Infection Control Today - 11/2001: Invite an OEM to Join Your MedicalTeam

November 1, 2001

Time To Design A New Generation Of Surgical Instruments
Invite An Instrument OEM To Join Your Medical Team

Now is the time. Now is the time for medicalfacilities to re-evaluate decontamination procedures, to format new instrumentpurchasing policies, and to invite us, the surgical instrument OEMs to join yourmedical team, in fact, you should insist that we do. Does the concept seemstrange? It should not. As makers and suppliers of surgical instrumentation, wehave a vested interest in the market. Though many OEMs do not have a medicalbackground, there are some who do, and who are designing and marketinginstruments specifically aimed at solving many of the problems that have plaguedthe medical field for years. Surgical instruments that cannot be disassembledhave long been a decontamination concern. The standard laminectomy punch is oneof those instruments.

With continuing threats of vCJD, Tuberculosis,HIV, and Hepatitis C, it is crucial for Health Care facilities to determine justhow effective their decontamination process really is. As surgical procedures,instruments and diseases become more and more sophisticated, it is vitallyimportant that future generations of surgical instruments be designed so thatthey can be easily and completely disassembled for thorough cleaning. The oldadage, If it ca not be cleaned, it will not be sterile, must be aconstant, and surgical instruments with hidden recesses and inaccessible areasmust be eliminated.

When the industry chose to adopt universalprecautions it was agreed upon that every patient was to be treated as if he/shewas an infection risk until proved otherwise. Universal precautions must extendto surgical instrumentation, as well. An instrument must be considered notsterile until ALL necessary steps have been taken to prove that it is.

All medical facilities are at risk fornosocomial infections. Now is the time to become proactive and to up-gradedecontamination practices. Prevention is always better than after the factinvestigation. The standard laminectomy punch with its hidden recesses isobviously a cross-contamination possibility. It cannot be disassembled withouttools. Disassembly is a lengthy process. Parts are not accessible, and are smalland easily lost. None of the medical institutions we surveyed disassembledlaminectomy punches after every surgical procedure, some disassembled them onlyduring their scheduled refurbishment rotation, and some never disassembled themat all. Though many medical personnel identified the laminectomy punch as adefinite cross-contamination possibility, no one felt they could afford the timerequired for total disassembly. Pictured below (fig. 1) is but one of manystandard laminectomy punches from a number of major institutions disassembledafter routine processing.

Most health care facilities rely upon standardcleaning practices for decontamination-- hand scrub, enzymatic soak, sonic wash,washer-sterilizer, etc. Though each of these is an important step in thecleaning procedure, none can assure that a laminectomy punch will be effectivelycleaned and made ready for sterilization. An instrument must be disassembled andvisually inspected to assure that all gross debris has been removed frominternal surfaces.

The emerging hard to kill prion diseases areonly one reason why Heath Care Providers must insist that future instrumentpurchases include only those surgical instruments that can be easily andthoroughly cleaned. The scare at Tulane University (October 2000) in whichseveral patients were exposed to CJD and reusable surgical instruments weredestroyed, is a worse case scenario that no Health Care institution can afford.Moreover, no institution can shoulder the cost of replacing instruments aftereach and every scare, nor can they afford to isolate any suspect instruments forany length of time. Disposable instruments are not a feasible option, at leastfor the foreseeable future. Because of the nature of prion diseases, and thefact that they can be transmitted via neuro matter and spinal fluid, makes itmandatory to fully disassemble the laminectomy punch after every procedure.

It has been well documented that bloodproteins, gross bone debris, and even limited amounts of bio burden caneffectively inhibit, if not prohibit sterilization. It is crucial that allcrevices and surfaces of an instrument be visually examined to ensure thatorganic material has been removed enabling the instrument to be effectivelysterilized. Remember that chemical and biological indicators do not provesterility, but merely show that necessary parameters for sterilization have beenmet within the processor.

Health Care professionals are by definitionpatient advocates, and as such, have, if not a legal, then a moral and ethicalobligation to provide sterile instruments to the end user. Patients expect andhave a right to sterile instrumentation, not a right to your best attempt atproviding sterile instrumentation. There is a huge difference. Just as there areno shades of truth, there are no shades of sterility. An instrument is eithersterile or it is not. Instrument manufacturers must adopt this same approachwhen considering instrument design, as they, too, have a moral and ethicalobligation to provide their accounts with surgical instruments that can beeffectively sterilized.

