Introduction

Several reports submitted to PA-PSRS describe problematic actions by or reliance on healthcare industry representatives:

A procedure was delayed while a surgeon was on the telephone with a sales representative, trying to learn how to use a new image-guided surgery system. This significantly lengthened the patient’s time under anesthesia.

A company representative photographed a patient’s x-rays with his cell phone without the patient’s permission.

A sales representative incorrectly advised a surgical services team that a drill being used on trial should be gravity flash sterilized at 270° for 10 minutes. After the procedure, the manufacturer’s literature was found to indicate that the drill should be gravity flashed at 270° for 15 minutes.

A sales representative removed a plate press from the shelf and opened the instrument for the sterile field. The circulating nurse, preoccupied with checking blood transfusion information, later found holes in the outer wrap indicating a break in sterile technique.

What is wrong with these pictures? This article provides information about the role of healthcare industry representatives (HCIRs) and strategies to reduce patient safety risks.

Definition

HCIRs are individuals who sell, promote, and give training and advice concerning medical devices, systems, and procedures.¹

Benefits

Physicians, nurses, and technicians have a responsibility to obtain education and training about newtechnology, products, and equipment for use on patients.² HCIRs can help the surgical staff stay current on rapidly changing surgical technology.^3-5 HCIRs can provide cutting edge knowledge to the perioperative team concerning drugs, research being developed, and new products, so that a facility and team may remain competitive in the healthcare market.⁶

There is a need for technical support in the OR due to the proliferation of new products, increasingly complex instrumentation, sophisticated equipment, and new procedures.⁷ Most medical schools do not teach students about the machines and equipment used in everyday practice.^4,5 Because of their knowledge and expertise about their products, HCIRs can provide technical support in the OR as well as in other settings, such as cardiac catheterization labs or special procedure rooms.¹ Their expertise and presence may be welcome, especially during use of complex technology such as cardiac pacemakers or orthopedic equipment.^4,5 HCIRs may be more familiar with their own devices, systems, or procedures than the multifaceted physician or healthcare team¹ and can enhance safe product use through verbal assistance, if called upon.

Risks

As the above-mentioned PA-PSRS reports indicate, healthcare industry representatives can be inappropriately involved in patient care in several ways:

• A surgeon may inappropriately rely upon the expertise of an HCIR, rather than directly acquiring the training/skills necessary to use a technology.
• An HCIR may deviate from established professional standards of conduct (for example, invasion of privacy).
• The surgical team may rely on the HCIR’s incorrect advice rather than reviewing manufacturer’s documents about the technology.
• The HCIR may become inappropriately involved as a member of or replacement for a member of the surgical team.

In most states, only a physician is authorized to perform surgery. While the law may provide that a physician may use assistants, HCIRs are not considered appropriate assistants, as they lack facility credentialing.^4,5 Therefore, an HCIR operating surgical equipment during a procedure may be considered practicing medicine without a license.⁸ The presence of an HCIR in the OR/special procedures room may also be considered a tort/wrongdoing of an invasion of privacy – allowing a non-medical person to intrude in private matters.^9,10 Touching a patient without specific consent may also constitute a battery.^4,5,8-10

Healthcare equipment and supply companies frequently have policies prohibiting their HCIRs from touching patients or instruments in contact with patients, helping nurses, or participating in extraneous conversations in the OR. These companies may also require their HCIRs to maintain technical expertise concerning the products for which they provide technical support and to be knowledgeable about infection control and sterility. However, these policies may not be consistent among the various healthcare companies.

It is incumbent upon the surgical services team and facility leadership to closely monitor and regulate the actions of all persons in the OR, including HCIRs.⁶ Risks can be reduced and patient safety enhanced by written policies and procedures^1,4,5,11 that clearly define the role of HCIRs in the facility, how their presence is authorized, what they are and are not allowed to do, and how their activities are monitored.¹² This uses the knowledge and expertise of HCIRs to best advantage, ensuring safe use of their products, while reducing the risks of having these “outsiders” in the OR.

