Sales Representatives in the Operating Room: Conflict of Interest or Clinical Support?

BACKGROUND: The Physician Payment Sunshine Act, which became federal law in January 2012, mandated that medical device manufacturers must disclose any financial support provided to individual physicians on a publicly available Web site. The law reflects increasing concern about physician-industry relationships. METHODS: The connection between surgeon and sales representative creates possibilities for both financial and non-financial conflicts of interest (COIs). Indeed, COIs may be inherent when a sales representative is motivated by profit while also serving a critical role in many surgeries. RESULTS: The potential benefits and risks for patients, who may not even be aware of the sales representative's presence in the operating room, must be considered. CONCLUSIONS: This paper adds to the national discussion about neurosurgical physician-industry conflicts of interests and the issues relative to sales representatives in the operating room.

Effects of opting-out from federal nurse anesthetists' supervision requirements on anesthesiologist work patterns.

OBJECTIVE: To estimate the impact of opting-out from Medicare supervision requirements for certified registered nurse anesthetists (CRNAs) on anesthesiologists' work patterns. DATA SOURCES/STUDY SETTING: Secondary data from two national surveys of anesthesiologists and the Area Health Resource File. STUDY DESIGN: We use a matching difference-in-difference regression which contrasts the change in work patterns for anesthesiologists in California, which dropped supervision requirements, to the change for similar anesthesiologists. Key outcome variables include the number of weekly hours worked, the type of work done, and type of care delivery teams. DATA COLLECTION/EXTRACTION METHODS: Self-reported national survey data drawn from members of the American Society of Anesthesiologists. PRINCIPAL FINDINGS: Anesthesiologists in California saw no change in time spent working or time spent supervising CRNAs. There was a decrease in direct care clinical work hours along with a shift in working more in intraoperative care, a decrease in postoperative care, and an increase in the percentage of cases supervising residents. CONCLUSIONS: Anesthesiologists had small but real responses to California's decisions to opt-out of the physician supervision requirement for CRNAs, doing more work in intraoperative care and less outside of the operating room. Total hours worked saw no change.

Patient injuries from anesthesia gas delivery equipment: a closed claims update.

BACKGROUND: Improvements in anesthesia gas delivery equipment and provider training may increase patient safety. The authors analyzed patient injuries related to gas delivery equipment claims from the American Society of Anesthesiologists Closed Claims Project database over the decades from 1970s to the 2000s. METHODS: After the Institutional Review Board approval, the authors reviewed the Closed Claims Project database of 9,806 total claims. Inclusion criteria were general anesthesia for surgical or obstetric anesthesia care (n = 6,022). Anesthesia gas delivery equipment was defined as any device used to convey gas to or from (but not involving) the airway management device. Claims related to anesthesia gas delivery equipment were compared between time periods by chi-square test, Fisher exact test, and Mann-Whitney U test. RESULTS: Anesthesia gas delivery claims decreased over the decades (P < 0.001) to 1% of claims in the 2000s. Outcomes in claims from 1990 to 2011 (n = 40) were less severe, with a greater proportion of awareness (n = 9, 23%; P = 0.003) and pneumothorax (n = 7, 18%; P = 0.047). Severe injuries (death/permanent brain damage) occurred in supplemental oxygen supply events outside the operating room, breathing circuit events, or ventilator mishaps. The majority (85%) of claims involved provider error with (n = 7) or without (n = 27) equipment failure. Thirty-five percent of claims were judged as preventable by preanesthesia machine check. CONCLUSIONS: Gas delivery equipment claims in the Closed Claims Project database decreased in 1990-2011 compared with earlier decades. Provider error contributed to severe injury, especially with inadequate alarms, improvised oxygen delivery systems, and misdiagnosis or treatment of breathing circuit events.

Operating room fires: a closed claims analysis.

