Second hand equipment: Ensuring quality

When donating equipment, especially second-hand equipment, it is vital to ensure the equipment is functional and of good quality.

“There should be no double standard in quality. If the quality of an item is unacceptable in the donor country it is also unacceptable as a donation”

WHO, Geneva 2000.¹

“Why do people think that if something doesn’t work in wealthy countries, it will work merely by shipping it across the sea, without taking the relevant actions to restore it to good working condition?”

Dr. Nicholas Adjabu, Deputy Director, Clinical Engineering Department, Ghana Health Service; THET, 2013.²

Meeting the necessary standards

Obviously, you need to ensure that the equipment to be donated is in good working order.

However, medical equipment is also subject to specific regulations. The exact regulations and standards will obviously vary.

To ensure that the equipment you are donating meets the necessary standards, you need to ask yourself the following questions:

• Are there safety and performance specifications provided by the manufacturer?
• Are there relevant standards set by international bodies, like the International Organisation for Standardization (ISO) and the International Electrotechnical Commission (IEC)?

If you are donating pre-used or second hand equipment from your home country, the quality and safety of the equipment must be verified before you send it to the receiving institution.

This is both good practice, and a legal requirement for shipping medical equipment outside of the EU, according to an EU Directive in 2012.

For equipment supplied by a hospital, all activities that the trust would usually undertake related to decommissioning, except making the device unusable, must be followed.

This may include:

• Decontaminating the equipment.
• Erasing confidential information.
• Verifying the safety of the device.
• Testing full functionality.

You will need to include records of all tests required to meet the above standards along with the device.

What if the hospital donating the equipment is not able to provide the support you need?

The manufacturer/supplier may be able to provide these services.

If this is not an option, there are organisations which may be able to help. A few examples based in the UK are:

• Hilditch Group’s Medical Engineering Team
• Medical Equipment Managing Organisation (MEMO)
• Medical Aid International

Refurbished versus reconditioned

If equipment is described as ‘refurbished’ it is important to confirm exactly what this means.

Fully refurbished equipment means that the device is essentially remanufactured and placed back on the market like new.

This involves taking it apart, testing each component and replacing as necessary, re-assembling and testing the whole. Fully refurbished devices require a new mark (e.g. a CE mark – which we will cover in the next step).

Partially refurbished equipment has been ‘reconditioned’. This means a routine cleaning and maintenance procedure. This may not meet all the requirements described above.

_{References
¹ WHO, ‘Guidelines for Health Care Equipment Donations’, Geneva 2000.
² THET, ‘Making it work – a toolkit for medical equipment donations to low-resource settings’, 2013, p 49.}