Policy Formulation

The challenge in developing your facility’s policy on HCIRs is to strike a balance between the benefits of an HCIR’s technical support and the facility’s need to ensure patient safety and privacy.¹² A periodic review of standards from government, accreditation, and professional organizations will determine whether revision is required.^1,11,13,14 The 2005 position statements of the American College of Surgeons¹¹ and The Association of Perioperative Registered Nurses are helpful in policy formulation.^13,14

Multidisciplinary input in policy development and revision promotes “buy-in” to the policy from the perioperative staff, surgeons, anesthesia, risk management, general counsel, and administration.¹³

For clarity and consistency, a policy on HCIRs should be consistent with related policies on credentialing/privileging, materials management, biomedical engineering, and surgical services.¹ Such policies may be integrated into protocols relating to all outsiders in the OR, such as visiting surgeons. The need for an HCIR policy applies not only to hospital ORs, but also ambulatory surgery centers and special procedure rooms – in fact, wherever HCIRs are admitted to witness procedures.^9,10 The protocols may specify appropriate HCIR behavior within and beyond the OR, in other areas of the facility.^9,10 Consider how best to communicate the policy to surgical team members, patients, the general public, manufacturers, and HCIRs.¹³

Education, Training, Competency

HCIRs

The education and experience of HCIRs varies considerably.^3,15 Some companies prepare their HCIRs to be present in the OR, with or without demonstrations/return demonstrations. Others rely on the facilities to provide such training. There is no universally accepted set of competencies for HCIRs.⁷ Each company determines how intensive or structured the training will be, and OR staff do not control the training that companies provide their HCIRs.³ A company may have a certification program requiring an HCIR to successfully complete several hundred hours of laboratory and classroom instruction as a condition of employment.¹⁵ Alternatively, the company may simply distribute written guidelines that inform an HCIR of simple OR protocols such as wearing surgical masks, donning OR attire, covering hair and shoes, and not touching tables with sterile materials.¹⁵

The Credentialing Resource Center outlines the following basic education for HCIRs: a baccalaureate degree with basic science courses in human anatomy and physiology, biology, chemistry, and physics.¹ In addition, the HCIR must know the medical system, device, or procedure (generically referred to as product). This can be shown by proof of experience in the OR with that product or proof of being successfully supervised by an experienced HCIR through a mentorship program^1,3,15 (such as providing technical support on at least five occasions in the past 12 months for that product).¹

The HCIR also must understand the standards and policies that pertain to the OR, including:

• The concept of a sterile field^1,8,12,14-17
• Aseptic technique^11,18
• Handwashing¹⁶
• Proper use of surgical attire^8,16-18 and when to use it^9,10,14,15
• Universal precautions^8,14,16-18
• Protection from bloodborne pathogens^1,12,14,16
• OR traffic patterns^{8-10,14-16,18}
• Infection control practices^{1,11,12,14,18}
• Tuberculosis¹⁶
• Back safety¹⁶
• Radiation safety^16,17
• Fire and electrical safety^{1,8,11,12,14,16-18} (including use of fire extinguishers and fire alarms, location of fire exits, overhead call codes)^2,7
• Patient rights and confidentiality,^11,12,14-16 including HIPAA compliance^1,12
• Appropriate conduct in the OR environment^1,8,11,14,15
• Other applicable protocols such as authorization for product use, patient consent, business procedures^1,3,11 and the role of various staff.¹⁸

Safe presence in the OR is promoted when HCIRs understand concepts such as sterility, asepsis, antiseptic, microorganisms, bacteria, sterilization, and the responsibilities of perioperative personnel.³ A lack of such basic information can jeopardize the patient and expose a facility to potential liability.^3,9,10 Yet, in a 1996 survey conducted by ECRI^9,10 few respondents indicated that such training and education was incorporated into their policies.^9,10

Facilities can provide this education in different ways. Some have developed self-learning modules with written quizzes the HCIR must complete after each section. The quizzes are graded, and individualized educational plans are developed to address deficiencies. The HCIR also signs a statement confirming that he/she has read the module, understands the information and agrees to abide by it.¹⁶

