LASER SAFETY. Patient Safety

Transcription

1 ACCREDITATION STANDA RDS LASER SAFETY A wide variety f lasers are used in health care and their use cntinues t grw with advancements in health-care technlgy, equipment and prcedures. While lasers ffer several advantages such as enhanced precisin, there are als risks such as eye and skin burns, fire, txic fumes and electrical shcks. Therefre, patient safety depends n the safe and effective use f lasers by knwledgeable health-care prviders. CSA Z Safe use f lasers in health care shall be referenced in additin t this dcument. Cnsideratin has als been taken t ensure cmpliance with ANSI Z Safe use f lasers in health care, since bth the CSA Z and the ANSI Z are referenced in the WrkSafeBC Occupatinal Health and Safety (OHS) Regulatin Part 7 Divisin 3 Radiatin Expsure. The intent f this dcument is t ensure that critical elements f health-care laser safety are incrprated int current practice f nn-hspital medical and surgical facilities as well as physician ffices where lasers may be used. While the same principles can be reasnably applied t health-care lasers used in ther applicatins (e.g. esthetics, laser hair remval), it is imprtant t nte that the Cllege f Physicians and Surgens f British Clumbia has n jurisdictin ver laser practices in these settings. NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 1 f 15

2 Definitins health-care laser Any laser prduct designed, manufactured, intended r prmted fr the purpses f diagnstic, surgical, aesthetic r therapeutic laser irradiatin f any part f the human bdy. laser safety fficer (LSO) One wh is knwledgeable in the evaluatin and cntrl f laser hazards and has respnsibility fr versight f the cntrl f laser hazards. laser-cntrlled area An area where the ccupancy and activity f thse within is subject t cntrl and supervisin fr the purpse f prtectin frm radiatin hazards. maximum permissible expsure (MPE) The level f laser radiatin t which a persn can be expsed withut hazardus effects r adverse bilgical changes in the eye r skin. NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 2 f 15

3 nminal cular hazard area (NOHA) risk assessment wavelength The area within which the beam irradiance r radiant expsure exceeds the apprpriate crneal maximum permissible expsure (MPE), including the pssibility f accidental misdirectin f the laser beam. A thrugh analysis f ptential risks and hazards (beam and nn-beam) assciated with the use f health-care lasers. The prcess f risk assessment includes: nm r λ a. identificatin f physical, chemical, and bilgical hazards based n tissue interactin, dsimetry, delivery system, and practice setting b. analysis r evaluatin f the risks assciated with thse hazards c. determinatin f apprpriate cntrl measures t eliminate r cntrl the hazards Laser classificatins Class 1 Class 1M Class 2 Class 2M Class 3R Class 3B Class 4 Laser equipment emitting radiatin that is nt cnsidered hazardus even fr lng-term expsure. These lasers d nt require hazard-warning labelling. Examples include psitining and alignment lasers, lw-level laser therapy and hme-use lasers. Laser equipment emitting radiatin that is nt cnsidered hazardus fr the naked eye even fr lng-term expsure. Laser equipment emitting visible radiatin in the wavelength range frm 400 nm t 700 nm that is cnsidered safe fr expsures f duratin less than 0.25 s. Examples include alignment lasers used in aiming invisible radiatin f CO 2 and Nd:YAG lasers. Laser equipment emitting visible radiatin in the wavelength range frm 400 nm t 700 nm that is cnsidered safe fr the naked eye fr expsures f duratin less than 0.25 s. Laser equipment emitting radiatin that can exceed the MPE when viewed directly but with lw risk f permanent eye injury. Laser equipment emitting radiatin cnsidered hazardus t the skin and eyes frm direct expsure r a specular reflectin. Laser equipment emitting radiatin cnsidered hazardus t the skin and eyes frm direct expsure r a specular r diffuse reflectin. NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 3 f 15

