorting to a new purchase. "Non-repairable" instruments can often be fixed by third-party services at a significant savings compared to the original vendor. 

• Rightsize your existing trays for faster processing, less labor and lower costs. Carefully list all items in a tray and have a scrub tech track usage of each item, creating new set lists when appropriate. Surgeons should review all updated trays; remove all unused items. Only add to a tray when you’re sure the instrument will be utilized in the majority of cases. 

• Weigh instruments costs against patient safety.
Although instrument sets can be a significant investment, the cost pales in comparison to the detriment associated with declining patient safety. Not only does this risk the patient health, but also the facility’s reputation, possibly leaving it vulnerable to lawsuits and compromised accreditation.

• The purpose for which an instrument is to be used and those purposes’ criteria will provide the goals of selection.

• The general rule has always been that stainless steel has been the metal best for use on most surgical procedures. 

• Titanium instruments are very good as well.  They are lighter, sometimes more delicate but they are also usually more expensive.

Stainless steel, titanium, cobalt chromium alloy or aluminum.

At minimum, all OR grade instrumentation should meet the ASTM F-899-02 standard for surgical grade stainless steel. Individual instruments have different requirements for their functional use and depending on that use, they may require different materials.

Instrument must be surgical grade quality which requires German stainless and pattern consistency.

• Instruments don’t function properly when you first receive them.

• Instruments rust or pit after first processing.

• Your repair/replacement budget is out of control.

• Sharp corners, or rough surfaces on an instrument can show poor overall quality.

• Instrument patterns vary from one order to the next. This shows that the company cannot consistently make the same instrument.

• Improperly machined steel can lead to poor quality.

• Pitting

• Box lock breakage

• Surface rust/Rusting during sterilization

• Sharpness

• Misalignment of tips

• Poor tolerance

• Excessive noise/vibration

• Poor service

• Frequency of repair

• Lack of durability during rough handling

• Corrosion

US customs requires that instruments state a Country of Origin for an instrument. The term "made" can have many different interpretations and therefore the only thing that can legally be looked at is Country of Origin, and Country of Origin does not always tell the whole story. One of the simplest tests could be price. If one vendor is charging $10 and another vendor is charging $50, you need to really ask yourself if both of these items are really coming from Germany.

Except for specialty instruments, most generic hand held instruments are not manufactured in the U.S. The quality of the instruments made in Germany is excellent while the Pakistani quality is not manufactured for the purpose of durability.

Brown parchment-like cardboard packaging indicates instruments from Pakistan.

· Resource availability considerations (internal/external)

· Established vendor relationships

· Non-bias viewpoint/objective decision making

· Ability to analyze purchasing data

· Takes the convenience factor out of the sale