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101 West 8th Avenue, Spokane, Washington, United States

Updated: August 18, 2021 12:00 PM
As of September 28, 2020, WSNA members at Providence Sacred Heart report the following workplace health and safety hazards related to COVID-19: - "Critical Staffing Status" (aka, "crisis staffing") - Health care workers who test positive and are asymptomatic must report to work - Re-using PPE until... See More it breaks - Failing to social distance in break rooms - Not practicing universal masking for visitors - Not masking COVID patients, even when a nurse enters the room (Please see the attached detailed hazard description, addendum and supporting documentation) Detailed Hazard Description is as follows: - "Critical Staffing Status" (aka, "crisis staffing") In an email to WSNA on September 23 (provided as attachment), Providence HR confirmed that Sacred Heart remains in "critical staffing status".as declared by Incident Command'. This status is being used for purposes of rapid return to work after COVID testing - see next bullet point. - Health care workers who test positive and are asymptomatic must report to work DOH and L&I's joint Hazard Alert issued in September 2020 states that hospitals must ¿[p]rohibit staff from working or being on the premises if exposed to COVID-19, and all staff who test positive must be excluded from work and isolated according to CDC guidelines¿. The CDC's return to work criteria for health care providers states: HCP who are not severely immunocompromised and were asymptomatic throughout their infection may return to work when at least 10 days have passed since the date of their first positive viral diagnostic test. However, Providence Sacred Heart is requiring employees who test positive, but who are asymptomatic, to return to work immediately citing its 'staffing crisis.- Further detail provided in the addendum. - Re-using PPE until it breaks Multiple units in the hospital report being asked to use PPE until it breaks, which fits under the CDC definition of crisis use of PPE. Further detail provided in the addendum. - Failing to social distance in break rooms Multiple units in the hospital report that management is not ensuring appropriate social distancing per the September Hazard Alert. Further detail provided in the addendum. - Not practicing universal masking for visitors The September 2020 Hazard Alert requires hospitals to "[e]nsure source control (public and patient masking) for patients and visitors throughout the hospital, especially when staff are in rooms or care areas.- Nurses report that the hospital is not practicing nor enforcing a universal masking policy for visitors, putting patients and employees at risk. Nurses note that the masking requirement for visitors in not well-emphasized in signage and could be easily missed by visitors. - Not masking COVID patients, even when a nurse enters the room The September 2020 Hazard Alert requires hospitals to "[e]nsure source control (public and patient masking) for patients and visitors throughout the hospital, especially when staff are in rooms or care areas.- Nurses report the hospital is not requiring patients to mask, meaning that even in COVID patient rooms, the patients are not masking even when a nurse or other hospital employee enters the room. Also please see attached addendum and supporting documentation #1 and #2. On October 9th DOSH received additional alleged hazards: SHMC as of a week ago started triaging COVID patients in the regular triage rooms within the ER department. Previously, they were room separately by PII. The triage room is small and caregivers are not being required to wear N95s - all staff are wearing surgical masks and face shields. The small room is being cleaned by the RN, not EVS, between patients that are PUI.


Source: Osha.gov | Receipt Date: 2020-09-29
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Filters in negative air flow rooms and filters in masks have not been changed since the beginning of COVID in 7N.


Source: Osha.gov | Receipt Date: 2020-11-27 See Less
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Water to the drinking fountains have been shut off with employee(s) not knowing where to get potable water.


Source: Osha.gov | Receipt Date: 2020-05-13 See Less
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Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA... See More SOFT pads were used. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.

Since that notification, we have continued to monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd degree patient burn. We are providing this additional broad public communication to increase awareness that MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should not be used for patients under the age of 12 years.

The list below contains the specific product and codes in scope.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode, Product Code: 0845, UDI-DI: 10614559103906.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode, Product Code: 0846, UDI-DI: 10614559104248.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode, Product Code: 0847, UDI-DI: 10614559104842.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode, Product Code: 0848, UDI-DI: 10614559104859.

Customers should review and follow the instructions provided in the December 2023 recall notification (link given below). Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes pads may continue to be used for patients over 12 years of age.

Confirm that personnel using the Mega Soft Universal and Universal Plus pads understand the intended use is changing to patients aged 12 years and older and have stopped using the pads on patients under the age of 12 years. Hospitals using this product should confirm receipt of the recall notification using the business reply form provided with the initial recall notification.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Megadyne Medical Products, Inc.
Brand name: Megadyne
Product recalled: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes
Reason for the recall: Limit use to patients aged 12 years or older.
FDA Recall date: February 29, 2024

Recall link of December 2023: jnjmedtech.com
Source: fda.gov
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