Surgical instruments are classified ascritical devices, and the FDA requires that cleaning and decontamination data beprovided by the manufacturer. You must insist on this data. Moreover, CentralProcessing, as the gatekeeper, those immediately responsible for the provisionof 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 andold technology to help you think out of the box to maximize your institutionscompetitive edge! And that is precisely what we need to do, Health Careproviders and OEMs alike. It is time for new thinking, time for exhaustivere-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 CareProvider. We owe it to you and your patients as an instrument OEM.

In any given institution, the immediate frontline 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 othersinvolved. 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, butnecessary concept that boldly steps away from the past.

Until now, and with few exceptions, most OEMshave simply offered the standard instrument lines from which you as a consumercould pick and choose. They may have listened off and on to a Surgeonssuggestion for a new instrument type, but, all in all, the overall attitude hasbeen business as usual. The same kind of attitude has prevailed in the medicalsetting. 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 surgicalsite infection, etc. Now is the time to effect a change...an innovative change.

Communications among front line team membersmust flow freely. Instrument cleaning data, sterilization information, newsurgery techniques, and potential hazards, must be shared. Walls and barriers tocommunication must come down. In terms of ensuring patient well being and apositive surgical outcome, the Surgeon can be no more important than the CentralProcessing Manager, the Materials Manager no more important than theEpidemiologist.

For instance, Central Processing on havingidentified a potential cross-contamination source (the standard laminectomypunch) must alert Infection Control, who in turn must alert the Surgeon,Purchasing/Materials, and Risk Management.

Materials must alert the OEM, and all mustmeet to discuss and provide suitable solutions. Each must "step out of thebox" in some way or another to change a negative situation, the threat ofcross-contamination via a surgical instrument, to a positive one, the advent ofa new breed of instrumentation designed specifically with cleaning in mind.

Infection Control must opt for preventionrather than after-the-fact discovery, and Purchasing/Materials must put asidecost containment for a moment. One lawsuit renders cost containment a muteissue, and as our lawyers have indicated, any litigation these days will nameall possible sources, from Surgeon to Housekeeper, from Housekeeper to OEM. Butmore important, any lawsuit simply means that we as Health Care Providers andOEMs have failed a patient in one regard or another.

A Surgeon can no longer afford to assume thatbecause her surgical instruments have reached the back-table they are, indeed,sterile. Surgeons should always question, and, if thinking of instrument designshould think as much as to how any new instrument will be cleaned as to how itwill function. After all, it is the Surgeon who bares the ultimateresponsibility for her patient and for any ensuing surgical site infections. Anypost operative infection means a Surgeons technique will be called intoquestion, and the increase in infection rate noted. Plying a patient withprophylactic antibiotics does not automatically prevent or solve a potentialinfection problem and does not release anyone from the legal hook. Since theSurgeon is usually named first in any malpractice or nosocomial site infectionlitigation traced to surgical instrumentation, it is important that thepractitioner be aware of the potential cross-contamination hazard posed by thestandard laminectomy punch as demonstrated in the fig. 1 picture above. Despitecost, the Surgeon must be made aware of new instrument products that mightreduce patient risk. The Surgeon must be included as an integral part of thefront line team. No one wants to be at risk, especially the patient.

At the time of this writing we know of onlyone surgical instrument OEM who has offered a laminectomy punch that can beeasily and completely disassembled without tools, in or out of Surgery. Butbringing it to market has not been easy. There are many hurdles to bringing anew instrument product to fruition, and every OEM faces these same hurdles. Weall need your help. As concerned manufacturers of surgical instrumentation weneed your input and we need it now! If we are to provide a new generation ofsurgical instrumentation in a timely manner, instrumentation that can be totallydisassembled for decontamination, then we must start immediately to develop newdesigns.