Continuing education companies offer live seminars.⁷ The AORN has partnered with an on-line training company to provide an OR Protocol Course for HCIRs.^7,19,20 The manufacturer may also provide such information.^2,12 In the United Kingdom (UK), HCIRs of many medical device manufacturers are required to attend a hands-on course. The course is successfully completed by passing a final examination. The HCIR receives a certificate that confirms competency. This card has become recognized as the “gold standard” in the UK.⁷ In the United States, most education programs provide a certificate of completion or wallet card that can be presented upon request.⁷

The AORN suggests that facilities develop a system to document that HCIRs have completed education in those areas required by the facility.¹²

If facility-specific education is provided, test/quiz results can be filed. If a letter, card, or certificate of attendance/completion is accepted from an outside organization, an outline of the curriculum can be requested and reviewed to assure that the education is consistent with facility requirements/policies.^2,7 Such information could be maintained in a file for each HCIR.^1,6 Other documentation to consider may include:

• Signed attestations that the HCIR understands and will abide by the facility policies/requirements.¹⁶
• Review sheets provided to the HCIR.¹²
• Verification of HCIR’s competency with the product for which technical assistance is to be provided.¹
• Documentation that competency with the product is maintained by providing technical support for that product at least five times over the past 12 months.¹
• Proof of continuing education pertaining to the product.¹
• Letter of sponsorship from an active member of the medical staff who has privileges compatible with privileges requested by the HCIR.¹
• Any recredentialing information for new products.
• Documentation of specialized training of HCIRs who may perform remote calibrations to adjust devices to surgeons’ specifications (such as pacemakers).^1,14
• Results of background checks.^1,11

Some facilities institute an annual process of reapproval of HCIRs to help ensure competencies when HCIRs return to the facility to train a second generation of personnel on a given product.¹ Proof of education, training, and competency can all be procured prior to the HCIR entering the OR,^3,16 and an HCIR may be prohibited from entering the OR without successful completion of this facility-defined credentialing process.¹  

Surgical Services Team

While a surgeon would generally be trained and credentialed well in advance of using a new product on a patient, other members of the surgical team may also need training in how a product will be used, closer to the time of a procedure. Also at the time of a procedure, the HCIR may be helpful when recent product changes have been introduced, to confirm that the entire team is aware of such changes.

Just as HCIRs must be trained in advance of their presence in the ORs, surgical teams must also be trained about the product prior to the day of the surgical procedure.^2,21 If situations arise in which training needs cannot be anticipated, the surgical team would at least expect training immediately prior to the surgical procedure.^2,21 The HCIR meets with the surgeon and other appropriate members of the surgical team to review the mechanism and proper function of the product, as well as its risks and benefits.⁶ This may help to avoid a scenario in which the surgical team must learn a new product “on the fly” during a procedure.

Many facilities maintain a record of all training provided in the form of attendance sign-in sheets and/or competency/skills checklists.^1,2,14

Training by an HCIR does not abrogate the responsibility of professionals to seek specialized training. Facilities may encourage staff training by offering educational time off or travel expenses. Physicians can also attend continuing education to learn the new technology, followed by obtaining additional privileges at the facility at which the new technology will be used.^4,5

An HCIR’s intra-operative technical support is no substitute for staff or the physician instruction before using the new product in the OR.¹³ However, even with fully trained staff and physicians, an HCIR’s presence in the OR may be beneficial when a new equipment model is used or during the first few times that a new prosthesis is implanted.^4,5

Approvals/Authorizations

A facility-defined approval process in advance of HCIRs entering the OR/surgical suite^1,11 allows department managers and staff to prepare for HCIR visits.² Such preparations may include obtaining patient consent, providing an adequate work space for the HCIR and equipment, confirming that documentation of HCIR competencies exists.² A standard protocol could include:

• Which authorities must give permission for an HCIR to be present^1,8,11,14 for what specific purpose.¹² Ordinarily, physician approval of the visit would be required prior to the procedure.^1,8,11,14,15
• A timeframe for securing such approval.^1,11,14,21
• Biomedical Department review and approval of the new equipment/device for use in the OR,^1,13,18,21 even if use is on a trial basis,¹³ and confirmation that it is approved by the FDA for the intended use.⁶
• Documenting and forwarding to Surgical Services all written authorizations and approvals.

