Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority Healthcare Industry Representatives: Maximizing Benefits and Reducing Risks S everal reports submitted to PA-PSRS describe problematic actions by or reliance on healthcare industry representatives: the proliferation of new products, increasingly com- plex instrumentation, sophisticated equipment, and new procedures.7 Most medical schools do not teach students about the machines and equipment used in A procedure was delayed while a surgeon was everyday practice.4,5 Because of their knowledge and on the telephone with a sales representative, expertise about their products, HCIRs can provide trying to learn how to use a new image-guided technical support in the OR as well as in other set- surgery system. This significantly lengthened tings, such as cardiac catheterization labs or special the patient’s time under anesthesia. procedure rooms.1 Their expertise and presence may be welcome, especially during use of complex tech- A company representative photographed a nology such as cardiac pacemakers or orthopedic patient’s x-rays with his cell phone without the equipment.4,5 HCIRs may be more familiar with their patient’s permission. own devices, systems, or procedures than the multi- A sales representative incorrectly advised a faceted physician or healthcare team1 and can en- surgical services team that a drill being used hance safe product use through verbal assistance, if on trial should be gravity flash sterilized at 270 called upon. ° for 10 minutes. After the procedure, the Risks manufacturer’s literature was found to indicate As the above-mentioned PA-PSRS reports indicate, that the drill should be gravity flashed at 270° healthcare industry representatives can be inappropri- for 15 minutes. ately involved in patient care in several ways: A sales representative removed a plate press • A surgeon may inappropriately rely upon the from the shelf and opened the instrument for expertise of an HCIR, rather than directly ac- the sterile field. The circulating nurse, preoccu- quiring the training/skills necessary to use a pied with checking blood transfusion informa- technology. tion, later found holes in the outer wrap indi- cating a break in sterile technique. • An HCIR may deviate from established pro- fessional standards of conduct (for example, What is wrong with these pictures? This article pro- invasion of privacy). vides information about the role of healthcare industry representatives (HCIRs) and strategies to reduce pa- • The surgical team may rely on the HCIR’s tient safety risks. incorrect advice rather than reviewing manu- Definition facturer’s documents about the technology. HCIRs are individuals who sell, promote, and give training and advice concerning medical devices, sys- • The HCIR may become inappropriately in- tems, and procedures.1 volved as a member of or replacement for a member of the surgical team. Benefits Physicians, nurses, and technicians have a responsi- bility to obtain education and training about newtech- This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 3, No. nology, products, and equipment for use on patients.2 1—March 2006. The Advisory is a publication of the Pennsylvania Patient HCIRs can help the surgical staff stay current on rap- Safety Authority, produced by ECRI & ISMP under contract to the Authority as idly changing surgical technology.3-5 HCIRs can pro- part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). vide cutting edge knowledge to the perioperative Copyright 2006 by the Patient Safety Authority. This publication may be re- team concerning drugs, research being developed, printed and distributed without restriction, provided it is printed or distributed in and new products, so that a facility and team may its entirety and without alteration. Individual articles may be reprinted in their remain competitive in the healthcare market.6 entirety and without alteration provided the source is clearly attributed. To see other articles or issues of the Advisory, visit our web site at There is a need for technical support in the OR due to www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. ©2006 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Healthcare Industry Representatives: Maximizing Benefits and Reducing Risks (Continued) In most states, only a physician is authorized to per- be consistent with related policies on credentialing/ form surgery. While the law may provide that a physi- privileging, materials management, biomedical engi- cian may use assistants, HCIRs are not considered neering, and surgical services.1 Such policies may be appropriate assistants, as they lack facility credential- integrated into protocols relating to all outsiders in the ing.4,5 Therefore, an HCIR operating surgical equip- OR, such as visiting surgeons. The need for an HCIR ment during a procedure may be considered practic- policy applies not only to hospital ORs, but also am- ing medicine without a license.8 The presence of an bulatory surgery centers and special procedure rooms HCIR in the OR/special procedures room may also be – in fact, wherever HCIRs are admitted to witness considered a tort/wrongdoing of an invasion of privacy procedures.9,10 The protocols