Here is what any instrument OEM is up against.Once a potential instrument problem has been identified a new design must bedrawn, an engineer must bring it to scale, and all facets of the new designscrutinized. Prototypes must then be machined and distributed to surgeons andhospitals for thorough testing and evaluation. Provided the instrument passes tothis stage it is presented for a patent search A new instrument design, if theOEM presses, may take six to twelve months to reach this point. The ensuingpatent search may take up to two years. The FDA 510K (seal of approval) willmost likely begin concurrently and may take from six to thirty six months. Ifall goes to plan production can begin. This is a crucial point, as nothing mustbe lost in the translation from prototype to end product. The specifications ofthe prototype must be consistent with each and every unit produced. The overalltime necessary to bring an instrument design to this point is approximatelythree to five years conservatively. The final and most costly step is to bringthe finished product to market. Up to this point only the OEM and the testingfacilities are aware of the new product.

The cost of advertising is the largest barrierto a new instruments entry into the market place. Advertising in trade andmedical magazines costs upwards of a million dollars. Shows and meetings addanother million or so. A new product begins to gather interest in about threemonths to a year. The total time from instrument conception to instrument saleranges from four to six years!

So the time literally is NOW! There really isno time to lose. If the next generation of surgical instruments is going tooffer easy disassembly for decontamination, then Care Providers and OEMs mustact quickly. But how? We suggest that you adapt our specific approach to meetthe needs of your Health Care facility.

As a concerned OEM we pulled together acommittee including representatives from all major front line disciplines. Weincluded Surgeons, Central Processing Managers, Materials Managers,Epidemiologists, and other OEM Instrument Representatives. We meet once a monthover dinner and discussion. As an OEM with extensive medical background we hadpreviously identified the standard laminectomy punch as our targeted instrument.Many instrument OEMs do not have this medical background, so your committee mayhave to approach things a little differently, as the OEM must rely on you forinput, however, the basic idea is the same. Again, invite different Surgeons,Epidemiologists, Material Managers, and Nurse Specialists from neighboringhospitals to join your core group each month. Rotate your invited surgicalinstrument OEMs, considering representatives from large and small companies. Setground rules...absolutely no selling, dedicated listening, free-rangediscussion. Set out to design an instrument that will meet the needs of allpresent. Try for the ultimate design. There are thousands of surgicalinstruments presently in use that deserve close study and scrutiny. Functionshould no longer be the only concern.

In the fashion described above, we gathereddesign ideas, and with our German partners, developed a new laminectomy punchthat exceeded our wildest dreams, one that we think represents the ultimate inlaminectomy punches. German engineering took it beyond the traditional anddesigned it to offer a little something for all involved. The new design leftthe old standard to become modular. Shafts were made to rotate a full 360degrees with forty-five degree stops. When that was not enough the shafts weredesigned to be interchangeable, and with varying shoe widths, lengths, andcutting angles. Our represented Surgeons were happy because they could performthe ipsilateral approaches without changing tablesides, and with less trauma,and less anesthesia time. Materials Management loved the price. But best, itcould be designed for easy, quick, and complete disassembly without the need fortools, which was our primary aim. The time is now to design the new generationof surgical instrumentation, and similar design meetings must take place allover the country...all over the world.

Surgical procedures, instruments and diseasesare fast becoming more and more sophisticated. It is vitally important that thenew generation of surgical instruments be designed with complete disassembly inmind. All instrument surfaces, including internal surfaces, need to be visuallyinspected to make sure that proper decontamination and final sterilization canbe achieved. Medical facilities cannot afford to discard laminectomy punchesbecause they have come in contact with neuro matter. Punches must be completelydisassembled for proper decontamination. Remember, if it cannot be properlycleaned, it simply will not be sterile! And remember, too, I thought theultrasonic would, or, I followed the OEM recommendations, or, CentralProcessing assured me... are no longer acceptable responses to why asurgical instrument was not sterile. Now is the time for new thinking andinnovative 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 withinstruments that can be easily and properly decontaminated. We need to worktogether. Invite us, the surgical instrument OEM, to join your medical team.

Written by William Lynn, B.A, ServiceManager, DunnAmics, Inc., instrument repairs eight years, and central processingsupervisor experience for twenty-three years, and James Edwin Dunn III, B.S.,A.S. President, DunnAmics, Inc., national & international OEM industrial andmedical background in service, sales, management, and marketing for twenty-fiveyears.