Moreover, a standard protocol can include a requirement for all HCIRs, sales calls/visitors or observers in the OR to make an advance appointment with facility leadership^1,8,15,17 to facilitate procedure preparations. Such persons would provide the following information when establishing the appointment whether in the OR or anywhere else in the facility: name, supplier, address, phone number, product and sales information, department/personnel to be visited.^9,10

References

As part of the HCIR approval process, Surgical Services may require letters of reference.¹ References considered may include:

• The director of the HCIR’s program of OR protocol training.
• The director of the training program pertaining to the product.
• The chief of surgery at the facility at which the HCIR most recently provided technical support for the product.
• A letter of sponsorship from the active medical staff member with privileges consistent with the services requested by the HCIR.¹ This letter could also indicate that the physician is responsible for the HCIR’s involvement in the case.¹

Patient Consent

The risk of invasion of privacy or battery claims may be reduced if the surgeon obtains written, informed consent from the patient concerning the HCIR’s presence in the OR.^9,10 Such consent may involve the following concepts.^1,8,11,12,14

• The presence and the purpose of the HCIR’s presence in the OR.^1,8
• The HCIR’s limited role and level of involvement.^1,6
• The benefits and risks of the new product.⁶
• Clearly specifying in the informed consent if an HCIR will be touching a piece of equipment directly attached to the patient.⁶

The patient has the right to refuse the HCIR’s presence and the use of the new product for the particular procedure.⁶

Some facilities document this consent on a form that is separate from the surgical consent,⁶ and it is placed in the permanent part of the patient’s medical record.^8,12 This consent can be signed by the patient and physician and even the HCIR before the HCIR is present in the OR.¹²

Health Status

The facility may require the HCIR to provide written evidence of good health prior to initial entry in the OR, as follows:

• Immunity to hepatitis B, rubella, rubeola, varicella, mumps, diphtheria, tetanus.^1,6
• Proof of not having tuberculosis as confirmed by annual purified protein derivative PPDs skin tests or chest x-rays.¹ 

Concerning Mycobacterium tuberculosis, the CDC has specified, “Administrators of healthcare facilities should ensure that physicians and other personnel not paid, but working in the facility, receive skin testing at appropriate intervals for their occupational group and work location.”³ Such requirements would be similar to those required for facility healthcare workers or volunteers.^7,9,10

The facility may also require the HCIR to agree, in writing, not to enter the OR if symptoms of a contagious disease exist.^1,6 A policy could also give the OR manager the authority to prevent an HCIR’s entry to the OR if such symptoms are evident. This health-related documentation could be maintained in a file for each HCIR.

Security/Identification

The facility can signify approval of the HCIR’s presence by implementing several security measures. The OR manager can formally introduce the HCIR to all members of the surgical team. The HCIR can be required to wear standard, facility-generated identification when in the OR or in any other part of the facility.^1,11,14,21 Such identification could include the HCIR’s name, company affiliation, destination within the facility, and date of approved presence.¹²

As with any other visitor, HCIRs can also be required to document in a sign-in log at the time of entering the facility/OR. The information provided can include name, company, sponsor, purpose of visit, department/contact person to be visited.^15,21 When the HCIR’s pre-approved business is completed, the HCIR can be escorted from the facility.¹⁷

Such practices are consistent with currently existing security practices of many facilities.

Documentation of HCIR’s Presence

The circulating nurse and/or the physician should specifically document the HCIR’s presence in the OR in the intraoperative record.^9,10,12

HCIR Role/Conduct

Policies can do more than describe the limited roles of the HCIR. Written protocols can be used to restrict specific HCIR behaviors, as well.^1,11 These restrictions may apply not only to the OR, but throughout the entire facility.^9,10,15 For example, HCIRs may not be permitted to participate directly in patient care, touching the patient,^3,8,15 or any procedures on the patient.^1,11,14 HCIRs may be prohibited from scrubbing,^1,11,14,15 performing circulating duties,¹⁵ and serving as an extra body for opening sterile or unsterile supplies or tying gowns.^1,13 Some facilities prohibit them from troubleshooting equipment made by another vendor.¹² While many facilities also restrict HCIRs from manipulating equipment while in use/connected to a patient,^8,13,15,21 HCIRs with specialized training may, under the surgeon’s direction, adjust remote calibrations of devices such as pacemakers.¹²