BACKGROUND: To assess patterns of injury and liability associated with operating room (OR) fires, closed malpractice claims in the American Society of Anesthesiologists Closed Claims Database since 1985 were reviewed. METHODS: All claims related to fires in the OR were compared with nonfire-related surgical anesthesia claims. An analysis of fire-related claims was performed to identify causative factors. RESULTS: There were 103 OR fire claims (1.9% of 5,297 surgical claims). Electrocautery was the ignition source in 90% of fire claims. OR fire claims more frequently involved older outpatients compared with other surgical anesthesia claims (P < 0.01). Payments to patients were more often made in fire claims (P < 0.01), but payment amounts were lower (median $120,166) compared to nonfire surgical claims (median $250,000, P < 0.01). Electrocautery-induced fires (n = 93) increased over time (P < 0.01) to 4.4% claims between 2000 and 2009. Most (85%) electrocautery fires occurred during head, neck, or upper chest procedures (high-fire-risk procedures). Oxygen served as the oxidizer in 95% of electrocautery-induced OR fires (84% with open delivery system). Most electrocautery-induced fires (n = 75, 81%) occurred during monitored anesthesia care. Oxygen was administered via an open delivery system in all high-risk procedures during monitored anesthesia care. In contrast, alcohol-containing prep solutions and volatile compounds were present in only 15% of OR fires during monitored anesthesia care. CONCLUSIONS: Electrocautery-induced fires during monitored anesthesia care were the most common cause of OR fires claims. Recognition of the fire triad (oxidizer, fuel, and ignition source), particularly the critical role of supplemental oxygen by an open delivery system during use of the electrocautery, is crucial to prevent OR fires. Continuing education and communication among OR personnel along with fire prevention protocols in high-fire-risk procedures may reduce the occurrence of OR fires.

Setting up an imaging center, adding CT, MR, [corrected] and an angiography suite to vascular labs.

Computed tomographic angiography (CTA), magnetic resonance angiography (MRA), and diagnostic arteriography are all vascular diagnostic tools that may be included in modern vascular diagnostic laboratories. Before undertaking the establishment of such an all-purpose diagnostic, and possibly interventional, facility the vascular specialist or group needs to ensure safe patient care and the ability to provide these diagnostic tests and procedures without incurring a financial loss. This article will detail one method of setting up such a facility and suggest some other approaches. It will also introduce some of the issues that may change the legislative landscape in the Unites States of America (USA) and may make these arrangements more complex in that country.

[Efficient OP management. Suggestions for optimisation of organisation and administration as a basis for establishing statutes for operating theatres]. / Effizientes OP-Management Vorschläge zur Optimierung von Prozessabläufen als Grundlage für die Erstellung eines OP-Statuts.

Economic aspects have gained increasing importance in recent years. The operating room (OR) is the most cost-intensive sector and determines the turnover process of a surgical patient within the hospital. Thus, optimisation of workflow processes is of particular interest for health care providers. If the results of surgery are viewed as a product, everything associated with surgery can be evaluated analogously to a manufacturing process. All steps involved in producing the end-result can and should be analysed with the goal of producing an efficient, economical and quality product. The leadership that physicians can provide to manage this process is important and leads to the introduction of a specialised "OR manager". This position must have the authority to issue directives to all other members of the OR team. An OR management subordinates directly to the administration of the hospital. By integrating and improving management of various elements of the surgical process, health care institutions are able to rationally trim costs while maintaining high-quality services. This paper gives a short introduction into the difficulties of organising an OR. Some suggestions are made to overcome common shortcomings in the daily practise. A proposal for an "OR statute" is presented that should be a basis for discussion within the OR team. It must be modified according to individual needs and prerequisites in every hospital. The single best opportunity for dramatic improvement in effective resource use in surgical services lies in the perioperative process. The management strategy must focus on process measurement using information technology and feed-back implementing modern quality management tools.However, no short-term effects can be expected from these changes. Improvements take about a year and continuous feed-back of all measures must accompany the reorganisation process.

HIPAA compliance in the OR.

Many current information management practices in the OR will have to change to comply with the Health Insurance Portability and Accountability Act and meet Joint Commission on Accreditation of Healthcare Organizations standards for managing health care information. Demands for accurate, timely, confidential, and secure data make an integrated automated system for information management imperative. Delivering health care in today's OR environment results in enormous amounts of data. Caregivers must transform this data into useable information, while protecting patient privacy, confidentiality, and the security of health care information.

[Requirements of mandatory accident insurance for hospitals, which participate in inpatient treatment of occupational accident patients: position of the National Reference Center for Hospital Hygiene]. / Anforderungen der Gesetzlichen Unfallversicherung (GUV) an Krankenhäuser, die sich an der stationären Behandlung Arbeitsunfallverletzter beteiligen: Stellungnahme des Nationalen Referenzzentrums für Krankenhaushygiene.

Aseptic operations as well as operations on infected sites can be done in the same operating room. Two or more theatres can share common facilities such as X-ray equipment, scrub-up or anaesthesia areas. Sophisticated air locks with double doors, which separate the protective zone from the operating room are not necessary to maintain a good hygienic standard. Nevertheless the new requirements for theatre design by the German "Gesetzliche Unfallversicherungen" are much higher. In this commentary we try to summarize scientific evidence regarding design of a theatre and infection control.