Skip to content Skip to sidebar Skip to footer

Objective: video recording surgical interventions, the state at the beginning of the project

Pacient român - legi juste și transparență maximă

FACIAS ran the "Be informed, not abused!" project between April 2021 and February 2022.

These issues were revealed, particularly by the approximately 1000 responses to the FACIAS Questionnaire and the over 3000 messages received."

One of the five major problems reported for which we were asked for support in the Health component is:

  • Video recording surgical interventions (many have observed benefits when, on laparoscope technology, video images of the interventions were shown to them, which facilitated their access to explanations, visually)

I. OFFICIAL UPDATED INFORMATION:

There is no requirement to film surgical interventions or install a video system in operating rooms. Whether they are recorded or not, surgeries involve costs.

The hospital makes the decision whether or not to record the surgeries.

A flash/memory card is included with the laparoscopes.

I.1 DATA COLLECTed FROM PRIMARY SOURCES (HUMAN)

Source: medical-surgery personnel

The registration of surgical interventions is voluntary.

In practice, we encounter the following scenarios:

  • The head doctor or surgeon can request to be filmed (if personnel/resources are available) or to take photos in order to show the patient later what he did or why he made a decision or another (the patient being under anesthesia)
  • Not all hospitals have the capability of filming surgical procedures.
  • The laparoscopes are equipped with a flash/memory card (allowing for laparoscopic interventions)/ If the doctor so desires, he may film and save the images.

    Source - Private hospitals (in the process of obtaining accurate information):
  • Source - state hospitals:

Many hospitals, particularly private ones, can and do record surgical interventions. This serves both educational and legal purposes.

  • Source - Suppliers of this type of equipment (not only the laparoscope memory card, but also for other types of interventions - in the process of obtaining valid information)

II.  WORLDWIDE LEGISLATION GOVERNING THE OBJECTIVE FIELD

There is no such legislation in Romania (from what we have learned so far, it is neither prohibited nor mandatory). It is done in hospitals, particularly private ones (mainly through the cameras mounted on the laparoscope equipment).

In the United States and Canada, for example:

Note: A bill requiring cameras in operating rooms has been introduced in the Wisconsin state legislature. The "Julie Ayer Rubenzer Law" is named after a Wisconsin woman who died as a result of a surgical error. This bill is supported by patient advocacy groups across the country.

The American Medical Association supports videotaping for educational purposes and has implemented a policy that allows videotaping of patients in a medical setting only when those being videotaped have given consent, citing privacy concerns. Because of hospital opposition, proposed legislation in Massachusetts that would have required hospitals to allow video recording by a licensed videographer at the patient's request failed.

Grantcharov created his "black box" not to be used in court in medical malpractice lawsuits, but rather to allow surgeons to reflect on and improve their performance. Grantcharov noted that in a pilot test of the black box device in 54 procedures, 38 had adverse events and 75% of the errors were missed by surgeons.

In France, for example, there is no legal requirement to record interventions, but all operating rooms are equipped with video recording equipment. The hospital records the surgical intervention on video at the patients' request.

In France, the paroscope interventions are recorded but not stored unless the patient requests it.

Doctors seek the patient's permission to record the intervention for research purposes (only with his consent).

III. WHAT WE DO NOT KNOW (AT THE MOMENT)

Preventable medical errors are extremely common in the United States, and what happens in operating rooms is not always meticulously documented. According to a study conducted by Patient Safety America, more than 400,000 people die each year as a result of preventable medical errors in hospitals and other healthcare settings. There have been several cases of preventable medical errors resulting in the death or permanent injury of a patient, and their loved ones have been unable to pursue medical malpractice actions because the surgery was not properly documented.

Records of surgical interventions in other EU countries or around the world

  • At the national level, there is a plan in this regard.
  • Could this be the first step toward a hybrid operating room?
  • Who would pay for widespread enforcement and investment?
  • What would the registration/operating room system cost?
  • In Romania, how many hospitals are recording surgical interventions?
  • In Romania, how many hospitals are recording surgical interventions?
  • Are there statistics on the number of deaths caused by surgical errors?
  • Are decision-makers willing to identify workable solutions (in accordance with GDPR)?
  • List of countries with legislation on surgical registration
  • Others

IV. BENEFITS AND LIMITATIONS OF OBJECTIVE IMPLEMENTATION

  • Image database useful for research, teaching, and collaborative work
  • Decreasing cases of death due to surgical errors.
  • The use of images in malpractice lawsuits (today's lawsuits last, the specialists are even colleagues of the doctors involved in the lawsuits, errors can happen, but images don't lie).
  • Video cameras in operating rooms can improve both patient safety and surgeon performance. However, because doctors continue to be concerned that video recordings and data collection will be used against them in malpractice cases, the practice will take some time to be implemented.
  • Operating theatre rooms are an effective way to reduce medical malpractice

Preventable medical errors are extremely common in the United States, and what happens in operating rooms is not always meticulously documented. According to a study conducted by Patient Safety America, more than 400,000 people die each year as a result of preventable medical errors in hospitals and other healthcare settings. There have been several cases of preventable medical errors resulting in the death or permanent injury of a patient, and their loved ones have been unable to pursue medical malpractice actions because the surgery was not properly documented.

