Time To Design A New Generation Of Surgical Instruments
Invite An Instrument OEM To Join Your Medical Team
Fig. 1 (grossly contaminated standard laminectomy punch disassembled after routine processing...including final sterilization...load indicators showed that necessary parameters for sterilization were met)
Now is the time. Now is the time for medical facilities to re-evaluate decontamination procedures, to format new instrument purchasing policies, and to invite us, the surgical instrument OEMs to join your medical team, in fact, you should insist that we do. Does the concept seem strange? It should not. As makers and suppliers of surgical instrumentation, we have a vested interest in the market. Though many OEMs do not have a medical background, there are some who do, and who are designing and marketing instruments specifically aimed at solving many of the problems that have plagued the medical field for years. Surgical instruments that cannot be disassembled have long been a decontamination concern. The standard laminectomy punch is one of those instruments.
With continuing threats of vCJD, Tuberculosis, HIV, and Hepatitis C, it is crucial for Health Care facilities to determine just how effective their decontamination process really is. As surgical procedures, instruments and diseases become more and more sophisticated, it is vitally important that future generations of surgical instruments be designed so that they can be easily and completely disassembled for thorough cleaning. The old adage, If it ca not be cleaned, it will not be sterile, must be a constant, and surgical instruments with hidden recesses and inaccessible areas must be eliminated.
When the industry chose to adopt universal precautions it was agreed upon that every patient was to be treated as if he/she was an infection risk until proved otherwise. Universal precautions must extend to surgical instrumentation, as well. An instrument must be considered not sterile until ALL necessary steps have been taken to prove that it is.
All medical facilities are at risk for nosocomial infections. Now is the time to become proactive and to up-grade decontamination practices. Prevention is always better than after the fact investigation. The standard laminectomy punch with its hidden recesses is obviously a cross-contamination possibility. It cannot be disassembled without tools. Disassembly is a lengthy process. Parts are not accessible, and are small and easily lost. None of the medical institutions we surveyed disassembled laminectomy punches after every surgical procedure, some disassembled them only during their scheduled refurbishment rotation, and some never disassembled them at all. Though many medical personnel identified the laminectomy punch as a definite cross-contamination possibility, no one felt they could afford the time required for total disassembly. Pictured below (fig. 1) is but one of many standard laminectomy punches from a number of major institutions disassembled after routine processing.
Most health care facilities rely upon standard cleaning practices for decontamination-- hand scrub, enzymatic soak, sonic wash, washer-sterilizer, etc. Though each of these is an important step in the cleaning procedure, none can assure that a laminectomy punch will be effectively cleaned and made ready for sterilization. An instrument must be disassembled and visually inspected to assure that all gross debris has been removed from internal surfaces.
The emerging hard to kill prion diseases are only one reason why Heath Care Providers must insist that future instrument purchases include only those surgical instruments that can be easily and thoroughly cleaned. The scare at Tulane University (October 2000) in which several patients were exposed to CJD and reusable surgical instruments were destroyed, is a worse case scenario that no Health Care institution can afford. Moreover, no institution can shoulder the cost of replacing instruments after each and every scare, nor can they afford to isolate any suspect instruments for any length of time. Disposable instruments are not a feasible option, at least for the foreseeable future. Because of the nature of prion diseases, and the fact that they can be transmitted via neuro matter and spinal fluid, makes it mandatory to fully disassemble the laminectomy punch after every procedure.
It has been well documented that blood proteins, gross bone debris, and even limited amounts of bio burden can effectively inhibit, if not prohibit sterilization. It is crucial that all crevices and surfaces of an instrument be visually examined to ensure that organic material has been removed enabling the instrument to be effectively sterilized. Remember that chemical and biological indicators do not prove sterility, but merely show that necessary parameters for sterilization have been met within the processor.
Health Care professionals are by definition patient advocates, and as such, have, if not a legal, then a moral and ethical obligation to provide sterile instruments to the end user. Patients expect and have a right to sterile instrumentation, not a right to your best attempt at providing sterile instrumentation. There is a huge difference. Just as there are no shades of truth, there are no shades of sterility. An instrument is either sterile or it is not. Instrument manufacturers must adopt this same approach when considering instrument design, as they, too, have a moral and ethical obligation to provide their accounts with surgical instruments that can be effectively sterilized.