may specify appropriate – allowing a non-medical person to intrude in private HCIR behavior within and beyond the OR, in other matters.9,10 Touching a patient without specific con- areas of the facility.9,10 Consider how best to commu- sent may also constitute a battery.4,5,8-10 nicate the policy to surgical team members, patients, the general public, manufacturers, and HCIRs.13 Healthcare equipment and supply companies fre- quently have policies prohibiting their HCIRs from Education, Training, Competency touching patients or instruments in contact with pa- HCIRs tients, helping nurses, or participating in extraneous The education and experience of HCIRs varies con- conversations in the OR. These companies may also siderably.3,15 Some companies prepare their HCIRs to require their HCIRs to maintain technical expertise be present in the OR, with or without demonstrations/ concerning the products for which they provide tech- return demonstrations. Others rely on the facilities to nical support and to be knowledgeable about infection provide such training. There is no universally ac- control and sterility. However, these policies may not cepted set of competencies for HCIRs.7 Each com- be consistent among the various healthcare compa- pany determines how intensive or structured the train- nies. ing will be, and OR staff do not control the training It is incumbent upon the surgical services team and that companies provide their HCIRs.3 A company may facility leadership to closely monitor and regulate the have a certification program requiring an HCIR to suc- actions of all persons in the OR, including HCIRs.6 cessfully complete several hundred hours of labora- Risks can be reduced and patient safety enhanced by tory and classroom instruction as a condition of em- written policies and procedures1,4,5,11 that clearly de- ployment.15 Alternatively, the company may simply fine the role of HCIRs in the facility, how their pres- distribute written guidelines that inform an HCIR of ence is authorized, what they are and are not allowed simple OR protocols such as wearing surgical masks, to do, and how their activities are monitored.12 This donning OR attire, covering hair and shoes, and not uses the knowledge and expertise of HCIRs to best touching tables with sterile materials.15 advantage, ensuring safe use of their products, while The Credentialing Resource Center outlines the reducing the risks of having these “outsiders” in the following basic education for HCIRs: a baccalau- OR. reate degree with basic science courses in hu- Policy Formulation man anatomy and physiology, biology, chemistry, The challenge in developing your facility’s policy on and physics.1 In addition, the HCIR must know HCIRs is to strike a balance between the benefits of the medical system, device, or procedure an HCIR’s technical support and the facility’s need to (generically referred to as product). This can be ensure patient safety and privacy.12 A periodic review shown by proof of experience in the OR with that of standards from government, accreditation, and pro- product or proof of being successfully supervised fessional organizations will determine whether revi- by an experienced HCIR through a mentorship sion is required.1,11,13,14 The 2005 position statements program1,3,15 (such as providing technical support of the American College of Surgeons11 and The Asso- on at least five occasions in the past 12 months ciation of Perioperative Registered Nurses are helpful for that product).1 in policy formulation.13,14 The HCIR also must understand the standards and Multidisciplinary input in policy development and revi- policies that pertain to the OR, including: sion promotes “buy-in” to the policy from the pe- rioperative staff, surgeons, anesthesia, risk manage- • The concept of a sterile field1,8,12,14-17 ment, general counsel, and administration.13 • Aseptic technique11,18 For clarity and consistency, a policy on HCIRs should • Handwashing16 Page 2 ©2006 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Healthcare Industry Representatives: Maximizing Benefits and Reducing Risks (Continued) • Proper use of surgical attire8,16-18 and when receives a certificate that confirms competency. This to use it9,10,14,15 card has become recognized as the “gold standard” in the UK.7 In the United States, most education pro- • Universal precautions8,14,16-18 grams provide a certificate of completion or wallet • Protection from bloodborne patho- card that can be presented upon request.7 gens1,12,14,16 The AORN suggests that facilities develop a system • OR traffic patterns8-10,14-16,18 to document that HCIRs have completed education in • Infection control practices1,11,12,14,18 those areas required by the facility.12 • Tuberculosis16 If facility-specific education is provided, test/quiz re- sults can be filed. If a letter, card, or certificate of at- • Back safety 16 tendance/completion is accepted from an outside or- • Radiation safety16,17 ganization, an outline of the curriculum can be re- quested and reviewed to assure that the education is • Fire and electrical safety1,8,11,12,14,16-18 consistent with facility requirements/policies.2,7 Such (including use of fire extinguishers and fire information could