Other HCIR requirements often include:

• Maintaining privacy and confidentiality at all times – of patients, staff, employees, physicians.^9,10 This could include a prohibition of taking photographs/digital images in the OR without prior knowledge and consent of the patient and surgical team.⁶
• Contacting only those personnel or departments for which prior authorization was given.^9,10 Attempting to circumvent the department’s contact would be prohibited^9,10 and considered grounds for removal from the facility.
• Unless prior arrangements were made to meet with a specific physician, not permitting HCIRs in physician’s lounges.^9,10,15,17
• Prohibiting personal or sales/marketing calls on department telephones.^9,10,15
• Keeping conversation/noise level to a minimum.¹⁵
• Prohibiting aggressiveness, harassing, abusive, vulgar behavior or language,^9,10,15 as well as behavior deemed disruptive or distracting by the surgeon, staff, or awake patients.³
• Negative comments about competitors, previous HCIRs or competitors’ products could be deemed unacceptable.^9,10,15
• Prohibiting wandering throughout the department, or from room to room, or throughout the facility.^8,15
• Removing from the OR anyone conducting unauthorized selling, marketing, or lobbying.^15,21
• Requiring HCIRs to present at in-services only information previously approved by the OR manager/designee.⁵
• Requiring the HCIR to use a disinfectant to wipe any equipment not requiring sterilization that an HCIR brings into the OR.^5,15
• The HCIR could be required to leave the area immediately when told to do so – with or without cause.^9,10 Some reasons may include: upsetting a member of the OR team, interference with the procedure, or not complying with instructions.¹⁷ Finally, HCIRs could be denied access to specific or aggregate patient information beyond that of the case for which the patient has consented. Such information is limited to a need-to-know clinical level.¹

Policy Deviations

Departures from policies place the facility, perioperative team, HCIRs, and their companies at increased risk for litigation and compromise patient safety. Policy breaches are less likely to occur, however, if the facility’s HCIR protocols are known and understood by the healthcare team.² A clearly defined policy can support the staff in addressing such departures, refusing to proceed with surgery, and reporting the issue through an established chain of command.^1,14,18

Some facilities report breaches (including accidental) to the immediate supervisor for action^1,14,17 and file a risk management report.² Corrective actions may begin with informing/educating the party. For repeated violations, the facility may contact the company and/or prohibit the HCIR from entering the facility.¹² If a physician repeatedly brings in HCIRs without following authorization/credentialing policies, Surgical Services could refer the issue to the medical staff executive process for resolution.¹²

If HCIR behavior is beyond the scope of policy boundaries, the circulating nurse can use the established chain of command. First, the HCIR can be asked to stop the behavior. If the behavior continues, the circulating nurse can notify the surgeon. If this does not resolve the issue, the nurse can contact the manager/charge nurse for administrative assistance to address the behavior.²¹

The facility’s HCIR deviation policy can be integrated into the system improvement and peer review activities established throughout the healthcare institution.

The Credentialing Resource Center suggests that HCIRs go through a credentialing and privileging process that is incorporated into the facility’s medical staff/allied health professional credentialing process. HCIR noncompliance with facility policies may result not only in removal from the OR^15,21 but also in termination of privileges without right to appeal.^4,9,10 The facility board might consider granting HCIRs privileges which, on behalf of the board, the CEO may rescind at any time for noncompliance.¹

There is no requirement that HCIRs be allowed in the OR.¹³ “Admission to the operating room is a privilege, not a right.”¹⁵ The privilege should be granted or maintained when the benefits to the patient and providers are clear and are agreed upon.⁶  

Benefits of an HCIR Policy

A comprehensive policy encourages consistency in how HCIRs are approved and function within the facility/OR suite. Healthcare workers will have the protection and support of the policy to: act upon policy deviations, use the chain of command, protect patient safety and privacy, and institute corrections if necessary. HCIRs will have clear expectations concerning OR access and appropriate conduct/behavior. Finally, a policy allows patients and healthcare providers to receive the benefit of the HCIR’s technical expertise, while reducing the risks.

