©2023 by the American Board for Certification in Orthotics, Prosthetics & Pedorthics, Inc. All rights reserved.
No part of this document may be produced in any form without written permission of the American Board for Certification in Orthotics, Prosthetics & Pedorthics, Inc.
The Product Safety Standards require that your organization affirm the safety and appropriateness of the DMEPOS items and services that you provide to patients. Your business is required to establish a product safety program to promote the safe use of items and to minimize the safety risks, infections and hazards for both your staff and patients. The Standards require you to have documented policies and procedures in place that address patient safety, equipment and device failures, repairs, product recalls and infection control. Effective product safety programs must adhere to four principles:
1. Product Safety -- Your business must be able to document that all patient items being dispensed are properly labeled, if applicable and are genuine and not counterfeit or adulterated.
2. Patient Safety -- Your business should have a plan to ensure that the patient and/or caregiver can use all of the items and equipment safely and effectively in the anticipated setting. Your business must have a policy for the investigation and documentation of all beneficiary reported incidents. If applicable, a policy must address the requirements for set up, delivery and pick up of equipment. Your business must have a policy documenting the education provided to patients and/or their caregivers.
3. Equipment and Device Failures, Repairs, Recalls and Preventative Maintenance -- An equipment management program must be implemented which allows your business to identify, monitor and communicate throughout the organization in the case of equipment failure, repair, recalls and preventative maintenance. ABC requires that you maintain an equipment log, which quickly identifies which patients are affected in the event of a recall.
4. Infection Control -- Your business must implement a program in accordance with appropriate infection control procedures that does not allow cross-contamination. As appropriate, you must establish a policy for cleaning, sanitizing, function testing, maintaining and preparing items or equipment for reuse or disposal.
You must have written policies and procedures that address the following:
1. Patient safety
2. Equipment and device failures
4. Product recalls
5. Infection control
These policies are intended to promote the safe use of equipment and items as well as minimize the safety risks, infections and hazards for both staff and patients.
You may only provide items that meet applicable Food and Drug Administration (FDA) regulations.
You may maintain a log to help you identify the equipment and supplies that are subject to Food and Drug Administration (FDA) regulations fda.gov.
Before you distribute or deliver items to a patient, you must verify and document that the items are not altered, counterfeit, suspected of being counterfeit, misbranded, are appropriately labeled for their intended use or distribution and have not been obtained by fraud or deceit.
You can inspect and document that when received, all items are in their original manufacturer packaging and contain original packing slips. Verify that wholesalers and billing companies are not included on the OIG exclusion entity list.
In order to document the verification of the authenticity of items purchased for use in providing patient care, you must obtain from the manufacturer copies of the features, warranties and instructions for each type of non-custom fabricated item or equipment.
You must document that all purchased items are genuine. This documentation must include copies of the features, warranties and instructions for every type of equipment or item obtained from a manufacturer that is provided to your patients. This information is often found in instruction guides or care and use materials. These copies must be maintained and easily accessible.
You must have written policies and procedures that promote the safe use of equipment and items and minimize safety risks, infection and hazards for your staff and patients.
You must implement policies and procedures that promote facility safety that include the promotion and use of universal precautions, the minimizing of safety risks and hazards and cleaning the facility. You must document all periodic safety management training programs that you provide for your staff.
You must have a record of all equipment used in the provision of patient care, as well as documentation of the appropriate maintenance of the equipment.
An equipment management program should include a comprehensive listing of all equipment, tools, analytical and measuring devices as well as other DME type equipment and their maintenance. Examples include, but are not limited to, CAD/CAM calibrations, torque wrenches, CPM machines, CPAP and oxygen equipment. Use the Equipment Maintenance Log in the online Resource Kit to document this information.
You must have a written policy for identifying and monitoring equipment and item failures, repairs and recalls and communicating these to your staff.
Documentation of the policy may include logs to identify equipment and items that are defective, require repair or maintenance or have been recalled. Any such failures, repairs or recalls must be communicated to your staff.
You must have a policy in place for the investigation and documentation of adverse events, including incidents, injuries and/or infections that may have been caused by the item you provided.
If an adverse event results in the patient’s hospitalization or death, you must initiate an investigation within 24 hours of becoming aware of the situation. For other adverse events, you must investigate within 72 hours of becoming aware of the incident, injury or infection.
Your investigation must include all necessary
information, pertinent conclusions and
whether changes in processes are needed. You
must consider any possible links between the
items and services provided and the adverse
You must implement a policy to make sure that the patient and/or caregiver can use all of the equipment and items that you provide safely and effectively in the settings the item will be used.
Patient and/or caregiver training on the safe and effective use of all provided equipment and items is essential. The patient’s record must reflect the patient or caregiver’s acknowledgement that they received equipment training.
The items and equipment you provide may have specific physical requirements. You must determine and document how each of those requirements is met in the environment in which that item or equipment will be used.
Your home assessment process must ensure that all of the physical requirements for each type of item or equipment provided are met. For example, what type of power cord is required? Is the electrical outlet appropriate for the use of that power cord? You must follow manufacturer guidelines for all equipment provided, including the environment in which the equipment is to be used. You must have a record of the physical features of the environment in which the equipment is to be used.