be maintained in a file for each alarms, location of fire exits, overhead call HCIR.1,6 Other documentation to consider may in- codes)2,7 clude: • Patient rights and confidentiality,11,12,14-16 in- cluding HIPAA compliance1,12 • Signed attestations that the HCIR under- stands and will abide by the facility policies/ • Appropriate conduct in the OR environ- requirements.16 ment1,8,11,14,15 • Review sheets provided to the HCIR.12 • Other applicable protocols such as authori- zation for product use, patient consent, busi- • Verification of HCIR’s competency with the ness procedures1,3,11 and the role of various product for which technical assistance is to staff.18 be provided.1 Safe presence in the OR is promoted when HCIRs • Documentation that competency with the understand concepts such as sterility, asepsis, anti- product is maintained by providing technical septic, microorganisms, bacteria, sterilization, and the support for that product at least five times responsibilities of perioperative personnel.3 A lack of over the past 12 months.1 such basic information can jeopardize the patient and • Proof of continuing education pertaining to expose a facility to potential liability.3,9,10 Yet, in a the product.1 1996 survey conducted by ECRI9,10 few respondents indicated that such training and education was incor- • Letter of sponsorship from an active member porated into their policies.9,10 of the medical staff who has privileges com- patible with privileges requested by the Facilities can provide this education in different ways. HCIR.1 Some have developed self-learning modules with • Any recredentialing information for new prod- written quizzes the HCIR must complete after each ucts. section. The quizzes are graded, and individualized educational plans are developed to address deficien- • Documentation of specialized training of cies. The HCIR also signs a statement confirming that HCIRs who may perform remote calibrations he/she has read the module, understands the infor- to adjust devices to surgeons’ specifications mation and agrees to abide by it.16 (such as pacemakers).1,14 Continuing education companies offer live seminars.7 • Results of background checks.1,11 The AORN has partnered with an on-line training company to provide an OR Protocol Course for Some facilities institute an annual process of reap- HCIRs.7,19,20 The manufacturer may also provide such proval of HCIRs to help ensure competencies when information.2,12 In the United Kingdom (UK), HCIRs of HCIRs return to the facility to train a second genera- many medical device manufacturers are required to tion of personnel on a given product.1 Proof of educa- attend a hands-on course. The course is successfully tion, training, and competency can all be procured completed by passing a final examination. The HCIR prior to the HCIR entering the OR,3,16 and an HCIR ©2006 Pennsylvania Patient Safety Authority Page 3 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Healthcare Industry Representatives: Maximizing Benefits and Reducing Risks (Continued) Many facilities maintain a record of all training pro- Highlights vided in the form of attendance sign-in sheets and/or 1. Healthcare industry representatives (HCIRs) can provide competency/skills checklists.1,2,14 technical support for new products within the healthcare setting. Training by an HCIR does not abrogate the responsi- 2. Their presence in the operative setting can provide an extra bility of professionals to seek specialized training. layer of safety, but cannot substitute for proper training and Facilities may encourage staff training by offering credentialing of healthcare providers. educational time off or travel expenses. Physicians can also attend continuing education to learn the new 3. The presence of the HCIR, like any other visitor, is a privi- lege, not a right. technology, followed by obtaining additional privileges at the facility at which the new technology will be 4. The role, conduct, and confirmation of credentials (including used.4,5 credentials reflecting an adequate standard of training) of the HCIR is the responsibility not only of the representative and/ An HCIR’s intra-operative technical support is no sub- or company, but also of the healthcare facility. stitute for staff or the physician instruction before us- 5. It is important for the role, responsibilities, and behavior of the ing the new product in the OR.13 However, even with HCIR to be clearly defined, documented, and apparent to the fully trained staff and physicians, an HCIR’s presence patient (such as through informed consent). in the OR may be beneficial when a new equipment 6. Most facilities have policies that prohibit HCIRs from touching model is used or during the first few times that a new a patient directly or indirectly and from acting beyond the prosthesis is implanted.4,5 scope of providing verbal technical support concerning the use of their product. Approvals/Authorizations A facility-defined approval process in advance of 7. In 2005, the American College of Surgeons (ACS) and the HCIRs entering the OR/surgical suite1,11 allows de- Association of Perioperative Registered Nurses (AORN) each partment managers and staff to prepare for HCIR vis- issued position