Sean Fenske, Editor-in-Chief06.04.20
In the May/June issue of Orthopedic Design & Technology, my editor’s letter focused on the return of elective surgeries. These procedures’ suspension has had a profound effect on the orthopedic sector. I mentioned several concerns and potential challenges that could complicate the process along with some guidance provided by the American Academy of Orthopaedic Surgeons (targeted advice for clinicians, nurses, surgeons, as well as the facilities in which they operate). Lacking were recommendations on handling device manufacturer reps and their return to the OR.
Soon after that issue went to print, AdvaMed joined with the American Hospital Association and the Association of periOperative Registered Nurses to issue “Re-entry Guidance for Health Care Facilities and Medical Device Representatives.” In its introduction, the guidance states the document is “intended to guide facilities, health care personnel, and medical device representatives as they adopt access policies that support safe reentry of medical device representatives into the facility.”
The guidance is divided into five segments: 1. All Areas of Hospitals and other Health Care Facilities; 2. COVID-19 Testing and Screening; 3. Elective Surgical Procedures and Personal Protective Equipment; 4. Crisis-Level Emergency Surgical Procedures and Personal Protective Equipment; and 5. Training and Education regarding COVID-19 Safety and Precautions.
The first section focuses on ensuring the device representative is wearing the appropriate protective garments (e.g., face mask) and notes the representative is expected to observe social distancing practices. The second section, which highlights testing, specifically calls out facilities to follow CDC COVID-19 testing recommendations. It suggests medical device reps not be required to present negative test results as it is not in accordance with CDC recommendations for healthcare workers and patients. It seems in section two, this guidance attempts to eliminate any extraordinary barriers to entry for device reps returning to the care environment that goes beyond those already in that setting.
Section three centers on elective procedures requiring medical device representatives. The guidance prefaces the considerations with the reminder that any surgeries should not take place unless “the facility has proper inventory of non-crisis level equipment and supplies, including PPE” and such materials can be provided to an essential medical device representative. The considerations note PPE should be provided by the facility rather than brought in from the outside (i.e., supplied by the representative) to ensure quality control. While this may make sense, part of me wonders if this was included to not give facilities an “out” in stating they only have PPE for their personnel. Then again, this is just guidance and facilities are not required to uphold them without question.
This section also notes when videoconferencing functionality is available in the OR and can be implemented to include the medical device representative, it should be used, so long as it does not impact patient safety or privacy.
The fourth section speaks to the earlier question raised on PPE. Per this segment, if a device representative is deemed to be essential to an emergency surgery and the facility is functioning at crisis level, that rep may be asked to provide his or her own PPE if there is short supply. In the case of a representative wearing a reusable mask or respirator, the facility should provide a mask to be worn over that mask to prevent chance of re-aerosolized contaminants. Further, all individuals unconfirmed as negative for COVID-19 should wear “proper respiratory protection (e.g., fit-tested N95 respirator with face shield or surgical N95 respirator).”
Finally, the fifth section simply states device representatives should be familiar with CDC recommendations regarding infection prevention and PPE usage, as well as the facility’s policy regarding safety.
The guidance seems fairly straightforward and common sense for such an environment as the OR, given the circumstances. Unfortunately, we’ve seen as states begin to reopen that people’s determination of what’s “common sense” regarding wearing protection varies. As a result, it was important to have these organizations issue these recommendations. Even if an individual doesn’t agree with the current level of COVID-19 restrictions and precautions, the OR environment represents a different situation and, understandably, a different set of rules.
We all want to see things begin to approach a sense of normalcy (even if that includes long-term changes to the details) and this guidance is a step forward. Its specific changes aren’t dramatically increased from previous standards, so I look forward to hearing of a safe return for all essential personnel to the OR to begin to address the backlog of waiting patients.
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
Soon after that issue went to print, AdvaMed joined with the American Hospital Association and the Association of periOperative Registered Nurses to issue “Re-entry Guidance for Health Care Facilities and Medical Device Representatives.” In its introduction, the guidance states the document is “intended to guide facilities, health care personnel, and medical device representatives as they adopt access policies that support safe reentry of medical device representatives into the facility.”
The guidance is divided into five segments: 1. All Areas of Hospitals and other Health Care Facilities; 2. COVID-19 Testing and Screening; 3. Elective Surgical Procedures and Personal Protective Equipment; 4. Crisis-Level Emergency Surgical Procedures and Personal Protective Equipment; and 5. Training and Education regarding COVID-19 Safety and Precautions.
The first section focuses on ensuring the device representative is wearing the appropriate protective garments (e.g., face mask) and notes the representative is expected to observe social distancing practices. The second section, which highlights testing, specifically calls out facilities to follow CDC COVID-19 testing recommendations. It suggests medical device reps not be required to present negative test results as it is not in accordance with CDC recommendations for healthcare workers and patients. It seems in section two, this guidance attempts to eliminate any extraordinary barriers to entry for device reps returning to the care environment that goes beyond those already in that setting.
Section three centers on elective procedures requiring medical device representatives. The guidance prefaces the considerations with the reminder that any surgeries should not take place unless “the facility has proper inventory of non-crisis level equipment and supplies, including PPE” and such materials can be provided to an essential medical device representative. The considerations note PPE should be provided by the facility rather than brought in from the outside (i.e., supplied by the representative) to ensure quality control. While this may make sense, part of me wonders if this was included to not give facilities an “out” in stating they only have PPE for their personnel. Then again, this is just guidance and facilities are not required to uphold them without question.
This section also notes when videoconferencing functionality is available in the OR and can be implemented to include the medical device representative, it should be used, so long as it does not impact patient safety or privacy.
The fourth section speaks to the earlier question raised on PPE. Per this segment, if a device representative is deemed to be essential to an emergency surgery and the facility is functioning at crisis level, that rep may be asked to provide his or her own PPE if there is short supply. In the case of a representative wearing a reusable mask or respirator, the facility should provide a mask to be worn over that mask to prevent chance of re-aerosolized contaminants. Further, all individuals unconfirmed as negative for COVID-19 should wear “proper respiratory protection (e.g., fit-tested N95 respirator with face shield or surgical N95 respirator).”
Finally, the fifth section simply states device representatives should be familiar with CDC recommendations regarding infection prevention and PPE usage, as well as the facility’s policy regarding safety.
The guidance seems fairly straightforward and common sense for such an environment as the OR, given the circumstances. Unfortunately, we’ve seen as states begin to reopen that people’s determination of what’s “common sense” regarding wearing protection varies. As a result, it was important to have these organizations issue these recommendations. Even if an individual doesn’t agree with the current level of COVID-19 restrictions and precautions, the OR environment represents a different situation and, understandably, a different set of rules.
We all want to see things begin to approach a sense of normalcy (even if that includes long-term changes to the details) and this guidance is a step forward. Its specific changes aren’t dramatically increased from previous standards, so I look forward to hearing of a safe return for all essential personnel to the OR to begin to address the backlog of waiting patients.
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