Notes

1. Credentialing Resource Center. Clinical privilege white paper: health care industry representatives in the operating room. Briefings on Credentialing, Supplement 2005;1010:1-11.
2. Fox V, Duffy W, Conner R. Applying the health care industry representative statement to your setting. AORN Journal 2000;72(2):266-7, 269-73.
3. Schultz M. Sales representatives in the OR: are they prepared? AORN Journal 1994;59(3):651-62.
4. ECRI. Sales representatives and other outsiders in the OR. Healthcare Risk Control 1999;4(Surgery and Anesthesia 24):1-10.
5. ECRI. Sales representatives and other outsiders in the OR. Operating Room Risk Management 1999;Quality Assurance/Risk Management 7:1-12.
6. Moltz K. Sales representatives in the operating room. QRC Advisor 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.
8. Fogg F. Clinical issues: Identifying surgical sites; Medicare reimbursement; artificial fingernails; acronyms; salespeople in the OR. AORN Journal 1999;69(3):657-8.
9. ECRI. Managing the risks of sales representatives in the operating room: an HRC survey. The Risk Management Reporter 1996;15(5):1,3-7.
10. ECRI. Managing the risks of sales representatives in the operating room: an ORRM survey. Operating Room Risk Management 1996:1-6.
11. American College of Surgeons. [ST-33] Statement on health care industry representatives in the operating room. Statements of the College [online]. 2005 Sep [cited 2005 Nov 2]. Available from Internet: http://www.facs.org/fellows_info/statements/st-33.html.
12. Setting boundaries for vendors in OR. OR Manager 2003;19(9):34,36,38.
13. Murphy E. The presence of sales representatives in the OR. AORN Journal 2001;73(4):822-4.
14. The Association of Perioperative Registered Nurses (AORN). AORN statement on the role of the health care industry representative in the operating room. AORN Online [online]. 2005 Apr [cited 2005 Apr 1]. Available from Internet: http://www.aorn.org/about/positions/industryrep.htm.
15. Matthews K. The other side of the phone: sales representatives in the OR. Today's OR Nurse 1990;12(12):21-3.
16. ECRI. Self-directed learning module: sales representatives in the operating room. Operating Room Risk Management 1998;Education/Credentialing 14:1-56.
17. Most hospitals allow salespeople in the OR. Healthcare Risk Management 1999;21(1):5-6.
18. Do you have the right policies for sales reps in OR? Hosp Peer Rev 1999;24(2):24-6.
19. Guidelines for health care industry representatives in the operating room. [cited 2005 Apr 1]. Available from Internet: http://www.ormanager.com/PDF/rep.
20. HealthStream, Inc. AORN OR Protocol [online]. 2004-2005 [cited 2006 Jan 25]. Available from Internet: http://www.healthstream.com/Products/STS/RepDirect/orProtocol.htm.
21. ECRI. Sample policy: health care industry representatives in the OR. Operating Room Risk Management 2001;Quality Assurance/Risk Management 7.2:1-2.

Supplemental Material

Highlights     

1. Healthcare industry representatives (HCIRs) can provide technical support for new products within the healthcare setting.
2. Their presence in the operative setting can provide an extra layer of safety, but cannot substitute for proper training and credentialing of healthcare providers.
3. The presence of the HCIR, like any other visitor, is a privilege, not a right.
4. The role, conduct, and confirmation of credentials (including credentials reflecting an adequate standard of training) of the HCIR is the responsibility not only of the representative and/or company, but also of the healthcare facility.
5. It is important for the role, responsibilities, and behavior of the HCIR to be clearly defined, documented, and apparent to the patient (such as through informed consent).
6. Most facilities have policies that prohibit HCIRs from touching a patient directly or indirectly and from acting beyond the scope of providing verbal technical support concerning the use of their product.
7. In 2005, the American College of Surgeons (ACS) and the Association of Perioperative Registered Nurses (AORN) each issued position statements concerning HCIRs.