THE MANDATE TO MAINTAIN AND FOLLOW MANUFACTURERS’ MAINTENANCE DOCUMENTS AND SERVICE MANUALS

THE ONESOURCE SAFETY AND COMPLIANCE SOLUTION

Celebrating 10 years of changing the face of patient safety

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BACKGROUNDManufacturers of healthcare devices, material and equipment provide extensive validated guidelines for the care and maintenance

of their products. These include:

Instructions for Use (IFUs) for tissues, implants and reusable instruments

Maintenance and Service Manuals for biomedical equipment

Safety Data Sheets (SDSs) and Material Safety Data Sheets (MSDSs) for dental equipment

These cleaning, decontamination, sterilization and maintenance instructions have become increasingly detailed and it is more

important than ever that healthcare technicians have easy access to this validated information.

Noncompliance with these directives can result in poor patient outcomes, increased healthcare-acquired infections (HAIs)

and surgical site infections (SSIs), injuries to staff, increased costs for repairs or replacement, citations from regulatory agencies,

failed accreditations and damaging public exposure.

However, adhering to these manufacturer requirements is not only critical to preserve patient health, it is essential for meeting

the requirements and standards set by these regulatory, professional and accrediting organizations:

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REGULATORY BODIES

Centers for Disease Control and Prevention (CDC)

Centers for Medicare & Medicaid Services (CMS)

Occupational Safety and Health Administration (OSHA)

PROFESSIONAL ORGANIZATIONS

The Association for the Advancement of Medical Instrumentation (ANSI/AAMI)1

The Association of periOperative Registered Nurses (AORN)

ACCREDITING ORGANIZATIONS (WITH DEEMING AUTHORITY BY CMS)

The Joint Commission (TJC)

The International Joint Commission (IJC)

Accreditation Association for Ambulatory Healthcare, Inc. (AAAHC)

Accreditation Commission for Health Care (ACHQ)

Healthcare Facilities Accreditation Program (HFAP)

Center for Improvement in Healthcare Quality (CIHQ)

Community Health Accreditation Partner (CHAP)

DNV GL Healthcare (DNV-GL)

The Compliance Team (TCT)

MANUFACTURERS’ IFUS

The U.S. Food & Drug Administration (FDA) requires manufacturers to provide current, validated IFUs2 to their healthcare

customers. The Sterile Processing Teams and other technicians at these facilities and clinics must comply with procedures described

in the IFUs and copies of the most current IFUs for every device used must be readily available to these processing technicians,

including those working in decontamination areas.

1 For example, ANSI/AAMI ST79:2017,7.3 states that device manufacturer’s current written IFU should be accessible, reviewed,

and followed….”To ensure patient safety, a reusable device needs to be capable of being thoroughly cleaned and sterilized.

The device labeling describes specific methods of cleaning and sterilization that have been validated by the manufacturer.”2 Validation” is a testing regimen performed by the device manufacturer that exposes the instruments or equipment to the

worst possible contamination conditions that could occur in a healthcare facility based on AAMI and ANSI Standards. It then

demonstrates, through an analysis of the results of the cleaning and sterilization, that the designated IFU procedure renders the

items safe and suitable for patient use. Manufacturer IFUs must be cleared by the U.S. FDA.

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In 2014, TJC reported that improper sterilization and disinfection was one of the top five non-compliant accreditation factors.

Subsequently, the organization issued a Safety Action recommending that healthcare facilities make manufacturers’ IFUs available

to all staff.3

Further, TJC’s Director of Infection Prevention and Control, Sylvia Garcia, has stated that one of the most challenging areas related

to TJC surveys is the reprocessing of medical equipment and devices. She noted that, “In 2017, 72% of surveyed hospitals and

critical-access hospitals and 60% of ambulatory facilities were found to be noncompliant with at least one aspect of reprocessing.”4

MANUFACTURERS’ SERVICE MANUALSSimilarly, TJC, AAMI and CMS guidelines and recommendations require that Service Manuals, Operators Manuals and other

biomedical equipment documentation be available onsite for Biomedical Equipment Technicians (BMETs), Biomedical Engineers,

Healthcare Technology Managers (HTMs) and others who need them. TJC is stepping up its auditing procedures in this area.5

These professionals require this information for maintenance as well as troubleshooting, repair, end of life equipment matters,

testing and parts information.

TISSUE AND IMPLANT IFUSCreating safe, efficient and accurate tissue management processes has become a top priority for Peri-Operative departments.

Biologic tissue IFUs include critical information about the storage, handling and preparation of human-, bovine- and porcine-

derived materials. IFUs for nonbiological implants include preparation and handling instructions for prostheses and devices

as well as re-sterilization instructions for certain materials unused in a given procedure that can be safely used in a future case.

Regulatory requirements designed to protect patients continue to evolve and expand with the increase in tissue usage and

advances in surgical life-saving and life-enhancing procedures. Technicians in Sterile Processing, the OR and other areas need

ready access to biological and non-biological tissue product and surgical implant IFUs.

3 Quick Safety: An advisory on safety and quality issues, Issue Two. The Joint Commission. Improperly sterilized or high-level

disinfected equipment. May 2014. Retrieved from: https://www.jointcommission.org/assets/1/23/Quick_safety_issue_two_

May_2014.pdf. 4 Garcia, S. The Joint Commission Provides Guidance for Meeting Infection Control Standards. AAMI News, January 2019.5 The Joint Commission’s October 2016 Prepublication Requirements - Standards Revisions, Section EC.02.04.01(4) states in part:

“The hospital identifies the activities and associated frequencies, in writing, for maintaining, inspecting and testing all medical

equipment on the inventory. These activities and associated frequencies are in accordance with manufacturers’ recommendations

or with strategies of an alternative equipment maintenance (AEM) program.” It goes on to clarify that for “high-risk” medical

equipment the completion rate must be 100%.