statements concerning HCIRs. its.2 Such preparations may include obtaining patient consent, providing an adequate work space for the may be prohibited from entering the OR without suc- HCIR and equipment, confirming that documentation cessful completion of this facility-defined credentialing of HCIR competencies exists.2 A standard protocol process.1 could include: Surgical Services Team • Which authorities must give permission for While a surgeon would generally be trained and cre- an HCIR to be present1,8,11,14 for what spe- dentialed well in advance of using a new product on a cific purpose.12 Ordinarily, physician ap- patient, other members of the surgical team may also proval of the visit would be required prior to need training in how a product will be used, closer to the procedure.1,8,11,14,15 the time of a procedure. Also at the time of a proce- dure, the HCIR may be helpful when recent product • A timeframe for securing such ap- changes have been introduced, to confirm that the proval.1,11,14,21 entire team is aware of such changes. • Biomedical Department review and approval of the new equipment/device for use in the Just as HCIRs must be trained in advance of their OR,1,13,18,21 even if use is on a trial basis,13 presence in the ORs, surgical teams must also be and confirmation that it is approved by the trained about the product prior to the day of the surgi- FDA for the intended use.6 cal procedure.2,21 If situations arise in which training needs cannot be anticipated, the surgical team would • Documenting and forwarding to Surgical Ser- at least expect training immediately prior to the surgi- vices all written authorizations and approv- cal procedure.2,21 The HCIR meets with the surgeon als. and other appropriate members of the surgical team Moreover, a standard protocol can include a require- to review the mechanism and proper function of the ment for all HCIRs, sales calls/visitors or observers in product, as well as its risks and benefits.6 This may the OR to make an advance appointment with facility help to avoid a scenario in which the surgical team leadership1,8,15,17 to facilitate procedure preparations. must learn a new product “on the fly” during a proce- Such persons would provide the following information dure. when establishing the appointment whether in the OR or anywhere else in the facility: name, supplier, ad- Page 4 ©2006 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Healthcare Industry Representatives: Maximizing Benefits and Reducing Risks (Continued) dress, phone number, product and sales information, • Immunity to hepatitis B, rubella, rubeola, department/personnel to be visited.9,10 varicella, mumps, diphtheria, tetanus.1,6 References • Proof of not having tuberculosis as confirmed As part of the HCIR approval process, Surgical Ser- by annual purified protein derivative PPDs vices may require letters of reference.1 References skin tests or chest x-rays.1 considered may include: Concerning Mycobacterium tuberculosis, the CDC • The director of the HCIR’s program of OR has specified, “Administrators of healthcare facilities protocol training. should ensure that physicians and other personnel not paid, but working in the facility, receive skin test- • The director of the training program pertain- ing at appropriate intervals for their occupational ing to the product. group and work location.”3 Such requirements would • The chief of surgery at the facility at which be similar to those required for facility healthcare the HCIR most recently provided technical workers or volunteers.7,9,10 support for the product. The facility may also require the HCIR to agree, in • A letter of sponsorship from the active medi- writing, not to enter the OR if symptoms of a conta- cal staff member with privileges consistent gious disease exist.1,6 A policy could also give the OR with the services requested by the HCIR.1 manager the authority to prevent an HCIR’s entry to This letter could also indicate that the physi- the OR if such symptoms are evident. This health- cian is responsible for the HCIR’s involve- related documentation could be maintained in a file ment in the case.1 for each HCIR. Patient Consent Security/Identification The risk of invasion of privacy or battery claims may The facility can signify approval of the HCIR’s pres- be reduced if the surgeon obtains written, informed ence by implementing several security measures. The consent from the patient concerning the HCIR’s pres- OR manager can formally introduce the HCIR to all ence in the OR.9,10 Such consent may involve the fol- members of the surgical team. The HCIR can be re- lowing concepts.1,8,11,12,14 quired to wear standard, facility-generated identifica- tion when in the OR or in any other part of the facil- • The presence and the purpose of the HCIR’s ity.1,11,14,21 Such identification could include the presence in the OR.1,8 HCIR’s name, company affiliation, destination within the facility, and date of approved presence.12 • The HCIR’s limited role and level of involve- ment.1,6 As with any other visitor, HCIRs can also be required • The benefits and risks of the new product. 