4 The medical directr assumes verall respnsibility fr the safe use f lasers in the nnhspital facility and/r physician ffice The medical directr ensures that: a laser safety prgram is established and maintained in accrdance with CSA Z386, applicable regulatins and prfessinal standards a laser safety fficer (LSO) is appinted the LSO has successfully cmpleted LSO training thrugh a recgnized laser safety educatin prvider (e.g. Rckwell Laser Industries, Laser Institute f America) the LSO has the authrity t suspend, restrict r terminate the peratin f a laser r laser system if he/she deems that laser hazard cntrls are inadequate r unsafe cnditins are present the LSO fulfills the LSO respnsibilities in accrdance with CSA Z Safe use f lasers in health care The medical directr verifies initial and cntinuing credentials r apprvals fr all persnnel respnsible fr wrking with lasers The medical directr ensures all laser persnnel have qualificatins, credentials, educatin and training as prescribed by CSA Z386 Safe use f lasers in health care (see Appendix A) The medical directr, in cllabratin with the LSO, ensures that laser safety and educatin prgrams fr all persnnel are cnducted The laser safety fficer (LSO) is respnsible fr directing the safe use f health-care lasers and ensuring cmpliance with laser hazard cntrls The LSO is respnsible fr: the develpment and implementatin f a laser safety prgram which includes quality assurance and risk management parameters cnducting hazard evaluatins (risk assessments), including the determinatin f the NOHA, and implementing apprpriate cntrl measures the enfrcement f all laser safety plicies and prcedures advising the medical directr with respect t the safe use f lasers and cmpliance with prtective measures the investigatin f all laser-related incidents and malfunctins and making recmmendatins fr remedial and preventive actin cnducting regular laser safety surveys t detect equipment prblems r any trends tward a decrease in the level f laser safety advising n the purchase f all laser equipment (systems and instrumentatin) NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 4 f 15

5 advising n the purchase f all laser-related persnal prtective equipment (PPE) t ensure apprpriate PPE selectin auditing the effectiveness f: the laser safety prgram maintenance f apprpriate dcumentatin cmpliance with plicies and prcedures cmpliance with applicable standards and regulatins suspending, restricting, r terminating the use f a laser r laser system if laser hazard cntrls are inadequate r unsafe cnditins are present the develpment and implementatin f maintenance guidelines fr the laser system verifying that preventive maintenance, repair, and servicing are perfrmed and advising the user f any resulting changes r mdificatins t the system ensuring the safety educatin and training f all persnnel invlved in laser prcedures establishing laser safety criteria fr granting laser privileges t qualified physicians verifying and maintaining a list f laser persnnel which includes their laser-specific privileges/rle (e.g. physician, nurse, technician, prcedure, wavelength) and dcumentatin f their clinical cmpetency the develpment, implementatin and apprval f laser dcumentatin (e.g. lgs, frms, checklists) The surgen (laser user) is respnsible fr ensuring the safety f the patient and all persnnel in the laser-cntrlled area during laser set-up and use The surgen: remains in the laser rm at all times during laser usage ensures the envirnmental and prcedural cntrl measures are in place (e.g. prtective eyewear, plume evacuatrs) ensures clear cmmunicatin with the laser peratr (assistant) handles the laser delivery device and is the nly ne perating the laser ftswitch r handheld device selects the apprpriate laser parameters fr the prcedure activates, fires and/r deplys the laser reprts any unusual events and safety cncerns t the LSO NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 5 f 15