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DENTAL SDS DOCUMENTSDental offices must not only maintain IFUs and reprocessing documentation for dental equipment, instruments and consumables,

OSHA Hazard Communications Standards require these facilities to adhere to and retain the newly formatted and updated

Safety Data Sheets (SDSs) as they become available from manufacturers.

The standards and requirements set by ANSI/AAMI and other organizations regarding IFUs and recommended practices

clearly apply to dental offices as well as hospitals and clinics.6

CHALLENGE Unfortunately, based on considerable anecdotal feedback from these frontline infection prevention and service technicians,

all too often IFUs, Service Manuals and SDSs are not readily available to them or are outdated.

Further, maintaining and storing single copies of these documents within a healthcare setting is not efficient or sufficient.

Technicians across the facility from multiple departments (and in offsite centers and clinics) – Sterilization Processing Areas,

Risk Management, BioMed, Healthcare Technology Management, Infection Control and numerous caregivers in labs and ORs –

need access to this information.

These technicians also report that obtaining IFUs, Service Manuals and SDSs can be extremely time consuming.

Contacting manufacturer support is not efficient – whether by phone or online. And general web searches do not always

bring up the correct and most recent version of a document. The average healthcare facility can spend more than 2,000

staff hours and up to $30,000 per year just to obtain and manage IFUs.

SOLUTIONIn 2009, Best Practice Professionals, Inc. developed oneSOURCE, a searchable, online document management service that

now provides Sterile Processing technicians, HTMs and BMETs with quick and efficient access to current, validated manufacturer

documents within four specialized online databases:

Surgical Instrument & Equipment Database (IFUs)

Service Manual Database (Maintenance, Operator and other Manuals)

Tissue & Implant Database (IFUs)

Dental Database (IFUs and SDSs)

6 For example, ANSI/AAMI ST79:2017 states that the guide also covers “…dental offices, and other areas where sterile products

are reprocessed, stored, and used.”

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More than 2,500 manufacturers work with oneSOURCE free of charge to have their IFUs, Service Manuals and SDSs uploaded to

these ISO 9001:2015-registered database service. oneSOURCE essentially serves as a free distribution service

for these manufacturers, ensuring their product information is available to healthcare technicians working for oneSOURCE’s

clients – nearly seven thousand facilities worldwide.

oneSOURCE uploads these documents exactly as they are received by the manufacturer and the manufacturer can securely

log on to the oneSOURCE databases to verify their documents.

Facilities also can arrange to store their own lawfully obtained health and safety information on their own private Cloud-based

area of the sites. This customer information often includes facility-specifi c policies and procedures, checklists, staff meeting notices,

accreditation/compliance information and proprietary or purchased IFUs and Manuals.

The oneSOURCE Document Database Service saves health care technicians time and saves facilities money.

Through one subscription, multiple departments across a single healthcare facility have access to the world’s most complete

online collection of manufacturers’ validated IFUs, Service Manuals and SDSs.

The databases are kept current as the oneSOURCE team routinely contacts manufacturers for updates. If a customer needs an

IFU not currently found on the database, oneSOURCE will obtain a copy from the manufacturer at no charge to the subscriber.

“Tech-ready” summaries are available for lengthy IFUs and Service Manuals.

Users can maintain a list of frequently used documents for convenient access.

The service can be enhanced to provide a customizable cloud-based document storage environment on our secure servers.

This includes facility-wide and department-level storage areas where IT Administrators and team members can maintain

proprietary or other information such as accreditation standards, competencies, policies and procedures and notes

and directives

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RESULTSPATIENT SAFETY. With access to these online, searchable databases, technicians can be confi dent that the IFUs, Service

Manuals and SDSs they pull up are the most current, validated versions provided by the manufacturer. This can reduce the

errors in sterile processing and equipment maintenance too often associated with HAIs, SSIs or worse.

COMPLIANCE AND ACCREDITATION. Accreditation agencies are increasingly focused on technician access to, and

compliance with, information related to manufacturers’ recommended procedures. oneSOURCE databases help ensure that

any needed IFUs, Service Manuals and SDSs are available to these technicians – a key metric for those reviews.

COST-SAVINGS. The cost of a oneSOURCE database subscription ranges from $2,000 to $4,000 per year. These costs are

easily offset, though. As noted above, the average healthcare facility can spend more than 2,000 staff hours each year managing

IFUs alone. Additionally, it can take 520 staff hours to address a noncompliance citation when a facility cannot demonstrate ready

access to current IFUs. Further, improved access to IFUs, Service Manuals and SDSs can decrease HAI cases, which have an

average treatment cost of $15,275.

CONCLUSION

To date, sterile processing and equipment maintenance technicians in more than 7,000 healthcare facilities in the U.S.

and around the world, including U.S. military and government facilities, use the oneSOURCE Document Database Service.

Many of oneSOURCE’s team have healthcare manufacturer experience or are former SPD, Infection Control, OR and BMET

technicians with fi rst-hand experience working with these manufacturer documents.

LEARN MORE ABOUT ONESOURCE’S DOCUMENT MANAGEMENT OPTIONS

AT ONESOURCEDOCS.COM OR CALL 1.800.701.3560