Medical Equipment Documentation

Medical equipment documentation is important for supply manufacturers as they produce and distribute equipment and supplies to the medical, dental, ophthalmic, and veterinarian fields. These supplies may include, but are not limited to, forceps, surgical tools and gloves, laboratory equipment, dressings, stethoscopes, and syringes. Companies within this industry provide a great service to the medical and health field.

Because of the medical nature of the industry, medical equipment and supplies manufacturing companies must adhere to strict documentation, purchasing, and identification and trace-ability procedures and standards set about by the federal government. Some of these rules and regulations include the following:

  • Document Approval and Distribution. All manufacturers have to designate an individual or individuals to review and approve all protocol through documentation. All saved documents must have the date and signature of the approved representative. All documents must be stored and available for immediate retrieval at all locations for which they are designated, and all obsolete documents must be promptly removed to prevent unintended use.
  • Document Changes. All changes to documents must be reviewed and approved by an individual or individuals in the same organization and capacity that performed the initial review and approval.  All approved changes must be communicated to designated personnel is a timely and orderly manner. In addition, all records of document changes must be maintained by the manufacturer. The changed records must include a detailed description of the change, the identity of the changed documents, the signatures of the approving individual or individuals, the date of approval, and the date when the changes will be put into effect.
  • Evaluation of Suppliers, Contractors, and Consultants. The manufacturer must institute and further maintain quality requirements that must be met by all suppliers, contractors, and consultants. The manufacturer must evaluate and choose potential suppliers, contractors, and consultants on the criteria that they are able to meet specified quality requirements; further, these evaluations must be documented. The manufacturer must also establish and further maintain all records of admissible suppliers, contractors, and consultants.
  • Purchasing Data. The manufacturer must institute and further maintain all data that details the specific requirements for purchased and received services and products. Documents must include an agreement that all suppliers, contractors, and consultants will notify the manufacturer of any changes made to the services or products so the manufacturer may determine if said changes affect the quality of the medical devices.
  • Identification. The manufacturer must institute procedures for product identification to prevent mix-ups during all stages of manufacturing, including receipt, production, distribution, and installation.
  • Trace-ability. The manufacturer of medical devices and supplies intended for surgical implantation into the body or for sustaining or supporting life must institute and further maintain protocol for identifying components and finished devices with a case or lot number. All identification for trace-ability must be documented. This is to ensure that equipment that has failed to perform as it is intended, despite being used according to the specified instructions, can be traced and corrective actions can take place.



DMS and the Medical Equipment and Supplies Manufacturing Industry

Medical equipment and supply manufacturing companies must establish and maintain a great deal of documentation. Managing this documentation can be time-consuming, space consuming, and risky. Such companies benefit greatly from using eFileCabinet’s document management system to establish a paperless method for maintaining files and essential documentation. Some of the benefits of using DMS include the following:

  • Security. DMS provides state-of-the-art security. Medical equipment companies can keep their medical equipment documentation and important documentation safe and secure. They don’t need to worry about their paper documents being misplaced, and they don’t have to worry about the wrong people getting hold of sensitive information. DMS is set up to allow only individuals with the appropriate security levels to access certain files. eFileCabinet software also tracks the history of when documents were accessed and by whom.
  • Keeps Documents Centrally Located. DMS provides a central location for all files, receipts, documentation, agreements, and supplier information. This greatly reduces the time and energy required to manage such documentation and helps to maximize workflow efficiency. eFileCabinet’s DMS also makes it much easier to access such information quickly and efficiently.
  • Compliance. It is important for medical equipment companies to adhere to the numerous federal documentation and record-keeping requirements. eFileCabinet’s document management software provides a way for companies to manage these standards and comply with established regulations. Also, all files will be kept organized and easily accessible when proof of medical equipment documentation compliance may be required.


Start Now

With its automated, safe, and secure document storage, quick file retrieval, and ease of federal regulation compliance, DMS is the perfect paperless solution for your medical equipment and supply company.  You can start now by simply filling out the form provided to receive a 15-minute demonstration on how DMS and eFileCabinet can help simplify your documentation storage needs.