6 Administrative cntrl measures ensure the safe use f lasers Health-care lasers, used in nn-hspital facilities r physician ffices, are registered with the Cllege s Nn-Hspital Medical and Surgical Facilities Accreditatin Prgram A risk assessment, t determine engineering and prcedural cntrls, is perfrmed prir t the develpment f laser plicies and prcedural guidelines; the NOHA is reassessed if it increases fllwing repair, service r maintenance f the laser Laser safety prgram plicy and prcedures are in place and include: equipment checks, safe-use, cntrls and prtective measures (safety features, precautins during use) educatin and training f persnnel unscheduled laser system shutdwn and/r equipment malfunctin Preventin and management f pssible expsure t gases, dyes and clants Inspectins, tests, service, and maintenance Laser persnnel qualificatins, credentials, educatin, and training recrds are maintained at the facility where the laser(s) are used All individuals in the laser-cntrlled area are respnsible fr maintaining safe practices and have the authrity t halt unsafe practice. Access t laser keys is restricted t nly persnnel authrized t perate the laser Laser keys are stred away frm the laser when nt in use Material safety data sheets fr gases, dyes and clants used in the lasers are current, within the last three years, and readily available Equipment malfunctin, service and maintenance recrds are maintained at the facility where the laser(s) are used Laser persnnel educatin and training supprts a safe envirnment f care All persnnel within the laser-cntrlled area have cmpleted training specific t his/her persnnel categry/rle in accrdance with CSA Z386 Safe use f lasers in health care (see Appendix A) Laser safety and educatin prgrams are cnducted fr all persnnel: when an existing laser system is used in a new applicatin, underges a change t peratinal cmpnents (e.g. sftware upgrade, r is used with a new delivery device) when a new r replacement laser system is t be placed int service fllwing a perid f absence frm participating in laser prcedures at the request f the medical directr, LSO r the staff member cncerned at a minimum f every tw years NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 6 f 15

7 Staff have a thrugh understanding f the prcedures fr establishing and maintaining a safe envirnment during laser prcedures Persnnel have been educated abut the fire triangle and are trained in fire drills and the use f fire extinguishers Prcedural, envirnmental and engineering cntrl measures ensure the safe use f lasers General Persnnel in the laser-cntrlled area are apprved by the LSO and aware f all necessary laser safety precautins Apprpriate prtective eyewear and persnal prtective equipment (PPE) are wrn by all persnnel in the NOHA during laser use Operatr/user manuals and facility plicy and prcedures are readily available in the lasercntrlled area All laser equipment malfunctins are recrded and crrected in accrdance t CSA Z386 Safe use f lasers in health care Warning signs and visual indicatrs Laser warning signs specify the wavelength and class f laser being used and indicate persnal prtective equipment (PPE) required (e.g. prtective eyewear) Laser warning signs are placed at all entrances t the laser rm, when lasers are in use, and are remved when the laser prcedure is cmpleted Beam-related hazards Fr Class 3R, 3B, and 4 lasers, the NOHA is determined Bundaries f the laser-cntrlled area are clearly established The NOHA des nt extend beynd the bundaries f the laser-cntrlled area Lasers and laser systems are perated in a cntrlled access area Drs t the laser rm remain clsed All windws are cvered with cverings r filters with an ptical density sufficiently high t prtect against all the wavelengths f the lasers in use in the NOHA Windw barriers are labeled in accrdance with IEC , cntrllable frm inside the laser rm, d nt allw light leakage at the perimeters (see Appendix B) Reflective surfaces (e.g. jewelry, mirrrs, highly plished glass) that culd interfere with the beam path are minimized NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 7 f 15

8 Andized, dull, nn-reflective r matte-finished instruments are used whenever pssible; reflective instruments, if used, are cvered with wet spnges/twels when lasers with thermal effect are being used Fire and electrical hazards Fire extinguisher(s) are lcated in the laser-cntrlled area and are free f bstructin The envirnment is free f flammable surfaces r materials that culd interfere with the beam path Fire drills are cnducted at the frequency required by the BC Fire Cde Heating, ventilatin, and air cnditining Heating, ventilatin, and air cnditining (HVAC) systems cmply with CSA-Z317.2 Laser equipment is used in a well-ventilated area t ensure excess heat generated by the laser is remved The air intakes and utlets are unbstructed at all times Gases, dyes, and liquid clants Plicy and prcedures n the preventin and management f pssible expsure t gases, dyes, and clants, used in the laser, are in place and include: educating all persnnel in the prper handling f gases, dyes and clants develping a plan t cntain gases, dyes, and clants in the event f a leak utlining persnnel, equipment, autmatic ventilatin/exhaust and hazardus materials dispsal requirements in the event f a leak establishing an evacuatin plan referring persns expsed t gases, dyes and clants t a physician and the apprpriate health and safety persnnel If the laser is equipped with a purge gas system, purge gases are filtered and whenever pssible, CO 2 is used as a purge gas instead f medical air Eye prtectin and persnal prtective equipment (PPE) eliminate r cntrl hazards assciated with laser use Prtective eyewear has side guards and is permanently labelled with the apprpriate ptical density (OD) and wavelength Prtective eyewear is sufficiently high t prtect against the wavelength fr the laser in use Apprpriate prtective eyewear is available at each pint f access t the laser-cntrlled area Prtective eyewear is wrn by all staff in the laser rm, as apprpriate NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 8 f 15

