Healthcare Industry Representatives Research Articles

AORN Position Statement on the Role of the Health Care Industry Representative in Perioperative Settings

<scp>AORN</scp> Position Statement on the Role of the Health Care Industry Representative in Perioperative Settings

Involving Patients in Research? Responsible Research and Innovation in Small- and Medium-Sized European Health Care Enterprises-ADDENDUM.

Health research is generally undertaken to resolve existing health problems or enhance existing solutions. Research ethics committees have been the main governance tool for research for more than half a century. Their role is to ensure that research is undertaken ethically. To close the increasing gap between science and society, other governance tools are required. The European Commission recommends and actively promotes the policy of responsible research and innovation (RRI). In addition to sound research ethics, a key feature of RRI is the involvement of different societal stakeholders throughout the research process.But how accepted is the involvement of societal stakeholders in the research of small- and medium-sized enterprises (SMEs) in the health care sector? This question is examined based on 18 in-depth interviews with private health care industry representatives from across Europe in companies focusing on developing medical device technology. Findings suggest that SMEs are reluctant to undertake research involving patients, especially in the early stages of the research and innovation process. For some SMEs this is due to concerns about the dangers of raising expectations they cannot meet, while for others the main concerns are increasing costs and producing less competitive products. Implications of the research findings are discussed.

Involving Patients in Research? Responsible Research and Innovation in Small- and Medium-Sized European Health Care Enterprises*

Abstract:Health research is generally undertaken to resolve existing health problems or enhance existing solutions. Research ethics committees have been the main governance tool for research for more than half a century. Their role is to ensure that research is undertaken ethically. To close the increasing gap between science and society, other governance tools are required. The European Commission recommends and actively promotes the policy of responsible research and innovation (RRI). In addition to sound research ethics, a key feature of RRI is the involvement of different societal stakeholders throughout the research process.But how accepted is the involvement of societal stakeholders in the research of small- and medium-sized enterprises (SMEs) in the health care sector? This question is examined based on 18 in-depth interviews with private health care industry representatives from across Europe in companies focusing on developing medical device technology. Findings suggest that SMEs are reluctant to undertake research involving patients, especially in the early stages of the research and innovation process. For some SMEs this is due to concerns about the dangers of raising expectations they cannot meet, while for others the main concerns are increasing costs and producing less competitive products. Implications of the research findings are discussed.

Potential infection control risks associated with roaming healthcare industry representatives.

Healthcare industry representatives (HCIR) visit multiple hospitals every day. Most enter hygiene sensitive areas and work in close proximity to caregivers and patients. The objective of the present study was to evaluate the HCIRs' current status in hygiene training and vaccination. An anonymous walking intercept study was used based on questionnaires to evaluate industry representatives in comparison to physicians and nurses (n = 311 participants, participation rate 30.2%) after their visit to the MEDICA Congress. The valid participants consisted of HCIR (n = 208), hospital nurses (n = 49) and physicians (n = 41). A total of 82.2% (n = 171) HCIR worked in varying hospitals. They frequently request access to hygiene and data-privacy sensitive areas: Among them 51.9% (n = 108) accessed the outpatient clinic, 41.8% (n = 87) the operating room (OR), 33.7% (n = 70) the central supply and sterilisation department (CSSD), and 32.7% (n = 68) the intensive care unit. HCIR requesting access to hygiene sensitive areas showed the lowest scores in hygiene training and a significantly lower Hepatitis B vaccination status, i.e. 37.5% compared to 70.7% for physicians and 53.1% for nurses. Status of HCIR hygiene training was inadequate - as was vaccination and contamination control. Therefore, HCIR are exposed to increased infection risk and may unknowingly act as infection vector between different hospitals.