You must have written policies and procedures to deal with inconsistencies between the observed physical environment in which the item and/or equipment will be used and the physical requirements of the items.
If you observe that the physical environment is different from the requirements for the item prescribed, you must have a contingency plan to contact the healthcare prescriber to discuss the needed items. For example, is an alternative item available that would be more consistent with the actual physical environment?
When providing equipment to patients, you must provide your contact information and options for rental or purchase of the equipment.
You must provide your patients with contact telephone numbers that allow them to reach the appropriate person. If applicable, you must have a written rental policy and patient records must reflect that equipment rental or purchase options have been explained to the patient. Include a copy of the Medicare capped rental form.
You must store the items and supplies for patient use in accordance with appropriate infection control procedures and ensure that cross-contamination does not occur.
You must have procedures that address the storage of patient equipment and supplies. Training must be provided to all staff and documented with meeting minutes or other records.
A consistent system must be established and maintained to assure the proper handling of equipment, both new and used, regardless of how or where those items come into your possession. You must document how you segregate clean and dirty equipment. You must also document each item’s progress through your system of dispensing and recovery of items.
You must document your clean and dirty equipment segregation process. This includes the proper handling of equipment that addresses cross-contamination and infection control procedures. Training must be provided to all staff and documented with meeting minutes or other records.
All of the equipment and supplies you provide to patients must be maintained in a state of patient-readiness in accordance with manufacturer’s guidelines.
Consult manufacturer’s guidelines to ensure accuracy for maintenance and patient-readiness.
You must deliver and setup all equipment and supplies in a timely manner. The timeframe should be agreed upon by the patient/ caregiver, the healthcare prescriber and you. You may coordinate the setup of the equipment and supplies by another entity; however, they must be a DMEPOS accredited supplier.
You must establish policies for a home delivery and setup process that ensures that patients receive equipment and supplies in a timely manner. If you use outside services, you must have contracts, proof of sub-contractor accreditation and appropriate Business Associate Agreements. Additionally, policy training must be provided to all staff and documented with meeting minutes or other records.
You must have policies and procedures to document the requirements for setup, delivery and pickup of equipment.
Training must be provided to all staff and documented with meeting minutes or other records. If you use outside services, you must have contracts, proof of sub-contractor accreditation and appropriate Business Associate Agreements.
Prior to final delivery of the item, you must:
1. Document that the item meets the specifications of the current prescription
2. Check the item for structural safety
3. Ensure that manufacturer guidelines have been followed
This can be documented in patient records, delivery receipts, warranties, tracking and equipment logs/tagging systems and/or other documentation.
If you provide complex rehabilitative
wheelchairs and assistive technology, you
must implement procedures for assembly
and setup of equipment as well as have
a process to verify that the final device
meets the specifications of the original
device recommendation approved by the
If patients are evaluated in your facility, you
must have an appropriate designated area
and equipment for assembly, modification,
adjustment and repair of provided equipment
and/or items in your facility or in a facility in
close and easily accessible proximity.
If you provide complex rehabilitative wheelchairs and assistive technology, you must provide the patient with equipment for trial and simulation, when applicable.
The patient record and/or delivery logs must reflect that trial equipment was provided.
You must track and document on a report the status of all equipment and supplies provided to patients. You must know at all times the condition and location of all equipment in the event that a recall or other similar events were to occur.
The status report must accurately reflect critical information including:
1. Contact and emergency contact information for all persons to whom equipment or items have been sold or rented
2. The manufacturer’s model, serial number and/or lot number for each piece of equipment
You should maintain a database or log that contains contact information for all persons to whom equipment or items have been sold or rented and the manufacturer’s model and serial number for each piece of equipment. Use the Equipment Maintenance Log in the online Resource Kit to document this information.
Your policies and procedures must establish a mechanism to minimize cross-contamination and infection during the setup, delivery and pickup process.
You must have written policies and procedures for cleaning, sanitizing, function testing, maintaining and preparing items or equipment for reuse. The area in which the equipment is stored in a patient-ready status must be clearly identified as clean.
You must have policies and procedures in place to ensure that any equipment you intend to make available for patients to reuse is cleaned, functioning properly, clearly labeled and stored in a clearly identified clean area. Policies should include universal precautions and cross-contamination procedures.
You must have written policies and procedures that provide for the cleaning, disinfection and/or proper disposal of returned items or equipment.
You must have policies and procedures in place to ensure that returned items and equipment are cleaned, disinfected and clearly labeled. Policies should include universal precautions and cross-contamination procedures.
You must implement and document a policy for identifying, monitoring and reporting repair and preventive maintenance for equipment and supplies provided to patients in accordance with manufacturer’s specifications.
This might include an equipment maintenance log that tracks preventive maintenance and repairs and an inventory of manufacturer instruction manuals/specifications. Use the Equipment Maintenance Log in the online Resource Kit.
You must provide or arrange for loaner equipment similar to the original equipment during any repair period.
You must have the inventory on hand or be able to obtain the equipment from another source. Your procedures should include a list of other equipment sources in the event that you do not have the inventory available.
You must provide all supplies that are necessary to operate the equipment and perform any necessary adjustments.