9 Prtective eyewear and/r a prtective filter is used with ptical viewing equipment (e.g. micrscpe, endscpe, phthalmscpe) t prtect the laser user frm expsure Prtective eyewear and filters are inspected prir t use fr pitting, crazing, cracking, mechanical integrity, disclratin, and cating damage Prtective eyewear and filters are maintained accrding t manufacturer s instructins Prtective eyewear is carefully handled and stred t prevent scratches and damage (e.g. stred in individual cases r sleeves when nt in use) Patient eye prtectin is selected accrding t the psitining f the patient, bdy part t be treated, level f anesthesia and laser wavelength and delivery system Laser equipment is set-up and mnitred fr safe peratin General The duties f each persn inside the laser-cntrlled area are clearly assigned The laser is perated by authrized persnnel nly The health care laser, at a minimum, includes the fllwing safety features: a pwer meter (r an energy meter in the case f a pulsed laser) capable f indicating tissue incident pwer fr Classes 3R, 3B, and 4 lasers; in the case f pulsed lasers, the energy meter indicates the average pwer f the laser, r the number f pulses per secnd, r bth, as well as the pulse energy (per pulse) a remvable key (i.e. the laser shall be inperable withut key) r similar device withut a key (i.e. keybard r ther means fr n/ff mechanism) fr Classes 3R, 3B, and 4 lasers a visual warning activated during laser emissin (in sme circumstances, an audible warning may als be present) a switch guard t prevent unintended peratin f the laser system (e.g. a guarded ft pedal) a laser perating manual that thrughly addresses its use and assciated hazards Only the manufacturer s laser delivery devices are used n the laser A laser safety checklist is cmpleted fr each prcedure Pre-peratin All cntrl measures are in place and functining (e.g. warning signs psted, windws cvered, persnal prtective equipment checked and dnned) The laser equipment is visually inspected fr ptential malfunctins r damage The laser system, including delivery system, micrscpe and lens, beam alignment, fiber and waveguide, is checked, tested and calibrated in accrdance with manufacturer s instructins befre peratin NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 9 f 15

10 The laser is in standby r ff mde (r shut dwn and key remved) when nt in use (r if laser use is delayed) Access t water/saline is immediately available Wet clths/drapes are n hand t prtect nn-targeted areas as needed Lasers are nt activated until flammable agents (e.g. skin prep, tinctures etc.) are dry and vaprs have dissipated Patient is fitted with prper prtective equipment, if indicated During laser peratin All aspects f laser and laser-related device use are mnitred at all times when the laser is in ready mde The laser user (physician) and the laser peratr (assistant) are in the rm at all times during laser usage The laser peratr (assistant) remains at the cntrl panel when the laser is in ready mde Gd cmmunicatin between the laser user and laser peratr (e.g. regarding status f laser and parameters) is maintained Apprpriate laser parameters fr a given clinical applicatin are selected by the laser user (physician) The laser user (physician) handling the laser delivery device is the nly ne perating the laser ftswitch r hand-held device The ftswitch is nt bagged, as this can cause inadvertent firing Apprpriate eye and skin prtectin is emplyed by all persnnel, if indicated Plume is captured and evacuated in accrdance with CSA Z Spnges and drapes near the surgical site are kept mist when using a laser Endtracheal (ET) tube prcedures A medical prtcl fr management f the airway during laser surgery is in place Laser-resistant endtracheal tubes purpsely manufactured fr laser airway prcedures are used ET tubes are selected based n the wavelength f laser t be used and prf f manufacturer s testing within the surgical parameters anticipated during the surgery If the ET tube is taped t the patient s tissue r materials n the surgical field, nn-flammable tape is used The CO 2 laser is tested fr caxial alignment f laser beams, and prper beam mde, prir t the patient underging anesthesia The laser peratr (assistant) des nt place the laser in the ready mde until a verbal rder is given t hld ventilatin NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 10 f 15