The Relationship of ERCP Facility Volume With Nurse/Associate Training and Functions of Health Care Industry Representatives (HCIR) During ERCP: A Survey of SGNA Members

Introduction: ERCP has become a predominantly therapeutic intervention and had an exponential increase in associated devices. HCIR are often present during ERCP, but their function has not been evaluated previously. Considering variable ERCP facility volume and training of ERCP Nurse/Associates (ERCP-NA), the primary aim was to measure the impact of onsite HCIR during ERCP. Methods: All members of the Society of Gastroenterology Nurses and Associates were asked to participate in an online survey evaluating: 1) respondent and facility characteristics, and 2) ERCP practice patterns and HCIR involvement. The analysis was stratified by ERCP facility volume, with moderate-high volume units (HVU) defined as 100+ ERCPs per year and low-volume units (LVU) as <100 ERCP per year. Results: Of 6,698 surveys distributed, there were 847 (13%) respondents; 726/847 (86%) participated in ERCP and reported their facility ERCP volume. Compared to LVU affiliates, ERCP-NAs at HVU were more likely to identify themselves as advanced endoscopy nurse/technicians (66% vs. 50%; p<0.001). Other respondent characteristics (mean age 52.7±8.6 years, 94% female) were similar, including ERCP training experience (Table). The majority (51%) shadowed an ERCP-NA for <25 cases prior to working independently. Self-reported interactions with HCIR were similar except providers at LVUs requested HCIR input during ERCPs more frequently (p=0.02; Figure). With increasing facility volume, we observed decreasing rates of requesting the presence of, and asking for hands-on assistance by, HCIR; these trends did not reach statistical significance. Irrespective of facility volume, 30% of respondents agreed/strongly agreed that they were more likely to utilize a company’s devices if that HCIR was present.Table 1Figure 1Conclusion: ERCP-NAs have limited training prior to their independent participation in ERCP. HCIR input is more frequently requested when ERCP is performed at LVUs, but the influence of HCIR on the intraprocedural choice of medical device(s) is similar irrespective of facility volume. The relationship between limited ERCP-NA training and on-site HCIR function requires further study. Disclosure - RNK - Consultant for Boston Scientific and Cook Medical. GAC - Consultant for Boston Scientific and Olympus.

A Survey of Healthcare Industry Representatives’ Participation in Surgery: Some New Ethical Concerns

To provide preliminary evidence of the types and amount of involvement by healthcare industry representatives (HCIRs) in surgery, as well as the ethical concerns of those representatives. A link to an anonymous, web-based survey was posted on several medical device boards of the website http://www. cafepharma.com. Additionally, members of two different medical device groups on LinkedIn were asked to participate. Respondents were self-identified HCIRs in the fields of orthopedics, cardiology, endoscopic devices, lasers, general surgery, ophthalmic surgery, oral surgery, anesthesia products, and urologic surgery. A total of 43 HCIRs replied to the survey over a period of one year: 35 men and eight women. Respondents reported attending an average of 184 surgeries in the prior year and had an average of 17 years as an HCIR and six years with their current employer. Of the respondents, 21 percent (nine of 43) had direct physical contact with a surgical team or patient during a surgery, and 88 percent (38 of 43) provided verbal instruction to a surgical team during a surgery. Additionally, 37 percent (16 of 43) had participated in a surgery in which they felt that their involvement was excessive, and 40 percent (17 of 43) had attended a surgery in which they questioned the competence of the surgeon. HCIRs play a significant role in surgery. Involvement that exceeds their defined role, however, can raise serious ethical and legal questions for surgeons and surgical teams. Surgical teams may at times be substituting the knowledge of the HCIR for their own competence with a medical device or instrument. In some cases, contact with the surgical team or patient may violate the guidelines not only of hospitals and medical device companies, but the law as well. Further study is required to determine if the patients involved have any knowledge or understanding of the role that an HCIR played in their surgery.

Perioperative Nurses and Health Care Industry Representatives: Promoting Ethical Boundaries

A perioperative nurse's first and foremost ethical obligation is to the patient. Obligations include not only advocating for the patient's best interests, welfare, and wishes, but ensuring that patient safety is never compromised and that the care provided is legal, evidenced-based, safe, ethical, and cost effective. Inherent goals in the nurse–patient relationship are: respect for personhood; upholding the ethical principal of autonomy; and respecting the patient's right to self-determination. This article discusses the perioperative nurse's ethical obligations within the context of the nurse–industry representative relationship and how to avoid conflict of interests within the context of the patient–nurse relationship. All products should be evaluated impartially, taking into consideration patient care needs, best evidence, cost effectiveness, and regulatory requirements.