  • Despite the fact that many hospitals provide video recording services, significant progress can still be made in this area, particularly in capturing high-quality video recordings from the surgeon's point of view. Using commercially available amateur video systems is a potential and cost-effective solution. Previous research has detailed the development of ”do-it-yourself” video systems for use in operating rooms , and more recent research has investigated the utility of popular "action" cameras such as the Contour headset camera.

Disadvantages/impediments:

There are hospitals that still record surgeries today/laws have not yet been identified, but implementation in accordance with the GDPR is desired.

V. PLANNED ACTIONS FOR THE OBJECTIVE FROM JULY TO SEPTEMBER 2022

Action 1:  Information request to the Ministry of Health and the Parliamentary Health Committees, in order to keep the situation up to date (as information) - implemented - responses are awaited:

  • ⮚     Information requested - European Commission level:
  • To the European Commission

COMMISSIONER Stella Kyriakides to the European Commission, Committee on Health and Food Safety

  • DIRECTOR: Marina Zanchi, European Executive Agency for Health and Digital Domain
  1. Is there legislation in any European country requiring video recording of surgical interventions in operating rooms, given the benefits of such a practice?
  2. Is there a plan to enact a European-level legal rule that allows and imposes the procedure (obviously in accordance with GDPR rules)?
  3. The funds could be used to finance such programs for hospitals (currently, video recordings of interventions are made sporadically, in certain hospitals, at their initiative, only if the doctor wishes, and only on laparoscope equipment).
  4. There are scientific studies all over the world that show the benefits of such a practice: at the didactic level/patient information/for intervention in cases of surgical errors/in cases of malpractice. Is the widespread practice, possibly mandated by law, of videotaping surgical interventions taken into account in the EU?
  5. Is there data on the number of deaths caused by surgical errors? How can we access them?
  • Information requested from the Ministry of Health
  1. Given the benefits of video recording in operating rooms, are there any laws/legal regulations requiring video recording of surgical interventions in any European country?
  2. Is the Ministry of Health aware of the total number of operating rooms in all hospitals? What about a situation in which the practice of recording surgical interventions is adopted? How many rooms are practiced in? How many doctors are there? In how many Romanian hospitals are surgical interventions recorded? If so, please grant us access to such information. If not, do you think about managing such information and disseminating it in public?
  3. Who would fund widespread adoption/investment? Romania could finance such programs for hospitals with the funds?
  4. What laws should be added or amended to allow for the widespread use of such a practice?
  5. Is there data on the number of deaths caused by surgical mistakes? What about malpractice suits in this case? How do we access them?
  • Information was requested regarding the Parliamentary Health and Information and Communication Technology Committees (questions 6-8 refer only to the Health Committees):
  1. Given the benefits of video recording in operating rooms, are there any laws/legal regulations requiring video recording of surgical interventions in any European country?
  2. If such legal standards do not exist, there is a national plan in place.
  3. In Romania, how many hospitals are recording surgical interventions?
  4. What laws should be added or amended to allow for the widespread use of such a practice? Are decision-makers willing to identify practical solutions (in accordance with GDPR)?
  5. Who would fund widespread adoption/investment? Romania could finance such programs for hospitals with the funds?
  6. Is there data on the number of deaths caused by surgical mistakes? What about malpractice suits in this case? How do we access them?
  7. Are there statistics on the number of deaths caused by surgical errors?
  8. List of countries with legislation on surgical registration

Action 2 (August): Questionnaire on the FACIAS Facebook page to determine how many Romanians believe it is useful/necessary to record surgical interventions (obviously, with the consent of the patient)

A short list of advantages and disadvantages of registering surgery will be included in the call to action.

VI. CONTEXT:

  • Video recordings of surgical procedures provide a method for analyzing operative performance, increasing surgical education, and presenting cases to a wider audience of plastic and reconstructive surgeons. Although many hospitals offer video recording services, significant improvements can still be made in this area, particularly in capturing high-quality video recordings from the surgeon's point of view. One potential cost-effective solution is the use of commercially available amateur video systems. Earlier studies have detailed the development of do-it-yourself video systems for use in the operating room 1 , while more recent studies have explored the utility of using popular "action" cameras such as the Contour helmet cam (Contour LLC, Provo, Utah). ) 2 , 3and the GoPro HERO 3 Silver Edition camera (GoPro, Inc., San Mateo, California). 4 Recently, a more advanced GoPro HERO 3+ Black Edition camera (GoPro, Inc.) has become available, and the purpose of this study was to examine the utility of this device for high-definition, point-of-view, plastic and reconstructive surgery recordings.

Alte surse de Informații:

Useful

About Us
Projects
Interpretation of Legislation
Advocacy

Support

Campaign 3.5%
Donate
I want to become a FACIAS volunteer

Legal

Terms and conditions
Privacy policy
Cookies Policy
Contact

en_US ENG
en_US ENG ro_RO RO

© 2022 — FACIAS All rights reserved.