11 Prtectin f the patient s face and eyes is prvided by applying wet eye pads, metal shields taped int place by nn-flammable tape, and wet twels placed ver the face The patient s teeth are prtected by a nn-flammable tth guard cvered with wet gauze r alternative methds apprved by the LSO and the surgen Cttn patties used t pack the inflated ET tube cuff are included in the surgical cunt Pst-peratin The laser is turned ff/shut dwn befre it is mved utside the laser-cntrlled area All unusual events and safety cncerns are reprted t the LSO Laser dcumentatin prvides an accurate accunt f the patient s status, the actins f the laser team and the patient s utcme Laser prcedure dcumentatin included in the medical recrd includes: type f laser used (e.g. wavelength, serial r bimedical number) laser settings and parameters safety measures implemented during laser use surgical prcedure n/ff laser activatin and deactivatin time fr head, neck and chest prcedures patient prtectin (e.g. eye prtectin) Laser safety checklist dcumentatin includes: perfrming a laser self-test check befre the patient is brught int the rm calibrating the laser, as apprpriate cnducting a test fire f the laser psting laser in use signs at all entrances t the prcedure rm prviding apprpriate eye prtectin cvering the windws f the prcedure rm, as apprpriate checking the availability f saline at the surgical field checking the apprpriate type and availability f fire extinguisher fr the laser being used A laser utilizatin recrd fr each laser system is maintained and includes: patient identificatin date, treatment and lcatin equipment identificatin wavelength f laser laser user laser peratr peratinal prcedures NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 11 f 15

12 delivery system (e.g. bjective lenses, fibre size, lt number, serial number) range f treatment parameters, e.g. pwer (watts), energy (jules), pulse duratin, pulse repetitin rate, ttal energy (delivered) signature f the laser peratr recrd f laser system shutdwns Appendix A: Educatin and training f laser persnnel Level 1 Laser Training This is necessary fr: nn-clinical facility persnnel wh are invlved in the management f the laser prgram r laser services bservers trainees The cntent includes, but is nt limited t: verview f CSA Z386 Safe use f lasers in health care facility plicy and prcedure types f lasers used and general applicatins in the facility rles, authrity and respnsibilities f laser team members cntact infrmatin fr the LSO Level 2 Laser Training This is necessary fr: laser peratr (assistant) This includes: level 1 laser training The cntent includes, but is nt limited t: laser physics laser-tissue interactin types f lasers and their delivery systems accessry equipment and instrumentatin needed fr specific applicatins understanding treatment parameters and dsimetry rles, authrity, and respnsibilities f laser team members assessment f hazards and risks NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 12 f 15

13 reprting applicable dcumentatin Level 3 Laser Training This is necessary fr: This includes: laser safety fficer (LSO) level 2 laser training The cntent includes, but is nt limited t: all items in level 1 and 2 training regulatry requirements in the specific jurisdictin applicatin f CSA Z386 Safe use f lasers in health care hazard identificatin and implementatin f applicable cntrl measures facility reprting fr accidents, incidents r ccurrences Level 4 Laser Training This is necessary fr: laser users (physician) The cntent includes, but is nt limited t: all items in level 1 and 2 training clinical applicatin and techniques fr intended prcedures treatment parameters and dsimetry fr intended prcedures patient safety management f cmplicatins cmpetency in perating the laser and its delivery systems cmpetency in use f safety equipment (e.g. prtective eyewear, emergency stp switch, standby switch, plume evacuatr, micrscpe eye safety filters, accessry instrumentatin, fire extinguisher, wet drapes, etc.) NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 13 f 15

