Health Care Facilities Experts
Consultation Services on Accreditation, Survey Preparation and Regulatory Affairs
We are dedicated to providing health care facilities expert consultation in the area of accreditation, survey preparation and regulatory affairs. SMS, Inc. assists healthcare organizations as they prepare the programs of their Physical Environment for survey, regardless of the accreditation entity. SMS, Inc. works with organizations accredited by:
- The Joint Commission® (TJC)
- American Osteopathic Association (AOA)/Healthcare Facilities Accreditation Program (HFAP)
- DNV/National Integrated Accreditation for Healthcare Organizations (NIAHOSM)
- Centers for Medicare & Medicaid Services (CMS)
SMS, Inc. provides comprehensive Environment of Care®, Emergency Management and Life Safety Code® support services, including Statement of Conditions™, mock surveys, safety risk assessments, and publishes a variety of technical publications.
We also host EC-Online™ The health care industry’s foremost web-based code and standards research service – EC-Online addresses facility-generated questions posed in relation to TJC, AOA, CMS, NFPA®, OSHA and EPA standards and guidelines. For an overview of EC-Online: http://safemgt.com/ec-online/ec-online-overview/
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Medical Bed Mattresses: FDA Safety Communication – Damaged or Worn Covers Pose Risk of Contamination and Infection
AUDIENCE: Biomedical Engineering, Infectious Disease, Nursing, Risk Managers
ISSUE: From January 2011 to January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress (fluid ingress). Fluid ingress may occur if mattress covers become worn or damaged from small holes or rips in the fabric or from incorrect cleaning, disinfecting and laundering procedures. The zipper on the cover may also allow fluid to penetrate the mattress. Some reports indicate that if blood and body fluids from one patient penetrate a mattress, they can later leak out from the mattress when another patient is placed on the bed. Patients are at risk for infection if they come into contact with blood and body fluids from other patients.
Medical literature shows that damaged and wet (soiled) mattresses can be a source of contamination during infection outbreaks. The FDA is concerned that fluid ingress from worn or damaged medical bed mattress covers may be widespread and largely under-recognized by health care providers, health care facility staff, and caregivers. The FDA will continue to monitor this issue and keep the public informed if new information becomes available.
BACKGROUND: A medical bed mattress cover provides outer protection to a medical bed mattress by preventing blood and body fluids from entering the inside (inner core) of the mattress. Medical bed mattress covers, whether water-resistant, water-proof, or water-repellent, may lose their effectiveness over time. The duration of time that a medical bed mattress cover is expected to last (expected life) varies from manufacturer to manufacturer. In addition, the expected life of a medical bed cover may differ from that of the mattress itself.
RECOMMENDATION:The Safety Communication lists several recommentations for inspection and maintenance including:
- Regularly check each medical bed mattress cover for any visible signs of damage or wear such as cuts, tears, cracks, pinholes, snags or stains.
- Routinely remove the medical bed mattress cover and check its inside surface. Once the mattress cover is removed, inspect the mattress for wet spots, staining, or signs of damage or wear. Check all sides and the bottom of the mattress.
- Immediately replace any medical bed mattress cover with visible signs of damage or wear to reduce the risk of infection to patients.
- DO NOT stick needles into a medical bed mattress through the mattress cover.
Refer to the Safety Communication for the complete list of recommendations.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Recall Notice, at:
Are you ready for the 2012 Hazard Communication Standard changes?
Question:
What are the changes in OSHA’s Hazard Communication 2012?
Answer:
OSHA’s Hazard Communication Standards hasn’t changed since 1994. These changes were brought about to improve safety and health of workers through more effective communications on chemical hazards. The changes in the standards are labeling, safety data sheets, hazard classification of chemicals. With these changes in the standard, all relevant documentation and training on chemicals will also need to be updated. This is a great opportunity to take a deeper look into your Hazard Communication Program for compliance and revise to the new standard.
Question:
What is GHS and how does that affect the Hazard Communication Standard (HCS)?
Answer:
GHS stands for Globally Harmonized System. The United Nations Conference on Environment and Development (UNCED) mandated, in June 1992, after little progress was made regarding international harmonization. Supported by the U.S., it called for the development of a globally harmonized chemical classification and labeling system. The globally harmonized hazard classification and compatible labeling system, including material safety data sheets and easily understandable symbols, should be available, if feasible, by the year 2000 was the mandate. It took another 12 years to change OSHA’s Hazard Communication Standard. The affect is changes to the standard through labeling, safety data sheets, and hazard classification of chemicals.
Question:
How do I get my hands around the HCS requirements?
Answer:
The significance of this revised standard is the employee’s knowledge on the “Right To Know” law. Employees have been using the acronym MSDS since 1983. The culture of safety will be a challenge in documentation and training for the next couple of years. Understanding of the requirements and their trickle-effect of changes will be the challenge for these new requirements. SMS Inc. can assist with this challenge.
Question:
How can Safety Management Services, Inc. help my organization to become compliant with the Hazard Communication Standards-Globally Harmonized System (HCS-GHS)?
Answer:
Safety Management Services, Inc. provides training to your staff on the new label elements and safety data sheet (SDS) format and will update all the policies, procedures and response plans of your organization related to HCS-GHS.
A typical consultation will:
- Assist in reviewing and revising existing hospital policies and procedures related to training and management regarding hazardous chemicals.
- Ensure the resulting policies and procedures will be compliant with HCS requirements as well as be integrated into current Joint Commission requirements.
- Develop a HCS orientation program.
- Conduct a facility review for compliance with Hazardous Material & Waste requirements under The Joint Commission and HCS.
