Laser Safety Incident Records Illustrate Deficiencies in Reporting and TrainingSidney S. Charschan Citation: Journal of Laser Applications 4, 13 (1992); doi: 10.2351/1.4745308 View online: http://dx.doi.org/10.2351/1.4745308 View Table of Contents: http://scitation.aip.org/content/lia/journal/jla/4/3?ver=pdfcov Published by the Laser Institute of America Articles you may be interested in SUET230: Patient Safety Improvement Related to Changes in Ongoing Radiation Treatment Plan Identified withNearMiss Incidents Reporting Med. Phys. 40, 257 (2013); 10.1118/1.4814665 Laser safety Phys. Teach. 35, 453 (1997); 10.1119/1.2344761 FDA Medical Incident Report Is Sobering Reminder of Laser Safety Education Needs J. Laser Appl. 1, 58 (1989); 10.2351/1.4745246 Operational Radiation SafetyTraining, NCRP Report No. 71 Med. Phys. 11, 220 (1984); 10.1118/1.595609 AEC's Safety Record Phys. Today 5, 26 (1952); 10.1063/1.3067629

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About The American National Standard Z136 SeriesThe Laser Institute of America, the nonprofit membership associationheadquartered in Orlando, Florida, is the official secretariat to theAccredited Standards Committee Z136 on the Safe Use of Lasers. Thescope of the ASC covers protection against hazards associated with theuse of lasers and optically radiating diodes. Training and education arerecommended throughout.

For example:

ANSI Z136.3-1988 For the Safe Use of Lasers in Health Care Facilitiesstates:

5.1 Scope. Safety training programs shall be established for HealthCare Personnel (HCP) using Class 3b or Class 4 Health Care LaserSystems (HCLS) and should be established for HCP using Class 2 orClass 3a HCLS. Sec. II Voluntary

GuidelinesPrevail

Personnel that may require some form of laser and laser safetytraining include: (1) Laser Safety Officers (LSO); (2) Laser physicians;(3) Laser technical support staff, e.g., clinical engineers, lasertechnicians; (4) Medical support staff, e.g., nurses; (5) Laser systemservice personnel, including either in-house or contractor servicepersonnel.

Laser Safety Incident Records Illustrate Deficiencies in Reporting and TrainingBy Sidney S. Charschan, Editor-in-Chief JLAand chairman ANSI Z136 Accredited Standards Committee

INADEQUATE OR NON-EXISTENTreporting of incidents has a majornegative effect on laser safety educationand training efforts. The laser industryalready has experienced several situa-tions in which improper or inadequateinformation has reflected poorly on theindustry. Media coverage generated asa result tempers the public's acceptanceof the benefits of laser technology.

Premature and misleading marketingby vested interests, particularly ofmedical devices and procedures, contrib-utes to disenchantment on the part ofpurchasers and patients. Only an accu-mulation of valid statistics over timeleads to a fact-based understanding ofwhat is actually happening in the "RealWorld."

Until recently, incident records avail-able from the Federal government werefiled by the laser manufacturers, not the

users. The U.S. Food & Drug Admin-istration (Safe Medical Devices Act of1990) now requires "user facilities" toreport incidents that reasonably suggestthere is a probability that a medicaldevice has caused or contributed to thedeath of a patient or to a serious injuryor a serious illness.

The FDA Center for Devices &Radiological Health (CDRH) has longrequired ALL equipment manufacturers(including industrial sources) to reportdeath or injury accidents. These statis-tics, however, are not laser-specific anddo not separate operator error fromequipment failure.

The Occupational Safety & HealthAdministration (U.S. Dept. of Labor) hasadopted Z136-based Guidelines forLaser Safety and Hazard Assessment,which will assist enforcement officersin the longtime OSHA goal of elimi-

nating or controlling workplace hazards.OSHA also has long required work-

places to report any lost-time accidents.The new Guidelines will make it morelikely that laser-specific incidents inindustrial, research, or medical facilitieswill be tracked.

Many in the laser safety field areconvinced that the limited medicalstatistics currently available throughFDA and OSHA reflect only the tip ofthe iceberg. And, as in all such reporting,it is difficult to determine whether thefault is equipment failure or operatorerror. It is certain, however, that oftenthe fault is not traceable to the laserprocedure itself, but rather to the lackof training and credentialing received bythe surgeons (or, more recently, dentists)performing the procedure.

(Continued next page)

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Situation C. The FDA Medical Laser Incident Report

Although this data is limited toMedical Devices, this information isfurnished to show that LASER SAFETYshould still be of major concern to allusers.