14 Appendix B: Signage and labels IEC Safety f laser prducts Part 1: Equipment classificatin, requirements and user s guide (referenced by CSA Z ) IEC Safety f laser prducts Part 1: Equipment classificatin, requirements and user s guide des nt directly specify labelling f laser guards (e.g. barriers, windws) IEC Safety f laser prducts Part 4: Laser guards addresses specificatins n laser guards (e.g. barriers, windws) IEC Safety f laser prducts Part 4: Laser guards labeling requirements Full specificatin f a prtective expsure limit (PEL) (fr passive laser guard): the magnitude and variatin with time f irradiance r radiant expsure at the frnt surface f the laser guard (in units f Wm-2 r Jm-2 respectively), specifying any upper limit t the area f expsure the verall duratin f expsure under these cnditins the wavelength fr which this PEL applies the angle f incidence and (if relevant) the plarizatin f the incident laser radiatin any minimum dimensins t the irradiated area The manufacturer s name, the date and place f manufacture accrding t ISO , and a statement f cmpliance with IEC ANSI Z136.7 Testing and Labeling f Laser Prtective Equipment Windw labeling Permanently labelled by the final manufacturer Legibly marked with: manufacturer (r registered trademark) mdel ptical density (r minimum OD ver crrespnding wavelength range) wavelength (r wavelength range) Barrier labeling Permanently labelled by the final manufacturer Legibly marked with: manufacturer (r registered trademark) mdel threshld limit (TL) expsure time fr which the limit applies NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 14 f 15

15 expsure cnditins References American Natinal Standards Institute (ANSI). Safe use f lasers in health care. Washingtn, DC: American Natinal Standards Institute; ANSI standard N: Z American Natinal Standards Institute (ANSI). Testing and labeling f laser prtective equipment. Washingtn, DC: American Natinal Standards Institute; ANSI standard N: Z Assciatin f perioperative Registered Nurses (AORN)]. Periperative standards and recmmended practices: 2014 editin. Denver, CO: Assciatin f perioperative Registered Nurses; Recmmended practices fr laser safety in periperative practice settings; p BC Centre fr Disease Cntrl, Health & Yur Envirnment. [Internet]. Vancuver: BC Centre fr Disease Cntrl; [2013 Jun 4]. General laser guidelines. [cited 2015 Mar26]; [abut 3 screens]. Available frm: British Clumbia, Office f Husing and Cnstructin Standards; Natinal Research Cuncil Canada. British Clumbia fire cde Victria, BC : Office f Husing and Cnstructin Standards; Divisin B - part 2: sectin 2.8 emergency planning fire drill frequency. [1 p.]. Canadian Standards Assciatin. Safe use f lasers in health care. Trnt: Canadian Standards Assciatin; p. CSA Standard N.: Z Internatinal Electrtechnical Cmmissin (IEC). Safety f laser prducts - part 4: laser guards. Geneva: Internatinal Electrtechnical Cmmissin, IEC standard N: :2006. Operating Rm Nurses Assciatin f Canada (ORNAC). Standards, guidelines, and psitin statements fr periperative registered nursing practice. 10th ed. [place unknwn]: ORNAC; Sectin 3: safety/risk preventin and management Laser safety and administratin. p WrkSafeBC, OHS, Guidelines. Part 7: Nise, vibratin, radiatin and temperature [Internet]. Richmnd, BC: WrkSafe BC; 2014 [cited 2015 Mar 26 3]; [abut 9 screens]. Available frm: WrkSafe BC, OHS Regulatin & Related Materials. Part 7: Nise, vibratin, radiatin and temperature [Internet]. Richmnd, BC: WrkSafe BC; 2014 [cited 2015 Mar 26 3]; [abut 9 screens]. Available frm: NHMSFAP Cllege f Physicians and Surgens f British Clumbia Page 15 f 15