6 to document in a sign-in log at the time of entering the facility/OR. The information provided can include • Clearly specifying in the informed consent if name, company, sponsor, purpose of visit, depart- an HCIR will be touching a piece of equip- ment/contact person to be visited.15,21 When the ment directly attached to the patient.6 HCIR’s pre-approved business is completed, the HCIR can be escorted from the facility.17 The patient has the right to refuse the HCIR’s pres- ence and the use of the new product for the particular Such practices are consistent with currently existing procedure.6 security practices of many facilities. Some facilities document this consent on a form that Documentation of HCIR’s Presence is separate from the surgical consent,6 and it is The circulating nurse and/or the physician should placed in the permanent part of the patient’s medical specifically document the HCIR’s presence in the OR record.8,12 This consent can be signed by the patient in the intraoperative record.9,10,12 and physician and even the HCIR before the HCIR is present in the OR.12 HCIR Role/Conduct Policies can do more than describe the limited roles Health Status of the HCIR. Written protocols can be used to restrict The facility may require the HCIR to provide written specific HCIR behaviors, as well.1,11 These restrictions evidence of good health prior to initial entry in the OR, may apply not only to the OR, but throughout the en- as follows: tire facility.9,10,15 For example, HCIRs may not be per- ©2006 Pennsylvania Patient Safety Authority Page 5 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Healthcare Industry Representatives: Maximizing Benefits and Reducing Risks (Continued) mitted to participate directly in patient care, touching • Requiring the HCIR to use a disinfectant to the patient,3,8,15 or any procedures on the patient.1,11,14 wipe any equipment not requiring sterilization HCIRs may be prohibited from scrubbing,1,11,14,15 per- that an HCIR brings into the OR.5,15 forming circulating duties,15 and serving as an extra body for opening sterile or unsterile supplies or tying • The HCIR could be required to leave the area gowns.1,13 Some facilities prohibit them from trouble- immediately when told to do so – with or with- shooting equipment made by another vendor.12 While out cause.9,10 Some reasons may include: many facilities also restrict HCIRs from manipulating upsetting a member of the OR team, interfer- equipment while in use/connected to a patient,8,13,15,21 ence with the procedure, or not complying HCIRs with specialized training may, under the sur- with instructions.17 Finally, HCIRs could be geon’s direction, adjust remote calibrations of devices denied access to specific or aggregate pa- such as pacemakers.12 tient information beyond that of the case for which the patient has con- Other HCIR requirements often include: sented. Such information is limited to a need- to-know clinical level.1 • Maintaining privacy and confidentiality at all times – of patients, staff, employees, physi- Policy Deviations cians.9,10 This could include a prohibition of Departures from policies place the facility, periopera- taking photographs/digital images in the OR tive team, HCIRs, and their companies at increased without prior knowledge and consent of the risk for litigation and compromise patient safety. Pol- patient and surgical team.6 icy breaches are less likely to occur, however, if the • Contacting only those personnel or depart- facility’s HCIR protocols are known and understood ments for which prior authorization was by the healthcare team.2 A clearly defined policy can given.9,10 Attempting to circumvent the de- support the staff in addressing such departures, re- partment’s contact would be prohibited9,10 fusing to proceed with surgery, and reporting the is- and considered grounds for removal from the sue through an established chain of command.1,14,18 facility. Some facilities report breaches (including accidental) • Unless prior arrangements were made to to the immediate supervisor for action1,14,17 and file a meet with a specific physician, not permitting risk management report.2 Corrective actions may be- HCIRs in physician’s lounges.9,10,15,17 gin with informing/educating the party. For repeated violations, the facility may contact the company and/ • Prohibiting personal or sales/marketing calls or prohibit the HCIR from entering the facility.12 If a on department telephones.9,10,15 physician repeatedly brings in HCIRs without follow- • Keeping conversation/noise level to a mini- ing authorization/credentialing policies, Surgical Ser- mum.15 vices could refer the issue to the medical staff execu- tive process for resolution.12 • Prohibiting aggressiveness, harassing, abu- sive, vulgar behavior or language,9,10,15 as If HCIR behavior is beyond the scope of policy well as behavior deemed disruptive or dis- boundaries, the circulating nurse can use the estab- tracting by the surgeon, staff, or awake pa- lished chain of command. First, the HCIR can be tients.3 asked to stop the behavior. If the behavior continues, • Negative comments about competitors, previ- the circulating nurse can notify the surgeon. If this ous HCIRs or competitors’ products could be does not resolve the issue, the nurse can contact the deemed unacceptable.9,10,15 