Stringent Standards

10 November 2010 (Last Updated November 10th, 2010 18:30)

A huge amount of time is spent making sure medical devices meet the highest standards. How do hospital managers ensure the device continues to be safe months or even years after it was acquired? Phil Thane explores how hospitals are increasingly engaging new software to make sure all equipment and medication meets stringent standards of compliance and testing.

Stringent Standards

Medical device manufacturers go to a lot of trouble to get, and keep, ISO 13485 certification for their products, their documentation and procedures, but what happens once the device is delivered, installed and used?

The problem is complex but can be broken down into two parts, first being able to identify each item and secondly being able to track the device to tell where it has been, where it is now and what has happened to it along the way. The first requires some form of ID tagging, the second a means of recording and processing data.

Identification

Most companies in the medical supplies sphere have long been using bar codes, and more recently RFID. Often products are bar coded for retail pharmacies and supermarkets and the same process is applied to products going into hospital pharmacies. ID tagging has, however, become the industry norm and is applied to devices of all kinds.

To be effective globally ID tagging needs to adhere to a standard so that a code assigned to a ventilator built in Germany isn't applied to a packet of latex gloves from Taiwan, causing system failure when both arrive at the same hospital. The standard was established and is maintained by GS1, a not-for-profit organisation owned by its members. GS1 standards are used in every sector and enable goods to be tracked through manufacturing, distribution, sale and use.

"Unique Device Identification (UDI) is a specific implementation of GS1 for medical devices."

A simple sticky paper barcode is sufficient for consumable items, but not for devices that need to be tracked throughout a long working life. Items such as operating theatre instruments can have bar codes, or the smaller matrix codes, etched on to the surface.

Leeds Teaching Hospitals NHS Trust is the largest in the UK and includes the largest teaching hospital in Europe. The Trust started its stock control system using GS1 bar codes in 1999 and now has 3,000 bar coded items which can all be scanned at its 270 stocking points.

Recently the Trust carried out a proof of concept RFID pilot to simplify the ad-hoc checking, receipting, issuing and final return of its orthopaedic kits. It is also looking at using the GS1 system to track 30,000 devices throughout the trust's sites.

RFID tags aren't appropriate for instruments going through sterilisation procedures, but they can hold a great deal more information and can be updated, making them ideal for use on larger pieces of equipment. A passive tag with a kilobyte of memory can record installation and service dates, tags on major components of a complex device can show when each part was inspected, adjusted or replaced.

UDI

Unique Device Identification (UDI) is a specific implementation of GS1 for medical devices. In 2007 the US Food and Drugs Administration (FDA) sponsored the FDA Amendments Act one of whose provisions was the establishment of a UDI system. Since then, the FDA has begun developing regulations to make it a reality.

The US UDI system is well advanced compared to Europe. Medical devices are often manufactured in one country and exported to another so the European Commission and the FDA are very keen for there to be a truly international UDI system and are working together to ensure this happens. If countries develop their own systems, tracking devices across national boundaries will be very difficult or impossible.

Databases and management

Correct ID is half the battle, managing the volume of data generated is the other half. Systems to manage data about physical assets and facilities go by various names: Computerized Maintenance Management System (CMMS), Enterprise Asset Management (EAM) and Computerized Maintenance Management Information System (CMMIS).

St. Croix Systems specialises in asset management, asset logistics, safety management, and capital planning for healthcare providers worldwide.

"St. Croix Systems can be used by a single department or in a multi-hospital system."

St. Croix Systems can be used by a single department or in a multi-hospital system, one of their larger customers is Aurora Health Care, Wisconsin's largest, fully-integrated, not-for-profit healthcare delivery system with 13 hospitals, over 100 clinics, 120 community pharmacies and 25,000 employees.

Patrick Trim, director of Capital Equipment Services at Aurora, led the centralisation of all of the health system's 44,000 pieces of mobile equipment into a single asset management solution.

Using the St. Croix System Aurora's capital equipment team is able to deploy, track and maintain assets, consolidate and evaluate vendor contracts, review asset performance, calculate total cost of ownership and useful life, and plan for and budget capital for new and replacement equipment.

Spectrum Health, another US not-for-profit health system has recently implemented an EAM combining Skytron Real-time Location (RTLS), Awarepoint and Intelligent InSites software, to automatically track and manage over 5,300 medical device assets throughout its many sites in West Michigan.

Skytron asset tags broadcast low power radio messages which provide real time automatic location data capture via the Intelligent InSites' Enterprise Visibility Platform. InSites uses the data to display the location and status of assets, track equipment utilisation rates, and generate rule-based notifications and alerts, resulting in increased productivity and efficient deployment of resources.

ECRI Institute is dedicated to applying scientific research in healthcare to improving patient care. ECRI is based in the US, but also has offices in Welwyn Garden City, England to serve the particular needs of UK and Europe.

ECRI-AIMS is a new system for managing all aspects of technology-based assets found in European and International healthcare institutions developed in partnership with Phoenix Data Systems Inc.

It is a web-browser application, enabling the data stored centrally by the hospital to be accessed simply via a web-browser connected to the hospital intranet. There is no client software to install and ECRI-AIMS is therefore straightforward to set up and can be used by personnel at all levels at any time.

The system provides a complete resource for managing equipment inventory information, work orders, service contracts, spare parts, purchasing and stock-control in a single, secure package. ECRI-AIMS is a modular system allowing hospitals to customise the system to meet specific requirements without paying for functionality that they don't need.

Backup and security

Hospitals generate huge amounts of data, medical as well as asset related, and all of it needs to be kept safe.

"ECRI-AIMS is a modular system allowing hospitals to customise the system to meet specific requirements."

KOM Networks is the world leading provider of storage management software solutions for compliance, archiving, and information lifecycle management.

KOM software is technology agnostic and vendor independent, hospitals are finding that they deploy a KOM device to store data from one department, then rapidly realise they can use it for other things.

With UDI and asset management software health care providers have the ability to track a device throughout its deployment in their premises, with KOM networks storage they will be able to access that data any time in future.

Another development which has the potential to revolutionise data storage is cloud computing, the concept is still fairly immature but is without doubt one to watch for the future.