Surgical instruments are classified as critical devices, and the FDA requires that cleaning and decontamination data be provided by the manufacturer. You must insist on this data. Moreover, Central Processing, as the gatekeeper, those immediately responsible for the provision of sterile instrumentation, must verify that these recommendations do, indeed, work, and that a properly decontaminated instrument can be obtained.
In a past issue of Infection Control Today (8/2001) Mary Ellen Fortenberry put forth a brilliant thought...Use new and old technology to help you think out of the box to maximize your institutions competitive edge! And that is precisely what we need to do, Health Care providers and OEMs alike. It is time for new thinking, time for exhaustive re-examination and evaluation, and time for innovative change. We need to "step out of the box." You owe it to your patients as a Health Care Provider. We owe it to you and your patients as an instrument OEM.
In any given institution, the immediate front line team in regards to instrumentation consists of (or something similar to) Surgeon/Physician, Surgery, Infection Control, Central Processing, Purchasing/Materials, and Risk Management. There may, of course, be others involved. A new member of your team must be the Original Equipment Manufacturer, and you must see to it that these OEMs are included. This is a new, but necessary concept that boldly steps away from the past.
Until now, and with few exceptions, most OEMs have simply offered the standard instrument lines from which you as a consumer could pick and choose. They may have listened off and on to a Surgeons suggestion for a new instrument type, but, all in all, the overall attitude has been business as usual. The same kind of attitude has prevailed in the medical setting. The Surgeon came to be responsible for the actual surgical procedure, Central Processing came to be responsible for providing sterile instrumentation, Infection Control came to be responsible for tracking the source of a surgical site infection, etc. Now is the time to effect a change...an innovative change.
Communications among front line team members must flow freely. Instrument cleaning data, sterilization information, new surgery techniques, and potential hazards, must be shared. Walls and barriers to communication must come down. In terms of ensuring patient well being and a positive surgical outcome, the Surgeon can be no more important than the Central Processing Manager, the Materials Manager no more important than the Epidemiologist.
For instance, Central Processing on having identified a potential cross-contamination source (the standard laminectomy punch) must alert Infection Control, who in turn must alert the Surgeon, Purchasing/Materials, and Risk Management.
Materials must alert the OEM, and all must meet to discuss and provide suitable solutions. Each must "step out of the box" in some way or another to change a negative situation, the threat of cross-contamination via a surgical instrument, to a positive one, the advent of a new breed of instrumentation designed specifically with cleaning in mind.
Infection Control must opt for prevention rather than after-the-fact discovery, and Purchasing/Materials must put aside cost containment for a moment. One lawsuit renders cost containment a mute issue, and as our lawyers have indicated, any litigation these days will name all possible sources, from Surgeon to Housekeeper, from Housekeeper to OEM. But more important, any lawsuit simply means that we as Health Care Providers and OEMs have failed a patient in one regard or another.
A Surgeon can no longer afford to assume that because her surgical instruments have reached the back-table they are, indeed, sterile. Surgeons should always question, and, if thinking of instrument design should think as much as to how any new instrument will be cleaned as to how it will function. After all, it is the Surgeon who bares the ultimate responsibility for her patient and for any ensuing surgical site infections. Any post operative infection means a Surgeons technique will be called into question, and the increase in infection rate noted. Plying a patient with prophylactic antibiotics does not automatically prevent or solve a potential infection problem and does not release anyone from the legal hook. Since the Surgeon is usually named first in any malpractice or nosocomial site infection litigation traced to surgical instrumentation, it is important that the practitioner be aware of the potential cross-contamination hazard posed by the standard laminectomy punch as demonstrated in the fig. 1 picture above. Despite cost, the Surgeon must be made aware of new instrument products that might reduce patient risk. The Surgeon must be included as an integral part of the front line team. No one wants to be at risk, especially the patient.
At the time of this writing we know of only one surgical instrument OEM who has offered a laminectomy punch that can be easily and completely disassembled without tools, in or out of Surgery. But bringing it to market has not been easy. There are many hurdles to bringing a new instrument product to fruition, and every OEM faces these same hurdles. We all need your help. As concerned manufacturers of surgical instrumentation we need your input and we need it now! If we are to provide a new generation of surgical instrumentation in a timely manner, instrumentation that can be totally disassembled for decontamination, then we must start immediately to develop new designs.