manager/charge nurse for administrative assistance to address the behavior.21 • Prohibiting wandering throughout the depart- ment, or from room to room, or throughout The facility’s HCIR deviation policy can be integrated the facility.8,15 into the system improvement and peer review activi- ties established throughout the healthcare institution. • Removing from the OR anyone conducting unauthorized selling, marketing, or lobby- The Credentialing Resource Center suggests that ing.15,21 HCIRs go through a credentialing and privileging • Requiring HCIRs to present at in-services process that is incorporated into the facility’s medical only information previously approved by the staff/allied health professional credentialing process. OR manager/designee.5 HCIR noncompliance with facility policies may result Page 6 ©2006 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Healthcare Industry Representatives: Maximizing Benefits and Reducing Risks (Continued) not only in removal from the OR15,21 but also in termi- 8. Fogg F. Clinical issues: Identifying surgical sites; Medicare reim- bursement; artificial fingernails; acronyms; salespeople in the OR. nation of privileges without right to appeal.4,9,10 The AORN Journal 1999;69(3):657-8. facility board might consider granting HCIRs privi- 9. ECRI. Managing the risks of sales representatives in the operat- leges which, on behalf of the board, the CEO may ing room: an HRC survey. The Risk Management Reporter rescind at any time for noncompliance.1 There is no 1996;15(5):1,3-7. requirement that HCIRs be allowed in the OR.13 10. ECRI. Managing the risks of sales representatives in the oper- “Admission to the operating room is a privilege, not a ating room: an ORRM survey. Operating Room Risk Management 1996:1-6. right.”15 The privilege should be granted or maintained 11.American College of Surgeons. [ST-33] Statement on health when the benefits to the patient and providers are care industry representatives in the operating room. Statements of clear and are agreed upon.6 the College [online]. 2005 Sep [cited 2005 Nov 2]. Available from Internet: http://www.facs.org/fellows_info/statements/st-33.html. Benefits of an HCIR Policy 12. Setting boundaries for vendors in OR. OR Manager 2003;19 A comprehensive policy encourages consistency in (9):34,36,38. how HCIRs are approved and function within the facil- 13. Murphy E. The presence of sales representatives in the OR. ity/OR suite. Healthcare workers will have the protec- AORN Journal 2001;73(4):822-4. tion and support of the policy to: act upon policy de- 14. The Association of Perioperative Registered Nurses (AORN). AORN statement on the role of the health care industry representa- viations, use the chain of command, protect patient tive in the operating room. AORN Online [online]. 2005 Apr [cited safety and privacy, and institute corrections if neces- 2005 Apr 1]. Available from Internet: http://www.aorn.org/about/ sary. HCIRs will have clear expectations concerning positions/industryrep.htm. OR access and appropriate conduct/behavior. Finally, 15.Matthews K. The other side of the phone: sales representatives a policy allows patients and healthcare providers to in the OR. Today's OR Nurse 1990;12(12):21-3. 16. ECRI. Self-directed learning module: sales representatives in receive the benefit of the HCIR’s technical expertise, the operating room. Operating Room Risk Management while reducing the risks. 1998;Education/Credentialing 14:1-56. 17. Most hospitals allow salespeople in the OR. Healthcare Risk Notes Management 1999;21(1):5-6. 1. Credentialing Resource Center. Clinical privilege white pa- 18. Do you have the right policies for sales reps in OR? Hosp Peer per: health care industry representatives in the operating room. Rev 1999;24(2):24-6. Briefings on Credentialing, Supplement 2005;1010:1-11. 19. Guidelines for health care industry representatives in the oper- 2. Fox V, Duffy W, Conner R. Applying the health care industry ating room. [cited 2005 Apr 1]. Available from Internet: http:// representative statement to your setting. AORN Journal www.ormanager.com/PDF/rep. 2000;72(2):266-7, 269-73. 20. HealthStream, Inc. AORN OR Protocol [online]. 2004-2005 3. Schultz M. Sales representatives in the OR: are they pre- [cited 2006 Jan 25]. Available from Internet: http:// pared? AORN Journal 1994;59(3):651-62. www.healthstream.com/Products/STS/RepDirect/orProtocol.htm. 4. ECRI. Sales representatives and other outsiders in the OR. Health- 21. ECRI. Sample policy: health care industry representatives in care Risk Control 1999;4(Surgery and Anesthesia 24):1-10. the OR. Operating Room Risk Management 2001;Quality Assur- 5. ECRI. Sales representatives and other outsiders in the OR. ance/Risk Management 7.2:1-2. Operating Room Risk Management 1999;Quality Assurance/Risk Management 7:1-12. 6. Moltz K. Sales representatives in the operating room. QRC Advi- sor 2000;17(2):4-7. 7. Reichert M, Schultz J. Do you know about the rep in your OR? OR Manager 2004;20(2):22-3. ©2006 Pennsylvania Patient Safety Authority Page 7 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP's efforts are built on a non-punitive approach and systems-based solutions. Page 8 ©2006 Pennsylvania Patient Safety Authority