Resources

Resources

Some Useful Links

here are some useful healthcare related links

Patients

Doctors

Education

Healthcare

Specialist Organisations

Glossary of Terms

here you will find some common industry related terms

Decontamination

Decontamination is the process of cleansing to remove contamination, or the possibility of contamination.

Electro-medical Devices

Electro-medical Devices are defined in IEC60601-1 as “equipment, provided with not more than one connection to a particular mains supply and intended to diagnose, treat, or monitor patient under medical supervision and which makes physical or electrical contact with the patient and/or transfers energy to or from the patient and /or detects such energy to or from the patient”. Examples of products fitting this definition include battery operated thermometers, MRI, endoscopy cameras, infusion pumps and patient monitors. Accessories used with such devices can also fall under this standard.

Fully Comprehensive Cover - FC

This service level will provide a complete package which includes planned preventative maintenance (PPM), provision of all labour during designated hours supply and fitting of parts (as recommended by OEM’s) and callouts.

Infection Control

Infection control measures practiced by healthcare personnel in healthcare facilities to decrease transmission and acquisition of infectious agents (e.g., proper hand hygiene, scrupulous work practices, use of personal protective equipment (PPE) [masks or respirators, gloves, gowns, and eye protection]; infection control measures are based on how an infectious agent is transmitted. The UK guidelines have been laid out by the National Institution for Clinical Excellence (NICE) in a document which was updated in 2003 and which is currently being updated again.

Lifting Operations and Lifting Equipment Regulations - LOLER

Lifting Operations and Lifting Equipment Regulations 1998. These regulations came into effect in December 1998. If you provide lifting equipment at work, then the LOLER regulations apply. You must ensure that your lifting equipment meets the requirements of LOLER, for example that the equipment is strong enough, stable enough, suitable for the proposed use and is maintained and tested accordingly.

Medical Device Electrical Safety Testing

BS EN 60601 (IEC 60601). This is essentially a design standard for manufacturers to ensure that equipment designed and produced for medical use are built and tested to a specific standard to ultimately ensure that patient safety is paramount from the design stage. It originated as a British Standard BS5724. As part of the production process all medical devices are rigorously tested to this design standard. The standard specifies the Type Testing Requirements for protection against potential electrical hazards including protective grounding, ground leakage currents, patient leakage currents, and patient auxiliary currents etc. Due to a lack of coherent policy on “Routine Testing” certain elements of the IEC 60601 Production Testing regimes were adopted for “Routine Testing”. HEI 95 and DB9801 also contain recommended testing standards for medical devices and the suggested test regimes are also utilised by BCAS Biomed. The current test standards have been derived to be consistent with the standards to which the equipment has been manufactured. They have been modified from the standards with the strict proviso that such tests do not damage or stress the equipment under test.

IEC 62353. This standard aims to provide a uniform standard that ensures safe practice and reduces the complexity of IEC60601 Production standards. It defines the requirements for ensuring the safety of medical electronic devices used in the treatment, care and diagnosis of patients. It recognises the laboratory conditions described in IEC 60601 cannot always be guaranteed when carrying out routine or repair testing, and that some type testing carried out on a routine basis can be destructive over a period of time.

Original Equipment Manufacturer - OEM

Original Equipment Manufacturer. This is the original manufacturer of the equipment or its UK based subsidiary. The OEM is not the same as distributor or even the supplier in certain cases.

Portable Appliance Testing – PAT Testing

Portable Appliance Testing. The “IEE Code of Practice for In-service Inspection and Testing of Electrical Equipment” gives guidance on the various equipment types. The requirements for testing come under several legislations including Health and Safety at Work Act 1974, Management of Health and Safety at Work Regulations 1999, The Electricity at Work Regulations 1989, Workplace (Health, Safety and Welfare) Regulations 1992, and the Provision and Use of Work Equipment Regulations 1998. The Health & Safety Executive states that 25% of all reportable electrical accidents involve portable appliances. The Electricity at Work Regulations place a legal responsibility on employers, employees and self-employed persons to comply with the provisions of the regulations and take reasonably practicable steps to ensure that no danger results from the use of such equipment. This in effect requires the implementation of a systematic and regular program of maintenance, inspection and testing.

Portable Electrical Appliance

Unfortunately there are many European standards and guidance notes but no real definition of a portable electrical appliance. But there seems to be a general agreement and a consensus that it is either hand held whilst being connected to the mains supply, or is intended to be moved whilst connected to the supply, or is capable of being moved without undue difficulty whilst connected to the supply”.

Planned Preventative Maintenance - PPM

This service level will meet manufacturers recommendations, or where these are not available good practice standards, for both frequency and content. This shall include, where appropriate, performance testing, calibration, PM Kit replacement (as recommended by the OEM) and functional checks to ensure that the operation of the equipment is to the original manufacturer’s specification.

Sterilisation v’s Disinfection

These terms can often be confused with each other. Disinfection is a process which aims to reduce the total number of viable microorganisms present, whilst sterilisation is the process by which all microorganisms are eradicated (killed).

Technical Audit

BCAS Biomed can offer various levels of financial and technical audits. They range from the most basic asset inventory check to a full technical and financial audit to integrate with a device lifecycle maintenance program.

A Technical Audit is an independent, objective assurance and consulting activity designed to assess the effectiveness, efficiency and accuracy of an organization’s operations or resources. It encompasses the accumulation of device information prior to being placed on a contract or for the purposes of device lifecycle management. It assists an organisation in compiling a complete inventory of assets, condition and serviceability.

The basis of the technical audit is to record the make, model, serial number and designation of all equipment on site and to record the departments they are located. Processed data is uploaded into HEMS Database system and presented to the customer in excel format on a line by line basis.

The information presented from the Tech Audit allows the customer to establish an accurate starting point to form a maintenance policy for device management and provides crucial information such as condition and age for capital replacement programs.

BCAS Biomed utilises various techniques to integrate and manage equipment records within the database and on-site. The use of Bar-coded asset labels is the most common, while new technologies like RFID labelling brings a whole new dimension to asset management.

Waste Electrical and Electronic Equipment Directive - WEEE Directive

The Waste Electrical and Electronic Equipment Directive (WEEE Directive) came into force in January 2007. The WEE Directive aims to both reduce the amount of electrical and electronic equipment being produced and to encourage everyone to reuse, recycle and recover it. The WEEE Directive also aims to improve the environmental performance of businesses that manufacture, supply, use, recycle and recover electrical and electronic equipment. You may also have obligations under the WEEE Regulations if you are a business with electrical or electronic equipment to dispose of, or if you sell electrical or electronic equipment.

Speak to the Experts

Our mission, by working in close partnership, is to enable our customers to concentrate on providing the highest possible standards of care to their patients through efficient and compliant management of healthcare engineering services and medical devices.

Contact us, whether a healthcare provider or OEM, to learn more about how BCAS Biomed can help you improve operational and monetary efficiencies and ultimately provide improved care to patients, their families and carers.