Here is what any instrument OEM is up against. Once a potential instrument problem has been identified a new design must be drawn, an engineer must bring it to scale, and all facets of the new design scrutinized. Prototypes must then be machined and distributed to surgeons and hospitals for thorough testing and evaluation. Provided the instrument passes to this stage it is presented for a patent search A new instrument design, if the OEM presses, may take six to twelve months to reach this point. The ensuing patent search may take up to two years. The FDA 510K (seal of approval) will most likely begin concurrently and may take from six to thirty six months. If all goes to plan production can begin. This is a crucial point, as nothing must be lost in the translation from prototype to end product. The specifications of the prototype must be consistent with each and every unit produced. The overall time necessary to bring an instrument design to this point is approximately three to five years conservatively. The final and most costly step is to bring the finished product to market. Up to this point only the OEM and the testing facilities are aware of the new product.
The cost of advertising is the largest barrier to a new instruments entry into the market place. Advertising in trade and medical magazines costs upwards of a million dollars. Shows and meetings add another million or so. A new product begins to gather interest in about three months to a year. The total time from instrument conception to instrument sale ranges from four to six years!
So the time literally is NOW! There really is no time to lose. If the next generation of surgical instruments is going to offer easy disassembly for decontamination, then Care Providers and OEMs must act quickly. But how? We suggest that you adapt our specific approach to meet the needs of your Health Care facility.
As a concerned OEM we pulled together a committee including representatives from all major front line disciplines. We included Surgeons, Central Processing Managers, Materials Managers, Epidemiologists, and other OEM Instrument Representatives. We meet once a month over dinner and discussion. As an OEM with extensive medical background we had previously identified the standard laminectomy punch as our targeted instrument. Many instrument OEMs do not have this medical background, so your committee may have to approach things a little differently, as the OEM must rely on you for input, however, the basic idea is the same. Again, invite different Surgeons, Epidemiologists, Material Managers, and Nurse Specialists from neighboring hospitals to join your core group each month. Rotate your invited surgical instrument OEMs, considering representatives from large and small companies. Set ground rules...absolutely no selling, dedicated listening, free-range discussion. Set out to design an instrument that will meet the needs of all present. Try for the ultimate design. There are thousands of surgical instruments presently in use that deserve close study and scrutiny. Function should no longer be the only concern.
In the fashion described above, we gathered design ideas, and with our German partners, developed a new laminectomy punch that exceeded our wildest dreams, one that we think represents the ultimate in laminectomy punches. German engineering took it beyond the traditional and designed it to offer a little something for all involved. The new design left the old standard to become modular. Shafts were made to rotate a full 360 degrees with forty-five degree stops. When that was not enough the shafts were designed to be interchangeable, and with varying shoe widths, lengths, and cutting angles. Our represented Surgeons were happy because they could perform the ipsilateral approaches without changing tablesides, and with less trauma, and less anesthesia time. Materials Management loved the price. But best, it could be designed for easy, quick, and complete disassembly without the need for tools, which was our primary aim. The time is now to design the new generation of surgical instrumentation, and similar design meetings must take place all over the country...all over the world.
Surgical procedures, instruments and diseases are fast becoming more and more sophisticated. It is vitally important that the new generation of surgical instruments be designed with complete disassembly in mind. All instrument surfaces, including internal surfaces, need to be visually inspected to make sure that proper decontamination and final sterilization can be achieved. Medical facilities cannot afford to discard laminectomy punches because they have come in contact with neuro matter. Punches must be completely disassembled for proper decontamination. Remember, if it cannot be properly cleaned, it simply will not be sterile! And remember, too, I thought the ultrasonic would, or, I followed the OEM recommendations, or, Central Processing assured me... are no longer acceptable responses to why a surgical instrument was not sterile. Now is the time for new thinking and innovative change. Do not be shy get involved. You, as a Health Care Provider, have an ethical obligation to provide sterile instrumentation to your patient. We, as an instrument OEM have a moral responsibility to provide you with instruments that can be easily and properly decontaminated. We need to work together. Invite us, the surgical instrument OEM, to join your medical team.
Written by William Lynn, B.A, Service Manager, DunnAmics, Inc., instrument repairs eight years, and central processing supervisor experience for twenty-three years, and James Edwin Dunn III, B.S., A.S. President, DunnAmics, Inc., national & international OEM industrial and medical background in service, sales, management, and marketing for twenty-five years.