Records available from the FederalGovernment are filed by the lasermanufacturers, not users. Therefore,

many are convinced that such informa-tion is only the tip of the iceberg. Asin all such reporting, it is difficult todetermine whether the fault is equipmentfailure or operator error. Perhaps it istime for OSHA to combine its talentswith the FDA.

Since 1985 to mid-1992:YEAR REPORTS INJURIES FIBER TIP LOCATION & COMMENT (*.DEATH)

1985 6 3 0 1 Eye (3)1986 10 7 0 0 Eye (5), Tube Fire (1), Bronchius (1)1987 8 5 0 0 Eye (3), Bladder (1), Hysterectomy (1*)1988 14 9 0 1 Eye (2), Burns (5), Hysterectomy (1*)1989 18 10 2 3 Eye (2), Burns (2), Hysterectomy (2*)1990 36 16 16 0 Eye (1), Burns (3), Embolism(2) (3*)1991 39 18 11 10 Eye (6), Burns (6), Embolism(1)1992 5 5 0 0 Eye (4), Burns (1)

Note: The data for Medical Devices was provided by Richard Felton of the FDA. The commentsand interpretations are those of Mr. Charschan.

Of the 136 reported instances morethan half resulted in injuries. The eyestill seems to be the major target.

During the period 1989 to 1991, itappears that the increasing use of smalldiameter (400 um) fiber, and contactlaser scalpels clarified the need for jacketimprovements by the manufacturer andadditional training for the user. Recentdata documents the need for keeping thetips cool and clean.

The seven reported deaths unfortu-

nately were due to insufficient exper-imental data and the deficient trainingin new procedures with such highpowered (lasers) thermal sources anduntried insufflation procedures. Tubeburnthroughs seem to be a problem ofthe past, along with incorrect combus-tible gas mixtures (for anesthesia). AnFDA alert (Journal of Applications, Vol.2, No. 1, 1990) seems to have eliminatedthe embolism problem. Let us hope thatwe have matured and Laser Safety issueshave abated.

Deficiencies — continued

Actions establishing guidelines forsurveillance of laser safety standards inhealth care facilities are still pending onthe part of the Joint Commission onAccreditation of Health Care Organiza-tions (JCAHO). Chair Dr. Rocco Lo-braico and Z136.3 representatives metwith the Commission more than a yearago to propose controls to be followedby JCAHO surveyors in the evaluationof clinical lasers and accreditationassessments for hospitals and ambula-tory care centers.

What's Really Happening?Situation A. New York State Health De-partment Memorandum

(Health Facilities Series, H-18;Series 92-20; 6/12/92.)Extensive negative media coverage

followed the release of a NYSHD memoreporting a high level of serious compli-cations associated with laparoscopiccholecystectomy at hospitals around thestate.

Between August 1990 and March1992, the Department received reportsof 128 incidents at 73 hospitals whichresulted in seven deaths and 24 casesof life-threatening or permanent injuries.The study did not focus on the energysource (laser or electrocautery) nor thenumber of laparoscopic cholecystecto-mies performed during the period. It hasbeen reported that only about 8% ofdoctors performing the procedure nowdo so with a laser.

The report attributed the problemnot so much to the procedure itself,but rather to the lack of trainingand credentialing received by thesurgeons performing the pro-cedure.

Situation B. National Institutes of Health(reported in the Wall Street Journal,September 17, 1992

Finding "no evidence of safetyproblems" an NIH expert panel thisSeptember said it found a widely popularnew technique for removing the gallbladder is "both safe' and cost-effective."

The panel compared results of more

than 100,000 patients who had thelaparoscopic cholecystectomy procedurewith more than 200,000 cases of tradi-tional gallbladder surgery. The reportsays death rates from both proceduresare well under 1%, and complicationrates range from 4% to 8% in the openprocedure and 2% to 5% with thelaparoscopic technique.

The technique, introduced in the U.S.in 1988, is estimated to be used in 80%of the 500,000 gallbladder operationsdone each year.

The panel recommends the devel-opment of strict guidelines fortraining and authorizing doctorsto perform the operation.

Conclusion: The continuing successfulapplication of laser technology is directlyattributable to an understanding of fun-damentals and theory coupled withtraining in safe useage.

Our safety record appears to be gooddespite the lack of adequate reportingmechanisms in all fields where lasers arethe primary application source.

It is self-evident that expanded Edu-cation and Training programs are vitalin all of those same fields.

Articles that follow by ANSI Z136committee experts discuss education(understanding laser fundamentals andsafety) and training (how to use the laser-safely) needs in their specific areas.

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